title: Randomised placebo-controlled trial of rhesus-human reassortant rotavirus vaccine for prevention of severe rotavirus gastroenteritis.
abstract: BACKGROUND
  Rotavirus is the most common cause of acute childhood gastroenteritis. Vaccination with live oral heterologous rotavirus vaccines may prevent rotavirus gastroenteritis. We assessed the efficacy of rhesus-human reassortant rotavirus tetravalent vaccine (RRV-TV) against severe rotavirus gastroenteritis in Finnish children in a randomised placebo-controlled double-blind trial.
  
  
  METHODS
  Placebo or RRV-TV (titre 4x10(5) plaque-forming units) was given to infants at ages 2, 3, and 5 months. The children were followed up for one or two rotavirus epidemic seasons. The main outcome measure was protection against severe rotavirus gastroenteritis (score > or =11 on a 20-point severity scale). 2398 children were enrolled and received at least one dose of RRV-TV (n=1191) or placebo (n=1207). The primary efficacy analysis was based on children who received three doses of RRV-TV (n=1128) or placebo (n=1145).
  
  
  RESULTS
  256 episodes of rotavirus gastroenteritis occurred at any time during the study; 65 were among 1191 RRV-TV recipients, and 191 among 1207 placebo recipients (vaccine efficacy 66% [95% CI 55-74]; intention-to-treat analysis). 226 episodes were included in the primary efficacy analysis of fully vaccinated children (54 among 1128 RRV-TV recipients, 172 among 1145 placebo recipients; vaccine efficacy 68% [57-76]). 100 episodes were severe, eight in RRV-TV recipients and 92 in placebo recipients (vaccine efficacy 91% [82-96]).
  
  
  CONCLUSIONS
  RRV-TV vaccine was highly effective against severe rotavirus gastroenteritis in young children. Incorporation of this vaccine into routine immunisation schedules of infants could reduce severe rotavirus gastroenteritis by 90% and severe gastroenteritis of all causes in young children by 60%.
authors.affiliation: University of Tampere, Medical School, Finland.
authors.forename: J
authors.initials: J
authors.lastname: Joensuu
authors.forename: E
authors.initials: E
authors.lastname: Koskenniemi
authors.forename: X L
authors.initials: XL
authors.lastname: Pang
authors.forename: T
authors.initials: T
authors.lastname: Vesikari
mesh_terms: D003968:Diarrhea, Infantile / Q000453:epidemiology / Q000517:prevention & control* / Q000821:virology; D004311:Double-Blind Method; D005387:Finland / Q000453:epidemiology; D005500:Follow-Up Studies; D005759:Gastroenteritis / Q000453:epidemiology / Q000517:prevention & control* / Q000821:virology; D006801:Humans; D007115:Immunization Schedule; D015994:Incidence; D007223:Infant; D012400:Rotavirus Infections / Q000453:epidemiology / Q000517:prevention & control*; D022243:Rotavirus Vaccines; D013997:Time Factors; D014613:Vaccines, Attenuated / Q000008:administration & dosage; D014765:Viral Vaccines / Q000008:administration & dosage*
chemical_list: D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated; D014765:Viral Vaccines; C052014:rhesus rotavirus vaccine