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Influenza A (H1N1) 2009 two-dose immunization of US children: an observer-blinded, randomized, placebo-controlled trial.
Vaccine. 2011 Feb 11; 29(8):1569-75.V

Abstract

The goal of this pediatric clinical trial was to assess the safety and immunogenicity of two different doses of a monovalent inactivated pandemic (H1N1) 2009 vaccine in US children aged 6 months to 9 years of age. Randomized, observer-blinded, US multicenter phase 2 study assessing 2 doses of vaccine given 21 days apart in 474 children aged 6-35 months or 3-9 years. Children in each age group were randomly assigned to receive either a pandemic (H1N1) 2009 vaccine containing 7.5 or 15 μg of hemagglutinin (HA) or placebo in a 4:4:1 ratio. Primary outcome was hemagglutination inhibition (HI) antibody responses 21 days following each vaccination. Safety was monitored throughout the study. The first dose of either A H1N1 vaccine formulation was more immunogenic in children older than 3 years than in younger children. 45-50% of children aged 6-35 months and 69-75% of children aged 3-9 year-old attained HI titers of ≥ 1:40. A second dose of A H1N1 vaccine further increased HI antibody responses with seroprotection and seroconversion rates reaching 90-99% in both age groups. Interestingly, the pandemic (H1N1) 2009 vaccine formulations elicited similar rates of solicited and unsolicited injection site and systemic reactions as the placebo. The data therefore demonstrate the high level immunogenicity in infants and children of an (H1N1) 2009 influenza vaccine displaying a safety and reactogenicity profile similar to placebo.

Authors+Show Affiliations

Clinical Development Department, sanofi pasteur, 1541 Avenue Marcel Mérieux, 69280 Marcy l'Etoile, Lyon, France.No 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
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

21219979

Citation

Plennevaux, Eric, et al. "Influenza a (H1N1) 2009 Two-dose Immunization of US Children: an Observer-blinded, Randomized, Placebo-controlled Trial." Vaccine, vol. 29, no. 8, 2011, pp. 1569-75.
Plennevaux E, Blatter M, Cornish MJ, et al. Influenza A (H1N1) 2009 two-dose immunization of US children: an observer-blinded, randomized, placebo-controlled trial. Vaccine. 2011;29(8):1569-75.
Plennevaux, E., Blatter, M., Cornish, M. J., Go, K., Kirby, D., Wali, M., Reeves-Hoché, M. K., & Denis, M. (2011). Influenza A (H1N1) 2009 two-dose immunization of US children: an observer-blinded, randomized, placebo-controlled trial. Vaccine, 29(8), 1569-75. https://doi.org/10.1016/j.vaccine.2010.12.116
Plennevaux E, et al. Influenza a (H1N1) 2009 Two-dose Immunization of US Children: an Observer-blinded, Randomized, Placebo-controlled Trial. Vaccine. 2011 Feb 11;29(8):1569-75. PubMed PMID: 21219979.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Influenza A (H1N1) 2009 two-dose immunization of US children: an observer-blinded, randomized, placebo-controlled trial. AU - Plennevaux,Eric, AU - Blatter,Mark, AU - Cornish,Matthew J, AU - Go,Kerry, AU - Kirby,Daniel, AU - Wali,Mostafa, AU - Reeves-Hoché,Mary-Kate, AU - Denis,Martine, Y1 - 2011/01/08/ PY - 2010/11/15/received PY - 2010/12/14/revised PY - 2010/12/20/accepted PY - 2011/1/12/entrez PY - 2011/1/12/pubmed PY - 2011/4/20/medline SP - 1569 EP - 75 JF - Vaccine JO - Vaccine VL - 29 IS - 8 N2 - The goal of this pediatric clinical trial was to assess the safety and immunogenicity of two different doses of a monovalent inactivated pandemic (H1N1) 2009 vaccine in US children aged 6 months to 9 years of age. Randomized, observer-blinded, US multicenter phase 2 study assessing 2 doses of vaccine given 21 days apart in 474 children aged 6-35 months or 3-9 years. Children in each age group were randomly assigned to receive either a pandemic (H1N1) 2009 vaccine containing 7.5 or 15 μg of hemagglutinin (HA) or placebo in a 4:4:1 ratio. Primary outcome was hemagglutination inhibition (HI) antibody responses 21 days following each vaccination. Safety was monitored throughout the study. The first dose of either A H1N1 vaccine formulation was more immunogenic in children older than 3 years than in younger children. 45-50% of children aged 6-35 months and 69-75% of children aged 3-9 year-old attained HI titers of ≥ 1:40. A second dose of A H1N1 vaccine further increased HI antibody responses with seroprotection and seroconversion rates reaching 90-99% in both age groups. Interestingly, the pandemic (H1N1) 2009 vaccine formulations elicited similar rates of solicited and unsolicited injection site and systemic reactions as the placebo. The data therefore demonstrate the high level immunogenicity in infants and children of an (H1N1) 2009 influenza vaccine displaying a safety and reactogenicity profile similar to placebo. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/21219979/Influenza_A__H1N1__2009_two_dose_immunization_of_US_children:_an_observer_blinded_randomized_placebo_controlled_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(10)01903-1 DB - PRIME DP - Unbound Medicine ER -