Immunogenicity, Safety and Tolerability of Prepandemic Influenza and Seasonal Influenza Vaccine in Adult Subjects

Summary

This study evaluates the immunogenicity, safety and tolerability of an H5N1 vaccine with a seasonal trivalent influenza vaccine, containing the strains recommended by WHO for the 2007 influenza season in the Southern Hemisphere.

Timeline

Start

2007-04

Primary completion

2008-12

Completion

2008-12

Outcome

Met primary endpoint

paper the vaccine for seasonal influenza met all CHMP criteria PMID 21606530 ↗

paper Responses to seasonal strains met all European licensure criteria PMID 23536690 ↗

Publications

• Results Lopez P, Caicedo Y, Sierra A, Tilman S, Banzhoff A, Clemens R. Combined, concurrent, and sequential administration of seasonal influenza and MF59-adjuvanted A/H5N1 vaccines: a phase II randomized, controlled trial of immunogenicity and safety in healthy adults. J Infect Dis. 2011 Jun 15;203(12):1719-28. doi: 10.1093/infdis/jir191.
• Lopez P, Caicedo Y, Sierra A, Tilman S, Clemens R, Banzhoff A. Combined administration of MF59-adjuvanted A/H5N1 prepandemic and seasonal influenza vaccines: long-term antibody persistence and robust booster responses 1 year after a one-dose priming schedule. Clin Vaccine Immunol. 2013 May;20(5):753-8. doi: 10.1128/CVI.00626-12. Epub 2013 Mar 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	MF59-eH5N1	Vaccine	—	—
Subject	eTIV_a	Unknown	—	—

Indications