Background rates of disease in Latin American children from a rotavirus vaccine study.

ABSTRACT:

Background

Knowledge of background rates of adverse events is crucial to assess vaccine safety concerns. We used data from a rotavirus vaccine study (Ruiz-Palacios et al., NEJM, 2006) including 63,225 infants from 11 Latin American countries to investigate reporting rates of serious adverse events (SAEs) among these infants, and describe rates by country, gender, age, and season.

Methods

For this randomized, double-blind, placebo-controlled, phase 3 trial, investigators from Argentina, Brazil, Chile, Colombia, Dominican Republic, Honduras, Mexico, Nicaragua, Panama, Peru, and Venezuela recruited 6-to-13-week-old healthy infants. The infants received 2 oral doses of vaccine or placebo. The study population was followed 100 d for the assessment of adverse events. SAEs were cap

SUBMITTER: Baay M 

PROVIDER: S-EPMC5557225 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature