title: Efficacy, immunogenicity, and safety of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine at the end of shelf life.
abstract: BACKGROUND
  Rotavirus is the leading cause of dehydrating acute gastroenteritis in infants worldwide. Previous studies of a live pentavalent human-bovine reassortant rotavirus vaccine have shown it to be efficacious across a range of potencies.
  
  
  OBJECTIVE
  Our goal was to evaluate the efficacy, immunogenicity, and safety of pentavalent rotavirus vaccine at the end of shelf life in healthy infants.
  
  
  METHODS
  During 2002-2004, 1312 healthy infants approximately 6 to 12 weeks old from the United States (47%) and Finland (53%) were randomly assigned to receive 3 oral doses of vaccine (vaccine at approximately 1.1 x 10(7) infectious U per dose) or placebo approximately 4 to 10 weeks apart. Infants were to be followed for acute gastroenteritis through 1 rotavirus season after vaccination and for adverse events postvaccination.
  
  
  RESULTS
  Three doses of pentavalent rotavirus vaccine at the end of shelf life demonstrated efficacy against rotavirus gastroenteritis caused by human G-serotypes included in the vaccine (G1-G4). Efficacy against severe rotavirus gastroenteritis was 100%, and efficacy against any rotavirus gastroenteritis regardless of severity was 72.5%. A threefold rise in G1 serum neutralizing was observed in 57% and in anti-rotavirus immunoglobulin A in 96% of pentavalent rotavirus vaccine recipients. No statistically significant increase in vomiting, diarrhea, or irritability was observed among pentavalent rotavirus vaccine recipients compared with placebo recipients within the 7-day period from each dose. A statistically significant increase in fevers (> or = 100.5 degrees F, rectal equivalent) was observed among pentavalent rotavirus vaccine recipients compared with placebo recipients after dose 1.
  
  
  CONCLUSIONS
  This pentavalent human-bovine rotavirus vaccine was generally well tolerated, efficacious, and immunogenic at the end of shelf life.
authors.affiliation: Kentucky Pediatric/Adult Research, Bardstown, Kentucky, USA.
authors.forename: Stan L
authors.initials: SL
authors.lastname: Block
authors.forename: Timo
authors.initials: T
authors.lastname: Vesikari
authors.forename: Michelle G
authors.initials: MG
authors.lastname: Goveia
authors.forename: Stephen B
authors.initials: SB
authors.lastname: Rivers
authors.forename: Ben A
authors.initials: BA
authors.lastname: Adeyi
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Dallas
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Bauder
authors.forename: John W
authors.initials: JW
authors.lastname: Boslego
authors.forename: Penny M
authors.initials: PM
authors.lastname: Heaton
mesh_terms: D000208:Acute Disease; D000914:Antibodies, Viral / Q000097:blood; D004311:Double-Blind Method; D005243:Feces / Q000821:virology; D005260:Female; D005759:Gastroenteritis / Q000517:prevention & control / Q000821:virology; D006760:Hospitalization; D006801:Humans; D007070:Immunoglobulin A / Q000097:blood; D007223:Infant; D008297:Male; D012401:Rotavirus / Q000276:immunology / Q000302:isolation & purification; D012400:Rotavirus Infections / Q000517:prevention & control / Q000821:virology; D022243:Rotavirus Vaccines / Q000009:adverse effects / Q000276:immunology*; D014611:Vaccination
chemical_list: D000914:Antibodies, Viral; D007070:Immunoglobulin A; D022243:Rotavirus Vaccines; C058442:WC3 rotavirus vaccine