Diarrheal Etiology and Impact of Coinfections on Rotavirus Vaccine Efficacy Estimates in a Clinical Trial of a Monovalent Human–Bovine (116E) Oral Rotavirus Vaccine, Rotavac, India

Abstract

While rotavirus was the dominant etiology of severe diarrhea even in vaccinated children, a broad range of other etiologies was identified. Accounting for coinfections led to an 11.3% increase in the VE estimate. Although not statistically significant, an 11.3% decrease in VE due to presence of coinfections would explain an important fraction of the low rotavirus VE in this setting.