Assessment of risk of intussusception after pilot rollout of rotavirus vaccine in the Indian public health system.

ABSTRACT:

Background

Pre-licensure trials of ROTAVAC® were not adequately powered to assess risk of intussusception, a rare adverse event associated with other rotavirus vaccines in some settings. We examined the risk of intussusception after ROTAVAC® vaccination among Indian infants during pilot rollout of the vaccine in the public health system in three states - Himachal Pradesh, Maharashtra and Tamil Nadu.

Methods

Passive surveillance for intussusception was set up in 35 sentinel health facilities covering 26.3 million population in the three states under monitoring of an Interministerial-Interagency Steering Committee. Clinical and immunization data were collected by independent teams. An expert committee blinded to vaccination status, classified intussusception cases using Bright

SUBMITTER: Early Rollout of ROTAVAC®India Network 

PROVIDER: S-EPMC7347004 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature