The Safety and Immunogenicity of a Quadrivalent Influenza Subunit Vaccine in Healthy Children Aged 6-35 Months: A Randomized, Blinded and Positive-Controlled Phase III Clinical Trial.

ABSTRACT: Background: Influenza is a serious contagious disease caused by influenza virus. It is particularly dangerous for children, potentially leading to severe and even fatal complications. The aim of this study was to evaluate the safety and immunogenicity of two candidate quadrivalent influenza subunit vaccines in children aged 6-35 months. Methods: The subjects were randomly divided into three groups at a 1:1:1 ratio and received the corresponding vaccines: QIV-Sub-HD (Quadrivalent Influenza Subunit Vaccine, High Dose), QIV-Sub-LD (Quadrivalent Influenza Subunit Vaccine, Low Dose) and QIV-Split-LD (Quadrivalent Influenza Split-Virion Vaccine, Low Dose). Adverse events were recorded at 30 min, 0-7 days and 8-28 and 30 days after each dose of immunization. Serious adverse events (

SUBMITTER: Huang L 

PROVIDER: S-EPMC12116156 | biostudies-literature | 2025 Apr

REPOSITORIES: biostudies-literature