A Study to Evaluate the Safety and Immunogenicity of a Candidate Ebola Vaccine in Children
Condition: Virus Diseases
MeSH terms: Virus Diseases
Intervention: GlaxoSmithKline (GSK) Biologicals' investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A); Nimenrix powder and solvent for solution for injection in pre-filled syringe; Meningococcal group A, C, W-135 and Y conjugate vaccine
Intervention description: A single dose administered intramuscular; A single dose administered intramuscular
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 600.0
Sex: All
Minimum age: 1 Year
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Protection against Ebola Zaire virus

Summary:

      The purpose of this study is to assess the safety and reactogenicity of a single IM dose of
      the GSK3390107A (ChAd3 EBO-Z) vaccine, overall and in children aged 1 to 5, 6 to 12, and 13
      to 17 years, separately.

      Considering the risk of exposure to Ebola and the potential (based on animal data) for the
      investigational GSK3390107A (ChAd3-EBO-Z) vaccine to afford at least partial protection, all
      children in the study will receive the investigational GSK3390107A (ChAd3 EBO-Z) vaccine. The
      children in the Group GSK3390107A+Nimenrix will receive the investigational GSK3390107A
      (ChAd3-EBO-Z) vaccine at Day 0 of the study, whereas the children in the Group
      Nimenrix+GSK3390107A will receive Nimenrix at Day 0 (as a control). At Month 6, the children
      in the Group Nimenrix+GSK3390107A will receive the investigational GSK3390107A (ChAd3-EBO-Z)
      vaccine (provided that no safety concerns are raised), whereas the children in the Group
      GSK3390107A+Nimenrix will receive Nimenrix.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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, availability 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
             in-formed 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.

        OR 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 estab-lished by medical history,
             clinical examination and haema-tology/ biochemistry laboratory parameters screening
             be-fore entering into the study.

          -  Female subjects of non-childbearing potential may be enrolled in the study.

               -  Non-childbearing potential is defined as pre-menarche 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

               -  has a negative pregnancy test at the Day 0 visit, and

               -  has agreed to continue adequate contraception until 30 days after the Month 6
                  visit

        Exclusion Criteria:

          -  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 chim-panzee 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 ana-phylaxis, urticaria (hives),
             respiratory difficulty, angioe-dema, 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 in-cluding, but not limited to:

          -  Clinically significant immunosuppressive or immunodeficient condition (e.g. clinical
             acquired immune deficiency syndrome [AIDS]).

          -  Major congenital defects.

          -  Malnutrition (defined as weight for age Z-score less than -3, or other clinical signs
             of malnutrition).

          -  Any clinically significant haematological or biochemical laboratory abnormality.

          -  Pregnant female.

          -  Any condition that in the Investigator's opinion may po-tentially compromise subject
             safety or interfere with sub-ject assessment or compliance.