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 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 af

SUBMITTER: Robertson CA 

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

REPOSITORIES: biostudies-literature