tetano
Editor, Senior Moderator
Pediatr Infect Dis J. 2014 Jun 20. [Epub ahead of print]
Immunogenicity and Tolerability of an MF59?-Adjuvanted, Egg-Derived, A/H1N1 Pandemic Influenza Vaccine in Children 6-35 Months of Age.
Knuf M1, Leroux-Roels G, R?mke HC, Abarca K, Rivera L, Lattanzi M, Pedotti P, Arora A, Kieninger-Baum D, Cioppa GD.
Author information
Abstract
BACKGROUND::
Vaccines against pandemic A/H1N1 influenza should provide protective immunity in children, because they are at greater risk of disease than adults. This study was conducted to identify the optimal dose of an MF59-adjuvanted, egg-derived, A/H1N1 influenza vaccine for young children.
METHODS::
Children 6-11 months (N=144) and 12-35 months (N=186) of age received vaccine formulations containing either 3.75 μg antigen with half the standard dose of MF59, or 7.5 μg antigen with a standard dose MF59, or a non-adjuvanted formulation containing 15 ?g antigen (children 12-35 months only). Participants were given two primary vaccine doses three weeks apart, followed by one booster dose of MF59-adjuvanted seasonal influenza vaccine one year later. Immunogenicity was assessed by hemagglutination inhibition and microneutralization assays.
RESULTS::
All vaccine formulations were highly immunogenic and met all three European licensure criteria after two doses. MF59-adjuvanted vaccines met all licensure criteria after one dose in both age cohorts, while non-adjuvanted vaccine did not meet all criteria after one dose in children 12-35 months. A single booster dose was highly immunogenic and stable antibody persistence was observed in response to all vaccines. All vaccines were well tolerated.
CONCLUSIONS::
In this study a single dose of 3.75μg antigen with half the standard dose of MF59 was shown to be optimal, providing adequate levels of immediate and long-term antibodies in pediatric subjects 6-35 months of age. These data demonstrated that MF59 adjuvant allowed for reduced antigen content and promoted significant long-term antibody persistence in children, with a satisfactory safety profile.
PMID:
24978857
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/24978857
Immunogenicity and Tolerability of an MF59?-Adjuvanted, Egg-Derived, A/H1N1 Pandemic Influenza Vaccine in Children 6-35 Months of Age.
Knuf M1, Leroux-Roels G, R?mke HC, Abarca K, Rivera L, Lattanzi M, Pedotti P, Arora A, Kieninger-Baum D, Cioppa GD.
Author information
Abstract
BACKGROUND::
Vaccines against pandemic A/H1N1 influenza should provide protective immunity in children, because they are at greater risk of disease than adults. This study was conducted to identify the optimal dose of an MF59-adjuvanted, egg-derived, A/H1N1 influenza vaccine for young children.
METHODS::
Children 6-11 months (N=144) and 12-35 months (N=186) of age received vaccine formulations containing either 3.75 μg antigen with half the standard dose of MF59, or 7.5 μg antigen with a standard dose MF59, or a non-adjuvanted formulation containing 15 ?g antigen (children 12-35 months only). Participants were given two primary vaccine doses three weeks apart, followed by one booster dose of MF59-adjuvanted seasonal influenza vaccine one year later. Immunogenicity was assessed by hemagglutination inhibition and microneutralization assays.
RESULTS::
All vaccine formulations were highly immunogenic and met all three European licensure criteria after two doses. MF59-adjuvanted vaccines met all licensure criteria after one dose in both age cohorts, while non-adjuvanted vaccine did not meet all criteria after one dose in children 12-35 months. A single booster dose was highly immunogenic and stable antibody persistence was observed in response to all vaccines. All vaccines were well tolerated.
CONCLUSIONS::
In this study a single dose of 3.75μg antigen with half the standard dose of MF59 was shown to be optimal, providing adequate levels of immediate and long-term antibodies in pediatric subjects 6-35 months of age. These data demonstrated that MF59 adjuvant allowed for reduced antigen content and promoted significant long-term antibody persistence in children, with a satisfactory safety profile.
PMID:
24978857
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/24978857