Safety and efficacy of human rotavirus vaccine during the first 2 years of life in Asian infants: randomised, double-blind, controlled study

Vaccine. 2009 Oct 9;27(43):5936-41. doi: 10.1016/j.vaccine.2009.07.098. Epub 2009 Aug 11.


This study evaluates the safety and efficacy against severe rotavirus gastroenteritis of the oral live attenuated human rotavirus vaccine RIX4414 (Rotarix) during the first 2 years of life in Asian infants from high-income countries. Healthy infants were enrolled to receive 2 doses of RIX4414 (N=5,359) or placebo (N=5,349). From 2 weeks post-dose 2 to 2 years of age, vaccine efficacy was 96.1% (95%CI:85.1%; 99.5%) against severe rotavirus gastroenteritis, 100% (95%CI:80.8%; 100%) against wild-type G1P[8] and 93.6% (95%CI:74.7%; 99.3%) against circulating non-G1 rotavirus types. No intussusception cases were reported within 31 days post-vaccination. RIX4414 shows a good safety profile and offers high protection during the first 2 years of life with potentially significant public health impact in this population.

Trial registration: NCT00197210.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Child, Preschool
  • Double-Blind Method
  • Gastroenteritis / prevention & control*
  • Gastroenteritis / virology
  • Humans
  • Infant
  • Rotavirus Infections / prevention & control*
  • Rotavirus Vaccines / administration & dosage*
  • Vaccines, Attenuated / administration & dosage


  • RIX4414 vaccine
  • Rotavirus Vaccines
  • Vaccines, Attenuated

Associated data