title: Oral live attenuated human rotavirus vaccine (Rotarix™) offers sustained high protection against severe G9P[8] rotavirus gastroenteritis during the first two years of life in Brazilian children.
abstract: In a large Phase III trial conducted in 10 Latin American countries, the safety and efficacy of the live attenuated monovalent rotavirus vaccine RIX4414 was evaluated in 15,183 healthy infants followed up during the first two years of life. Belém was the only site in Brazil included in this multicentre trial. The study in Belém included a subset of 653 infants who were followed up until 24 months of age for protection against severe rotavirus gastroenteritis. These subjects were randomly assigned in a 1:1 ratio to receive two doses of vaccine (n = 328) or two doses of placebo (n = 325) at approximately two and four months of age. Of the 653 enrolled infants, 23 dropped out during the study period. For the combined two-year period, the efficacy of RIX4414 was 72.3% [95% confidence interval (CI) 37.5-89.1%] against severe rotavirus-related gastroenteritis, reaching a protection rate of 81.8% (95% CI 36.4-96.6%) against circulating wild-type G9 rotavirus strains. It is concluded that two doses of RIX4414 are highly efficacious against severe rotavirus gastroenteritis in Belém during the first two years of life and provide high protection against the worldwide emergence and spread of G9P[8] strains.
authors.affiliation: Instituto Evandro Chagas, Secretaria de Vigilância em Saúde, Belém, PA, Brasil.
authors.forename: Maria Cleonice A
authors.initials: MC
authors.lastname: Justino
authors.forename: Eliete C
authors.initials: EC
authors.lastname: Araújo
authors.forename: Leen-Jan
authors.initials: LJ
authors.lastname: van Doorn
authors.forename: Consuelo S
authors.initials: CS
authors.lastname: Oliveira
authors.forename: Yvone B
authors.initials: YB
authors.lastname: Gabbay
authors.forename: Joana D'Arc P
authors.initials: JD
authors.lastname: Mascarenhas
authors.forename: Yllen S
authors.initials: YS
authors.lastname: Miranda
authors.forename: Sylvia de Fátima S
authors.initials: Sde F
authors.lastname: Guerra
authors.forename: Veronilce B da
authors.initials: VB
authors.lastname: Silva
authors.forename: Alexandre C
authors.initials: AC
authors.lastname: Linhares
mesh_terms: D000284:Administration, Oral; D000914:Antibodies, Viral / Q000235:genetics / Q000276:immunology*; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D005759:Gastroenteritis / Q000517:prevention & control* / Q000821:virology; D005838:Genotype; D006801:Humans; D007223:Infant; D008297:Male; D012400:Rotavirus Infections / Q000517:prevention & control* / Q000821:virology; D022243:Rotavirus Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D012720:Severity of Illness Index; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D000914:Antibodies, Viral; C492457:RIX4414 vaccine; D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated