Study to Evaluate the Safety and Immunogenicity of a Pandemic Influenza Vaccine in Adults Aged Between 18 and 60 Years

Summary

Today, the leading contender for the next pandemic of influenza is H5N1, a strain of avian virus. Prevention and control of a pandemic will depend on the rapid production and worldwide distribution of specific pandemic vaccines. Candidate 'pandemic-like' vaccines must be developed and tested in clinical trials to determine the most optimal formulation and the best vaccination schedule.This study is designed to test in healthy adults aged between 18-60 years the reactogenicity and immunogenicity of one and two administrations of a candidate pandemic H5N1 vaccine formulated from Split Virus. The vaccines contain different antigen doses . For each dose, adjuvanted vaccine will be compared to the plain vaccine in order to detect the optimal formulation for immunization against the H5N1 influenza strain.

Timeline

Start

2006-03-27

Primary completion

2006-10-28

Completion

2006-10-28

Publications

• Leroux-Roels I, Bernhard R, Gerard P, Drame M, Hanon E, Leroux-Roels G. Broad Clade 2 cross-reactive immunity induced by an adjuvanted clade 1 rH5N1 pandemic influenza vaccine. PLoS One. 2008 Feb 27;3(2):e1665. doi: 10.1371/journal.pone.0001665.
• Leroux-Roels I, Borkowski A, Vanwolleghem T, Drame M, Clement F, Hons E, Devaster JM, Leroux-Roels G. Antigen sparing and cross-reactive immunity with an adjuvanted rH5N1 prototype pandemic influenza vaccine: a randomised controlled trial. Lancet. 2007 Aug 18;370(9587):580-9. doi: 10.1016/S0140-6736(07)61297-5.

Drugs

Indications