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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.
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.
