Virus Diseases Clinical Trial
Official title:
Safety and Immunogenicity Study of GSK Biologicals' Investigational Recombinant Chimpanzee Adenovirus Type 3-vectored Ebola Zaire Vaccine (GSK3390107A) in Children in Africa
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.
n/a
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