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Immunogenicity, safety and reactogenicity of a mammalian cell-culture-derived influenza vaccine in healthy children and adolescents three to seventeen years of age.
Pediatr Infect Dis J. 2012 May; 31(5):494-500.PI

Abstract

BACKGROUND

The safety and immunogenicity of the cell-culture-derived seasonal trivalent influenza vaccine ([CCIV]; Optaflu) has been reported previously in adults and the 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

A total of 3604 subjects were randomized to receive 2 doses of CCIV or TIV (3-8 years, n = 2630) at a 28-day interval or a single vaccination (9-17 years, n = 974). Antibody levels on days 1, 29 and 50 were measured by hemaglutination inhibition assay using egg-derived and cell-derived test antigens. Adverse reactions were solicited via memory aids for 7 days after each injection, and unsolicited adverse events/serious adverse events were collected for 6 months postvaccination.

RESULTS

Noninferiority of CCIV versus TIV was demonstrated for most immunogenicity measures, particularly by using cell-derived antigen in the hemaglutination inhibition assay. In 3- to 8-year-olds (the primary objective), both CCIV and TIV met all 3 Committee for Medicinal Products for Human Use immunogenicity criteria for A/H1N1 and A/H3N2 strains. Lower immune responses were observed against the B strain, fulfilling Committee for Medicinal Products for Human Use criteria only for geometric mean ratio (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 adverse events/serious adverse events.

CONCLUSION

CCIV produced in mammalian cell culture is a safe, well-tolerated and immunogenic alternative to conventional egg-derived influenza vaccines for children and adolescents.

Links

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Authors+Show Affiliations

Vesikari T
University of Tampere Medical School, Tampere, Finland. timo.versikari@uta.fi .
Block SL
No affiliation info available
Guerra F
No affiliation info available
Lattanzi M
No affiliation info available
Holmes S
No affiliation info available
Izu A
No affiliation info available
Gaitatzis N
No affiliation info available
Hilbert AK
No affiliation info available
Groth N
No affiliation info available

MeSH

AdolescentAnimalsAntibodies, ViralCell LineChick EmbryoChildChild, PreschoolDouble-Blind MethodFemaleHemagglutination Inhibition TestsHumansInfluenza A Virus, H1N1 SubtypeInfluenza A Virus, H3N2 SubtypeInfluenza B virusInfluenza VaccinesInfluenza, HumanMaleTreatment OutcomeVaccines, Subunit

Pub Type(s)

Clinical Trial, Phase II
Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22301476

Clinical Trial Links

Clinical trial which this article describes

Citation

Vesikari, Timo, et al. "Immunogenicity, Safety and Reactogenicity of a Mammalian Cell-culture-derived Influenza Vaccine in Healthy Children and Adolescents Three to Seventeen Years of Age." The Pediatric Infectious Disease Journal, vol. 31, no. 5, 2012, pp. 494-500.
Vesikari T, Block SL, Guerra F, et al. Immunogenicity, safety and reactogenicity of a mammalian cell-culture-derived influenza vaccine in healthy children and adolescents three to seventeen years of age. Pediatr Infect Dis J. 2012;31(5):494-500.
Vesikari, T., Block, S. L., Guerra, F., Lattanzi, M., Holmes, S., Izu, A., Gaitatzis, N., Hilbert, A. K., & Groth, N. (2012). Immunogenicity, safety and reactogenicity of a mammalian cell-culture-derived influenza vaccine in healthy children and adolescents three to seventeen years of age. The Pediatric Infectious Disease Journal, 31(5), 494-500. https://doi.org/10.1097/INF.0b013e31824bb179
Vesikari T, et al. Immunogenicity, Safety and Reactogenicity of a Mammalian Cell-culture-derived Influenza Vaccine in Healthy Children and Adolescents Three to Seventeen Years of Age. Pediatr Infect Dis J. 2012;31(5):494-500. PubMed PMID: 22301476.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Immunogenicity, safety and reactogenicity of a mammalian cell-culture-derived influenza vaccine in healthy children and adolescents three to seventeen years of age. AU - Vesikari,Timo, AU - Block,Stan L, AU - Guerra,Fernando, AU - Lattanzi,Maria, AU - Holmes,Sandra, AU - Izu,Allen, AU - Gaitatzis,Nicolaos, AU - Hilbert,Anne Katrin, AU - Groth,Nicola, PY - 2012/2/4/entrez PY - 2012/2/4/pubmed PY - 2012/8/7/medline SP - 494 EP - 500 JF - The Pediatric infectious disease journal JO - Pediatr Infect Dis J VL - 31 IS - 5 N2 - BACKGROUND: The safety and immunogenicity of the cell-culture-derived seasonal trivalent influenza vaccine ([CCIV]; Optaflu) has been reported previously in adults and the 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: A total of 3604 subjects were randomized to receive 2 doses of CCIV or TIV (3-8 years, n = 2630) at a 28-day interval or a single vaccination (9-17 years, n = 974). Antibody levels on days 1, 29 and 50 were measured by hemaglutination inhibition assay using egg-derived and cell-derived test antigens. Adverse reactions were solicited via memory aids for 7 days after each injection, and unsolicited adverse events/serious adverse events were collected for 6 months postvaccination. RESULTS: Noninferiority of CCIV versus TIV was demonstrated for most immunogenicity measures, particularly by using cell-derived antigen in the hemaglutination inhibition assay. In 3- to 8-year-olds (the primary objective), both CCIV and TIV met all 3 Committee for Medicinal Products for Human Use immunogenicity criteria for A/H1N1 and A/H3N2 strains. Lower immune responses were observed against the B strain, fulfilling Committee for Medicinal Products for Human Use criteria only for geometric mean ratio (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 adverse events/serious adverse events. CONCLUSION: CCIV produced in mammalian cell culture is a safe, well-tolerated and immunogenic alternative to conventional egg-derived influenza vaccines for children and adolescents. SN - 1532-0987 UR - https://www.unboundmedicine.com/medline/citation/22301476/Immunogenicity_safety_and_reactogenicity_of_a_mammalian_cell_culture_derived_influenza_vaccine_in_healthy_children_and_adolescents_three_to_seventeen_years_of_age_ L2 - https://doi.org/10.1097/INF.0b013e31824bb179 DB - PRIME DP - Unbound Medicine ER -