Safety of a heat-stable rotavirus vaccine among children in Niger: Data from a phase 3, randomized, double-blind, placebo-controlled trial.

Matthew E Coldiron,Ousmane Guindo,Rockyath Makarimi,Issaka Soumana,Amadou Matar Seck,Souna Garba,Emilie Macher,Sheila Isanaka,Rebecca F Grais

Vaccine（2018）

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摘要

•RotaSIIL has been shown effective against severe rotavirus gastroenteritis in Niger.•Two-year follow-up of the intention-to-treat population shows no safety concerns.•Overall mortality was very low for the region.•One case of intussusception was notified, and was unrelated to RotaSIIL.

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关键词

Rotavirus vaccines,Rotavirus infection,Niger,Intussusception,Diarrhea,Gastroenteritis,Adverse event,Safety

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