Protocol No: ECCT/16/07/01 Date of Protocol: 25-11-2015

Study Title:

A Multi-country, prospective, Clinical Safety Study of Subjects Exposed to the Candidate Ebola Vaccines AD26.ZEBOV and or/ MVA-BN-Filo

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Study Objectives:
3 The purpose of the study is to assess the long-term safety profile of Ad26.ZEBOV and MVA-BN-Filo in participants previously exposed to these vaccines in Phase 1, 2, or 3 clinical studies.
Laymans Summary:
3 Ebola virus disease is caused by an infection with a virus known as the Ebolavirus. The disease is characterized by symptoms such as fever, body aches, diarrhoea, bleeding, and vomiting. Vaccination is one of the most effective ways to prevent illness caused by viruses. A vaccine contains a non-functional part of the virus that is recognized by the body's protective immune system. The body then produces a response that prevents illness if the person is exposed to that virus again. This process is known as an immune response. In this study, researchers want to learn more about the long-term safety of Ad26.ZEBOV and MVA-BN-Filo vaccines. Researchers also want to know about the safety and effectiveness of Ad26.ZEBOV and MVA-BN-Filo vaccines in female participants who became pregnant after receiving the vaccine in previous Phase 1, 2, or 3 clinical studies and in children born to these female participants. Participants can take part in this study if they have participated in a Phase 1, 2, or 3 clinical study and have received a minimum of 1 dose of study vaccine (Ad26.ZEBOV and/or MVA-BN-Filo) or placebo. In this study, participants will not receive any treatment, but will be monitored to collect safety information about the study vaccine for an extended period of time. Participants will be divided into 3 groups, Cohort 1, 2, and 3 as shown below. • Cohort 1: Participants (adults, adolescents, and children) who have received the study vaccine (Ad26.ZEBOV and/or MVA-BN-Filo) or placebo in other studies will be monitored from the time of first vaccination received until 60 months. Any side effects reported by the participants will be recorded. • Cohort 2: Female participants who became pregnant within 28 days of MVA-BN-Filo (or placebo) vaccination or within 3 months of Ad26.ZEBOV (or placebo) vaccination will be monitored to understand the safety of the study vaccine during pregnancy. Researchers are also interested to learn about the results of the pregnancy. This includes collecting information on successful deliveries, as well as number of pregnancies that ended before giving birth. Participant monitoring will start when a pregnancy is confirmed and last until the end of the pregnancy. If also a part of Cohort 1, participants will continue to be monitored up to 60 months after the first vaccination is received. • Cohort 3: Children born to the female participants in Cohort 2 will be monitored to track their growth up to 60 months after birth. This includes height, weight, and other parameters of growth. The overall duration of the study can be up to 6 years and 7 months.
Abstract of Study:

This is a multi-country, prospective, long-term clinical safety study designed to extend the total follow-up period of vaccinated subjects up to 60 months (including the duration in the subject's original study), to allow collectio of serious adverse events and pregnancy outcomes (including spontaneous/elective abortion, intrauterine death/stillbirth, information on delivery) following administration of Ad26.ZEBOV and/or MVA-BN-Filo for theprevention of Ebola virus disease among subjects who participated in a Phase 1, 2 or 3 clinical study. In addition, offspring from vaccinated female subjects who became pregnant with estimated conception within 28 days after vaccination with MVA-BN-Filo or within 3 months after vaccination with Ad26.ZEBOV in a Phase 1, 2 or 3 clinical study will be followed up to 60 months after birth. Up to approximately 5, 500 subjects may potentially be enrolled in this study, based on the number of exposed subjects in the contributing Phase 1, 2 or 3 clinical studies.

This study will consist of an enrollment visit, a number of follow-up contacts and an end-of-study contact. These contacts are preferably conducted by phone; if not possible, a study site visit needs to be organized. Preferably, offspring from vaccinated female subjects will visit the study site for every study visit. If not possible, the child may be visited at home by study site staff or a qualified health care worker for data collection.

Data collection can start when a signed informed consent from (ICF) is available for the current study. Preferably, signing of the ICF occurs at the last visit of the subject's original study (or at birth for offspring). If this is not possible, baseline data will be collected when a signed ICF is available and data need to be captured retrospectively up to the moment of enrollment in the current study.

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