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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.

ABSTRACT: BACKGROUND:For children <3 years of age, a half dose of inactivated influenza vaccine (7.5 ?g hemagglutinin per strain) has been used for more than 30 years, but several studies indicate that a full dose (15 ?g 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.

SUBMITTER: Robertson CA

PROVIDER: S-EPMC6437098 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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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.

Robertson Corwin A CA Mercer Monica M Selmani Alexandre A Klein Nicola P NP Jeanfreau Robert R Greenberg David P DP

The Pediatric infectious disease journal 20190301 3

<h4>Background</h4>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 ag ...[more]

PMID: 30395011

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Project description:BackgroundThe European Medicines Agency (EMA) requires enhanced safety surveillance to be conducted for annual seasonal influenza vaccines with the aim of rapidly detecting any potential new safety concerns before the peak immunisation period of the vaccine in any given year. The aim of this study was to detect any clinically significant change in the frequency or severity of expected reactogenicity of the quadrivalent inactivated split-virion influenza vaccine (IIV4) during routine immunisation in Finland for the 2020/21 season. The primary objective was to investigate the frequency of suspected adverse drug reactions (ADRs) occurring within 7 days following vaccination.MethodsEnhanced passive safety surveillance of individuals vaccinated with IIV4 was conducted from October 9, 2020 to November 30, 2020 across seven sites in Finland. The vaccinee reporting rate and ADR reporting rate were calculated and compared with known or expected safety data in order to identify any clinically significant changes.ResultsData were collected from 1008 individuals with 29 vaccinees reporting 82 suspected ADRs. Of these, 28 people reported 79 suspected ADRs within 7 days following vaccination, corresponding to a vaccinee reporting rate of 2.78% (95% CI: 1.85, 3.99) (ADR reporting rate, 7.84% [95% CI: 6.25, 9.67%]). The most frequently reported ADRs were injection site reactions (vaccination site pain, vaccination site erythema and vaccination site swelling) (n = 46, 2.28%), myalgia (n = 9, 0.89%) and headache (n = 8, 0.79%). No serious suspected adverse events were reported at any point post-vaccination and ADR reporting rates were in general lower compared to those reported for IIV4 in the 2019/20 surveillance study.ConclusionNo clinically significant changes in what is known or expected for IIV4 were reported for the 2020/21 season which supports the safety profile of this vaccine and will help maintain public confidence in influenza vaccination.

Dataset Information

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.

Publications

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.

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