tetano
Editor, Senior Moderator
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.
http://www.docguide.com/news/content.nsf/news/852576140048867C85257721006D33D8
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.
http://www.docguide.com/news/content.nsf/news/852576140048867C85257721006D33D8