Long-term Safety Follow-up of Participants Exposed to the Candidate Ebola Vaccines Ad26.ZEBOV and/or MVA-BN-Filo
Condition: Hemorrhagic Fever, Ebola
MeSH terms: Hemorrhagic Fever, Ebola; Hemorrhagic Fevers, Viral
Intervention: Ad26.ZEBOV; MVA-BN-Filo
Intervention description: No vaccine will be administered in the current study. Safety data will be collected from participants who were previously exposed to Ad26.ZEBOV vaccine in Phase 1, 2, or 3 clinical studies up to 60 months and also safety data will be collected from live born children to female participants up to 60 months after birth.; No vaccine will be administered in the current study. Safety data will be collected from participants who were previously exposed to MVA-BN-Filo vaccine in Phase 1, 2, or 3 clinical studies up to 60 months and also safety data will be collected from live born children to female participants up to 60 months after birth.
Intervention MeSH terms: Smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 677.0
Sex: All
Minimum age: 0 Years
Maximum age: 71 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy; Ebola viruses; Ebola virus disease (EVD); Filoviruses; Safety; Human adenovirus serotype 26 (Ad26) expressing the Ebola virus Mayinga variant glycoprotein (Ad26.ZEBOV); Modified Vaccinia Virus Ankara - Bavarian Nordic Filo-vector (MVA-BN Filo); Hemorrhagic fever

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female who participated in a Phase 1, 2 or 3 clinical study with Human
             adenovirus serotype 26 (Ad26) expressing the Ebola virus Mayinga variant glycoprotein
             (Ad26.ZEBOV) and/or Modified Vaccinia Virus Ankara - Bavarian Nordic Filo-vector
             (MVA-BN-Filo) and has been exposed to Ad26.ZEBOV and/or MVA-BN-Filo (Cohort 1)

          -  Female who participated in a Phase 1, 2 or 3 clinical study with Ad26.ZEBOV and/or
             MVA-BN-Filo and became pregnant with estimated conception within 28 days after
             vaccination with MVA-BN-Filo or within 3 months after vaccination with Ad26.ZEBOV
             (Cohort 2)

          -  Child born to female participants exposed to Ad26.ZEBOV and/or MVA-BN-Filo in a Phase
             1, 2, or 3 clinical study who became pregnant with estimated conception within 28 days
             after vaccination with MVA-BN-Filo or within 3 months after vaccination with
             Ad26.ZEBOV (Cohort 3)

          -  Must sign an informed consent form for the current study (or their legally acceptable
             representative must sign) indicating that he or she understands the purpose of, and
             procedures required for, the study and is willing to participate in the study (or let
             their child participate); Assent is also required of children capable of understanding
             the nature of the study (typically 7 years of age and older)

        Exclusion Criteria:

          -  No exclusions beyond those that are not meeting the inclusion criteria