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

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.

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