A Study to Evaluate the Safety and Immunogenicity of a Candidate Ebola Vaccine in Children

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02548078
• Date of registration: 10/09/2015
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline
• Public title: A Study to Evaluate the Safety and Immunogenicity of a Candidate Ebola Vaccine in Children
• Scientific title: Safety and Immunogenicity Study of GSK Biologicals' Investigational Recombinant Chimpanzee Adenovirus Type 3-vectored Ebola Zaire Vaccine (GSK3390107A) in Children in Africa
• Date of first enrolment: November 9, 2015
• Target sample size: 600
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02548078
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Care Provider, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Mali, Nigeria, Senegal

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

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, 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.



Age minimum: 1 Year
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Virus Diseases

Intervention(s)

Biological: Nimenrix powder and solvent for solution for injection in pre-filled syringe; Meningococcal group A, C, W-135 and Y conjugate vaccine

Biological: GlaxoSmithKline (GSK) Biologicals' investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A)

Primary Outcome(s)

Number of Subjects With Serious Adverse Events, Overall [Time Frame: During the entire study period: From Screening to Month 12]

Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum [Time Frame: At Month 12]

Percentage of Subjects With Haematological Laboratory Abnormalities, Overall [Time Frame: At Day 30.]

Number of Subjects With Adverse Events of Specific Interest (AESI), by Age Stratum [Time Frame: During the 7 day follow-up period after vaccination at Day 0 (i.e. Day 0 up to Day 6)]

Number of Subjects With Solicited General Symptoms, Overall [Time Frame: During a 7-day follow-up period after each vaccination (i.e. the day of vaccination and 6 subsequent days)]

Number of Subjects With Unsolicited Adverse Events (AEs), by Age Stratum [Time Frame: During the 30-day follow-up period after each vaccination (i.e. the day of vaccination and 29 subsequent days)]

Number of Subjects With Unsolicited Adverse Events (AEs), Overall [Time Frame: During the 30-day follow-up period after each vaccination (i.e. the day of vaccination and 29 subsequent days)]

Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum [Time Frame: At Day 3]

Number of Subjects With Adverse Events of Specific Interest (AESI), Overall [Time Frame: During the 7 day follow-up period after vaccination at Day 0 (i.e., Day 0 up to Day 6)]

Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum [Time Frame: At Day 30]

Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum [Time Frame: At Day 6]

Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall [Time Frame: At Month 12.]

Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum [Time Frame: At Screening]

Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum [Time Frame: At Month 6]

Number of Subjects With Serious Adverse Events, by Age Stratum [Time Frame: During the entire study period: From Screening to Month 12]

Number of Subjects With Solicited General Symptoms, by Age Stratum [Time Frame: During a 7-day follow-up period after each vaccination (i.e. the day of vaccination and 6 subsequent days)]

Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum [Time Frame: At Month 12]

Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall [Time Frame: At Day 30.]

Number of Subjects With Solicited Local Symptoms, by Age Stratum [Time Frame: During a 7-day follow-up period after each vaccination (i.e. the day of vaccination and 6 subsequent days)]

Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum [Time Frame: At Month 6 + 30 Days]

Number of Subjects With Solicited Local Symptoms, Overall [Time Frame: During a 7-day follow-up period after each vaccination (i.e. the day of vaccination and 6 subsequent days)]

Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall [Time Frame: At Month 6 + 6 Days.]

Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum [Time Frame: At Month 6 + 30 Days]

Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum [Time Frame: At Screening]

Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall [Time Frame: At Day 3.]

Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall [Time Frame: At Month 6 + 30 Days.]

Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall [Time Frame: At Day 6.]

Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum [Time Frame: At Day 30]

Percentage of Subjects With Haematological Laboratory Abnormalities, Overall [Time Frame: At Month 6 + 6 Days.]

Percentage of Subjects With Haematological Laboratory Abnormalities, Overall [Time Frame: At Month 12.]

Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum [Time Frame: At Month 6 + 6 Days]

Percentage of Subjects With Haematological Laboratory Abnormalities, Overall [Time Frame: At Screening.]

Percentage of Subjects With Haematological Laboratory Abnormalities, Overall [Time Frame: At Month 6 + 30 Days.]

Percentage of Subjects With Haematological Laboratory Abnormalities, Overall [Time Frame: At Day 6.]

Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum [Time Frame: At Month 6]

Percentage of Subjects With Haematological Laboratory Abnormalities, Overall [Time Frame: At Month 6.]

Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum [Time Frame: At Month 6 + 6 Days]

Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall [Time Frame: At Month 6.]

Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall [Time Frame: At Screening.]

Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum [Time Frame: At Day 3]

Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum [Time Frame: At Day 6]

Percentage of Subjects With Haematological Laboratory Abnormalities, Overall [Time Frame: At Day 3.]

Secondary Outcome(s)

Anti-glycoprotein (GP) Ebola Virus Zaire (EBOV) Antibody Titers, Overall [Time Frame: At Day 0, Day 30, Month 6, Month 6 + 30 Days and Month 12.]

Anti-GP EBOV Antibody Titers, by Age Stratum [Time Frame: At Day 0, Day 30, Month 6, Month 6 + 30 Days and Month 12]

Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum [Time Frame: At Day 0, Day 30, Month 6 and Month 6 + 30 Days]

Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, Overall [Time Frame: At Day 0, Day 30, Month 6 and Month 6 + 30 Days.]

Secondary ID(s)

202090

2014-004714-28

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 03/05/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02548078