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Sanofi Pasteur Announces Results of U.S. Clinical Trials in Adults Following One Dose of Influenza A (H1N1) Vaccine
Date:10/1/2009

age and older, and in children 6 months of age through 9 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 U.S. Food and Drug Administration on September 15 as a monovalent strain change to Sanofi Pasteur's licensed seasonal influenza vaccine.

Sanofi Pasteur Clinical Trial Design

Sanofi Pasteur reported today on interim immunogenicity and safety results following one dose of the company's Influenza A (H1N1) 2009 Monovalent Vaccine in adults. Interim data from clinical trials in children, 21 days post-dose vaccination, will be available in early October. Both clinical trials are continuing to evaluate immunogenicity and safety following a second dose of vaccine.

The multi-center, randomized, placebo-controlled adult trial is being conducted in 849 adults divided into two age cohorts: 18 years through 64 years of age or 65 years of age and older. Study participants in each age cohort were randomized to four treatment groups. Three groups received a 0.5 mL injection of non-adjuvanted vaccine formulated to be either 7.5 mcg, 15 mcg or 30 mcg. The fourth group received the saline placebo control.

In the trial two doses of vaccine were administered, the second dose 21 days after the first. Immunogenicity was measured at day 21 prior to administration of the second dose and will be measured again 21 days after the second dose at day 42. An antibody titer of 1:40 or greater is generally considered a marker of seroprotection. A lower rise in antibody titers following vaccination may minimize the occurrence of disease and its consequences but is not considered seroprotective. Adverse events are being monitored throughout the clinical trial and will continue for 6 months after the second dose of vaccine.


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