title: A rotavirus vaccine for prophylaxis of infants against rotavirus gastroenteritis.
abstract: The need for safe and effective vaccines to reduce morbidity and mortality caused by rotavirus gastroenteritis in children is well-known. A live attenuated monovalent rotavirus 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 settings 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-tolerated, with no increase in any solicited symptoms as compared with the placebo. After 2 doses, 61-91% of vaccinated infants developed rotavirus-specific IgA antibodies. There was no interference with immunogenicity of coadministered routine pediatric vaccines. Rotarix significantly reduced rotavirus gastroenteritis episodes and rotavirus-related hospitalizations in vaccinated infants compared with placebo recipients (P < 0.05). Vaccine efficacy was observed against severe rotavirus gastroenteritis caused by G1 and non-G1 types including the emerging G9 type (P < 0.05) in Latin America. These results show prospects for widespread use of Rotarix to reduce rotavirus disease burden and warrant continued worldwide evaluation.
authors.affiliation: GlaxoSmithKline Biologicals, Rixensart, Belgium.
authors.forename: Beatrice
authors.initials: B
authors.lastname: De Vos
authors.forename: Timo
authors.initials: T
authors.lastname: Vesikari
authors.forename: Alexandre C
authors.initials: AC
authors.lastname: Linhares
authors.forename: Belén
authors.initials: B
authors.lastname: Salinas
authors.forename: Irene
authors.initials: I
authors.lastname: Pérez-Schael
authors.forename: Guillermo M
authors.initials: GM
authors.lastname: Ruiz-Palacios
authors.forename: Maria de Lourdes
authors.initials: Mde L
authors.lastname: Guerrero
authors.forename: Kong Boo
authors.initials: KB
authors.lastname: Phua
authors.forename: Andrée
authors.initials: A
authors.lastname: Delem
authors.forename: Karin
authors.initials: K
authors.lastname: Hardt
mesh_terms: D002986:Clinical Trials as Topic; D005759:Gastroenteritis / Q000517:prevention & control* / Q000821:virology*; D006801:Humans; D007223:Infant; D012400:Rotavirus Infections / Q000517:prevention & control*; D022243:Rotavirus Vaccines / Q000276:immunology*
chemical_list: D022243:Rotavirus Vaccines