Immunogenicity & Safety of GSK's Influenza Vaccine 1557484A Given to Adults Aged ≥18 Years

Summary

The purpose of this Phase 3, observer-blind, placebo-controlled, multi-center study is to characterize the immunogenicity \& safety of the investigation vaccination regimen of GSK 1557484A vaccine given to adults aged ≥18 years.

Timeline

Start

2008-01-23

Primary completion

2008-10-15

Completion

2009-03-19

Outcome

Met primary endpoint

paper Humoral antibody responses in the H5N1 vaccine groups fulfilled US and European immunogenicity licensure criteria for pandemic vaccines in all age strata 21 days PMID 21606531 ↗

paper At 6 months after the administration of the primary dose, serum antibody seroconversion rates continued to fulfill licensure criteria. PMID 21606531 ↗

Publications

• Langley JM, Risi G, Caldwell M, Gilderman L, Berwald B, Fogarty C, Poling T, Riff D, Baron M, Frenette L, Sheldon E, Collins H, Shepard M, Dionne M, Brune D, Ferguson L, Vaughn D, Li P, Fries L. Dose-sparing H5N1 A/Indonesia/05/2005 pre-pandemic influenza vaccine in adults and elderly adults: a phase III, placebo-controlled, randomized study. J Infect Dis. 2011 Jun 15;203(12):1729-38. doi: 10.1093/infdis/jir172.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted	Vaccine	3.75 ug	Intramuscular

Indications