A Phase 2, randomised, observer-blind, controlled, multi country study to assess the safety and immunogenicity of a single intramuscular dose of GSK Biologicals’ investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A), in children 1 to 17 years of age in Africa - EBOLA Z CHAD3-004

GlaxoSmithKline Biologicals0 sites600 target enrollmentSeptember 21, 2015

Overview

No summary available.

Registry

who.int

Start Date

September 21, 2015

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Subject’s parent(s)/ legally acceptable representative(s) (LAR\[s]) who, in the opinion of the Investigator, can and will comply with the requirements of the protocol (e.g. availability for Diary Card completion, return for follow\-up visits, availa\-bility for clinical follow\-up throughout the study period).
•Written/ thumb printed informed consent obtained from the subject’ parent(s)/ LAR\[s] prior to performing any study specific procedure. In addition, written/ thumb printed informed assent should be obtained if appropriate (from all subjects aged 13 to 17 years and from younger subjects as per local requirements).
•A male or female child aged 1 to 17 years inclusive at the time of Screening.
•Subjects with a negative RDT test for Malaria within 30 days prior to randomisation into the study.
•Subjects with a positive RDT test for Malaria who completed antimalarial treatment at least 5 days prior to randomisation into the study.
•Healthy subjects as per Investigator judgement, as established by medical history, clinical examination and haematology/ biochemistry laboratory parameters screening before entering into the study.
•Female subjects of non\-childbearing potential may be enrolled in the study.
•\- Non\-childbearing potential is defined as premenarche or ovariectomy.
•Female subjects of childbearing potential may be enrolled in the study, if the subject:
•\- has practiced adequate contraception for 30 days prior to the Day 0 visit, and

•Child in care.
•Use of any investigational or non\-registered product (drug or vaccine) other than the study vaccine during the period starting 30 days before the Day 0 visit, or planned use during the study period.
•Previous vaccination with an investigational EBOV or Marburg vaccine, or previous vaccination with a chimpanzee adenoviral vectored investigational vaccine.
•Known prior EBOV or SUDV disease.
•Travel to country affected by the EBOV epidemic or direct contact with person with EVD within 21 days prior to the Day 0 visit.
•History of any reaction or hypersensitivity (such as anaphylaxis, urticaria (hives), respiratory difficulty, angioedema, or abdominal pain) likely to be exacerbated by any component of the study vaccine.
•Planned administration/ administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after each vaccination visit.
•Acute or chronic illness determined by medical history, clinical examination and laboratory screening tests including, but not limited to:
•Clinically significant immunosuppressive or immunodeficient condition (e.g. clinical acquired immune deficiency syndrome \[AIDS]).
•Major congenital defects.