| Protocol No: | ECCT/18/07/05 | Date of Protocol: | 02-03-2017 |
| 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: | |
| Laymans Summary: | |
| 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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