Sanofi Pasteur announced an interim analysis of data from clinical trials of the Influenza A (H1N1) 2009 Monovalent Vaccine in infants and children. This randomized, placebo-controlled, multicenter trial evaluated the immunogenicity and safety of the vaccine in 474 children, 6 months to 9 years of age. Patients received either a 7.5mcg or 15mcg dose of Influenza A (H1N1) Vaccine given on a two-dose schedule, 21 days apart. Immunogenicity was measured at day 21, just prior to administration of the second dose, and will be measured again 21 days after the second dose at day 42. In this clinical trial 76% of children 3–9 years of age and 50% of children 6–35 months of age had immune responses considered seroprotective following one 15mcg dose of vaccine. The data indicate the vaccine is immunogenic and that one dose may protect many children. However, the study suggests that two doses of vaccine will be required for optimal protection of children <10 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.
Sanofi Pasteur’s Influenza A (H1N1) 2009 Monovalent Vaccine is an inactivated influenza virus vaccine approved by the FDA for the active immunization of persons ≥6 months of age against influenza disease caused by the H1N1 2009 virus.
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