A Phase 2 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of a Heterologous 2-dose Vaccination Regimen Using Ad26.ZEBOV and MVA-BN®-Filo in Infants Aged 4-11 Months in Guinea and Sierra Leone

Janssen Vaccines & Prevention B.V.0 个研究点开始时间: 2021年3月10日最近更新: 2022年4月4日

适应症

试验速览

暂无简介。

•Main Study - 1 - 5:
•1. Parent(s) (preferably both if available or as per local requirements)/guardian must sign an 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.
•2. Parent(s)/guardian are willing/able to ensure that their child adheres to the prohibitions and restrictions specified in this protocol (see Section 4.3).
•3. The parent(s)/guardian must be at or above the age of legal consent in the jurisdiction in which the study is taking place.
•4. Infant must be aged between 4 and 11 months (ie, ?4 months up to <12 months) on the day of randomization.
•5. 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.
•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
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 107
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Main Study:
•1. Having received any candidate or other Ebola vaccine.
•2. History of EVD, or prior exposure to Ebola virus, including travel to an area with a current Ebola outbreak less than 1 month prior to screening.
•3. Having received any experimental candidate Ad26- or MVA-based vaccine in the past.
•4. 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 [eg, polysorbate 80, ethylenediaminetetraacetic acid (EDTA) or Lhistidine 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).
•5.Presence of acute illness (this does not include minor illnesses such as mild diarrhea or mild upper respiratory tract infection) or axillary temperature =37.5ºC 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

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