tetano
Editor, Senior Moderator
Pediatr Infect Dis J. 2012 Apr 4. [Epub ahead of print]
A Dose-Range Study of MF59?-Adjuvanted Versus Non-Adjuvanted Monovalent A/H1N1 Pandemic Influenza Vaccine in 6 to <36 Month-Old Children.
Block SL, Ruiz-Palacios GM, Guerrero ML, Beygo J, Sales V, Holmes SJ.
Source
1Kentucky Pediatric and Adult Research Inc., Bardstown Kentucky, USA 2Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico City, Mexico 3Novartis Vaccines and Diagnostics, Cambridge, MA, USA.
Abstract
BACKGROUND:
The successful vaccination of children 6 to 36 months of age against 2009 A/H1N1 influenza was essential to help reduce the burden of pandemic disease in both the pediatric and adult populations.
OBJECTIVES:
We compared the immunogenicity and safety of four alternative monovalent vaccine formulations to identify which provided optimal levels of seroprotection according to U.S. and E.U. licensure criteria.
SUBJECTS AND METHODS:
A total of 654 healthy subjects (6 to <36 months-old) were given two vaccine doses three weeks apart. Participants were assigned to one of four immunization groups, receiving MF59?-adjuvanted (Novartis Vaccines, Marburg, Germany) vaccine either containing 3.75 μg or 7.5 μg of A/H1N1 California/7/2009 antigen, or non-adjuvanted vaccine containing 7.5 μg or 15 μg of antigen. Antibody titers were assessed by hemagglutination inhibition assay 3 weeks, 3 months, and one year after immunization. Vaccine safety was monitored throughout the study.
RESULTS:
After one dose, both adjuvanted formulations met the U.S. and E.U. criteria for seroconversion; the 15 μg non-adjuvanted vaccine met the E.U. criterion for seroconversion alone. The U.S. and E.U. criteria for seroprotection were only met by adjuvanted groups. MF59-adjuvanted formulations alone resulted in clinically significant persisting antibody titers after twelve months. All vaccines were well tolerated.
CONCLUSIONS:
A single dose of MF59-adjuvanted vaccine containing 3.75 μg A/H1N1 antigen was highly immunogenic, met both the U.S. and E.U. licensure criteria, and was well tolerated. These data support the suitability of this monovalent vaccine formulation for pandemic use in children 6 to <36 months of age.
PMID:
22481427
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/22481427
A Dose-Range Study of MF59?-Adjuvanted Versus Non-Adjuvanted Monovalent A/H1N1 Pandemic Influenza Vaccine in 6 to <36 Month-Old Children.
Block SL, Ruiz-Palacios GM, Guerrero ML, Beygo J, Sales V, Holmes SJ.
Source
1Kentucky Pediatric and Adult Research Inc., Bardstown Kentucky, USA 2Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico City, Mexico 3Novartis Vaccines and Diagnostics, Cambridge, MA, USA.
Abstract
BACKGROUND:
The successful vaccination of children 6 to 36 months of age against 2009 A/H1N1 influenza was essential to help reduce the burden of pandemic disease in both the pediatric and adult populations.
OBJECTIVES:
We compared the immunogenicity and safety of four alternative monovalent vaccine formulations to identify which provided optimal levels of seroprotection according to U.S. and E.U. licensure criteria.
SUBJECTS AND METHODS:
A total of 654 healthy subjects (6 to <36 months-old) were given two vaccine doses three weeks apart. Participants were assigned to one of four immunization groups, receiving MF59?-adjuvanted (Novartis Vaccines, Marburg, Germany) vaccine either containing 3.75 μg or 7.5 μg of A/H1N1 California/7/2009 antigen, or non-adjuvanted vaccine containing 7.5 μg or 15 μg of antigen. Antibody titers were assessed by hemagglutination inhibition assay 3 weeks, 3 months, and one year after immunization. Vaccine safety was monitored throughout the study.
RESULTS:
After one dose, both adjuvanted formulations met the U.S. and E.U. criteria for seroconversion; the 15 μg non-adjuvanted vaccine met the E.U. criterion for seroconversion alone. The U.S. and E.U. criteria for seroprotection were only met by adjuvanted groups. MF59-adjuvanted formulations alone resulted in clinically significant persisting antibody titers after twelve months. All vaccines were well tolerated.
CONCLUSIONS:
A single dose of MF59-adjuvanted vaccine containing 3.75 μg A/H1N1 antigen was highly immunogenic, met both the U.S. and E.U. licensure criteria, and was well tolerated. These data support the suitability of this monovalent vaccine formulation for pandemic use in children 6 to <36 months of age.
PMID:
22481427
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/22481427