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Rotarix is GlaxoSmithKline's oral vaccine against rotavirus infections. It worked well in Latin America, and the company has now completed a large phase III trial in nearly 4000 infants in Europe. Two doses of the vaccine given with other routine vaccinations reduced rotavirus gastroenteritis by 87.1% (95% CI 79.6 to 92.1) compared with placebo during one rotavirus season and by 78.9% (72.7 to 83.8) over two seasons. The vaccine also prevented 92-100% of hospital admissions for rotavirus infection. These infants had their first dose of vaccine at a mean age of 11.5 weeks and their second at a mean age of 20 weeksweeks.
Rotarix is a live attenuated vaccine containing just one strain of rotavirus (G1P(8)). But it also protected infants against other strains and was associated with a 72% reduction in hospital admissions for gastroenteritis of any cause. The groups had an even distribution of serious adverse events, including intussusception, a complication that led to the withdrawal of the first licensed rotavirus vaccine.
Rotarix must now be tested in the low income countries of Asia and Africa where malnutrition, HIV, virus diversity, and breaks in the cold chain (the system of transporting and storing vaccines within the safe temperature range) all conspire against the effectiveness of rotavirus vaccines, says a commentary (p 1739).