tetano
Editor, Senior Moderator
Pediatr Infect Dis J. 2012 Feb 1. [Epub ahead of print]
Immunogenicity, Safety, and Reactogenicity of a Mammalian Cell-Culture-Derived Influenza Vaccine in Healthy Children and Adolescents 3 to 17 Years of Age.
Vesikari T, Block SL, Guerra F, Lattanzi M, Holmes S, Izu A, Gaitatzis N, Hilbert AK, Groth N.
Source
1University of Tampere Medical School, Tampere, Finland 2Kentucky Pediatric/Adult Research, Bardstown, KY, USA 3San Antonio Metropolitan Health District Immunization, San Antonio, TX, USA 4Novartis Vaccines and Diagnostics, Siena, Italy 5Novartis Vaccines and Diagnostics Cambridge, Boston, MA, USA 6Novartis Vaccines and Diagnostics Marburg, Germany.
Abstract
BACKGROUND:
The safety and immunogenicity of the cell-culture derived seasonal trivalent influenza vaccine ([CCIV] Optaflu?, Novartis) has been reported previously in adults and elderly. In this study we compared the safety, reactogenicity, and immunogenicity of CCIV with a conventional egg-derived trivalent influenza vaccine (TIV) in a healthy pediatric population.
METHODS:
3604 subjects were randomized to receive 2 doses of CCIV or TIV (3-8 y, n=2630) at a 28-day interval or a single vaccination (9-17 y, n=974). Antibody levels on Days 1, 29, and 50 were measured by hemaglutination inhibition (HI) assay using egg-derived and cell-derived test antigens. Adverse reactions were solicited via diary cards for 7 days after each injection, and unsolicited AEs/SAEs were collected for 6 months postvaccination.
RESULTS:
Non-inferiority of CCIV versus TIV was demonstrated for most immunogenicity measures, particularly by using cell-derived antigen in the HI assay. In 3 to 8 year olds (the primary objective), both CCIV and TIV met all 3 Committee for Medicinal Use for Human Products (CHMP) immunogenicity criteria for A/H1N1 and A/H3N2 strains. Lower immune responses were observed against the B strain, fulfilling CHMP criteria only for GMR (TIV, CCIV) and seroconversion rate (TIV, CCIV [cell-derived antigen]). Both CCIV and TIV were safe and well tolerated, with no differences in local and systemic solicited reactions or in unsolicited AEs/SAEs.
CONCLUSION:
CCIV produced in mammalian cell culture is a safe, well-tolerated and immunogenic alternative to conventional egg-derived influenza vaccine for children and adolescents.
PMID:
22301476
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/22301476
Immunogenicity, Safety, and Reactogenicity of a Mammalian Cell-Culture-Derived Influenza Vaccine in Healthy Children and Adolescents 3 to 17 Years of Age.
Vesikari T, Block SL, Guerra F, Lattanzi M, Holmes S, Izu A, Gaitatzis N, Hilbert AK, Groth N.
Source
1University of Tampere Medical School, Tampere, Finland 2Kentucky Pediatric/Adult Research, Bardstown, KY, USA 3San Antonio Metropolitan Health District Immunization, San Antonio, TX, USA 4Novartis Vaccines and Diagnostics, Siena, Italy 5Novartis Vaccines and Diagnostics Cambridge, Boston, MA, USA 6Novartis Vaccines and Diagnostics Marburg, Germany.
Abstract
BACKGROUND:
The safety and immunogenicity of the cell-culture derived seasonal trivalent influenza vaccine ([CCIV] Optaflu?, Novartis) has been reported previously in adults and elderly. In this study we compared the safety, reactogenicity, and immunogenicity of CCIV with a conventional egg-derived trivalent influenza vaccine (TIV) in a healthy pediatric population.
METHODS:
3604 subjects were randomized to receive 2 doses of CCIV or TIV (3-8 y, n=2630) at a 28-day interval or a single vaccination (9-17 y, n=974). Antibody levels on Days 1, 29, and 50 were measured by hemaglutination inhibition (HI) assay using egg-derived and cell-derived test antigens. Adverse reactions were solicited via diary cards for 7 days after each injection, and unsolicited AEs/SAEs were collected for 6 months postvaccination.
RESULTS:
Non-inferiority of CCIV versus TIV was demonstrated for most immunogenicity measures, particularly by using cell-derived antigen in the HI assay. In 3 to 8 year olds (the primary objective), both CCIV and TIV met all 3 Committee for Medicinal Use for Human Products (CHMP) immunogenicity criteria for A/H1N1 and A/H3N2 strains. Lower immune responses were observed against the B strain, fulfilling CHMP criteria only for GMR (TIV, CCIV) and seroconversion rate (TIV, CCIV [cell-derived antigen]). Both CCIV and TIV were safe and well tolerated, with no differences in local and systemic solicited reactions or in unsolicited AEs/SAEs.
CONCLUSION:
CCIV produced in mammalian cell culture is a safe, well-tolerated and immunogenic alternative to conventional egg-derived influenza vaccine for children and adolescents.
PMID:
22301476
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/22301476