Trials / Completed
CompletedNCT02548078
A Study to Evaluate the Safety and Immunogenicity of a Candidate Ebola Vaccine in Children
Safety and Immunogenicity Study of GSK Biologicals' Investigational Recombinant Chimpanzee Adenovirus Type 3-vectored Ebola Zaire Vaccine (GSK3390107A) in Children in Africa
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 600 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 1 Year – 17 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | GlaxoSmithKline (GSK) Biologicals' investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A) | A single dose administered intramuscular |
| BIOLOGICAL | 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 |
Timeline
- Start date
- 2015-11-09
- Primary completion
- 2017-05-15
- Completion
- 2017-05-15
- First posted
- 2015-09-14
- Last updated
- 2018-05-03
- Results posted
- 2018-05-03
Locations
2 sites across 2 countries: Mali, Senegal
Source: ClinicalTrials.gov record NCT02548078. Inclusion in this directory is not an endorsement.