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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; 31(5):494-500PI

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.

Authors+Show Affiliations

University of Tampere Medical School, Tampere, Finland. timo.versikari@uta.fi .No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

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

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., ... 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), pp. 494-500. doi: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 - http://Insights.ovid.com/pubmed?pmid=22301476 DB - PRIME DP - Unbound Medicine ER -