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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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.

Detailed Summary: 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.
Sponsor: Janssen Vaccines & Prevention B.V.

Current Primary Outcome:

  • Percentage of Serious Adverse Events (SAEs) [ Time Frame: up to 60 months after prime vaccination (including the duration in the participants original study) ]
  • Percentage of pregnancies with estimated conception within 28 days after vaccination with MVA-BN-Filo or within 3 months after vaccination with Ad26.ZEBOV [ Time Frame: up to 3 months after vaccination ]
  • Percentage of pregnancies (with estimated conception within 28 days after vaccination with MVA-BN-Filo or within 3 months after vaccination with Ad26.ZEBOV) by pregnancy outcome [ Time Frame: up to 3 months after vaccination ]
  • Percentage of live-born children from a pregnancy with estimated conception within 28 days after vaccination with MVA-BN-Filo or within 3 months after vaccination with Ad26.ZEBOV [ Time Frame: up to 3 months after vaccination ]
  • Percentage of serious adverse events in children born from a pregnancy with estimated conception within 28 days after vaccination with MVA-BN-Filo or within 3 months after vaccination with Ad26.ZEBOV [ Time Frame: Up to 60 months after birth in children born from an eligible pregnancy (with estimated conception within 28 days after vaccination with MVA-BN-Filo or within 3 months after vaccination with Ad26.ZEBOV) ]


Original Primary Outcome:

  • Percentage of Serious Adverse Events (SAEs) [ Time Frame: up to 60 months after prime vaccination (including the duration in the participants original study) ]
  • Percentage of pregnancies with estimated conception within 28 days after vaccination with MVA-BN-Filo or within 3 months after vaccination with Ad26.ZEBOV [ Time Frame: up to 3 months after vaccination ]
  • Percentage of pregnancies (with estimated conception within 28 days after vaccination with MVA-BN-Filo or within 3 months after vaccination with Ad26.ZEBOV) by pregnancy outcome [ Time Frame: up to 3 months after vaccination ]
  • Percentage of live-born children from a pregnancy with estimated conception within 28 days after vaccination with MVA-BN-Filo or within 3 months after vaccination with Ad26.ZEBOV [ Time Frame: up to 3 months after vaccination ]
  • Percentage of serious adverse events in children born from a pregnancy with estimated conception within 28 days after vaccination with MVA-BN-Filo or within 3 months after vaccination with Ad26.ZEBOV [ Time Frame: up to 60 months after birth ]


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Janssen Vaccines & Prevention B.V.

Dates:
Date Received: January 8, 2016
Date Started: May 31, 2016
Date Completion: April 11, 2023
Last Updated: March 28, 2017
Last Verified: March 2017