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| | | ![]() Single-Dose of H1N1 Vaccine Elicits Strong Immune Response in Children: Presented at ESPID By Jenny Powers NICE, France -- May 12, 2010 -- A single dose of monovalent influenza A (H1N1) vaccine in both adjuvanted (MF59) and non-adjuvanted forms elicit a strong immune response within 3 weeks in children aged 3 to <9 years, researchers reported here at the 28th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID). Matthew Hohenboken, MD, Novartis Vaccines and Diagnostics, Cambridge, Massachusetts, presented interim results of a study here on May 7. A total of 1,254 healthy children were randomised to receive intramuscular H1N1 vaccine injections (day 1 and 22) formulated with 3.75, 7.5, 15, or 30 mcg of antigen, with or without adjuvant. Interim immunogenicity (by haemagglutination inhibition [HI] assay) and seroconversion rate were evaluated on day 22. The baseline seropositivity (HI titre >=10) rates in each group were comparable (18%-27%) and all adjuvanted groups satisfied the HI titre >=1:40 criteria after 1 dose. However, the non-adjuvanted groups met these criteria only after 2 doses. Children in all vaccine groups -- except the group that received 7.5 mcg without adjuvant -- satisfied the seroconversion criterion (prevaccination HI titre < 1:10 and post-vaccination titre >=1:40 or prevaccination HI titre >=1:10 and >=4-fold rise in postvaccination titre). All adjuvanted vaccines (3.75, 7.5, and 15 mcg antigen content) were superior to all non-adjuvanted vaccines. One episode of febrile convulsion was reported on day 4 post vaccination in the adjuvanted group. No other noteworthy difference in frequency or type of adverse events was observed between groups. Funding for this study was provided by Novartis. [Presentation title: An Adjuvanted and Non-Adjuvanted Egg-Derived, Inactivated A/H1N1 Monovalent Subunit Influenza Vaccine in Children 3 to <9 Years of Age. Abstract 520]
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