A Study of Different Formulations of an A/H1N1 Pandemic Vaccine in Healthy Adults and the Elderly

Phase 2 Completed 849 enrolled Sanofi Pasteur, a Sanofi Company

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine. Primary Objectives: * To describe the immunogenicity of the candidate vaccines after each injection. * To describe the safety of the candidate vaccines after each injection.

Timeline

Start: 2009-08
Primary completion: 2010-03
Completion: 2010-12

Publications

Results Plennevaux E, Sheldon E, Blatter M, Reeves-Hoche MK, Denis M. Immune response after a single vaccination against 2009 influenza A H1N1 in USA: a preliminary report of two randomised controlled phase 2 trials. Lancet. 2010 Jan 2;375(9708):41-8. doi: 10.1016/S0140-6736(09)62026-2. Epub 2009 Dec 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Monovalent Subvirion A/H1N1 Influenza vaccine	Vaccine	7.5 ug	Intramuscular
Subject	Monovalent Subvirion A/H1N1 Influenza vaccine	Vaccine	15 ug	Intramuscular
Subject	Monovalent Subvirion A/H1N1 Influenza vaccine	Vaccine	30 ug	Intramuscular

A Study of Different Formulations of an A/H1N1 Pandemic Vaccine in Healthy Adults and the Elderly

Summary

Timeline

Publications

Drugs

Indications