title: Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine.
abstract: BACKGROUND
  Rotavirus is a leading cause of childhood gastroenteritis and death worldwide.
  
  
  METHODS
  We studied healthy infants approximately 6 to 12 weeks old who were randomly assigned to receive three oral doses of live pentavalent human-bovine (WC3 strain) reassortant rotavirus vaccine containing human serotypes G1, G2, G3, G4, and P[8] or placebo at 4-to-10-week intervals in a blinded fashion. Active surveillance was used to identify subjects with serious adverse and other events.
  
  
  RESULTS
  The 34,035 infants in the vaccine group and 34,003 in the placebo group were monitored for serious adverse events. Intussusception occurred in 12 vaccine recipients and 15 placebo recipients within one year after the first dose including six vaccine recipients and five placebo recipients within 42 days after any dose (relative risk, 1.6; 95 percent confidence interval, 0.4 to 6.4). The vaccine reduced hospitalizations and emergency department visits related to G1-G4 rotavirus gastroenteritis occurring 14 or more days after the third dose by 94.5 percent (95 percent confidence interval, 91.2 to 96.6 percent). In a nested substudy, efficacy against any G1-G4 rotavirus gastroenteritis through the first full rotavirus season after vaccination was 74.0 percent (95 percent confidence interval, 66.8 to 79.9 percent); efficacy against severe gastroenteritis was 98.0 percent (95 percent confidence interval, 88.3 to 100 percent). The vaccine reduced clinic visits for G1-G4 rotavirus gastroenteritis by 86.0 percent (95 percent confidence interval, 73.9 to 92.5 percent).
  
  
  CONCLUSIONS
  This vaccine was efficacious in preventing rotavirus gastroenteritis, decreasing severe disease and health care contacts. The risk of intussusception was similar in vaccine and placebo recipients. (ClinicalTrials.gov number, NCT00090233.)
authors.affiliation: University of Tampere Medical School, Tampere, Finland.
authors.forename: Timo
authors.initials: T
authors.lastname: Vesikari
authors.forename: David O
authors.initials: DO
authors.lastname: Matson
authors.forename: Penelope
authors.initials: P
authors.lastname: Dennehy
authors.forename: Pierre
authors.initials: P
authors.lastname: Van Damme
authors.forename: Mathuram
authors.initials: M
authors.lastname: Santosham
authors.forename: Zoe
authors.initials: Z
authors.lastname: Rodriguez
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Dallas
authors.forename: Joseph F
authors.initials: JF
authors.lastname: Heyse
authors.forename: Michelle G
authors.initials: MG
authors.lastname: Goveia
authors.forename: Steven B
authors.initials: SB
authors.lastname: Black
authors.forename: Henry R
authors.initials: HR
authors.lastname: Shinefield
authors.forename: Celia D C
authors.initials: CD
authors.lastname: Christie
authors.forename: Samuli
authors.initials: S
authors.lastname: Ylitalo
authors.forename: Robbin F
authors.initials: RF
authors.lastname: Itzler
authors.forename: Michele L
authors.initials: ML
authors.lastname: Coia
authors.forename: Matthew T
authors.initials: MT
authors.lastname: Onorato
authors.forename: Ben A
authors.initials: BA
authors.lastname: Adeyi
authors.forename: Gary S
authors.initials: GS
authors.lastname: Marshall
authors.forename: Leif
authors.initials: L
authors.lastname: Gothefors
authors.forename: Dirk
authors.initials: D
authors.lastname: Campens
authors.forename: Aino
authors.initials: A
authors.lastname: Karvonen
authors.forename: James P
authors.initials: JP
authors.lastname: Watt
authors.forename: Katherine L
authors.initials: KL
authors.lastname: O'Brien
authors.forename: Mark J
authors.initials: MJ
authors.lastname: DiNubile
authors.forename: H Fred
authors.initials: HF
authors.lastname: Clark
authors.forename: John W
authors.initials: JW
authors.lastname: Boslego
authors.forename: Paul A
authors.initials: PA
authors.lastname: Offit
authors.forename: Penny M
authors.initials: PM
authors.lastname: Heaton
mesh_terms: D000284:Administration, Oral; D000818:Animals; D000914:Antibodies, Viral / Q000097:blood; D002417:Cattle; D003968:Diarrhea, Infantile / Q000517:prevention & control / Q000821:virology; D004311:Double-Blind Method; D005260:Female; D005334:Fever / Q000209:etiology; D005759:Gastroenteritis / Q000517:prevention & control* / Q000821:virology; D006471:Gastrointestinal Hemorrhage / Q000209:etiology; D006295:Health Resources / Q000706:statistics & numerical data; D006760:Hospitalization; D006801:Humans; D007070:Immunoglobulin A / Q000097:blood; D007223:Infant; D007443:Intussusception / Q000209:etiology*; D008297:Male; D016865:Reassortant Viruses; D012306:Risk; D012401:Rotavirus / Q000145:classification / Q000276:immunology; D012400:Rotavirus Infections / Q000517:prevention & control*; D022243:Rotavirus Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D000914:Antibodies, Viral; D007070:Immunoglobulin A; C492535:RotaTeq; D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated