Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Influenza Vaccine(s) GSK3206641A and GSK3206640A Administered in Adults 18 to 64 Years of Age

NCT01999842 ↗

Phase 1 Completed 424 enrolled GlaxoSmithKline

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The purpose of this study is to evaluate the safety and immunogenicity of different formulations of GSK Biologicals' H7N9 influenza vaccine in subjects 18 to 64 years of age.

Timeline

Start: 2013-11-25
Primary completion: 2014-02-01
Completion: 2015-01-19

Outcome

Met primary endpoint

paper All adjuvanted vaccines met regulatory acceptance criteria. PMID 27609809 ↗

Publications

Madan A, Segall N, Ferguson M, Frenette L, Kroll R, Friel D, Soni J, Li P, Innis BL, Schuind A. Immunogenicity and Safety of an AS03-Adjuvanted H7N9 Pandemic Influenza Vaccine in a Randomized Trial in Healthy Adults. J Infect Dis. 2016 Dec 1;214(11):1717-1727. doi: 10.1093/infdis/jiw414. Epub 2016 Sep 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GSK3206640A	Unknown	—	Intramuscular
Subject	GSK3206641A	Unknown	—	Intramuscular