Overview

This trial is active, not recruiting.

Condition virus diseases
Treatments 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
Phase phase 2
Sponsor GlaxoSmithKline
Start date November 2015
End date June 2017
Trial size 600 participants
Trial identifier NCT02548078, 2014-004714-28, 202090

Summary

The purpose of this study is 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 Considering the risk of exposure to Ebola and the potential (based on animal data) for the investigational ChAd3-EBO-Z vaccine to afford at least partial protection, all children in the study will receive the investigational ChAd3 EBO-Z vaccine. The children in the Group EBO-Z/ MENACWY-TT will receive the investigational ChAd3-EBO-Z vaccine at Day 0 of the study, whereas the children in the Group MENACWY-TT/ EBO-Z will receive Nimenrix at Day 0 (as a control). At Month 6, the children in the Group MENACWY-TT/ EBO-Z will receive the investigational ChAd3-EBO-Z vaccine (provided that no safety concerns are raised), whereas the children in the Group EBO-Z/ MENACWY-TT will receive Nimenrix..

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model crossover assignment
Masking double blind (subject, caregiver, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Subjects in Group EBO-Z/ MENACWY-TT will receive the investigational ChAd3-EBO-Z vaccine at the Day 0 visit and Nimenrix at the Month 6 visit.
glaxosmithkline (gsk) biologicals' investigational recombinant chimpanzee adenovirus type 3-vectored ebola zaire vaccine (chad3-ebo-z) (gsk3390107a)
A single dose administered intramuscular
nimenrix powder and solvent for solution for injection in pre-filled syringe; meningococcal group a, c, w-135 and y conjugate vaccine
A single dose administered intramuscular
(Experimental)
Subjects in Group MENACWY-TT/ EBO-Z will receive Nimenrix at the Day 0 visit and the investigational ChAd3-EBO-Z vaccine at the Month 6 visit.
glaxosmithkline (gsk) biologicals' investigational recombinant chimpanzee adenovirus type 3-vectored ebola zaire vaccine (chad3-ebo-z) (gsk3390107a)
A single dose administered intramuscular
nimenrix powder and solvent for solution for injection in pre-filled syringe; meningococcal group a, c, w-135 and y conjugate vaccine
A single dose administered intramuscular

Primary Outcomes

Measure
Occurrence of each solicited local and general AE
time frame: At Day 7 after each vaccination (i.e. the day of vaccination and 6 subsequent days) in all subjects, in both groups.
Occurrence of any unsolicited AE
time frame: At 30 days after each vaccination (i.e. the day of vaccination and 29 subsequent days), in all subjects, in both groups.
Occurrence of haematological (complete blood count [CBC], including differential count and platelet count) and biochemical (alanine aminotransferase [ALT], creatinine) laboratory abnormalities
time frame: At Screening.
Occurrence of haematological (complete blood count [CBC], including differential count and platelet count) and biochemical (alanine aminotransferase [ALT], creatinine) laboratory abnormalities
time frame: At Day 3.
Occurrence of haematological (complete blood count [CBC], including differential count and platelet count) and biochemical (alanine aminotransferase [ALT], creatinine) laboratory abnormalities
time frame: At Day 6.
Occurrence of haematological (complete blood count [CBC], including differential count and platelet count) and biochemical (alanine aminotransferase [ALT], creatinine) laboratory abnormalities
time frame: At Day 30.
Occurrence of haematological (complete blood count [CBC], including differential count and platelet count) and biochemical (alanine aminotransferase [ALT], creatinine) laboratory abnormalities
time frame: At Month 6.
Occurrence of haematological (complete blood count [CBC], including differential count and platelet count) and biochemical (alanine aminotransferase [ALT], creatinine) laboratory abnormalities
time frame: At Month 6 + 6 days
Occurrence of haematological (complete blood count [CBC], including differential count and platelet count) and biochemical (alanine aminotransferase [ALT], creatinine) laboratory abnormalities
time frame: At Month 6 + 30 days
Occurrence of haematological (complete blood count [CBC], including differential count and platelet count) and biochemical (alanine aminotransferase [ ALT], creatinine) laboratory abnormalities
time frame: At Month 12
Occurrence of clinical symptoms of thrombocytopenia (AE of specific interest)
time frame: At Day 7 after vaccination (i.e. Day 0 up to Day 6), in all subjects, in both groups
Occurrence of any SAE, in all subjects, in both groups.
time frame: For the whole study duration (from Day 0 to Month 12)

Secondary Outcomes

Measure
Anti-GP EBOV antibody titres, as measured by enzyme-linked immunosorbent assay (ELISA)
time frame: At Day 0 and Day 30 in all subjects in both groups.
Anti-GP EBOV antibody titres, as measured by enzyme-linked immunosorbent assay (ELISA)
time frame: At Month 6 and Month 6 + 30 days in all subjects, in the Group MENACWY TT/ EBO-Z

Eligibility Criteria

Male or female participants from 1 year up to 17 years old.

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.

Additional Information

Official title Safety and Immunogenicity Study of GSK Biologicals' Investigational Recombinant Chimpanzee Adenovirus Type 3-vectored Ebola Zaire Vaccine (GSK3390107A) in Children in Africa
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by GlaxoSmithKline.