Ebola
Conditions
Interventions
Vaccination of control arm
Sponsors
Janssen Vaccines and Preventions B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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)
Exclusion criteria
Exclusion criteria: 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; and tris (hydroxymethyl)-amino methane (THAM) for MVA-BN-Filo vaccine]), including known allergy to egg, egg products and aminoglycosides - Presence of acute illness (this does not include minor illnesses such as mild diarrhea or mild upper respiratory tract infection) or temperature greater than or equal to (>=)38.0 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Following local AEs: pain, erythema, and induration at the study vaccine injection site, and systemic AEs: loss of appetite, vomiting, diarrhea, decreased activity, irritability will be noted in the participant diary for 7 days. The extent (largest diameter) of any redness or induration will be measured daily and recorded, along with any functional limitation of activity.;Following local AEs: pain, erythema, and induration at the study vaccine injection site, will be noted in the participant diary for 7 days. The extent (largest diameter) of any redness or induration will be measured daily and recorded, along with any functional limitation of activity.;Percentage of participants with unsolicited AEs will be evaluated. Unsolicited AEs will include all AEs for which the participant is not specifically questioned in the participant diary.;An SAE is any adverse event (AE) that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is lifethreatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum samples will be collected for analysis of binding antibodies against EBOV GP using filovirus animal nonclinical group enzymelinked immunosorbent assay (FANG ELISA), to determine humoral responses following vaccination. | — |
Countries
Guinea, Sierra Leone
Contacts
Public ContactEdward Choi
Public Enquiries
Outcome results
None listed