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Safety and Immunogenicity of a Full-dose, Split-virion, Inactivated, Quadrivalent Influenza Vaccine in Healthy Children 6-35 Months of Age: A Randomized Controlled Clinical Trial

BACKGROUND: For children <3 years of age, a half dose of inactivated influenza vaccine (7.5 μg hemagglutinin per strain) has been used for more than 30 years, but several studies indicate that a full dose (15 μg hemagglutinin per strain) can be used in this population without increasing the rate...

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Autores principales: Robertson, Corwin A., Mercer, Monica, Selmani, Alexandre, Klein, Nicola P., Jeanfreau, Robert, Greenberg, David P.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Williams & Wilkins 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6437098/
https://www.ncbi.nlm.nih.gov/pubmed/30395011
http://dx.doi.org/10.1097/INF.0000000000002227
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author Robertson, Corwin A.
Mercer, Monica
Selmani, Alexandre
Klein, Nicola P.
Jeanfreau, Robert
Greenberg, David P.
author_facet Robertson, Corwin A.
Mercer, Monica
Selmani, Alexandre
Klein, Nicola P.
Jeanfreau, Robert
Greenberg, David P.
author_sort Robertson, Corwin A.
collection PubMed
description BACKGROUND: For children <3 years of age, a half dose of inactivated influenza vaccine (7.5 μg hemagglutinin per strain) has been used for more than 30 years, but several studies indicate that a full dose (15 μg hemagglutinin per strain) can be used in this population without increasing the rate of fever or other reactions. Here, we compare the safety and immunogenicity of full and half doses of quadrivalent, split-virion, inactivated influenza vaccine (IIV4) in children 6–35 months of age. METHODS: In this phase IV, randomized, observer-blinded, multi-center study, healthy children 6–35 months of age were randomized 1:1 to be vaccinated with a half or full dose of IIV4 (NCT02915302). The primary objective was to demonstrate that the rate of any fever (≥38.0°C) up to 7 days after a full dose of IIV4 was noninferior to the rate of fever after a half dose. RESULTS: The study included 1950 children. Noninferiority in the rate of fever was demonstrated for the full dose versus the half dose of IIV4 (difference in rate = 0.84%; 95% confidence interval, −2.13% to 3.80%). Solicited reactions and unsolicited adverse events were similar between the dose groups. No vaccine-related serious adverse events were reported. Noninferiority of both hemagglutination inhibition geometric mean titers and seroconversion rates was demonstrated for all 4 vaccine strains for the full dose versus the half dose. CONCLUSIONS: In children 6–35 months of age, a full dose of IIV4 was immunogenic and had a safety profile comparable to that of a half dose, with no new safety concerns observed.
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spelling pubmed-64370982019-04-19 Safety and Immunogenicity of a Full-dose, Split-virion, Inactivated, Quadrivalent Influenza Vaccine in Healthy Children 6-35 Months of Age: A Randomized Controlled Clinical Trial Robertson, Corwin A. Mercer, Monica Selmani, Alexandre Klein, Nicola P. Jeanfreau, Robert Greenberg, David P. Pediatr Infect Dis J Vaccine Reports BACKGROUND: For children <3 years of age, a half dose of inactivated influenza vaccine (7.5 μg hemagglutinin per strain) has been used for more than 30 years, but several studies indicate that a full dose (15 μg hemagglutinin per strain) can be used in this population without increasing the rate of fever or other reactions. Here, we compare the safety and immunogenicity of full and half doses of quadrivalent, split-virion, inactivated influenza vaccine (IIV4) in children 6–35 months of age. METHODS: In this phase IV, randomized, observer-blinded, multi-center study, healthy children 6–35 months of age were randomized 1:1 to be vaccinated with a half or full dose of IIV4 (NCT02915302). The primary objective was to demonstrate that the rate of any fever (≥38.0°C) up to 7 days after a full dose of IIV4 was noninferior to the rate of fever after a half dose. RESULTS: The study included 1950 children. Noninferiority in the rate of fever was demonstrated for the full dose versus the half dose of IIV4 (difference in rate = 0.84%; 95% confidence interval, −2.13% to 3.80%). Solicited reactions and unsolicited adverse events were similar between the dose groups. No vaccine-related serious adverse events were reported. Noninferiority of both hemagglutination inhibition geometric mean titers and seroconversion rates was demonstrated for all 4 vaccine strains for the full dose versus the half dose. CONCLUSIONS: In children 6–35 months of age, a full dose of IIV4 was immunogenic and had a safety profile comparable to that of a half dose, with no new safety concerns observed. Williams & Wilkins 2019-03 2018-11-02 /pmc/articles/PMC6437098/ /pubmed/30395011 http://dx.doi.org/10.1097/INF.0000000000002227 Text en Copyright © 2018 The Author(s). Published by Wolters Kluwer Health, Inc. This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND) (http://creativecommons.org/licenses/by-nc-nd/4.0/) , where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.
spellingShingle Vaccine Reports
Robertson, Corwin A.
Mercer, Monica
Selmani, Alexandre
Klein, Nicola P.
Jeanfreau, Robert
Greenberg, David P.
Safety and Immunogenicity of a Full-dose, Split-virion, Inactivated, Quadrivalent Influenza Vaccine in Healthy Children 6-35 Months of Age: A Randomized Controlled Clinical Trial
title Safety and Immunogenicity of a Full-dose, Split-virion, Inactivated, Quadrivalent Influenza Vaccine in Healthy Children 6-35 Months of Age: A Randomized Controlled Clinical Trial
title_full Safety and Immunogenicity of a Full-dose, Split-virion, Inactivated, Quadrivalent Influenza Vaccine in Healthy Children 6-35 Months of Age: A Randomized Controlled Clinical Trial
title_fullStr Safety and Immunogenicity of a Full-dose, Split-virion, Inactivated, Quadrivalent Influenza Vaccine in Healthy Children 6-35 Months of Age: A Randomized Controlled Clinical Trial
title_full_unstemmed Safety and Immunogenicity of a Full-dose, Split-virion, Inactivated, Quadrivalent Influenza Vaccine in Healthy Children 6-35 Months of Age: A Randomized Controlled Clinical Trial
title_short Safety and Immunogenicity of a Full-dose, Split-virion, Inactivated, Quadrivalent Influenza Vaccine in Healthy Children 6-35 Months of Age: A Randomized Controlled Clinical Trial
title_sort safety and immunogenicity of a full-dose, split-virion, inactivated, quadrivalent influenza vaccine in healthy children 6-35 months of age: a randomized controlled clinical trial
topic Vaccine Reports
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6437098/
https://www.ncbi.nlm.nih.gov/pubmed/30395011
http://dx.doi.org/10.1097/INF.0000000000002227
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