Defining and reporting adverse events of special interest in comparative maternal vaccine studies: a systematic review.

ABSTRACT:

Introduction

The GAIA (Global Alignment on Immunisation Safety Assessment in Pregnancy) consortium was established in 2014 with the aim of creating a standardised, globally coordinated approach to monitoring the safety of vaccines administered in pregnancy. The consortium developed twenty-six standardised definitions for classifying obstetric and infant adverse events. This systematic review sought to evaluate the current state of adverse event reporting in maternal vaccine trials following the publication of the case definitions by GAIA, and the extent to which these case definitions have been adopted in maternal vaccine safety research.

Methods

A comprehensive search of published literature was undertaken to identify maternal vaccine research studies. PubMed, EMBASE, Web o

SUBMITTER: Davies HG 

PROVIDER: S-EPMC10943481 | biostudies-literature | 2024 Jun

REPOSITORIES: biostudies-literature