title: Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis.
abstract: BACKGROUND
  The safety and efficacy of an attenuated G1P[8] human rotavirus (HRV) vaccine were tested in a randomized, double-blind, phase 3 trial.
  
  
  METHODS
  We studied 63,225 healthy infants from 11 Latin American countries and Finland who received two oral doses of either the HRV vaccine (31,673 infants) or placebo (31,552 infants) at approximately two months and four months of age. Severe gastroenteritis episodes were identified by active surveillance. The severity of disease was graded with the use of the 20-point Vesikari scale. Vaccine efficacy was evaluated in a subgroup of 20,169 infants (10,159 vaccinees and 10,010 placebo recipients).
  
  
  RESULTS
  The efficacy of the vaccine against severe rotavirus gastroenteritis and against rotavirus-associated hospitalization was 85 percent (P<0.001 for the comparison with placebo) and reached 100 percent against more severe rotavirus gastroenteritis. Hospitalization for diarrhea of any cause was reduced by 42 percent (95 percent confidence interval, 29 to 53 percent; P<0.001). During the 31-day window after each dose, six vaccine recipients and seven placebo recipients had definite intussusception (difference in risk, -0.32 per 10,000 infants; 95 percent confidence interval, -2.91 to 2.18; P=0.78).
  
  
  CONCLUSIONS
  Two oral doses of the live attenuated G1P[8] HRV vaccine were highly efficacious in protecting infants against severe rotavirus gastroenteritis, significantly reduced the rate of severe gastroenteritis from any cause, and were not associated with an increased risk of intussusception. (ClinicalTrials.gov numbers, NCT00139347 and NCT00263666.)
authors.affiliation: Instituto Nacional de Ciencas Medicas y Nutricion, México Distrito Federal, Mexico.
authors.forename: Guillermo M
authors.initials: GM
authors.lastname: Ruiz-Palacios
authors.forename: Irene
authors.initials: I
authors.lastname: Pérez-Schael
authors.forename: F Raúl
authors.initials: FR
authors.lastname: Velázquez
authors.forename: Hector
authors.initials: H
authors.lastname: Abate
authors.forename: Thomas
authors.initials: T
authors.lastname: Breuer
authors.forename: SueAnn Costa
authors.initials: SC
authors.lastname: Clemens
authors.forename: Brigitte
authors.initials: B
authors.lastname: Cheuvart
authors.forename: Felix
authors.initials: F
authors.lastname: Espinoza
authors.forename: Paul
authors.initials: P
authors.lastname: Gillard
authors.forename: Bruce L
authors.initials: BL
authors.lastname: Innis
authors.forename: Yolanda
authors.initials: Y
authors.lastname: Cervantes
authors.forename: Alexandre C
authors.initials: AC
authors.lastname: Linhares
authors.forename: Pío
authors.initials: P
authors.lastname: López
authors.forename: Mercedes
authors.initials: M
authors.lastname: Macías-Parra
authors.forename: Eduardo
authors.initials: E
authors.lastname: Ortega-Barría
authors.forename: Vesta
authors.initials: V
authors.lastname: Richardson
authors.forename: Doris Maribel
authors.initials: DM
authors.lastname: Rivera-Medina
authors.forename: Luis
authors.initials: L
authors.lastname: Rivera
authors.forename: Belén
authors.initials: B
authors.lastname: Salinas
authors.forename: Noris
authors.initials: N
authors.lastname: Pavía-Ruz
authors.forename: Jorge
authors.initials: J
authors.lastname: Salmerón
authors.forename: Ricardo
authors.initials: R
authors.lastname: Rüttimann
authors.forename: Juan Carlos
authors.initials: JC
authors.lastname: Tinoco
authors.forename: Pilar
authors.initials: P
authors.lastname: Rubio
authors.forename: Ernesto
authors.initials: E
authors.lastname: Nuñez
authors.forename: M Lourdes
authors.initials: ML
authors.lastname: Guerrero
authors.forename: Juan Pablo
authors.initials: JP
authors.lastname: Yarzábal
authors.forename: Silvia
authors.initials: S
authors.lastname: Damaso
authors.forename: Nadia
authors.initials: N
authors.lastname: Tornieporth
authors.forename: Xavier
authors.initials: X
authors.lastname: Sáez-Llorens
authors.forename: Rodrigo F
authors.initials: RF
authors.lastname: Vergara
authors.forename: Timo
authors.initials: T
authors.lastname: Vesikari
authors.forename: Alain
authors.initials: A
authors.lastname: Bouckenooghe
authors.forename: Ralf
authors.initials: R
authors.lastname: Clemens
authors.forename: Béatrice
authors.initials: B
authors.lastname: De Vos
authors.forename: Miguel
authors.initials: M
authors.lastname: O'Ryan
mesh_terms: D000284:Administration, Oral; D003968:Diarrhea, Infantile / Q000453:epidemiology / Q000517:prevention & control / Q000821:virology; D004311:Double-Blind Method; D005260:Female; D005759:Gastroenteritis / Q000453:epidemiology / Q000517:prevention & control* / Q000821:virology; D006760:Hospitalization; D006801:Humans; D015994:Incidence; D007223:Infant; D007443:Intussusception / Q000209:etiology; D008297:Male; D012306:Risk; D012401:Rotavirus; D012400:Rotavirus Infections / Q000150:complications / Q000401:mortality / Q000517:prevention & control*; D022243:Rotavirus Vaccines / Q000008:administration & dosage / Q000009:adverse effects; D016019:Survival Analysis; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: C492457:RIX4414 vaccine; D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated