At a glance
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A Study to Evaluate GlaxoSmithKline (GSK) Biologicals' Investigational Vaccination Regimen in Healthy Young Adults
In Brief
A Phase 1 clinical trial evaluating GSK2231395A and Engerix-B for Streptococcus Pneumoniae and Haemophilus Influenzae. Completed, enrolled 40 participants across 1 site.
Detailed Summary
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of 2 formulations of a non-typable Haemophilus influenzae and pneumococcal candidate vaccine in young adults. Subjects will be vaccinated 2 times in an observer-blind manner with an interval of 2 months. The subjects receiving Engerix-B will receive in an open-manner a third dose of the vaccine at Month 6. The protocol posting has been updated following a protocol amendment.
Study Details
Timeline
Interventions
Two doses will be administered intramuscularly; one dose at Month 0 and the second dose a Month 2. Two different formulations of this vaccine will be tested.
Two doses will be administered intramuscularly; one dose at Month 0 and the second dose a Month 2.