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Long-term Safety Follow-up of Participants Exposed to the Candidate Ebola Vaccines Ad26.ZEBOV and/or MVA-BN-Filo

Hemorrhagic Fever, Ebola Clinical Trial

Official title:
A Multi-country, Prospective, Clinical Safety Study of Subjects Exposed to the Candidate Ebola Vaccines Ad26.ZEBOV and/or MVA-BN-Filo

Clinical Trial Summary

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.

Clinical Trial Description

This is a multi-country, prospective, long-term clinical safety study for collection of serious adverse events and pregnancy outcomes following administration of Ad26.ZEBOV and/or MVA-BN-Filo vaccines among participants who were enrolled in Phase 1, 2 or 3 clinical studies. The safety data will be collected in 3 cohorts; Cohort 1- adult and pediatric participants that received Ad26.ZEBOV and/or MVA-BN-Filo in Phase 1, 2 or 3 clinical studies (adults, adolescents and children), Cohort 2- Female participants who became pregnant with estimated conception within 28 days after vaccination with MVA-BN-Filo or within 3 months after vaccination with Ad26.ZEBOV will be followed to the end of their pregnancy for pregnancy outcomes (Cohort 2). After the end of pregnancy, female participants will continue to be followed in Cohort 1. Cohort 3 - children born to female participants exposed to Ad26.ZEBOV and/or MVA-BN-Filo who became pregnant with estimated conception within 28 days after vaccination with MVA-BN-Filo or within 3 months after vaccination with Ad26.ZEBOV. Safety data will be collected on all consenting participants. ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02967003
Study type Interventional
Source Janssen Vaccines & Prevention B.V.
Contact Use link at the bottom of the page to see if you qualify for an
Email JNJ.CT@sylogent.com
Status Recruiting
Phase Phase 3
Start date May 2016
Completion date May 2022
View Details
See also
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