A Study of 2-dose Vaccination Regimen of Ad26.ZEBOV and MVA-BN-Filo in Infants
Condition: Ebola Virus Disease
MeSH terms: Virus Diseases; Hemorrhagic Fever, Ebola
Intervention: Ad26.ZEBOV; MVA-BN-Filo; MenACWY
Intervention description: Participants will receive 0.5 mL IM injection of Ad26.ZEBOV as first vaccination.; Participants will receive 0.5 mL IM injection of MVA-BN-Filo as second vaccination.; Participants will receive 0.5 mL IM injection of MenACWY.
Intervention MeSH terms: Smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 108.0
Sex: All
Minimum age: 4 Months
Maximum age: 11 Months
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to assess the safety and reactogenicity of a heterologous 2-dose
      regimen utilizing Ad26.ZEBOV (first vaccination; Dose 1) and MVA-BN-Filo (second vaccination;
      Dose 2) administered intramuscularly (IM) on Days 1 and 57, respectively (Main Study) and
      also to provide the heterologous 2-dose vaccination regimen (Ad26.ZEBOV on Day 1 and
      MVABN-Filo on Day 57) to participants in the control arm of the main study (Extension Phase).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Parent(s) (preferably both if available or as per local requirements)/guardian must
             sign an informed consent form (ICF) indicating that he or she understands the purpose
             of, and procedures required for the study, and potential risks and benefits of the
             study, and are willing to allow their child to participate in the study

          -  Parent(s)/guardian are willing/able to ensure that their child adheres to the
             prohibitions and restrictions

          -  The parent(s)/guardian must be at or above the age of legal consent in the
             jurisdiction in which the study is taking place

          -  Infant must be healthy in the investigator's clinical judgment (and the
             parent(s)/guardian) on the basis of medical history, physical examination, vital signs
             and clinical laboratory tests performed at screening

          -  Infant has received all routine immunizations appropriate for his or her age at the
             time of enrollment as documented in the vaccination cards presented by the
             parent(s)/guardian. Participants are allowed to catch up on routine immunizations if
             needed (support for beneficial vaccines may be offered to participants)

          -  Extension Phase: Prior enrollment in the control arm of the main study and did not
             withdraw consent, and receipt of at least the first vaccination (Dose 1) in the main
             study

        Exclusion Criteria:

          -  Having received any candidate or other Ebola vaccine

          -  History of Ebola virus disease (EVD), or prior exposure to Ebola virus, including
             travel to an area with a current Ebola outbreak less than 1 month prior to screening

          -  Having received any experimental candidate Ad26- or modified vaccinia ankara
             (MVA)-based vaccine in the past

          -  Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines
             or vaccine products (including any of the constituents of the study vaccines [for
             example, polysorbate 80, ethylenediaminetetraacetic acid (EDTA) or L-histidine for
             Ad26.ZEBOV vaccine; tris (hydroxymethyl)-amino methane (THAM) for MVA-BN-Filo vaccine
             and Neisseria meningitidis polysaccharide or tetanus toxoid for MenACWY]), including
             known allergy to chicken or egg proteins and aminoglycosides (gentamicin)

          -  Presence of acute illness (this does not include minor illnesses such as mild diarrhea
             or mild upper respiratory tract infection) or axillary temperature greater than or
             equal to (>=) 37.5 degree celsius on Day 1. Participants with such symptoms will be
             excluded from enrollment at that time but may be rescheduled for enrollment at a later
             date

          -  Extension Phase: Having received any candidate or other Ebola vaccine