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The oral live attenuated human rotavirus vaccine Rotarix (RIX4414) does not increase the risk of intussusception and was shown to have high efficacy against severe rotavirus infection in infants in a trial in Latin America. Now a trial in Finland and five other European countries (Czech Republic, France, Germany, Italy and Spain) has confirmed the high degree of protection (Lancet 2007;370:1757–63; see also Comment, ibid: 1739–40). Nearly 4000 infants were randomised (2:1) to RIX4414 or placebo, two oral doses to be given at the same time as the first two doses of the routine infant immunisations. On follow-up from 2 weeks after the second dose to the end of the first post-immunisation rotavirus season vaccine efficacy against rotavirus gastroenteritis of any severity was 87%. With follow-up through two rotavirus seasons vaccine efficacy against severe rotavirus gastroenteritis was 90%, against hospital admission for rotavirus gastroenteritis 96%, and against rotavirus-related medical attention 84%. Severe gastroenteritis of any cause was halved and there was a 72% reduction in admissions for gastroenteritis. The vaccine provided significant protection against severe gastroenteritis caused by circulating rotavirus of types G1, G2, G3, G4 and G9. One infant developed intussusception 8 days after the second dose of the vaccine and two infants (one in the vaccine group and one in the placebo group) developed intussusception in the second rotavirus …
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