Sanofi Pasteur, the vaccines division of the sanofi-aventis Group, announced an interim analysis of data from clinical trials of the US licensed Influenza A (H1N1) 2009 Monovalent Vaccine in adults 18 years through 64 years of age and over the age of 65 years.
These data indicate that a single 15 mcg dose of Sanofi Pasteur's Influenza A (H1N1) 2009 Monovalent Vaccine, administered to adults, including the oldest study participants, induces a robust antibody response 21 days post-vaccination that is considered protective. These data from a placebo controlled study of 849 adults help confirm preliminary data from a few vaccine recipients 10-days post immunization reported from another study by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH).
"The development of an A (H1N1) vaccine and the efficient execution of clinical trials to evaluate the safety and immunogenicity of this vaccine demonstrate the tremendous achievements that can occur when public and private sectors work collaboratively to address public health challenges," said Wayne Pisano, president and chief executive officer of Sanofi Pasteur. "The independent clinical trials conducted by NIH and Sanofi Pasteur provide a rich data set that can be utilized to make informed decisions on vaccine administration. In addition, the consistency of findings among these separate independent trials will help build public confidence in the vaccine."
Sanofi Pasteur began clinical trials in the US on August 6 to test the immunogenicity and safety of its Influenza A (H1N1) 2009 Monovalent Vaccine. Clinical trials are being conducted in adults 18 years of age and older including a group 65 years of age and older, and in children 6 months of age through nine years of age. Final data from these clinical trials, following a second dose of vaccine, will provide additional information to guide recommendations on the optimal dosage, number of doses and schedule. Influenza A (H1N1) 2009 Monovalent Vaccine was licensed by the US Food and Drug Administration on September 15 as a monovalent strain change to Sanofi Pasteur's licensed seasonal influenza vaccine.
The US licensed Influenza A (H1N1) 2009 Monovalent Vaccine manufactured by Sanofi Pasteur is an inactivated influenza virus vaccine indicated for active immunization of persons six months of age and older against influenza disease caused by pandemic (H1N1) 2009 virus.