Immunogenicity and Safety of GSK Biologicals' (Pre-) Pandemic Influenza Candidate Vaccine

Phase 2 Completed 100 enrolled GlaxoSmithKline

Non-randomizedSingle-groupOpen-labelPrevention

Summary

This trial will assess the immunogenicity and safety elicited by the adjuvanted GSK Biologicals' (pre-) pandemic influenza candidate vaccine in healthy Japanese adults.

Timeline

Start: 2008-09-01
Primary completion: 2009-03-07
Completion: 2009-03-07

Outcome

Met primary endpoint

paper This fulfilled all regulatory acceptance criteria for the vaccine-homologous HI antibody level. PMID 21108818 ↗

Publications

Nagai H, Ikematsu H, Tenjinbaru K, Maeda A, Drame M, Roman FP. A phase II, open-label, multicentre study to evaluate the immunogenicity and safety of an adjuvanted prepandemic (H5N1) influenza vaccine in healthy Japanese adults. BMC Infect Dis. 2010 Nov 25;10:338. doi: 10.1186/1471-2334-10-338.

Drugs

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