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• trial_statuses(array)
  • 1Recruiting
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• applications(array)
  • 0(array)
    • Application(array)
      • id1478
      • user_id693
      • trial_status_id(null)
      • abstract_of_study<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n <strong>BACKGROUND</strong></div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n Chronic Obstructive Pulmonary Disease (COPD) was the third leading cause of death worldwide in 2019, accounting for approximately 6% of all deaths. Chronic obstructive pulmonary disease is distinguished by persistent respiratory symptoms and restricted airflow due to airway and/or alveolar abnormalities. COPD exacerbation, defined as an acute worsening of respiratory symptoms requiring additional therapy, is one of the key indicators of disease activity. Chronic obstructive pulmonary disease exacerbations represent the largest burden in terms of healthcare utilization, patient morbidity, and risk of mortality. Current COPD treatment options include non-pharmacologic and pharmacologic measures, which are insufficient to prevent symptoms or slow disease progression. Other safe and efficacious treatment modalities are desperately needed.</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n  </div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n <strong>STUDY RATIONALE</strong></div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n The purpose of this study is to assess the long-term safety and to explore the efficacy of astegolimab, a human IgG2 mAb that selectively inhibits the interleukin-33 (IL-33) receptor ST2, in participants with chronic obstructive pulmonary disease (COPD) who have completed the 52-week placebo-controlled treatment period in Phase III (GB44332) astegolimab study. The open-label design will allow assessment of the impact of longer treatment duration of astegolimab on safety, lung function, COPD exacerbations, and patient-reported outcomes (PROs).</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n  </div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n <strong>OBJECTIVES AND ENDPOINTS</strong></div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n Primary Objective:</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n To evaluate the long-term safety of astegolimab</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n Corresponding Endpoint:</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n Incidence and severity of adverse events, with severity determined according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (hereafter referred to as the DAIDS Toxicity Grading Scale), with slight modifications for clarity and for alignment with internal practices</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n  </div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n <strong>OVERALL DESIGN AND STUDY POPULATION</strong></div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n This is a Phase III multicenter, single group open-label extension (OLE) study to evaluate the long-term safety and explore the efficacy of astegolimab (RO7187807) in combination with standard of care (SOC). The study population will be adults aged 40-90 years (at time of consent in parent study), with Chronic obstructive pulmonary disease (COPD). Approximately 2,000 participants with COPD are expected to be enrolled globally, with the sites targeting approximately five patients with COPD who have completed the 52-week treatment period in Study GB44332 and fulfill the eligibility criteria for the OLE, for enrolment.</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n Patients who have discontinued treatment in the parent study will not be eligible to enroll into the OLE.</div>\n
      • study_title<p>\n <span style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">A PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY OF ASTEGOLIMAB IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE</span></p>\n
      • laymans_summary<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n Chronic Obstructive Pulmonary Disease (COPD) is a long-term lung disease that mostly affects older people who have smoked cigarettes in the past or have been exposed to or breathed in other harmful particles for a long time, like smoke from biomass fuels. It is the third leading cause of death worldwide, and the number of people who have it is growing around the world. Even though smoking cigarettes has always been the biggest risk factor for COPD, there is clear evidence that non-smokers can also get the disease.</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n The risk of COPD goes up with age, and most people with COPD are 40 years old or older. Men are more likely to have COPD than women. COPD is a disease that affects different people in different ways and gets worse over time. The progression of the disease is strongly linked to thickening and narrowing of the airway walls, reducing the lungs' ability to stretch and reducing airflow. Patients withn COPD will present with some of the following signs and symptoms; Cough, shortness of breath and production of a thick mixture of saliva and mucus (sputum) coughed from the airways.</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n As symptoms worsen and the disease progresses, the likelihood of death increases. Current existing treatments have been unable to significantly slow down the progression of the disease and prevent episodes of worsened symptoms. New, more effective ways to treat patients that will relieve their symptoms and change the course of the disease are urgently needed.</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n Astegolimab is a drug that is under investigation for the treatment of patients with COPD. It has been noted to potentially prevent the worsening of symptoms and improve lung function and quality of life for the respective patient populations. This study will look at the long term safety and how well astegolimab works in people with COPD who have used the drug for 1 year in a previous study.</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n If found to be safe and efficacious, astegolimab will be recommended for market registration to make it commercially available locally so that people with COPD can have access to the drug in the market, subject to approval by relevant health authorities.</div>\n
      • short_titleALNASA
      • protocol_noECCT/24/10/01
      • version_no2
      • date_of_protocol03-04-2023
      • study_drugAstegolimab (RO7187807)
      • disease_conditionChronic Obstructive Pulmonary Disease (COPD)
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals1
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressPPDSubmissionsMembers.SM@ppd.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantPhoebe Mercy Otieno
      • declaration_date111-10-2024
      • declaration_principal_investigatorProf. Nduba
      • declaration_date211-10-2024
      • placebo_presentNo
      • study_objectives<div font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <strong>Primary Objective</strong></div>\n<ul font-size:=\"\" style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <li style=\"line-height: 20px;\">\n To evaluate the long-term safety of astegolimab</li>\n</ul>\n<div font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <strong>Exploratory Objectives</strong></div>\n<ul font-size:=\"\" style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <li style=\"line-height: 20px;\">\n To evaluate the efficacy of astegolimab</li>\n <li style=\"line-height: 20px;\">\n To evaluate health status utility scores of participants treated with astegolimab</li>\n <li style=\"line-height: 20px;\">\n To evaluate the long-term safety of astegolimab</li>\n <li style=\"line-height: 20px;\">\n To characterize the PK profile of astegolimab</li>\n <li style=\"line-height: 20px;\">\n To evaluate the immune response to astegolimab</li>\n <li style=\"line-height: 20px;\">\n To identify and/or evaluate biomarkers that are predictive of response to astegolimab (i.e., predictive biomarkers), are early surrogates of efficacy, are associated with progression to a more severe disease state (i.e., prognostic biomarkers), can provide evidence of astegolimab activity (i.e., PD biomarkers), or can increase the knowledge and understanding of disease biology and drug safety or pharmacokinetics</li>\n</ul>\n
      • principal_inclusion_criteria<ul font-size:=\"\" style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <li style=\"line-height: 20px;\">\n Signed Informed Consent Form.</li>\n <li style=\"line-height: 20px;\">\n Ability to comply with the requirements of the study protocol, according to the investigator’s best judgment.</li>\n <li style=\"line-height: 20px;\">\n Completion of the 52-week treatment period in either Study GB43311 or Study GB44332. For patients in Study GB43311 eligible for the additional treatment period: Continued participation in the additional treatment period up to local availability of the OLE is required.</li>\n <li style=\"line-height: 20px;\">\n For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception. Women must remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for 12 weeks after the final dose of astegolimab. A woman is considered to be of childbearing potential if she is postmenarchal, has not reached apostmenopausal state (at least12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Mü llerian agenesis). The definition of childbearingpotential may be adapted for alignment with local guidelines or regulations. Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-release intrauterine devices, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception. If required per local guidelines or regulations, locally recognized adequate methods of contraception and information about the reliability of abstinence will be described in the local Informed Consent Form.</li>\n</ul>\n
      • principal_exclusion_criteria<ul font-size:=\"\" style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <li style=\"line-height: 20px;\">\n Withdrawal of consent and/or premature discontinuation from parent study</li>\n <li style=\"line-height: 20px;\">\n Any permanent discontinuation of study drug in parent study</li>\n <li style=\"line-height: 20px;\">\n Significant non-compliance in the parent study, specifically defined as missing scheduled visits, per investigator’s judgment.</li>\n <li style=\"line-height: 20px;\">\n Pregnant or breastfeeding, or intending to become pregnant during the study or within 12 weeks after the final dose of study drug.\\</li>\n <li style=\"line-height: 20px;\">\n Any new diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines since enrolling in the parent study</li>\n</ul>\n<div font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <ul style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px;\">\n <li style=\"line-height: 20px;\">\n Any new clinically significant pulmonary disease other than COPD (e.g., pulmonary fibrosis, sarcoidosis, chronic pulmonary embolism or primary pulmonary hypertension, alpha-1-antitrypsin deficiency) since enrolling in the parent study.</li>\n </ul>\n <div>\n <ul style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px;\">\n <li style=\"line-height: 20px;\">\n Treatment with a licensed respiratory biologic agent (e.g., omalizumab, dupilumab, and/or anti-IL-5 therapies) at the time of study entry.</li>\n <li style=\"line-height: 20px;\">\n Initiation of treatment that is considered palliative (e.g., for life expectancy < 12 months) since enrolling in the parent study.</li>\n <li style=\"line-height: 20px;\">\n History of severe allergic reaction or anaphylactic reaction to any biologic agent or known hypersensitivity to any component of astegolimab.</li>\n <li style=\"line-height: 20px;\">\n Any other new serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study since enrolling in the parent study.</li>\n <li style=\"line-height: 20px;\">\n Any new unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure since enrolling in the parent study</li>\n <li style=\"line-height: 20px;\">\n Any new abnormal ECG that is deemed clinically significant by the investigator, including complete left bundle branch block or second- or third-degree atrioventricular heart block since enrolling in the parent study</li>\n <li style=\"line-height: 20px;\">\n QT interval corrected through use of Fredericia’s formula (QTcF) > 450ms if patient is male of QTcF > 470ms if patient is female. For male or female patients with QRS > 120ms: QTcF > 480ms</li>\n </ul>\n </div>\n</div>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n  </p>\n
      • primary_end_points<div font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <strong>Primary Objective Endpoints</strong></div>\n<div font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Incidence and severity of all adverse events, including SAEs, AESIs and AEs leading to death or discontinuation. Severity determined according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (HHS 2017) (hereafter referred to as the DAIDS Toxicity Grading Scale), with slight modifications for clarity and for alignment with internal practices</div>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n <span style=\"font-family:arial,helvetica,sans-serif;\"><span style=\"font-size:12px;\">KEMRI/CRDR Nairobi clinical research annex is located within the KNH complex. This facility has several clinical rooms available for consenting, nursing procedures, clinical exams, and dosing. There are also additional facilities that include 3 bed male and female inpatient ward for admission when required, staff work areas, a monitoring space, a pharmacy, a conference board room, a laboratory, and kitchen for preparing participant meals. Site staff include the principal investigator, 5 medical officers, 3 pharmacists, 1 pharm tech, 8 nurses, 9 lab personnel, 5 quality assurance officers, 10 clinical officers, 3 administrators and 13 community health workers.</span></span></p>\n
      • other_details_explanation<p>\n <span font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">Switzerland is the host country and we already received approval in Switzerland. CEC and RA approvals were received on 17-Sep-2024</span></p>\n
      • other_details_regulatory_notapproved<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" font-size:=\"\" style=\"max-width: 100%; border-collapse: collapse; border-spacing: 0px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\" width=\"589\" width:=\"\">\n <tbody>\n <tr>\n <td colspan=\"3\" style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 589px; height: 21px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>INDIA                                                                                DATE SUBMITTED</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 287px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Competent Authority</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 141px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n 30-Apr-2024</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 161px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Pending</p>\n </td>\n </tr>\n <tr>\n <td colspan=\"3\" style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 589px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 287px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>C</strong><strong>HINA</strong></p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 141px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n To be submitted</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 161px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n To be submitted</p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 287px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>B</strong><strong>RAZIL</strong></p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 141px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n  </p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 161px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n  </p>\n </td>\n </tr>\n </tbody>\n</table>\n<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" font-size:=\"\" style=\"max-width: 100%; border-collapse: collapse; border-spacing: 0px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\" width=\"589\" width:=\"\">\n <tbody>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 287px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Competent Authority</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 141px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n 16-May-2024</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 161px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Pending</p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 287px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>K</strong><strong>ENYA</strong></p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 141px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n  </p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 161px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 287px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Competent Authority</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 141px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n 13-Jun-2024 (first site)</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 161px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Pending</p>\n </td>\n </tr>\n </tbody>\n</table>\n<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" font-size:=\"\" style=\"max-width: 100%; border-collapse: collapse; border-spacing: 0px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\" width=\"589\" width:=\"\">\n <tbody>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 287px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>P</strong><strong>ERU</strong></p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 141px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n  </p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 161px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 287px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Competent Authority</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 141px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n 15-Mar-2024 (first site)</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 161px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Pending</p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 287px; height: 18px;\">\n  </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 141px; height: 18px;\">\n  </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221); width: 161px; height: 18px;\">\n  </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_regulatory_approved<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" font-size:=\"\" style=\"max-width: 100%; border-collapse: collapse; border-spacing: 0px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\" width=\"589\" width:=\"\">\n <tbody>\n <tr>\n <td colspan=\"3\" style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 589px; height: 37px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>List of Competent Authorities inside the EU/EEA to which the Application Approved</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 37px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>Member State </strong></p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 37px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>Date Submitted</strong></p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 37px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>Outcome Date</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 107px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>EU</strong> <strong>CTR</strong></p>\n <p style=\"margin: 0px 0px 10px;\">\n BELGIUM (11 sites), BULGARIA(25 sites), CZECH REPUBLIC (10sites), DENMARK (6sites), FRANCE (7sites), GERMANY (30sites), NETHERLANDS (5 sites), POLAND (36sites) , ROMANIA (4 sites), SPAIN (16sites), SWEDEN (6sites)</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 107px;\">\n <p style=\"margin: 0px 0px 10px;\">\n 30-May-2023</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 107px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Approved, 2-Oct2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 107px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>EU</strong> <strong>CTR</strong></p>\n <p style=\"margin: 0px 0px 10px;\">\n GREECE, HUNGARY, ITALY, LATVIA, AUSTRIA</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 107px;\">\n <p style=\"margin: 0px 0px 10px;\">\n 25-Jun-2024</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 107px;\">\n <p style=\"margin: 0px 0px 10px;\">\n  </p>\n <p style=\"margin: 0px 0px 10px;\">\n GREECE – Approved, 18-Sep2024</p>\n <p style=\"margin: 0px 0px 10px;\">\n HUNGARY - Approved, 03-Sep2024</p>\n <p style=\"margin: 0px 0px 10px;\">\n ITALY - Approved, 16-Sep2024</p>\n <p style=\"margin: 0px 0px 10px;\">\n LATVIA - Approved, 17-Sep2024</p>\n <p style=\"margin: 0px 0px 10px;\">\n AUSTRIA - Approved, 22Sep2024</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n<p>\n  </p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n  </p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <strong>List of Competent Authorities outside the EU/EEA to which the Application has been approved</strong></p>\n<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" font-size:=\"\" style=\"max-width: 100%; border-collapse: collapse; border-spacing: 0px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\" width=\"589\" width:=\"\">\n <tbody>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 37px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>Country</strong></p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 37px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>Date Submitted</strong></p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 37px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>Outcome Date</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>UNITED KINGDOM (17sites)</strong></p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 18px;\">\n  </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 18px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 36px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Competent Authority</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 36px;\">\n <p style=\"margin: 0px 0px 10px;\">\n 25-May-2023</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 36px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Approved, 31-Aug2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>ARGENTINA (40sites)</strong></p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 18px;\">\n  </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 18px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Competent Authority</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n 22-Jun-2023</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n 11-Sep-2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>AUSTRALIA (4 sites)</strong></p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 18px;\">\n  </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 18px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 37px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Competent Authority</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 37px;\">\n <p style=\"margin: 0px 0px 10px;\">\n 02-Jun-2023</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 37px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Approved, 15-Jun2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 19px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>CHILE (10sites)</strong></p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 19px;\">\n  </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 19px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 37px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Competent Authority</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 37px;\">\n <p style=\"margin: 0px 0px 10px;\">\n 18-Oct-2023</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 37px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Approved, 20-Dec2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 19px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>HONG KONG (1 site)</strong></p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 19px;\">\n  </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 19px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 37px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Competent Authority</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 37px;\">\n <p style=\"margin: 0px 0px 10px;\">\n 24-Aug-2023</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 37px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Approved, 21-Nov2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 21px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>MEXICO (4 sites)</strong></p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 21px;\">\n  </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 21px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 37px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Competent Authority</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 37px;\">\n <p style=\"margin: 0px 0px 10px;\">\n 28-Jul-2023 </p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 37px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Approved, 6-Nov-2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>CANADA (14sites)</strong></p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 18px;\">\n  </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 18px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 36px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Competent Authority</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 36px;\">\n <p style=\"margin: 0px 0px 10px;\">\n 24-May-2023</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 36px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Approved, 23-Jun2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>NEW ZEALAND (7sites)</strong></p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 18px;\">\n  </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 18px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 36px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Competent Authority</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 36px;\">\n <p style=\"margin: 0px 0px 10px;\">\n 14-Jun-2023</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 36px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Approved, 7-Jul2023</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n  </p>\n<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" font-size:=\"\" style=\"max-width: 100%; border-collapse: collapse; border-spacing: 0px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\" width=\"589\" width:=\"\">\n <tbody>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 37px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>Country</strong></p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 37px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>Date Submitted</strong></p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 37px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>Outcome Date</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>SOUTH AFRICA (15sites)</strong></p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 18px;\">\n  </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 18px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 36px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Competent Authority</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 36px;\">\n <p style=\"margin: 0px 0px 10px;\">\n 30-May-2023</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 36px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Approved,12-Sep2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>SOUTH KOREA (13sites)</strong></p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 18px;\">\n  </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 18px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 36px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Competent Authority</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 36px;\">\n <p style=\"margin: 0px 0px 10px;\">\n 9-Jun-2023</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 36px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Approved, 10Oct2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>UNITED STATES OF AMERICA (74sites)</strong></p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 18px;\">\n  </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 18px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Competent Authority</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n 13-Feb-2023</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Approved </p>\n </td>\n </tr>\n <tr>\n <td colspan=\"3\" style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 589px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>TAIWAN (6sites)</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Competent Authority</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n 29-Mar-2024</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Approved,28-May2024</p>\n </td>\n </tr>\n <tr>\n <td colspan=\"3\" style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 589px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>TURKEY (3sites)</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Competent Authority</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n 20-Mar-2024</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Approved，9 Aug2024</p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>S</strong><strong>WITZERLAND (1site)</strong></p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n  </p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Competent Authority</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n 29-Jul-2024</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Approved,16-Sep2024</p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n <strong>T</strong><strong>HAILAND (2 sites)</strong></p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n  </p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 161px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n Competent Authority</p>\n </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 18px;\">\n  </td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 18px;\">\n <p style=\"margin: 0px 0px 10px;\">\n 21-May-2024</p>\n </td>\n </tr>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 18px;\">\n <strong>Philippines</strong></td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 287px; height: 18px;\">\n 18Apr2024</td>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top: 1px solid rgb(221, 221, 221); width: 141px; height: 18px;\">\n 23Sep2024</td>\n </tr>\n </tbody>\n</table>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n  </p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n  </p>\n
      • other_details_regulatory_rejected<p>\n <span font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">Not applicable. None of the Regulatory Authorities or Ethics Committees have rejected this trial.</span></p>\n
      • other_details_regulatory_halted<p>\n <span font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">Not applicable.</span></p>\n
      • estimated_durationStudy participation for each individual is expected to range from 1 day to more than 51 months
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states39
      • number_of_sites5
      • multi_country_listAUSTRALIA, CHINA,HONG KONG,INDIA,JAPAN, NEW ZEALAND, PHILIPPINES, SOUTH KOREA, TAIWAN, THAILAND, BRAZIL, ARGENTINA, CANADA, CHILE, MEXICO, PERU, AUSTRIA, BELGIUM, BULGARIA, CZECH REPUBLIC, DENMARK, FRANCE, GERMANY, GREECE, HUNGARY, ITALY, LATVIA, NETHERLANDS, POLAND, ROMANIA, SPAIN, SWEDEN, ISRAEL, KENYA, SOUTH AFRICA, SWITZERLAND, TURKEY, UNITED KINGDOM, USA
      • data_monitoring_committeeYes
      • total_enrolment_per_siteApproximately 2 participants for this site.
      • total_participants_worldwideApproximately 2000 participants
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameVidelis
      • investigator1_middle_nameNduba
      • investigator1_family_nameNzioka
      • investigator1_qualificationMedical Doctor
      • investigator1_professional_addressKenyatta National Hospital Grounds, Off Hospital Road, Behind Government Chemist, P.O. BOX 47855-00100, Nairobi, Kenya
      • investigator1_telephone+254790484654
      • investigator1_emailvnduba@gmail.com
      • organisations_transferred_Yes
      • number_participantsApproximately 18 participants
      • notification
      • approval_date21-12-2024
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted11-10-2024
      • is_child0
      • unsubmitted1
      • initial_date_submitted11-10-2024
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonReviewers\' comments addressed satisfactorily
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-05-07 15:34:42
      • created2024-10-09 14:42:04
      • total_sites5
      • ecitizen_invoice322481
    • InvestigatorContact(array)
      • 0(array)
        • id1174
        • application_id1478
        • given_nameVidelis
        • middle_nameNduba
        • family_nameNzioka
        • qualificationMedical Doctor
        • professional_addressKenyatta National Hospital Grounds, Off Hospital Road, Behind Government Chemist, P.O. BOX 47855-00100, Nairobi, Kenya
        • telephone+254790484654
        • emailvnduba@gmail.com
        • created2024-10-09 15:03:31
        • modified2024-11-07 15:27:32
    • SiteDetail(array)
      • 0(array)
        • id1795
        • application_id1478
        • county_id47
        • site_nameKEMRI-CRDR Clinical Research Annex
        • physical_addressKenyatta National Hospital Grounds, Off Hospital Road, Behind Government Chemist, P.O. BOX 47855-00100, Nairobi, Kenya
        • contact_details+254790484654
        • contact_personProf. Videlis Nduba
        • site_capacity(null)
        • misc(null)
        • created2024-10-09 15:03:31
        • modified2024-11-07 15:27:32
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 1(array)
        • id1796
        • application_id1478
        • county_id16
        • site_nameClinical Research Health Network (CREA-N)
        • physical_addressMachakos Level 5 Hospital Site P.O. Box 19 -90100 Machakos Kenya
        • contact_details+254115021107
        • contact_personDr Jacqueline Mirera
        • site_capacity(null)
        • misc(null)
        • created2024-10-10 09:21:24
        • modified2024-11-07 15:27:32
        • County(array)
          • id16
          • county_nameMachakos
          • created2012-06-15 10:23:55
          • modified2012-06-15 10:23:55
      • 2(array)
        • id1797
        • application_id1478
        • county_id47
        • site_nameCenter for Research In Tropical Medicine and Community Development
        • physical_addressP.O. Box 6387, Thika, Kenya
        • contact_details+254722425613
        • contact_personDr Jesse Gitaka
        • site_capacity(null)
        • misc(null)
        • created2024-10-10 09:22:49
        • modified2024-11-07 15:27:32
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 3(array)
        • id1798
        • application_id1478
        • county_id3
        • site_nameKEMRI-Mtwapa Clinical Annex
        • physical_addressP.O. Box 428-80108, Mtwapa
        • contact_details+254722523370
        • contact_personDr Mary Matilu
        • site_capacity(null)
        • misc(null)
        • created2024-10-10 09:24:15
        • modified2024-11-07 15:27:32
        • County(array)
          • id3
          • county_nameKilifi
          • created2012-05-31 16:15:49
          • modified2012-05-31 16:15:49
      • 4(array)
        • id1799
        • application_id1478
        • county_id47
        • site_nameUniversity of Nairobi Clinical Research Centre
        • physical_addressProf Mungai Road Off Wasawo Drive Off Riverside Drive Chiromo Campus University Of Nairobi P.O. Box 19676 00202 Nairobi Kenya
        • contact_details+254 707028067
        • contact_personDr Teresa Kinyari
        • site_capacity(null)
        • misc(null)
        • created2024-10-10 09:25:23
        • modified2024-11-07 15:27:32
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
    • Sponsor(array)
      • 0(array)
        • id786
        • application_id1478
        • sponsorF. Hoffmann-La Roche Ltd
        • sponsor_typeIndustry
        • contact_personHeather Schofield
        • addressGrenzacherstrasse 124, 4070 Basel, Switzerland
        • telephone_number+ 41 6168 81111
        • fax_numberNot available
        • cell_number+41 61 688 1111
        • email_addressglobal.eudract@roche.com
        • created2024-10-09 15:03:31
        • modified2024-11-07 15:27:32
  • 1(array)
    • Application(array)
      • id1479
      • user_id263
      • trial_status_id(null)
      • abstract_of_study<p class=\"SynchrogenixBodyText\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n <span lang=\"EN-US\">Modeling suggests that the most effective contribution to TB control in high burden countries would be a vaccine that prevents pulmonary TB in adolescents and adults [</span><span lang=\"EN-US\" style=\"color: blue;\">WHO</span><span lang=\"EN-US\" style=\"color: blue;\">2021</span><span lang=\"EN-US\">]. In very high incidence geographies, the incidence rate of TB is highest in older adolescents and young adults (e.g., 15 to 44 years of age). In addition, pulmonary TB is the predominant form of TB in this age group (with the primary mode of TB transmission being via aerosol), and young adults are more likely to transmit to more contacts because they are active and mix extensively [</span><span lang=\"EN-US\" style=\"color: blue;\">Knight</span><span lang=\"EN-US\" style=\"color: blue;\">2014</span><span lang=\"EN-US\">].</span></p>\n<p class=\"SynchrogenixBodyText\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n The primary objective of this Phase 3 efficacy trial is to evaluate VE in the prevention of laboratory-confirmed pulmonary TB in IGRA-positive participants who do not have HIV. The rationale for focusing on IGRA-positive participants is based on Phase 3 trial simulations that evaluated the feasibility of demonstrating VE in an “all-comer” population (i.e., regardless of IGRA status) of young adults (15 to 44 years of age) in very high burden settings with an IGRA-positive prevalence of 67%. Based on these simulations, it appears feasible to demonstrate vaccine efficacy against tuberculosis disease (VE[D]) in an IGRA-positive, HIV-negative population, with a sample size of <span class=\"msoIns\"><ins cite=\"mailto:Debbie%20Daehnick%20(DT%20Medical%20Writing%20Corp)\" datetime=\"2024-01-08T12:19\">9</ins></span>,000 participants per arm, within 4 years from start of enrollment, whereas a trial in an all-comer population would have to be much larger, and the larger population would still be inadequate to demonstrate VE(D) in IGRA-negative participants.</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n Trial simulation assumptions included an annual IGRA conversion rate of 3% per person-year, and an incidence of active pulmonary TB of 0.4% per person-year. These simulations suggested that even with a 67% IGRA-positive prevalence at enrollment, more than 90% of laboratory-confirmed cases of TB would be observed in IGRA-positive participants, and less than 10% in IGRA-negative participants; such a trial would not be powered to demonstrate VE(D) in IGRA-negative participants as a subset.</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n A confirmatory trial in IGRA-negative participants is not considered feasible (in a reasonable amount of time and with a reasonable population size), given the low rate of laboratory-confirmed cases expected in baseline IGRA-negative participants. Given the inability to demonstrate VE(D) in IGRA-negative participants as a subset in an ‘all-comer’ trial, this Phase 3 trial aims to demonstrate VE(D) in IGRA-positive participants only, and to generate descriptive safety, immunogenicity, and VE(D) data in a HIV-negative, IGRA-negative Cohort  (N=1,000) and in a cohort of PLHIV (N=1,000) of either positive or negative IGRA status.</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n GlaxoSmithKline Biologicals, SA (GSK) developed M72/AS01<span style=\"position: relative; font-size: 9.375px; line-height: 0; vertical-align: baseline; bottom: -0.25em;\">E-4</span>, an investigational TB vaccine, to protect against the development of TB in <em>Mtb</em>-infected adolescents and adults. The GSK Phase 2b trial (TB-018) evaluated vaccine safety and efficacy in approximately 3500 IGRA-positive adults (1:1, M72/AS01<span style=\"position: relative; font-size: 9.375px; line-height: 0; vertical-align: baseline; bottom: -0.25em;\">E-4 </span>and placebo) [Van Der Meeren2018; Tait2019]. Most participants in the TB-018 trial had previously received the BCG vaccine as neonates. The observed VE against active pulmonary TB in the Phase 2b trial was 49.7% (95% CI: 2.1% to 74.2%) at 36 months and no safety signals that would prevent further development were observed [Tait2019].</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n In 2020, the Bill & Melinda Gates Medical Research Institute (Gates MRI) licensed the M72/AS01<span style=\"position: relative; font-size: 9.375px; line-height: 0; vertical-align: baseline; bottom: -0.25em;\">E-4 </span>investigational TB vaccine for continued development.</p>\n
      • study_title<p>\n <span style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">A Phase 3, randomized, double-blind, placebo-controlled, multicenter, clinical trial to assess the prophylactic efficacy, safety, and immunogenicity of the investigational M72/AS01</span><span style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; position: relative; font-size: 9.375px; line-height: 0; vertical-align: baseline; bottom: -0.25em;\">E-4</span><span style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\"> Mycobacterium tuberculosis (Mtb) vaccine when administered intramuscularly on a 0,1-month schedule to adolescents and adults.</span></p>\n
      • laymans_summary<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n Tuberculosis (TB) is caused by the bacterium Mycobacterium tuberculosis (Mtb); it typically affects the lungs but can also affect other sites. TB is spread from person to person via the respiratory route and is manifested by the presence of Mtb in sputum. TB is the second leading infectious killer after COVID-19 (above HIV/AIDS). It is present in all countries and age groups, but the larger number of new cases occur in countries of the South-East Asian Region and African Region.</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n Bacille Calmette-Guérin, known as BCG, is the only licensed TB vaccine to date; however, the impact of BCG on the transmission of Mtb in adults is limited, since it offers minimal or no protection against pulmonary TB in adults. TB treatment is lengthy, and compliance is often incomplete, resulting in an increasing incidence of multi-drug resistant (MDR)-TB and extensively drug resistant (XDR)-TB.</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n Given the substantial morbidity and mortality associated with TB, the challenges associated with TB treatment, and the limited options for prevention, a vaccine is urgently needed, both to protect against disease, including the progression from latent Mtb infection to active TB, and to accelerate the end of the TB epidemic.</p>\n
      • short_titleGates MRI TBV02-301
      • protocol_noECCT/24/10/02
      • version_no2.0
      • date_of_protocol08-01-2024
      • study_drugM72/AS01E-4 investigational vaccine
      • disease_conditionTuberculosis (TB)
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines1
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorNo
      • comparator_nameN/A
      • comparator_registeredN/A
      • comparator_countriesN/A
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressamina.salim@iqvia.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantMaureen Anyango Olwero
      • declaration_date111-10-2024
      • declaration_principal_investigatorDr Isaac Tsikhutsu- PI - Kenya Medical Research Institute/Walter Reed Project, Clinical Research Center
      • declaration_date211-10-2024
      • placebo_presentYes
      • study_objectives<div font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <div font-size:=\"\" trebuchet=\"\">\n <strong>Primary Efficacy Objective:</strong></div>\n <ul font-size:=\"\" style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px;\" trebuchet=\"\">\n <li style=\"line-height: 20px;\">\n To evaluate the vaccine efficacy (VE) of M72/AS01<span style=\"position: relative; font-size: 9.375px; line-height: 0; vertical-align: baseline; bottom: -0.25em;\">E-4</span> in the prevention of laboratory-confirmed pulmonary TB among IGRA-positive participants without HIV infection (IGRA-Positive Cohort) in the per-protocol (PP) analysis set</li>\n </ul>\n <p font-size:=\"\" style=\"margin: 0px 0px 10px;\" trebuchet=\"\">\n <strong font-size:=\"\" trebuchet=\"\">Secondary Efficacy Objectives:</strong></p>\n <ul font-size:=\"\" style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px;\" trebuchet=\"\">\n <li style=\"line-height: 20px;\">\n To evaluate the VE of M72/AS01<span style=\"position: relative; font-size: 9.375px; line-height: 0; vertical-align: baseline; bottom: -0.25em;\">E-4</span> in the prevention of <em>Mtb</em> infection among the IGRA-Negative Cohort in the PP analysis set</li>\n <li style=\"line-height: 20px;\">\n To evaluate the VE of M72/AS01<span style=\"position: relative; font-size: 9.375px; line-height: 0; vertical-align: baseline; bottom: -0.25em;\">E-4</span> in the prevention of laboratory-confirmed pulmonary TB among the IGRA-Negative Cohort in the PP analysis set</li>\n <li style=\"line-height: 20px;\">\n To evaluate the VE of M72/AS01<span style=\"position: relative; font-size: 9.375px; line-height: 0; vertical-align: baseline; bottom: -0.25em;\">E-4</span> in the prevention of laboratory-confirmed pulmonary TB among the HIV Cohort in the PP analysis set</li>\n <li style=\"line-height: 20px;\">\n To evaluate the VE of M72/AS01<span style=\"position: relative; font-size: 9.375px; line-height: 0; vertical-align: baseline; bottom: -0.25em;\">E-4</span> in the prevention of less stringently defined laboratory-confirmed pulmonary TB among the IGRA-Positive Cohort in the PP analysis set</li>\n </ul>\n <p font-size:=\"\" style=\"margin: 0px 0px 10px;\" trebuchet=\"\">\n <strong>Secondary Safety Objective:</strong></p>\n <ul font-size:=\"\" style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px;\" trebuchet=\"\">\n <li style=\"line-height: 20px;\">\n To evaluate the safety and reactogenicity following administration of M72/AS01<span style=\"position: relative; font-size: 9.375px; line-height: 0; vertical-align: baseline; bottom: -0.25em;\">E-4</span> vaccine or placebo</li>\n </ul>\n <p font-size:=\"\" style=\"margin: 0px 0px 10px;\" trebuchet=\"\">\n <strong>Secondary Immunogenicity Objective:</strong></p>\n <ul font-size:=\"\" style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px;\" trebuchet=\"\">\n <li style=\"line-height: 20px;\">\n To assess the humoral immunogenicity of M72/AS01<span style=\"position: relative; font-size: 9.375px; line-height: 0; vertical-align: baseline; bottom: -0.25em;\">E-4</span> vaccination</li>\n </ul>\n <p font-size:=\"\" style=\"margin: 0px 0px 10px;\" trebuchet=\"\">\n <strong>Exploratory Objectives:</strong></p>\n <ul font-size:=\"\" style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px;\" trebuchet=\"\">\n <li style=\"line-height: 20px;\">\n To further explore the VE of M72/AS01<span style=\"position: relative; font-size: 9.375px; line-height: 0; vertical-align: baseline; bottom: -0.25em;\">E-4</span> in the prevention of <strong>laboratory</strong>-confirmed pulmonary TB as defined for the primary endpoint, among the IGRA-Positive Cohort in the mITT analysis set</li>\n <li style=\"line-height: 20px;\">\n To explore the effect of potential covariates on the VE of M72/AS01<span style=\"position: relative; font-size: 9.375px; line-height: 0; vertical-align: baseline; bottom: -0.25em;\">E-4</span> in the prevention of <strong>laboratory</strong>-confirmed pulmonary TB as defined for the primary endpoint, among the IGRA-Positive Cohort in the PP analysis set</li>\n <li style=\"line-height: 20px;\">\n To explore the VE of M72/AS01<span style=\"position: relative; font-size: 9.375px; line-height: 0; vertical-align: baseline; bottom: -0.25em;\">E-4 </span>in the prevention of <strong>laboratory-confirmed</strong> pulmonary TB, where sputum was collected up to 28 days after treatment initiation among IGRA-positive, IGRA-negative, and HIV Cohorts, respectively, in the mITT analysis set.</li>\n <li style=\"line-height: 20px;\">\n To explore the VE of M72/AS01<span style=\"position: relative; font-size: 9.375px; line-height: 0; vertical-align: baseline; bottom: -0.25em;\">E-4</span> in the prevention of <strong>clinical</strong> TB (including extrapulmonary TB) defined as a participant for whom a clinician has diagnosed TB, and has initiated TB treatment, in the absence of laboratory-confirmed pulmonary TB, among IGRA-positive, IGRA-negative, and HIV Cohorts, respectively, in the mITT analysis set. </li>\n <li style=\"line-height: 20px;\">\n To explore the VE of M72/AS01<span style=\"position: relative; font-size: 9.375px; line-height: 0; vertical-align: baseline; bottom: -0.25em;\">E-4 </span>in the prevention of <strong>subclinical </strong>TB, defined as a participant with a positive result from Xpert Ultra or similar assay (excluding “trace positive”) from a single sputum sample at the EoT visit, in the absence of signs or symptoms of pulmonary TB, among IGRA-positive, IGRA-negative, and HIV Cohorts, respectively, in the mITT analysis set.</li>\n <li style=\"line-height: 20px;\">\n To assess the cellular immunogenicity of M72/AS01<span style=\"position: relative; font-size: 9.375px; line-height: 0; vertical-align: baseline; bottom: -0.25em;\">E-4</span> vaccination using M72-specific CD4+ and CD8+ T-cell responses measured by co-expression of 2 or more cytokines using intracellular cytokine staining (ICS)</li>\n <li style=\"line-height: 20px;\">\n To further explore the cellular immunogenicity of M72/AS01<span style=\"position: relative; font-size: 9.375px; line-height: 0; vertical-align: baseline; bottom: -0.25em;\">E-4</span> vaccination using M72-specific CD4+ and CD8+ T-cell responses measured by co-expression of multiple functional markers by ICS</li>\n <li style=\"line-height: 20px;\">\n To confirm candidate CoP and CoR if identified in the M72 Immune Correlates Program and to explore new candidate CoP and CoR</li>\n <li style=\"line-height: 20px;\">\n To explore characteristics of <em>Mtb </em>isolates, including drug susceptibility profiles and genetic diversity</li>\n </ul>\n</div>\n<p>\n  </p>\n
      • principal_inclusion_criteria<p class=\"SynchrogenixBodyText\" font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <span lang=\"EN-US\">Participants are eligible for randomization and trial intervention administration only if all of the following criteria apply.</span></p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n    <strong>Age</strong></p>\n<ol font-size:=\"\" style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <li style=\"line-height: 20px;\">\n Participant must be 15 to 44 years of age (inclusive), at the time of signing the consent or assent.</li>\n</ol>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <strong>Type of Participant and Disease Characteristics</strong></p>\n<ol font-size:=\"\" style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <li style=\"line-height: 20px;\" value=\"2\">\n Capable of giving informed consent or informed assent (as appropriate). For participants below the age of consent, the participant’s parent, or legally authorized representative (LAR) will be required to sign a statement of informed consent, in addition to the minor’s signed statement of assent.</li>\n <li style=\"line-height: 20px;\" value=\"3\">\n In the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of diary cards as applicable, and return for follow-up visits).</li>\n <li style=\"line-height: 20px;\" value=\"4\">\n Agree to actively stay in contact with the trial site for the duration of the trial for the participants own safety.</li>\n <li style=\"line-height: 20px;\" value=\"5\">\n Agree to provide updated contact information as necessary, and have no current plans to relocate from the trial area for the duration of the trial.</li>\n <li style=\"line-height: 20px;\" value=\"6\">\n Healthy, or with preexisting stable disease, as established by medical history and physical examination and as determined by the investigator. Preexisting stable disease is defined as not requiring significant change in therapy or hospitalization for worsening disease during the 28 days before enrollment.</li>\n <li style=\"line-height: 20px;\" value=\"7\">\n Negative sputum Xpert Ultra or similar assay result at screening </li>\n <li style=\"line-height: 20px;\" value=\"8\">\n Both males and females are included. Females are included with restrictions. Females must either be of non-childbearing potential, defined as pre-menarche, have a history of either current tubal ligation, hysterectomy, or ovariectomy, or post-menopause, <strong>or</strong>, if she is of childbearing potential, she has practiced abstinence from penile-vaginal intercourse or adequate contraception for 28 days prior to vaccination, has a negative pregnancy test on the day of screening and the day of first vaccination, and agrees to continue abstinence or adequate contraception until 2 months after the second dose of trial intervention.</li>\n <li style=\"line-height: 20px;\" value=\"9\">\n HIV-negative test result at screening (IGRA-Positive Cohort and IGRA-Negative Cohort only)</li>\n <li style=\"line-height: 20px;\" value=\"10\">\n HIV Cohort only: Participants with documented<ins cite=\"mailto:Debbie%20Daehnick%20(DT%20Medical%20Writing%20Corp)\" datetime=\"2024-01-08T12:19\">*</ins> HIV infection who fulfill all of the following criteria:</li>\n</ol>\n<ul font-size:=\"\" style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <li style=\"line-height: 20px;\">\n have reactive anti-HIV antibody at screening</li>\n <li style=\"line-height: 20px;\">\n have been on ART for at least 3 consecutive months at screening and agree to remain on ART throughout the trial</li>\n <li style=\"line-height: 20px;\">\n have documented HIV RNA <200 copies/mL at screening</li>\n <li style=\"line-height: 20px;\">\n have CD4+ cell count ≥200 cells/µL at screening</li>\n <li style=\"line-height: 20px;\">\n have had TPT in the past and are not receiving TPT at the time of screening, according to the judgment of the investigators</li>\n <li style=\"line-height: 20px;\">\n have an IGRA-positive or negative result at screening.</li>\n</ul>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <ins cite=\"mailto:Debbie%20Daehnick%20(DT%20Medical%20Writing%20Corp)\" datetime=\"2024-01-08T12:19\">*Note that ‘documented’ refers to documentation from the site personnel’s review of the participant’s medical records, medical examination, or medical history interview.</ins></p>\n
      • principal_exclusion_criteria<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Participants are excluded from the trial if any of the following criteria apply:</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <strong>Medical Conditions</strong></p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 1. Current TB, or history of TB or treatment for TB disease</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 2. Clinical suspicion of pulmonary TB at screening, defined as a participant presenting with one or more of the following signs or symptoms: unexplained cough, unexplained fever, night sweats, unintentional weight loss, hemoptysis, pleuritic chest pain</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 3. Any current medical, psychiatric, occupational, or substance abuse problems that, in the opinion of the investigator, will make it unlikely that the participant will comply with the protocol, or that will interfere with the assessments or the safety of the participant</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 4. Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., invasive, or malignant cancers), other than HIV infection in the HIV Cohort</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 5. Known bleeding disorder that is considered a contracindication to intramuscular injection or phlebotomy </p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <strong>Prior/Concomitant Therapy</strong></p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 6. Any cytotoxic drugs or administration of medications known to have a major impact on the immune system, as determined by the investigator, within 90 days prior to Day 1. These include immune globulin, blood, or blood products, potent immunosuppressants and immunomodulators, and systemic corticosteroids (exceeding 20 mg/day prednisone equivalent). Inhaled, topical, and intra-articular corticosteroids are allowed.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n  </p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n  </p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <strong>Prior/Concurrent Clinical Trial Experience</strong></p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 7. Planned receipt of blood, or blood products during the trial period</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 8. Receipt or planned receipt of any vaccine in the period starting 28 days before, and ending 28 days after, each dose of the trial vaccine</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 9. History of previous administration of an experimental <em>Mtb</em> vaccine including M72/AS01<span style=\"position: relative; font-size: 9.375px; line-height: 0; vertical-align: baseline; bottom: -0.25em;\">E </span>in a previous trial</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 10. History of allergy or hypersensitivity to the trial intervention, excipients, or related substances</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <strong>Diagnostic assessments</strong></p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 11. An indeterminate IGRA test result at screening</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 12. Female participants with any one of the following conditions: currently pregnant or lactating; having positive serum pregnancy test during the screening window, positive urine pregnancy test on Day 1, planning a pregnancy within 2 months after completion of the vaccination series</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 13. Only in the HIV Cohort: Safety laboratory values at screening that are of concern, based on investigator’s judgment. Note that preexisting stable chronic disease will not necessarily lead to exclusion, especially if laboratory values are graded as mild (Section 13).</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <strong>Other Exclusions</strong></p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 14. Participation in an interventional clinical trial in which the participant has been or will be exposed to an investigational product (pharmaceutical product or device), within 28 days prior to signing consent or assent, or during the trial period.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 15. Individuals who are acting as personnel for this trial, or who have immediate family members (brother, sister, child, parent, or the spouse/partner) who are acting as personnel for this trial.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 16. Child in Care, defined as a child who is under the care (control or protection) of an agency, organization, institution or entity by the courts, the government body, acting in accordance with powers conferred in them by law or regulations. The definition of a child in care can include a child who is cared for by foster parents or living in a care home or institution, provided that the arrangements fall within the definition above. The definition of a child in care <strong>does not include</strong> a child who is adopted or has an appointed LAR.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 17. Participants who had a Tuberculin Skin Test (TST) within 6 months prior to Day 1</p>\n
      • primary_end_points<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51);\" trebuchet=\"\">\n <strong>Primary Efficacy Endpoint:</strong></p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51);\" trebuchet=\"\">\n Laboratory-confirmed pulmonary TB over a period starting 1 month post Dose 2 and lasting up to End of Trial (EoT) where a laboratory-confirmed pulmonary TB case is defined as a participant with:</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px 21.6pt; color: rgb(51, 51, 51);\" trebuchet=\"\">\n ·       Suspected pulmonary TB as defined as a participant presenting with one or more of the following signs or symptoms:</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px 39.7pt; color: rgb(51, 51, 51);\" trebuchet=\"\">\n o   unexplained cough, unintentional weight loss, hemoptysis, unexplained fever, night sweats, pleuritic chest pain</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51);\" trebuchet=\"\">\n who has</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51);\" trebuchet=\"\">\n At least 2 positive <em>Mtb</em> test results (positive <em>Mtb</em> culture and/or positive test result from Xpert Ultra or similar assay, excluding “trace positive”), from the same or from different sputum samples collected during 3 suspected TB visits, preferably within a 7-day time frame, before initiation of TB treatment</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51);\" trebuchet=\"\">\n <strong>Secondary Efficacy Endpoints:</strong></p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51);\" trebuchet=\"\">\n Sustained QuantiFERON®-TB Gold Plus assay (or similar) conversion (i.e., initial conversion and IGRA-positive test result at next attended scheduled visit) over a period starting 1 month post dose 2 and lasting up to EoT </p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51);\" trebuchet=\"\">\n Laboratory-confirmed pulmonary TB over a period starting 1 month post Dose 2 and lasting up to EoT, where a laboratory-confirmed pulmonary TB case follows the same definition as the primary endpoint</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51);\" trebuchet=\"\">\n Laboratory-confirmed pulmonary TB over a period starting 1 month post Dose 2 and lasting up to EoT, where a laboratory-confirmed pulmonary TB case follows the same definition as the primary endpoint</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51);\" trebuchet=\"\">\n Laboratory-confirmed pulmonary TB over a period starting 1 month post Dose 2 and lasting up to EoT, where a laboratory-confirmed pulmonary TB case is defined less stringently as a participant with:</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px 17.3pt; color: rgb(51, 51, 51);\" trebuchet=\"\">\n ·       Suspected pulmonary TB as defined for the primary efficacy endpoint, and</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51);\" trebuchet=\"\">\n At least 1 positive <em>Mtb</em> culture or at least 1 positive result from Xpert Ultra or similar assay (excluding “trace positive”),from the same or from different sputum samples collected during the 3 suspected TB visits, preferably within a 7-day time frame, before initiation of TB treatment</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51);\" trebuchet=\"\">\n <strong>Secondary Safety Endpoints:</strong></p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51);\" trebuchet=\"\">\n Occurrence of solicited AEs during the 7 days following each vaccination (starting on day of vaccination and 6 subsequent days after each vaccine dose) Safety analysis set</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51);\" trebuchet=\"\">\n Occurrence of unsolicited AEs during the 28 days following each vaccination (starting on day of vaccination and 27 subsequent days after each vaccine dose) Safety analysis set</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51);\" trebuchet=\"\">\n Occurrence of all serious adverse events (SAEs) and potential immune-mediated diseases (pIMDs) from Day 1 through Month 13, Safety analysis set</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51);\" trebuchet=\"\">\n Occurrence of SAEs related to trial participation through <ins cite=\"mailto:Debbie%20Daehnick%20(DT%20Medical%20Writing%20Corp)\" datetime=\"2024-01-08T12:19\">trial</ins> end, Safety analysis set</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51);\" trebuchet=\"\">\n <strong>Secondary Immunogenicity Endpoint:</strong></p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51);\" trebuchet=\"\">\n Geometric mean concentration (GMC) and seropositivity of M72-specific antibodies at Day 1, Month 1, Month 2, Month 7, Month 13, Month 37, and Month 49 among each of the IGRA-Positive Cohort, IGRA-Negative Cohort, and HIV Cohorts in the per-protocol for immunogenicity (PPI) analyses set</p>\n<p style=\"margin: 0px 0px 10px;\">\n  </p>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<div>\n  </div>\n<div>\n <div>\n The site has a long-standing experience in conducting several studies including clinical trials,</div>\n <div>\n ranging from therapeutics that included a study of the safety and impact of broadly neutralizing</div>\n <div>\n monoclonal antibody therapy with VRC01 on viremia in acute HIV infection, alone or in</div>\n <div>\n combination with antiretroviral therapy (ART), vaccines (HIV, Polio, Ebola, Shigella) and</div>\n <div>\n cohort studies. The clinical trials range from phase I to IV with age ranges from birth to the elderly,</div>\n <div>\n some of which are randomized double blind, placebo controlled and United States</div>\n <div>\n Investigational New Drug (IND)/ Food and Drug Administration (FDA)- regulated. </div>\n <div>\n Kericho County has a TB prevalence of 200 per 100,000 people with an HIV prevalence of 3.7%. </div>\n <div>\n Kericho also has a large youthful population in schools and colleges who are willing to participate</div>\n <div>\n in vaccine trials.</div>\n <div>\n  </div>\n <div>\n The Kericho CRC is equipped with two emergency rooms (one per floor) with equipment and medications to provide immediate emergency care in the event of emergencies during vaccinations such as anaphylaxis, convulsions, hypotension, and provisions (resuscitation equipment) are in place for immediate resuscitation on site. Additionally, the Kericho site has a standby, fully equipped ambulance for evacuation of participants for more specialized care when necessary. The</div>\n <div>\n Kericho County Referral Hospital, which sits in the same compound as the CRC is a COVID-19 treatment center and has an Intensive Care Unit (ICU) which will be utilized should need arise. The study staffs (clinicians/nurses) are trained on handling emergencies. All study procedures will be done at KEMRI/USAMRD-A Clinical Research Center, Kericho with additional satellite sites setup to cater for the anticipated large number of participants to be enrolled. The site uses UTK</div>\n <div>\n hospital as a satellite site for inpatient admissions of participants needing inpatient services. The hospital is located about two kilometers from the CRC and has both outpatient and inpatient services.</div>\n <div>\n  </div>\n <div>\n <div>\n The Kericho CRC pharmacy Infrastructure. The site has two pharmacies one located on the first floor of the Clinical Research Center (CRC) building and the other located in the USHMA building. Entry to the pharmacies is restricted through biometric access doors. The pharmacies are equipped with lockable filing cabinets, and granite-topped workstations and are designed with window/hatch access to adjacent examination rooms allowing direct passage for blinded vaccine studies. The pharmacies are connected to the main national electric power grid, with two automatic back-up generators.</div>\n <div>\n  </div>\n <div>\n <div>\n  </div>\n <div>\n Pharmacy equipment. For cold storage, each pharmacy is equipped with a -20°C freezers, a -80°C freezers, and a 2-8°C refrigerators. An additional set of cold chain equipment made up of a -20°C freezer, a -80°C freezer and a 2-8°C refrigerator is located in the freezer farm that is on the ground floor of the CRC building. This equipment in the freezer farm serves as back up to the main equipment in both pharmacies. The CRC pharmacy has a two-class II biological safety cabinet</div>\n <div>\n (BSC), a Type B2 and Type A, while the USHMA pharmacy has a class II Type A BSC. Temperature monitoring in both pharmacies is done by an Eltek temperature and Humidity monitoring system with built-in sensor phone that sends short text message alerts in the event of an excursion. In addition, both pharmacies have dual air conditioning system, temperature data loggers and a dehumidifier. The pharmacy equipment is annually calibrated.</div>\n <div>\n  </div>\n <div>\n <div>\n The pharmacies are staffed by 5 full time employees.2 pharmacists and 3 Pharmaceutical technologists. The pharmacy operations are governed by policies that include standard operating procedures, Study specific procedures, quality management plans, local pharmacy regulations and any sponsor specific pharmacy manuals. The pharmacy supports end to end supply chain  management for all vaccine conducted at the KEMRI/WRP Kericho site.  This entails IMP forecasting, ordering, importation, receipt, storage, accountability, preparation, inventory, dispensing, and disposal. The Kericho site laboratory was the first (2008) and to date, only CAP-accredited laboratory in Kenya and has since undergone six reaccreditation cycles. The Laboratory is also Certified by the Kenya Medical Laboratory Board as Class “G” – the highest class in the country. The laboratory consists of two main sections: HIV and Microbiology. The HIV laboratory is divided into</div>\n </div>\n <div>\n <div>\n subsections that encompass specimen-processing and associated freezer farm, clinical (hematology, chemistry and flow cytometry), serology and molecular diagnostics. All specimens are accessioned using either the Freezerworks (FW) or Laboratory Data Management Systems (LDMS). The laboratory has the capacity to process peripheral blood mononuclear cells (PBMCs), plasma, serum and mucosal specimens. The   laboratory is equipped with several class II biosafety cabinets (BSC), centrifuges, refrigerators and freezers (range: -20 degrees to -196 degrees)  and an on-site liquid nitrogen production facility. Temperature-sensitive storage is monitored through Eltek, a continuous, automatic, electronic temperature-monitoring system with in-built sensor phones and short text message capability and manual checks.  </div>\n <div>\n  </div>\n </div>\n </div>\n <div>\n  </div>\n </div>\n <div>\n <div>\n The hematology subsection performs complete blood counts (CBC) including five-part differentials, estimated sedimentation rate (ESR), reticulocyte counts and blood parasites including malaria. Additionally, this subsection performs Prothrombin Time/International Normalized Ratio (PT/INR), fibrinogen, and Activated Partial Thromboplastin Time (APTT) assays with a platform that has additional capacity including factor assays. The chemistry subsection uses Roche platforms (Cobas</div>\n <div>\n C311) and performs all chemistry analytes including liver function tests (LFTs), renal function tests (RFTs), electrolytes, and lipid profile. The flow cytometry subsection has a Beckman Coulter AQUIOS CL  and BD FACSCanto platforms that can stain for all lymphocyte subsets (CD4/8,NK, B lymphocytes) in addition to doing intracellular cytokine staining (ICS) research assays. The serology subsection has capacity to test for Cryptococcal antigen, hepatitis B surface antigen</div>\n <div>\n (HBsAg) screening and confirmatory, hepatitis C antibody (HCV Ab), pregnancy, syphilis and HIV1 using rapid , Enzyme-Linked Immuno-Sorbent Assay (ELISA)- both third abd fourth generation ELISAs, and Immunoblot assays.</div>\n </div>\n <div>\n  </div>\n <div>\n <div>\n The Molecular subsection has the Roche Taqman Ampliprep and Abbott m2000 and Alinity platforms for quantitative HIV viral load monitoring and the Hologic Aptima qualitative RNA assay for detection of acute HIV infection (AHI) and monitoring. HIV-Drug resistance testing is performed using the ThermoFisher HIV-1 Genotyping Kit with Integrase features. </div>\n <div>\n  </div>\n <div>\n <div>\n  All laboratory assays are monitored through several external proficiency testing (EPT) panels from CAP, United Kingdom National External Quality Assessment Service (UKNEQAS); Human Quality Assessment Services (HUQAS); and the Virology Quality Assurance (VQA) </div>\n <div>\n  </div>\n <div>\n <div>\n The microbiology section provides expertise and laboratory support for the detection and diagnosis of bacterial, parasitic and viral causes of acute diarrhea in Kenya. The laboratory provides support for outbreak response preparation and ongoing surveillance of microbial agents, including antimicrobial resistance patterns. The laboratory’s diagnostic focus includes blood and body fluid samples including cerebrospinal fluid (CSF). Automated Identification and Antimicrobial</div>\n <div>\n Susceptibility Testing (ID/AST) are performed using the MicroScan Walkaway system. Several platforms are available for polymerase chain reaction (PCR), allowing for rapid identification and subtyping of pathogens. Serotyping capabilities are being expanded and pulsed field gel electrophoresis (PFGE) is being implemented to further characterize isolated agents. The laboratory has also recently implemented the Matrix-Assisted Laser Desorption/Ionization (MALDI) Biotyper to improve identification time. In a collaborative partnership with HJF/MHRP, the microbiology facility is enrolling participants for several protocols. The laboratory also has capacity to perform Candida albicans and cryptococcal fungal cultures.</div>\n <div>\n  </div>\n <div>\n <div>\n KEMRI/WRP BSL-3 Laboratory is the first and only College of American Pathologist accredited and DAIDS GCLP Certified BSL-3 Laboratory in Kenya. The state-of-the-art Laboratory has enhanced BSL-3 capacities: engineering, physical, and administrative controls, and therefore, conforms to WHO biosafety and other international standards for performing TB testing. The laboratory has the technical capacity (including human resources, infrastructure and equipment) to perform AFB microscopy, culture, identification, and drug susceptibility testing (DST) of M. tuberculosis using phenotypic and molecular methods according to current WHO policy guidance. The Laboratory is officially recognized by Kenya Ministry of Health as one of the National Level TB Reference Laboratory, supporting a functional national laboratory as well as conducting cutting edge clinical research. </div>\n <div>\n  </div>\n <div>\n <div>\n The laboratory has a strong QA/QC department to ensure that the most current documents are in use. Internal semi-annual audits are done with alternating two-year accreditation cycles by by the United States National Institute of Health-DAIDS contracted auditor, the Pharmaceutical Product Development (PPD).and CAP. The laboratory supports inter-laboratory quality assurance (QA) programs with memoranda of understanding with the Centers for Disease Control and Prevention (CDC) lab, Kisumu, Kenya, that is South African National Accreditation System (SANAS)accredited and the Moi University/Academic Model Providing Access to Healthcare (AMPATH) Partnership., Eldoret, Kenya, that is Kenya Accrediation National Service (KENAS)- Accredited.</div>\n <div>\n  </div>\n <div>\n <div>\n The laboratory performance evaluations for shipping, export and storage by both ACTG and IMPAACT networks have been outstanding. The average performance for the last six months has been over 90%.  </div>\n <div>\n  </div>\n </div>\n <div>\n The Kericho site laboratory is good clinical laboratory practice (GCLP) compliant and all members of the technical staff are GCLP-certified. Total staff are 34 working in different sections as described above.</div>\n </div>\n </div>\n <div>\n  </div>\n </div>\n </div>\n </div>\n <div>\n  </div>\n</div>\n<p>\n  </p>\n
      • other_details_explanation<p>\n <span font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">This Phase 3 TB vaccine trial will be conducted in adolescents and adults in communities with a high burden of pulmonary tuberculosis (TB). The trial is being conducted in Kenya because TB is significantly more prevalent (>200 cases per 100,000 population) than the USA (<3 cases per 100,000 population). </span></p>\n
      • other_details_regulatory_notapproved<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" width=\"648\">\n <tbody>\n <tr>\n <td rowspan=\"2\" style=\"width:97px;height:19px;\">\n <p>\n  </p>\n <p style=\"margin-left:4.85pt;\">\n <strong>C</strong><strong>o</strong><strong>u</strong><strong>ntry</strong></p>\n </td>\n <td rowspan=\"2\" style=\"width:213px;height:19px;\">\n <p>\n  </p>\n <p style=\"margin-left:5.0pt;\">\n <strong>N</strong><strong>ame of Competent Authority</strong></p>\n </td>\n <td rowspan=\"2\" style=\"width:187px;height:19px;\">\n <p>\n  </p>\n <p style=\"margin-left:5.0pt;\">\n <strong>Submission status</strong></p>\n </td>\n <td rowspan=\"2\" style=\"width:151px;height:19px;\">\n <p style=\"margin-left:4.85pt;\">\n <strong>C</strong><strong>ompetent</strong></p>\n <p style=\"margin-left:4.85pt;\">\n <strong>A</strong><strong>uthority decision</strong></p>\n </td>\n <td height=\"29\" style=\"height:19px;\">\n  </td>\n </tr>\n <tr>\n <td height=\"28\" style=\"height:19px;\">\n  </td>\n </tr>\n <tr>\n <td rowspan=\"2\" style=\"width:97px;height:19px;\">\n <p>\n <strong>Kenya</strong></p>\n </td>\n <td colspan=\"3\" style=\"width:551px;height:19px;\">\n <p style=\"margin-left:5.0pt;\">\n Kenya Pharmacy and Poison Board (KPPB):</p>\n </td>\n <td height=\"28\" style=\"height:19px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:213px;height:23px;\">\n <p style=\"margin-left:5.0pt;\">\n Site 1206</p>\n <p>\n  </p>\n </td>\n <td style=\"width:187px;height:23px;\">\n <p>\n Current submission</p>\n </td>\n <td style=\"width:151px;height:23px;\">\n <p>\n Current submission</p>\n </td>\n <td height=\"35\" style=\"height:23px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:97px;height:81px;\">\n <p style=\"margin-left:4.85pt;\">\n <strong>V</strong><strong>ietnam</strong></p>\n </td>\n <td style=\"width:213px;height:81px;\">\n <p style=\"margin-left:5.0pt;\">\n Vietnam Ministry of Health</p>\n </td>\n <td style=\"width:187px;height:81px;\">\n <p style=\"margin-left:5.0pt;\">\n V1.0 Submitted 08 Jan 2024</p>\n <p style=\"margin-left:5.0pt;\">\n  </p>\n <p style=\"margin-left:5.0pt;\">\n V2.0 submitted 11 June 2024</p>\n </td>\n <td style=\"width:151px;height:81px;\">\n <p style=\"margin-left:4.85pt;\">\n Pending</p>\n </td>\n <td height=\"122\" style=\"height:81px;\">\n  </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_regulatory_approved<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" width=\"648\">\n <tbody>\n <tr>\n <td rowspan=\"2\" style=\"width:97px;height:19px;\">\n <p>\n  </p>\n <p style=\"margin-left:4.85pt;\">\n <strong>C</strong><strong>o</strong><strong>u</strong><strong>ntry</strong></p>\n </td>\n <td colspan=\"2\" rowspan=\"2\" style=\"width:213px;height:19px;\">\n <p>\n  </p>\n <p style=\"margin-left:5.0pt;\">\n <strong>N</strong><strong>ame of Competent Authority</strong></p>\n </td>\n <td rowspan=\"2\" style=\"width:187px;height:19px;\">\n <p>\n  </p>\n <p style=\"margin-left:5.0pt;\">\n <strong>Submission status</strong></p>\n </td>\n <td rowspan=\"2\" style=\"width:151px;height:19px;\">\n <p style=\"margin-left:4.85pt;\">\n <strong>C</strong><strong>ompetent</strong></p>\n <p style=\"margin-left:4.85pt;\">\n <strong>A</strong><strong>uthority decision</strong></p>\n </td>\n <td height=\"29\" style=\"height:19px;\">\n  </td>\n </tr>\n <tr>\n <td height=\"28\" style=\"height:19px;\">\n  </td>\n </tr>\n <tr>\n <td rowspan=\"9\" style=\"width:97px;height:19px;\">\n <p>\n <strong>Kenya</strong></p>\n </td>\n <td colspan=\"4\" style=\"width:551px;height:19px;\">\n <p style=\"margin-left:5.0pt;\">\n Kenya Pharmacy and Poison Board (KPPB):</p>\n </td>\n <td height=\"28\" style=\"height:19px;\">\n  </td>\n </tr>\n <tr>\n <td colspan=\"2\" style=\"width:213px;height:19px;\">\n <p style=\"margin-left:5.0pt;\">\n Site 1201</p>\n <p>\n  </p>\n </td>\n <td style=\"width:187px;height:19px;\">\n <p style=\"margin-left:5.0pt;\">\n V2.0 Submitted 28 Mar 2024</p>\n <p>\n  </p>\n </td>\n <td style=\"width:151px;height:19px;\">\n <p>\n Approved: 25 Apr 2024</p>\n </td>\n <td height=\"28\" style=\"height:19px;\">\n  </td>\n </tr>\n <tr>\n <td colspan=\"2\" style=\"width:213px;height:19px;\">\n <p style=\"margin-left:5.0pt;\">\n Site 1202</p>\n <p>\n  </p>\n </td>\n <td style=\"width:187px;height:19px;\">\n <p style=\"margin-left:5.0pt;\">\n V2.0 Submitted 08 May 2024</p>\n <p>\n  </p>\n </td>\n <td style=\"width:151px;height:19px;\">\n <p>\n Approved: 27 May 2024</p>\n </td>\n <td height=\"28\" style=\"height:19px;\">\n  </td>\n </tr>\n <tr>\n <td colspan=\"2\" style=\"width:213px;height:50px;\">\n <p style=\"margin-left:5.0pt;\">\n Site 1203</p>\n <p>\n  </p>\n </td>\n <td style=\"width:187px;height:50px;\">\n <p>\n V2.0 Submitted 30 July 2024</p>\n </td>\n <td style=\"width:151px;height:50px;\">\n <p>\n Approved: 20 Aug 2024</p>\n </td>\n <td height=\"76\" style=\"height:50px;\">\n  </td>\n </tr>\n <tr>\n <td colspan=\"2\" style=\"width:213px;height:41px;\">\n <p style=\"margin-left:5.0pt;\">\n Site 1204</p>\n <p>\n  </p>\n </td>\n <td style=\"width:187px;height:41px;\">\n <p>\n V2.0 Submitted 11 June 2024</p>\n </td>\n <td style=\"width:151px;height:41px;\">\n <p>\n Approved: 02 July 2024</p>\n </td>\n <td height=\"62\" style=\"height:41px;\">\n  </td>\n </tr>\n <tr>\n <td colspan=\"2\" style=\"width:213px;height:19px;\">\n <p style=\"margin-left:5.0pt;\">\n Site 1205</p>\n <p>\n  </p>\n </td>\n <td style=\"width:187px;height:19px;\">\n <p>\n V2.0 Submitted_ 28 June 2024</p>\n </td>\n <td style=\"width:151px;height:19px;\">\n <p>\n Approved: 28 July 2024</p>\n </td>\n <td height=\"28\" style=\"height:19px;\">\n  </td>\n </tr>\n <tr>\n <td colspan=\"2\" style=\"width:213px;height:19px;\">\n <p style=\"margin-left:5.0pt;\">\n Site 1207 </p>\n <p>\n  </p>\n </td>\n <td style=\"width:187px;height:19px;\">\n <p style=\"margin-left:5.0pt;\">\n V2.0 Submitted 30 Apr 2024</p>\n </td>\n <td style=\"width:151px;height:19px;\">\n <p>\n Approved: 08 May 2024</p>\n </td>\n <td height=\"28\" style=\"height:19px;\">\n  </td>\n </tr>\n <tr>\n <td colspan=\"2\" style=\"width:213px;height:19px;\">\n <p style=\"margin-left:5.0pt;\">\n Site 1208</p>\n <p>\n  </p>\n </td>\n <td style=\"width:187px;height:19px;\">\n <p style=\"margin-left:5.0pt;\">\n V2.0 Submitted 03 May 2024</p>\n </td>\n <td style=\"width:151px;height:19px;\">\n <p>\n Approved: 08 May 2024</p>\n </td>\n <td height=\"28\" style=\"height:19px;\">\n  </td>\n </tr>\n <tr>\n <td colspan=\"2\" style=\"width:213px;height:24px;\">\n <p>\n   Site 1209</p>\n </td>\n <td style=\"width:187px;height:24px;\">\n <p style=\"margin-left:5.0pt;\">\n V2.0 Submitted 02 May 2024</p>\n </td>\n <td style=\"width:151px;height:24px;\">\n <p>\n Approved: 08 May 2024</p>\n </td>\n <td height=\"36\" style=\"height:24px;\">\n  </td>\n </tr>\n <tr>\n <td rowspan=\"2\" style=\"width:97px;height:28px;\">\n <p>\n  </p>\n <p style=\"margin-left:5.25pt;\">\n <strong>South Africa</strong></p>\n </td>\n <td colspan=\"2\" rowspan=\"2\" style=\"width:213px;height:28px;\">\n <p>\n  </p>\n <p style=\"margin-left:5.0pt;\">\n South Africa Health Products</p>\n <p style=\"margin-left:5.0pt;\">\n Regulatory Authority (SAHPRA)</p>\n </td>\n <td style=\"width:187px;height:28px;\">\n <p>\n  </p>\n <p style=\"margin-left:5.0pt;\">\n V1.0 Submitted – 11Aug 2023</p>\n </td>\n <td style=\"width:151px;height:28px;\">\n <p>\n Approved: 15 Nov 2023</p>\n <p>\n  </p>\n <p>\n  </p>\n </td>\n <td height=\"42\" style=\"height:28px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:187px;height:63px;\">\n <p>\n  </p>\n <p style=\"margin-left:5.0pt;\">\n  </p>\n <p style=\"margin-left:5.0pt;\">\n V2.0 Submitted – 19 Jan 2024</p>\n <p style=\"margin-left:5.0pt;\">\n  </p>\n </td>\n <td style=\"width:151px;height:63px;\">\n <p>\n  </p>\n <p>\n  </p>\n <p>\n Approved: 02 Feb 2024</p>\n </td>\n <td height=\"95\" style=\"height:63px;\">\n  </td>\n </tr>\n <tr>\n <td rowspan=\"2\" style=\"width:97px;height:33px;\">\n <p style=\"margin-left:2.6pt;\">\n <strong>I</strong><strong>ndonesia</strong></p>\n </td>\n <td colspan=\"2\" rowspan=\"2\" style=\"width:213px;height:33px;\">\n <p style=\"margin-left:5.0pt;\">\n Indonesian Food and Drug Authority</p>\n <p style=\"margin-left:5.0pt;\">\n (Indonesia NADFC-BPOM)</p>\n <p style=\"margin-left:5.0pt;\">\n  </p>\n <p style=\"margin-left:5.0pt;\">\n  </p>\n <p style=\"margin-left:5.0pt;\">\n  </p>\n <p style=\"margin-left:5.0pt;\">\n  </p>\n <p style=\"margin-left:5.0pt;\">\n  </p>\n <p style=\"margin-left:5.0pt;\">\n  </p>\n <p style=\"margin-left:5.0pt;\">\n  </p>\n <p style=\"margin-left:5.0pt;\">\n  </p>\n <p style=\"margin-left:5.0pt;\">\n  </p>\n <p style=\"margin-left:5.0pt;\">\n  </p>\n <p style=\"margin-left:5.0pt;\">\n  </p>\n </td>\n <td style=\"width:187px;height:33px;\">\n <p style=\"margin-left:5.0pt;\">\n V1.0 Submitted –07Sep2023</p>\n <p style=\"margin-left:5.0pt;\">\n  </p>\n </td>\n <td rowspan=\"2\" style=\"width:151px;height:33px;\">\n <p style=\"margin-left:4.85pt;\">\n V1.0 – N/A</p>\n <p style=\"margin-left:4.85pt;\">\n  </p>\n <div style=\"margin-left:4.85pt;\">\n <p>\n V2.0 – Approved</p>\n <p>\n Site 2201: 06 May 2024</p>\n <p>\n Site 2202: 21 May 2024</p>\n <p>\n Site 2203: 19 Apr 2024</p>\n <p>\n Site 2204: 26 Apr 2024</p>\n <p>\n Site 2205: 06 May 2024</p>\n <p>\n  </p>\n <p>\n  </p>\n </div>\n <p style=\"margin-left:4.85pt;\">\n  </p>\n </td>\n <td height=\"49\" style=\"height:33px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:187px;height:174px;\">\n <p>\n  </p>\n <p style=\"margin-left:5.0pt;\">\n V2.0 – Submitted  19 Jan 2024</p>\n </td>\n <td height=\"260\" style=\"height:174px;\">\n  </td>\n </tr>\n <tr>\n <td rowspan=\"2\" style=\"width:97px;height:62px;\">\n <p>\n  </p>\n <p style=\"margin-left:4.85pt;\">\n <strong>Z</strong><strong>a</strong><strong>mbia</strong></p>\n </td>\n <td style=\"width:15px;height:62px;\">\n <p style=\"margin-left:.05pt;\">\n §</p>\n </td>\n <td style=\"width:198px;height:62px;\">\n <p style=\"margin-left:6.1pt;\">\n Zambia Medicines Regulatory</p>\n <p style=\"margin-left:6.1pt;\">\n Authority (ZAMRA)</p>\n <p style=\"margin-left:6.1pt;\">\n  </p>\n <p style=\"margin-left:6.1pt;\">\n  </p>\n <p style=\"margin-left:6.1pt;\">\n  </p>\n <p style=\"margin-left:6.1pt;\">\n  </p>\n <p style=\"margin-left:6.1pt;\">\n  </p>\n </td>\n <td style=\"width:187px;height:62px;\">\n <p>\n  </p>\n <p style=\"margin-left:4.85pt;\">\n V1.0 Submitted- 31 Oct 2023</p>\n <p style=\"margin-left:4.85pt;\">\n V2.0 Submitted: 04 Apr 2024</p>\n <p style=\"margin-left:4.85pt;\">\n  </p>\n <p style=\"margin-left:4.85pt;\">\n  </p>\n <p style=\"margin-left:4.85pt;\">\n  </p>\n <p style=\"margin-left:4.85pt;\">\n  </p>\n <p style=\"margin-left:4.85pt;\">\n  </p>\n <p style=\"margin-left:4.85pt;\">\n  </p>\n <p style=\"margin-left:4.85pt;\">\n  </p>\n </td>\n <td rowspan=\"2\" style=\"width:151px;height:62px;\">\n <p style=\"margin-left:4.85pt;\">\n V1.0 N/A</p>\n <p style=\"margin-left:4.85pt;\">\n V2.0 approved 10 May 2024</p>\n <p style=\"margin-left:4.85pt;\">\n  </p>\n <p style=\"margin-left:4.85pt;\">\n V2.0 19 June 2024</p>\n </td>\n <td height=\"94\" style=\"height:62px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:15px;height:42px;\">\n <p style=\"margin-left:.05pt;\">\n §</p>\n </td>\n <td style=\"width:198px;height:42px;\">\n <p style=\"margin-left:6.1pt;\">\n National Health Research</p>\n <p style=\"margin-left:6.1pt;\">\n Authority (NHRA)</p>\n </td>\n <td style=\"width:187px;height:42px;\">\n <p>\n V2.0 – Submitted  05 Apr 2024</p>\n </td>\n <td height=\"63\" style=\"height:42px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:97px;height:275px;\">\n <p style=\"margin-left:4.85pt;\">\n <strong>M</strong><strong>alawi</strong></p>\n </td>\n <td colspan=\"2\" style=\"width:213px;height:275px;\">\n <p style=\"margin-left:5.0pt;\">\n Pharmacy and Medicines Regulatory</p>\n <p style=\"margin-left:5.0pt;\">\n Authority (PMRA)</p>\n </td>\n <td style=\"width:187px;height:275px;\">\n <p style=\"margin-left:5.0pt;\">\n V1.0 Submitted – 08 Dec 2023</p>\n <p style=\"margin-left:5.0pt;\">\n  </p>\n <p style=\"margin-left:5.0pt;\">\n V2.0 Submitted – 15 Mar 2024</p>\n </td>\n <td style=\"width:151px;height:275px;\">\n <p style=\"margin-left:4.85pt;\">\n V1.0  approved 27 May 2024</p>\n <p style=\"margin-left:4.85pt;\">\n  </p>\n <p style=\"margin-left:4.85pt;\">\n Site 2401_ V2.0 Approved_ 11 July 2024, Cover letter _corrected 22 July 2024</p>\n <p style=\"margin-left:4.85pt;\">\n  </p>\n <p style=\"margin-left:4.85pt;\">\n Site 2402_V2.0 Approved_ 07 June 2024 corrected 11 July 2024 (Site 2402)</p>\n <p style=\"margin-left:4.85pt;\">\n  </p>\n <p style=\"margin-left:4.85pt;\">\n Site 2402_ V2.0_Final approval_16Sep2024</p>\n <p style=\"margin-left:4.85pt;\">\n  </p>\n </td>\n <td height=\"413\" style=\"height:275px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:97px;height:69px;\">\n <p>\n  </p>\n <p>\n  </p>\n <p style=\"margin-left:4.85pt;\">\n <strong>M</strong><strong>o</strong><strong>z</strong><strong>a</strong><strong>m</strong><strong>bi</strong><strong>que</strong></p>\n </td>\n <td colspan=\"2\" style=\"width:213px;height:69px;\">\n <p>\n  </p>\n <p>\n  </p>\n <p style=\"margin-left:2.7pt;\">\n National Medicines Regulatory</p>\n <p style=\"margin-left:.05pt;\">\n Authority (ANARME)</p>\n </td>\n <td style=\"width:187px;height:69px;\">\n <p>\n  </p>\n <p>\n  </p>\n <p style=\"margin-left:5.0pt;\">\n V2.0 Submitted – 04 June 2024</p>\n </td>\n <td style=\"width:151px;height:69px;\">\n <p>\n  </p>\n <p>\n  </p>\n <p style=\"margin-left:4.85pt;\">\n V2.0 Approved_19 Sep 2024</p>\n </td>\n <td height=\"104\" style=\"height:69px;\">\n  </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration4 Years
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorPlacebo
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states7
      • number_of_sites9
      • multi_country_listKenya, South Africa, Malawi, Zambia, Mozambique, Indonesia and Vietnam
      • data_monitoring_committeeYes
      • total_enrolment_per_siteCompetitive enrolment approximated at 500 per Site
      • total_participants_worldwide20,000
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameDr Videlis
      • investigator1_middle_name
      • investigator1_family_nameNduba
      • investigator1_qualificationMBChB, MPH,PhD
      • investigator1_professional_addressKEMRI Centre for Clinical Respiratory Diseases Research (KEMRI CRDR), KEMRI/ CRDR Clinical Research Annex, KNH Complex Behind Government Chemist and Off Raila Odinga Way, P.O Box 47855 - 00100,Nairobi Kenya
      • investigator1_telephone+254 724 522 474
      • investigator1_emailvnduba@gmail.com
      • organisations_transferred_Yes
      • number_participants4,500
      • notification
      • approval_date12-11-2024
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted11-10-2024
      • is_child0
      • unsubmitted1
      • initial_date_submitted11-10-2024
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonApproved as per the AVAREF Assessment report.\n
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-03-11 13:55:36
      • created2024-10-11 14:48:39
      • total_sites1
      • ecitizen_invoice322983
    • InvestigatorContact(array)
      • 0(array)
        • id1176
        • application_id1479
        • given_nameDr Isaac
        • middle_name
        • family_nameTsikhutsu
        • qualificationMBChB, MMED, FPCCM
        • professional_addressKenya Medical Research Institute/Walter Reed Project, Clinical Research Center, P.O Box 1357, 20200, Kericho, Kenya
        • telephone+254 729 110124
        • emailIsaac.tsikhutsu@usamru-k.org
        • created2024-10-11 14:57:37
        • modified2024-10-28 16:23:26
    • SiteDetail(array)
      • 0(array)
        • id1800
        • application_id1479
        • county_id35
        • site_nameKenya Medical Research Institute/Walter Reed Project, Clinical Research Center
        • physical_addressKenya Medical Research Institute/Walter Reed Project, Clinical Research Center, P.O Box 1357, 20200, Kericho, Kenya
        • contact_details+254 729 110124; P.O Box 1357, 20200, Kericho, Kenya
        • contact_personDr Isaac Tsikhutsu
        • site_capacity(null)
        • misc(null)
        • created2024-10-11 14:57:37
        • modified2024-10-28 16:23:27
        • County(array)
          • id35
          • county_nameKericho
          • created2012-06-15 10:26:16
          • modified2012-06-15 10:26:16
    • Sponsor(array)
      • 0(array)
        • id787
        • application_id1479
        • sponsorBill & Melinda Gates Medical Research Institute (Gates MRI)
        • sponsor_typeResearch Institution
        • contact_personKristen Mayer
        • addressOne Kendall Square, Building 600, Suite 6-301, Cambridge, MA 02139, USA
        • telephone_number+1 617-465-0089
        • fax_numberN/A
        • cell_number+1 617-465-0089
        • email_addressKristen.mayer@gatesmri.org
        • created2024-10-11 14:57:37
        • modified2024-10-28 16:23:26
  • 2(array)
    • Application(array)
      • id1492
      • user_id263
      • trial_status_id(null)
      • abstract_of_study<div>\n This is an interventional, multi-national, multi-centre, open-label, phase 3b study in adults (participants ≥ 18 years old), adolescents (participants ≥ 12 to < 18 years old) and children(participants ≥ 11 months to < 12 years old) with sickle cell disease (SCD), with SCD who have been on chronic transfusions to prevent primary stroke or recurrence of stroke (SCDTD), non-transfusion-dependent thalassaemia (NTDT) or transfusion-dependent thalassaemia (TDT).</div>\n<div>\n The purpose of this rollover study is to investigate the long-term safety of etavopivat in participants 11 months of age and older with SCD or thalassaemia who have completed a treatment period in previous etavopivat studies.  Long-term clinical efficacy measures of etavopivat treatment will also be assessed.</div>\n<div>\n Etavopivat is an orally bioavailable, selective activator of erythrocyte pyruvate kinase (PKR), currently under development in clinical studies as a potential treatment for inherited haemoglobinopathies, including SCD and thalassemia</div>\n<div>\n Approximately 325 participants are planned to be enrolled in the study in about 120 sites worldwide. All participants will receive etavopivat. Participants ≥ 12 years old will receive an oral dose of 400 mg QD administered as 2 × 200 mg tablets. Participants < 12 years old will receive an age- and weight-adjusted dose (400 mg QD equivalent dose) administered as granules </div>\n<div>\n  </div>\n
      • study_title<p>\n An open-label, multi-centre, rollover study to characterise long-term safety and efficacy of etavopivat in adults, adolescents and children who have sickle cell disease or thalassaemia and have completed a treatment period in an etavopivat study.</p>\n
      • laymans_summary<div>\n A research study looking at long-term treatment with etavopivat in people with sickle cell disease or thalassaemia.</div>\n<div>\n The purpose of this rollover study is to investigate the long-term safety of etavopivat in participants 11 months of age and older with SCD or thalassaemia who have completed a treatment period in previous etavopivat studies.</div>\n<div>\n <div>\n Long-term clinical efficacy measures of etavopivat treatment will also be assessed. This study will also ensure that participants who are benefiting from etavopivat treatment have prolonged access to the drug in the time before it is commercially available in their country.</div>\n <div>\n Etavopivat is an orally bioavailable, small-molecule activator of pyruvate kinase red blood cell (PKR) isozyme. The investigational medicinal product (IMP) is being developed for the treatment of inherited haemoglobinopathies, such as Sickle cell disease (SCD) and thalassemia.</div>\n <div>\n  </div>\n</div>\n<p>\n  </p>\n
      • short_titleFLORAL
      • protocol_noECCT/25/01/01
      • version_no1
      • date_of_protocol03-05-2024
      • study_drugEtavopivat
      • disease_conditionsickle cell disease
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameetavopivat
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressamina.salim@iqvia.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantSylvia Macharia
      • declaration_date108-01-2025
      • declaration_principal_investigatorBenhards Ogutu
      • declaration_date204-12-2024
      • placebo_presentNo
      • study_objectives<p>\n To investigate long-term safety of etavopivat in adults, adolescents and children with SCD, SCDTD, TDT or NTDT transferring from other studies with etavopivat</p>\n<p>\n To investigate long-term clinical efficacy measures of etavopivat treatment in adults, adolescents and children with SCD transferring from other studies with etavopivatb</p>\n<p>\n To evaluate the effects of etavopivat on hospitalisations in adults, adolescents and children with SCD transferring from other studies with etavopivatb</p>\n<p>\n To investigate long-term clinical efficacy measures of etavopivat treatment in adults and adolescents with NTDT transferring from other studies with etavopivat</p>\n<p>\n To investigate long-term clinical efficacy measures of etavopivat treatment in adults and adolescents with TDT or SCDTD, transferring from other studies with etavopivat</p>\n
      • principal_inclusion_criteria<p>\n Participants are eligible to be included in the study only if all the following criteria apply:</p>\n<p>\n 1. Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. United Kingdom: Please see country-specific requirements in Appendix 8 (Section 10.8).</p>\n<p>\n 2. Participant must have ongoing participation in an etavopivat parent study (Table 4-1) for treatment of SCD or thalassaemia and have completed at least a treatment period of the parent study.</p>\n<p>\n  3. Participant must have derived clinical benefit from treatment with etavopivat, as determined by the investigator.</p>\n<p>\n 4. Any participant with dose reduction or temporary discontinuation will need to be rechallenged before transferring.</p>\n<p>\n  5. Participants on hydroxyurea (HU), crizanlizumab or l-glutamine oral powder (Endari®) treatment at the time of consent may be eligible if they:</p>\n<p>\n  a. Have been on a stable dose during participation in the parent study (i.e., no changes to the dose except for changes to weight or age reasons).</p>\n<p>\n b. Have been compliant with the treatment regimen at the discretion of the investigator during participation of the parent study.</p>\n<p>\n  </p>\n<p>\n  </p>\n
      • principal_exclusion_criteria<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" style=\"width:677px;\" width=\"677\">\n <tbody>\n <tr>\n <td style=\"width:677px;height:242px;\">\n <p>\n  List them here;</p>\n <p>\n  Participants are excluded from the study if any of the following criteria apply:</p>\n <p>\n 1. Previous participation in this study. Participation is defined as signed informed consent.</p>\n <p>\n 2. Female who is pregnant or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method, as defined in Appendix 4 (Section 10.4).</p>\n <p>\n 3. Any disorder, except for conditions associated with SCD or thalassaemia, which in the investigator’s opinion might jeopardise participant’s safety or compliance with the protocol.</p>\n <p>\n 4. Participant withdrew or had permanent treatment discontinuation from an etavopivat clinical study.</p>\n <p>\n 5. Participants on permanent treatment dose reduction or temporary treatment discontinuation.</p>\n <p>\n 6. Use of any of the following within the timeframes prior to the transfer visit as stated:</p>\n <p>\n      a. Use of voxelotor within participation of the parent study or anticipated need for this agent during this study</p>\n <p>\n      b. Use of an experimental selectin antagonist (e.g., monoclonal antibody or small molecule) within the parent study or anticipated need for such agents during this study.</p>\n <p>\n      c. Use of erythropoietin or other haematopoietic growth factor treatment within the parent study or anticipated need for such agents during this study.</p>\n <p>\n     d. Receiving or use of concomitant medications that are strong inducers of cytochrome P450 (CYP) 3A4 within 2 weeks of the transfer visit or anticipated need for such agents during the study.</p>\n <p>\n 7. Current participation in a study that is not a designated parent study, or planned participation in any other clinical trial, for the duration of FLORAL</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • primary_end_points<p>\n ·       Number of TEAEs, reported for each indication and age group separately.</p>\n<p>\n Number of adverse reactions, reported for each indication and age group separately </p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n The study will be conducted at Ahero Clinical Trials Unit (ACTU), a satellite unit of Centre for Clinical Research of the Kenya Medical Research Institute (KEMRI) and also affiliated to the Center for Research in Therapeutic Sciences (CREATES), Strathmore University. The unit was set up in the year 2008 for the conduct of clinical trials in malaria as the area is within an area of all year transmission of malaria.</p>\n<p>\n The site has a well-equipped consultation office with coaches, emergency tray and drugs including oxygen with the ability to manage appropriately medical emergencies. There is also a pharmacy, well equipped laboratory with the ability to perform routine tests and a spacious archive and data entry rooms.</p>\n<p>\n The site has 2 pediatricians assisted by 4 medical officers and a number of clinical officers, nurses and laboratory technicians to conduct the clinical trials and offer medical care to research participants.</p>\n<p>\n The ACTU is capable of conducting regulated clinical trials to evaluate vaccines, drugs, or diagnostic platforms for a variety of pathogens found in the area and the other emerging infectious diseases such as COVID-19. Recently, the site began conducting epidemiological studies in various fields. The ACTU is located within Ahero County Hospital along Nairobi – Kisumu Road. The research team has a close affiliation with the Kenyan Ministry of Health at the county and national levels and has personnel working in the Ministry of Health facilities within the study area. Trained unit field workers and Ministry of Health Community Health Workers assist with study activities conducted in the field and in satellite facilities </p>\n
      • other_details_explanation<p style=\"margin-left:-.25pt;\">\n The trial is to be conducted in the host country.</p>\n<p>\n  </p>\n
      • other_details_regulatory_notapproved<p style=\"margin-left:-.25pt;\">\n Turkey JA Submitted 11 Jul 2024</p>\n<p style=\"margin-left:-.25pt;\">\n US FDA submitted 26 June 2024</p>\n<p>\n Nigeria National Foods and Drugs Authority submitted 15 October 2024</p>\n
      • other_details_regulatory_approved<p style=\"margin-left:-.25pt;\">\n Health Canada Submitted 16 Jul 2024 received an approval on 12 Aug 2024</p>\n<p style=\"margin-left:-.25pt;\">\n EMA Submitted 31 Jul 2024 received approval on 22 Nov 2024</p>\n<p>\n  </p>\n
      • other_details_regulatory_rejected<p>\n Not Applicable</p>\n
      • other_details_regulatory_halted<p>\n This trial has not been halted by any regulatory authorities.</p>\n
      • estimated_durationup to 260 weeks.
      • design_controlled_randomisedNo
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorNon Randomised
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states17
      • number_of_sites7
      • multi_country_listCanada, Egypt, France, Germany, Ghana, Greece, India, Italy, Lebanon, Nigeria, Oman, Saudi Arabia, Spain, Turkey, USA, United Kingdom, Kenya
      • data_monitoring_committeeNo
      • total_enrolment_per_siteTotal enrolment in each Kenyan site: (if competitive enrolment, state minimum and maximum number per site.) As this is a rollover trial, we cannot predict the enrollment in each site as the parent trials have competitive enrollment
      • total_participants_worldwide325
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenYes
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyConsent of pediatric participants (below 18 years of age) is obtained by means of parents or legally acceptable representatives
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameBernhards
      • investigator1_middle_name
      • investigator1_family_nameOgutu
      • investigator1_qualificationMD
      • investigator1_professional_addressStrathmore University- CREATES Ole Sangale Road, Madaraka Estate, P.O BOX 59857-00200, Nairobi, Kenya
      • investigator1_telephone254733812613/254733966065
      • investigator1_emailogutu6@gmail.com
      • organisations_transferred_Yes
      • number_participants25
      • notification<p>\n Attached above are reponses to second round of screening comments also attached in the checklist section.</p>\n
      • approval_date24-04-2025
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted08-01-2025
      • is_child0
      • unsubmitted1
      • initial_date_submitted08-01-2025
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonReviewer comments have been addressed.
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-04-30 16:31:26
      • created2024-11-27 17:42:24
      • total_sites1
      • ecitizen_invoice332522
    • InvestigatorContact(array)
      • 0(array)
        • id1195
        • application_id1492
        • given_nameBernhard
        • middle_name
        • family_nameOgutu
        • qualificationMD
        • professional_addressStrathmore University- CREATES Ole Sangale Road, Madaraka Estate, P.O BOX 59857-00200, Nairobi, Kenya
        • telephone254733812613/254733966065
        • emailogutu6@gmail.com
        • created2024-11-27 17:43:29
        • modified2025-01-30 11:46:31
    • SiteDetail(array)
      • 0(array)
        • id1822
        • application_id1492
        • county_id42
        • site_nameCenter for Research in Therapeutic Sciences (CREATES)
        • physical_addressAhero County Hospital
        • contact_detailsogutu6@gmail.com
        • contact_personDr Benhards Ogutu
        • site_capacity(null)
        • misc(null)
        • created2024-11-27 17:43:29
        • modified2025-01-30 11:46:31
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 1(array)
        • id1824
        • application_id1492
        • county_id47
        • site_nameGertrude’s Children’s Hospital
        • physical_addressGertrude\'s Children\'s Hospital 34 Muthaiga road
        • contact_detailsjgithanga3@gmail.com
        • contact_personProf Jessie Githanga
        • site_capacity(null)
        • misc(null)
        • created2024-12-04 08:43:37
        • modified2025-01-30 11:46:31
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 2(array)
        • id1829
        • application_id1492
        • county_id41
        • site_nameKEMRI Siaya Clinical Research Annex
        • physical_addressSiaya County Referral hospital grounds
        • contact_detailsvduba@gmail.com
        • contact_personProf V Nduba
        • site_capacity(null)
        • misc(null)
        • created2024-12-16 10:17:16
        • modified2025-01-30 11:46:31
        • County(array)
          • id41
          • county_nameSiaya
          • created2012-06-15 10:26:56
          • modified2012-06-15 10:26:56
      • 3(array)
        • id1830
        • application_id1492
        • county_id42
        • site_nameKEMRI/ WRAIR-Africa, Kombewa Clinical Research Center
        • physical_addressPO Box 54-40100, Kisumu , Kenya
        • contact_detailsjanet.oyieko@usamru-k.org or janet.oyieko@gmail.com
        • contact_personDr Janet Oyieko
        • site_capacity(null)
        • misc(null)
        • created2024-12-16 10:17:16
        • modified2025-01-30 11:46:31
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 4(array)
        • id1831
        • application_id1492
        • county_id35
        • site_nameKEMRI WALTER REED KERICHO
        • physical_addressP.O. BOX 1357- 20200
        • contact_detailsisaac.tsikhutsu@usamru-k.org or itsikhutsu@yahoo.com
        • contact_personDr Isaac Tsikhutsu
        • site_capacity(null)
        • misc(null)
        • created2024-12-16 10:17:16
        • modified2025-01-30 11:46:31
        • County(array)
          • id35
          • county_nameKericho
          • created2012-06-15 10:26:16
          • modified2012-06-15 10:26:16
      • 5(array)
        • id1832
        • application_id1492
        • county_id42
        • site_nameKEMRI Kondele Children\'s Hospital
        • physical_addressCentre for Clinical Research Within Jaramogi Oginga Odinga Hospital
        • contact_detailsogutu6@gmail.com
        • contact_personDr Benhards Ogutu
        • site_capacity(null)
        • misc(null)
        • created2024-12-16 10:17:16
        • modified2025-01-30 11:46:31
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 6(array)
        • id1833
        • application_id1492
        • county_id42
        • site_nameKEMRI/ WRAIR-Africa, Kombewa Clinical Research Center
        • physical_addressPO Box 54-40100, Kisumu , Kenya
        • contact_detailswalter.otieno@usamru-k.org
        • contact_personDr Walter Otieno
        • site_capacity(null)
        • misc(null)
        • created2024-12-16 10:17:16
        • modified2025-01-30 11:46:31
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
    • Sponsor(array)
      • 0(array)
        • id793
        • application_id1492
        • sponsorNovo Nordisk A/S
        • sponsor_typeOthers
        • contact_personIsabella Andreotti
        • addressNovo Allé, 2880 Bagsvaerd, Denmark
        • telephone_number+45-34481755
        • fax_number
        • cell_number+45-34481755
        • email_address7822-HQ-TM@novonordisk.com
        • created2024-11-27 17:43:29
        • modified2025-01-30 11:46:31
• page_options(array)
  • 55
  • 1010
• redir
• $request->data(array)
  • Application(array)
    • trial_therapeutic_confirmatory1
• $this->validationErrors(array)
  • Permission(empty)
  • Aro(empty)
  • Aco(empty)
  • Application(empty)
  • User(empty)
  • TrialStatus(empty)
  • InvestigatorContact(empty)
  • Sponsor(empty)
  • SiteDetail(empty)
  • County(empty)
• Loaded Helpers(array)
  • 0Html
  • 1Form
  • 2Session
  • 3Text
  • 4Number
  • 5SimpleGraph
  • 6Paginator
  • 7DebugTimer
  • 8Toolbar
  • 9HtmlToolbar

App Constants

CakePHP Constants

PHP Environment

Included Files

Include Paths

• 0/var/www/html/ctr/app/Plugin/Media/Lib/mm/src
• 1/var/www/html/ctr/lib
• 3/usr/share/php
• 4-> /var/www/html/ctr/lib/Cake/

Included Files

• core(array)
  • Behavior(array)
    • 0CORE/Model/Behavior/TreeBehavior.php
    • 1CORE/Model/Behavior/ContainableBehavior.php
    • 2CORE/Model/Behavior/AclBehavior.php
  • Cache(array)
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    • 3CORE/Controller/Component/AuthComponent.php
    • 4CORE/Controller/Component/RequestHandlerComponent.php
    • 5CORE/Controller/Component/SessionComponent.php
    • 6CORE/Controller/Component/PaginatorComponent.php
  • Config(array)
    • 0CORE/Config/routes.php
    • 1CORE/Config/config.php
  • Controller(array)
    • 0CORE/Controller/Controller.php
    • 1CORE/Controller/ComponentCollection.php
    • 2CORE/Controller/Component.php
  • Datasource(array)
    • 0CORE/Model/Datasource/CakeSession.php
    • 1CORE/Model/Datasource/Database/Mysql.php
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    • 3CORE/Model/Datasource/DataSource.php
  • Error(array)
    • 0CORE/Error/exceptions.php
    • 1CORE/Error/ErrorHandler.php
  • I18n(array)
    • 0CORE/I18n/I18n.php
    • 1CORE/I18n/L10n.php
  • Log(array)
    • 0CORE/Log/CakeLog.php
    • 1CORE/Log/LogEngineCollection.php
    • 2CORE/Log/Engine/FileLog.php
    • 3CORE/Log/Engine/BaseLog.php
    • 4CORE/Log/CakeLogInterface.php
  • Model(array)
    • 0CORE/Model/ConnectionManager.php
    • 1CORE/Model/Permission.php
    • 2CORE/Model/Model.php
    • 3CORE/Model/BehaviorCollection.php
    • 4CORE/Model/Aro.php
    • 5CORE/Model/AclNode.php
    • 6CORE/Model/Aco.php
    • 7CORE/Model/ModelBehavior.php
  • Network(array)
    • 0CORE/Network/CakeRequest.php
    • 1CORE/Network/CakeResponse.php
  • Other(array)
    • 0CORE/bootstrap.php
    • 1CORE/basics.php
    • 2CORE/Core/App.php
    • 3CORE/Core/Configure.php
    • 4CORE/Core/CakePlugin.php
    • 5CORE/Event/CakeEventListener.php
    • 6CORE/Event/CakeEvent.php
    • 7CORE/Event/CakeEventManager.php
    • 8CORE/Core/Object.php
  • Routing(array)
    • 0CORE/Routing/Dispatcher.php
    • 1CORE/Routing/Filter/AssetDispatcher.php
    • 2CORE/Routing/DispatcherFilter.php
    • 3CORE/Routing/Filter/CacheDispatcher.php
    • 4CORE/Routing/Router.php
    • 5CORE/Routing/Route/CakeRoute.php
    • 6CORE/Routing/Route/PluginShortRoute.php
  • Utility(array)
    • 0CORE/Utility/Hash.php
    • 1CORE/Utility/Inflector.php
    • 2CORE/Utility/ObjectCollection.php
    • 3CORE/Utility/Debugger.php
    • 4CORE/Utility/String.php
    • 5CORE/Utility/ClassRegistry.php
    • 6CORE/Utility/Set.php
    • 7CORE/Utility/Sanitize.php
  • View(array)
    • 0CORE/View/HelperCollection.php
• app(array)
  • Behavior(array)
    • 0APP/Model/Behavior/SoftDeleteBehavior.php
  • Config(array)
    • 0APP/Config/core.php
    • 1APP/Config/bootstrap.php
    • 2APP/Config/routes.php
    • 3APP/Config/database.php
  • Controller(array)
    • 0APP/Controller/ApplicationsController.php
    • 1APP/Controller/AppController.php
  • Model(array)
    • 0APP/Model/AppModel.php
    • 1APP/Model/Application.php
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    • 3APP/Model/TrialStatus.php
    • 4APP/Model/InvestigatorContact.php
    • 5APP/Model/Sponsor.php
    • 6APP/Model/SiteDetail.php
    • 7APP/Model/County.php
  • Other(array)
    • 0APP/webroot/index.php
• plugins(array)
  • CakePdf(array)
    • Config(array)
      • 0CakePdf/Config/bootstrap.php
      • 1CakePdf/Config/routes.php
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      • 0CakeResque/Config/bootstrap.php
    • Plugin(array)
      • 0CakeResque/Lib/CakeResque.php
      • 1CakeResque/vendor/kamisama/php-resque-ex/lib/Resque.php
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      • 6DebugKit/Lib/Panel/TimerPanel.php
      • 7DebugKit/Lib/Panel/LogPanel.php
      • 8DebugKit/Lib/Log/Engine/DebugKitLog.php
      • 9DebugKit/Lib/Panel/VariablesPanel.php
      • 10DebugKit/Lib/Panel/EnvironmentPanel.php
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      • 12DebugKit/Lib/DebugTimer.php
  • Media(array)
    • Config(array)
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    • Plugin(array)
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      • 1Media/Lib/mm/src/Mime/Type/Magic/Adapter/Fileinfo.php
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      • 3Media/Lib/mm/src/Mime/Type/Glob/Adapter/Memory.php
      • 4Media/Lib/mm/src/Mime/Type/Glob/Adapter.php
      • 5Media/Lib/mm/src/Media/Process.php
      • 6Media/Lib/mm/src/Media/Info.php
  • Search(array)
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    • Behavior(array)
      • 0Search/Model/Behavior/SearchableBehavior.php
  • Shim(array)
    • Config(array)
      • 0Shim/Config/bootstrap.php
  • Tools(array)
    • Config(array)
      • 0Tools/Config/bootstrap.php