Gastroenteritis prevention with rotavirus vaccine

Canadian Medical Association Journal 1996; 155: 306

Researchers in the United States conducted a double-blind multicentre trial to test the efficacy and safety of high-dose rhesus-human reassortant rotavirus vaccine (RRV) in reducing the incidence and severity of gastroenteritis over one rotavirus season. The researchers randomly assigned 1278 healthy infants aged 5 to 25 weeks to receive either monovalent serotype 1 (S1) or tetravalent (TV) RRV or a placebo at roughly 2, 4 and 6 months of age. Both vaccine groups had a significantly lower incidence of rotavirus gastroenteritis than the placebo group. For RRV-S1 and RRV-TV respectively, efficacy against all rotavirus gastroenteritis was calculated as 54% and 49%, against severe disease as 69% and 80%, and against dehydrating rotavirus gastroenteritis as 85% and 100%. The incidence of possible vaccine reactions did not differ significantly between the treatment groups.

Source: Rennels MB, Glass RI, Dennehy PH, Bernstein DI, Pichichero ME, Zito ET, et al. Safety and efficacy of high-dose rhesus-human reassortant rotavirus vaccines: report of the National Multicenter Trial. Pediatrics 1996; 97: 7-13.

| CMAJ August 1, 1996 (vol 155, no 3) |