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Evidence-based medicine
A rotavirus vaccine for infants prevented rotavirus gastroenteritis with no increase in risk of intussusception

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    Vesikari T, Matson DO, Dennehy P, et al. Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine. N Engl J Med2006;354:23–33.
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    Q In healthy infants, does a rotavirus vaccine prevent rotavirus gastroenteritis and reduce use of healthcare resources without i

    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 gastroenteritis.

    Embedded ImageOutcomes:

    intussusception, other serious adverse …

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    Footnotes

    • ↵* See glossary.

    • For correspondence: Dr P Heaton Mereck Research Laboratories, West Point, PA, USA. Penny_heaton{at}mereck.com

    • Source of funding: Mereck