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Safety of a Heat-Stable Rotavirus Vaccine Among Children in Niger: Data From a Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial

This article, published in Vaccine, describes the safety results from an efficacy trial of ROTASIIL, a pentavalent rotavirus vaccine, conducted in Niger. Follow-up of safety outcomes began upon administration of the first dose of vaccine or placebo and continued until all participants reached two years of age. Passive surveillance was also carried out in health centers, and community health workers carried out active surveillance. After two years of follow-up, the children who received the vaccine had similar safety outcomes to children who received placebo and the vaccine was found to be safe.

Author: Coldiron ME, Guindo O, Makarimi R, et al.

Published: 2018

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(Located at www.sciencedirect.com)

Citation: Coldiron ME, Guindo O, Makarimi R, et al. Safety of a Heat-Stable Rotavirus Vaccine Among Children in Niger: Data From a Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial. Vaccine. 2018;36(25):3674-3680.

Resource types: Peer-reviewed journal

Diseases/vaccines: Rotavirus

Topics: Vaccine safety and performance, Disease/vaccine specific information

Regions: Africa