Post-marketing safety surveillance of the rotavirus vaccine in India.

ABSTRACT:

Background

ROTASIIL, an oral live attenuated bovine-human reassortant pentavalent rotavirus vaccine, was approved in 2017. This post-marketing surveillance (PMS) was conducted to collect real-world data on the safety of ROTASIIL in India.

Methods

Observational, active PMS was conducted in approximately 10,000 infants aged ≥ 6 weeks. ROTASIIL was administered as a 3-dose regimen, at least 4 weeks apart, beginning at ≥ 6 weeks of age concomitantly with other Expanded Programme on Immunization (EPI) vaccines. Participants were followed for one month after the last dose. The adverse events (AEs) and serious adverse events (SAEs), including intussusception (IS) reported during the follow up period were collected.

Findings

A total of 9940 infants were enrolled and were cons

SUBMITTER: Kang G 

PROVIDER: S-EPMC10430202 | biostudies-literature | 2023 Dec

REPOSITORIES: biostudies-literature