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A rotavirus vaccine for infants prevented rotavirus gastroenteritis with no increase in risk of intussusception

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 Q In healthy infants, does a rotavirus vaccine prevent rotavirus gastroenteritis and reduce use of healthcare resources without increasing the risk of intussusception?

Clinical impact ratings GP/FP/Primary care ★★★★★☆☆ Public health ★★★★★★★

METHODS

Embedded ImageDesign:

randomised controlled trial.

Embedded ImageAllocation:

unclear allocation concealment.*

Embedded ImageBlinding:

blinded (parents, healthcare providers, outcome assessors, and sponsors).*

Embedded ImageFollow up period:

1 year (through ⩾1 full rotavirus season).

Embedded ImageSetting:

hundreds of centres in the US, Taiwan, Europe, and Central America.

Embedded ImageParticipants:

69 274 healthy infants 6–12 weeks of age (mean age 10 wks, 51% boys) without recent (⩽42 d) or planned use of oral poliovirus vaccine.

Embedded ImageIntervention:

oral, live pentavalent (G1, G2, G3, G4, and P[8]) human bovine (WC3) reassortant rotavirus vaccine (n = 34 644) or placebo (n = 34 630), 3 doses 4–10 weeks apart. Parents were contacted regularly to ascertain adverse events and cases of …

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