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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
Design:
randomised controlled trial.
Allocation:
unclear allocation concealment.*
Blinding:
blinded (parents, healthcare providers, outcome assessors, and sponsors).*
Follow up period:
1 year (through ⩾1 full rotavirus season).
Setting:
hundreds of centres in the US, Taiwan, Europe, and Central America.
Participants:
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.
Intervention:
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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