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

Corwin A Robertson, Monica Mercer, Alexandre Selmani, Nicola P Klein, Robert Jeanfreau, David P Greenberg, Corwin A Robertson, Monica Mercer, Alexandre Selmani, Nicola P Klein, Robert Jeanfreau, David P Greenberg

Abstract

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.

Conflict of interest statement

This work is funded by Sanofi Pasteur. N.P.K. reports grants from Sanofi Pasteur during the conduct of the study and grants from GlaxoSmithKline, Protein Sciences, Pfizer, Merck, Dynavax and MedImmune outside the submitted work. C.A.R., M.M., A.S. and D.P.G. are employees of Sanofi Pasteur. R.J. declares no conflicts of interest. The authors have no other conflicts of interest or funding to disclose.

Figures

FIGURE 1.
FIGURE 1.
Study design and disposition of participants. Healthy children 6–35 months of age were randomly assigned 1:1 to receive the half dose or the full dose of IIV4 by intramuscular injection.

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Source: PubMed

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