A study to evaluate the safety and immunogenicity of a candidate Ebola Vaccine in children.

• Register: EUCTR
• Last refreshed on: 28 September 2015
• Main ID: EUCTR2014-004714-28-Outside-EU/EEA
• Date of registration: 21/09/2015
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline Biologicals
• Public title: A study to evaluate the safety and immunogenicity of a candidate Ebola Vaccine in children.
• Scientific title: 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
• Target sample size: 600
• Recruitment status: NA
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-004714-28
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Cameroon, Ghana, Mali, Nigeria, Senegal

Contacts

• Name: Clinical Disclosure Advisor
• Affiliation: GlaxoSmithKline Biologicals

• Name: Clinical Disclosure Advisor
• Affiliation: GlaxoSmithKline Biologicals

Key inclusion & exclusion 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, 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.
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 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
- 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
Are the trial subjects under 18? yes
Number of subjects for this age range: 600
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

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 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.
•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 potentially compromise subject safety or interfere with subject assessment or compliance.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Virus Diseases [C02]

Primary immunisation against Ebola Zaire virus on healthy volunteers

Intervention(s)

Trade Name: Nimenrix
Product Name: Nimenrix
Product Code: MenACWY-TT
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: -
Other descriptive name: NEISSERIA MENINGITIDIS GROUP A POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 5-
INN or Proposed INN: -
Other descriptive name: N. MENINGITIDIS GROUP C (STRAIN C11) POLYSACCHARIDE (DE-O-ACETYLATED) CONJUGATED TO TETANUS TOXOID
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 5-
INN or Proposed INN: -
Other descriptive name: NEISSERIA MENINGITIDIS GROUP W-135 POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 5-
INN or Proposed INN: -
Other descriptive name: NEISSERIA MENINGITIDIS GROUP Y POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 5-

Product Name: Recombinant Replication-Defective Chimpanzee Adenovirus Type 3-Vectored Ebola Zaire Vaccine (ChAd3-E
Product Code: ChAd3-EBO-Z (GSK3390107A)
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: -
Current Sponsor code: ChAd3-EBO-Z
Other descriptive name: Recombinant replication-defective simian (chimpanzee-derived) adenovirus serotype 3 (ChAd3) viral vector construct engineered to express the membrane glycoprotein (GP) of the Ebolavirus Zaire strain
Concentration unit: Other
Concentration type: equal
Concentration number: 200000000000-

Primary Outcome(s)

Primary end point(s): 1. Occurrence of each solicited local and general AE
2. Occurrence of any unsolicited AE
3. Occurrence of haematological (complete blood count [CBC], including differential count and platelet count) and biochemical (alanine aminotransferase [ALT], creatinine) laboratory abnormalities
4. Occurrence of clinical symptoms of thrombocytopenia (AE of specific interest)
5. Occurrence of any SAE, in all subjects, in both groups.

Timepoint(s) of evaluation of this end point: 1. At Day 7 after each vaccination (i.e. the day of vaccination and 6 subsequent days) in all subjects, in both groups.
2. At 30 days after each vaccination (i.e. the day of vaccination and 29 subsequent days), in all subjects, in both groups.
3. At Screening, Day 3, Day 6, Day 30, Month 6, Month 6+6 days, Month 6+30 days, Month 12
4. At Day 7 after vaccination (i.e. Day 0 up to Day 6), in all subjects, in both groups
5. For the whole study duration (from Day 0 to Month 12)

Main Objective: To assess the safety and reactogenicity of a single IM dose of the ChAd3 EBO-Z vaccine, overall and in children aged 1 to 5, 6 to 12, and 13 to 17 years, separately.

Secondary Objective: To assess the humoral immunogenicity of a single IM dose of the ChAd3 EBO-Z vaccine, in terms of anti-GP EBOV antibody responses, overall and in children aged 1 to 5, 6 to 12, and 13 to 17 years separately.

Secondary Outcome(s)

Secondary end point(s): Anti-GP EBOV antibody titres, as measured by enzyme-linked immunosorbent assay (ELISA)

Timepoint(s) of evaluation of this end point: At Day 0 and Day 30 in all subjects in both groups.
At Month 6 and Month 6 + 30 days in all subjects, in the Group MENACWY TT/ EBO-Z

Secondary ID(s)

202090

Source(s) of Monetary Support

GlaxoSmithKline Biologicals