Safety and Immunogenicity of H5N1 Adjuvanted, Inactivated, Split-Virion Pandemic Influenza Vaccine in Healthy Adults

Phase 1 Completed 251 enrolled Sanofi Pasteur, a Sanofi Company

RandomizedParallel-groupSingle-blindPrevention

Summary

The purpose of this study is to test different adjuvanted vaccine formulations as a two-dose schedule in immunologically naïve adults against one vaccine formulation without adjuvant in terms of tolerance and immunogenicity Primary Objective: To describe the safety profile and immunogenicity following each injection.

Timeline

Start: 2007-01
Primary completion: 2009-11
Completion: 2010-09

Publications

Levie K, Leroux-Roels I, Hoppenbrouwers K, Kervyn AD, Vandermeulen C, Forgus S, Leroux-Roels G, Pichon S, Kusters I. An adjuvanted, low-dose, pandemic influenza A (H5N1) vaccine candidate is safe, immunogenic, and induces cross-reactive immune responses in healthy adults. J Infect Dis. 2008 Sep 1;198(5):642-9. doi: 10.1086/590913.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	A/H5N1 inactivated, split-virion influenza vaccine	Vaccine	1.9 ug	Intramuscular
Subject	A/H5N1 inactivated, split-virion influenza vaccine	Vaccine	3.8 ug	Intramuscular
Subject	A/H5N1 inactivated, split-virion influenza vaccine	Vaccine	7.5 ug	Intramuscular
Comparator	A/H5N1 inactivated, split-virion influenza vaccine	Vaccine	7.5 ug	Intramuscular
Subject	A/H5N1 inactivated, split-virion influenza vaccine	Vaccine	15 ug	Intramuscular
Subject	A/H5N1 inactivated, split-virion influenza vaccine	Vaccine	0.5 ml	Intramuscular
Comparator	A/H5N1 inactivated, split-virion influenza vaccine	Vaccine	0.5 ml	Intramuscular

Safety and Immunogenicity of H5N1 Adjuvanted, Inactivated, Split-Virion Pandemic Influenza Vaccine in Healthy Adults

Summary

Timeline

Publications

Drugs

Indications