Immunogenicity and Safety Study of a GSK Influenza Vaccine Candidate in Adults.

Phase 1 Completed 420 enrolled GlaxoSmithKline

RandomizedParallel-groupSingle-blindPrevention

Summary

The purpose of this study is to evaluate the safety and immunogenicity of GSK influenza vaccine candidate compared to a licensed trivalent influenza vaccine in adults.

Timeline

Start: 2008-07-14
Primary completion: 2009-01-28
Completion: 2009-01-28

Outcome

Met primary endpoint

paper Pre-defined non-inferiority and superiority criteria were reached for both QIVs compared to the TIVs. PMID 23688546 ↗

Publications

Beran J, Peeters M, Dewe W, Raupachova J, Hobzova L, Devaster JM. Immunogenicity and safety of quadrivalent versus trivalent inactivated influenza vaccine: a randomized, controlled trial in adults. BMC Infect Dis. 2013 May 20;13:224. doi: 10.1186/1471-2334-13-224.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GSK 2115160A	Vaccine	—	Intramuscular
Comparator	GSK Biologicals' trivalent influenza vaccine	Vaccine	—	Intramuscular