A rotavirus vaccine for prophylaxis against rotavirus gastroenteritis

Glaxo SmithKline Biologicals. Rixensart, Belgium.University of Tampere. Medical School. Tampere, Finland.Ministério da Saúde. Secretaria de Vigilância em Saúde. Instituto Evandro Chagas. Belém, PA, Brasil.Universidad de Carabobo. Dr. Enrique Tejera. Ciudad Hospitalaria. Insalud, Valencia, Venezuela.Universidad Central de Venezuela. Instituto de Biomedicina. Caracas, Venezuela.Instituto Nacional de Ciencias Medicas y Nutricion. Mexico.Instituto Nacional de Ciencias Medicas y Nutricion. Mexico.KK Women’s and Children’s Hospital. Singapore.Glaxo SmithKline Biologicals. Rixensart, Belgium.Glaxo SmithKline Biologicals. Rixensart, Belgium.The need for safe and efective vaccines to reduce morbidity and mortality caused by rotavirus gastroenteritis in children is weel-known. A live attenuated monovalent ratavirus vaccine (Rotarix) containing human rotavirus strain RIX4414 of G1P1A P[8] specificity is being developed to meet the global need. An overview of RIX4414 trials in developed and developing sttings is presented for 3 selected trials conducted in Finland (pilot study), Latin America (Brazil, Mexico and venezuela) and Singapore involving 5024 infants. The vaccine was well-tolerte, with no increase in any solicited symptoms as compared with the placebo. After 2 doses, 61-91 per cent of vaccineted infants developed rotavirus-specific IgA antibodies. There was no interference with immunogenicity of coadministere routine pediatric vaccines. Rotarix significantly reduced rotavirus gastroenteritis episodes and rotavirus related hospitalizations in vaccinated infants compared wiyh placebo recipients (p0.05), Vaccine efficacy was observed against severe rotavirus gastroenteritis caused by G1 and non-G1 types including the emerging G9 tyoe (p0.05) in Latin America. these results show prospects for widespread us of Rotarix to reduce raotavieus disease burden ans warrant continued worldwide evaluation