Safety and Immunogenicity of a New Rotavirus-Inactivated Vaccine in the Chinese Adolescent Population: A Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Trial.

ABSTRACT:

Background

We performed a phase I experiment in a healthy teenage population in Sui County, Henan Province, China. The trial was randomized, double-blind, and placebo-controlled.

Methods

Ninety-six adolescents were randomly assigned in three groups (high-dose, medium-dose, and low-dose) to receive a dose of the vaccine or the placebo. The patients were monitored for adverse events (AEs) for up to 30 days after each dose of the vaccine and for up to 6 months after all doses of serious AEs (SAEs). All observed AEs and SAEs were reported. Microneutralization assays were used to measure geometric mean titers (GMTs) and seroconversion rates for neutralizing antibodies. IgA and IgG antibodies specific to the rotavirus were detected.

Results

The rates of total AEs in these g

SUBMITTER: Liu Y 

PROVIDER: S-EPMC12031238 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature