Efficacy, safety and immunogenicity of a human rotavirus vaccine (RIX4414) in Hong Kong children up to three years of age: a randomized, controlled trial

Vaccine. 2013 Apr 26;31(18):2253-9. doi: 10.1016/j.vaccine.2013.03.001. Epub 2013 Mar 13.

Abstract

Background: A phase III, double-blind, randomized, controlled trial was conducted in Hong Kong to evaluate the efficacy, safety and immunogenicity of a human rotavirus vaccine, RIX4414 (Rotarix) against severe rotavirus gastroenteritis in children up to three years of age.

Methods: Healthy infants aged 6-12 weeks were enrolled between 08-December-2003 and 31-August-2005 and received two oral doses of either RIX4414 vaccine (N=1513) or placebo (N=1512) given 2 months apart. Vaccine efficacy was assessed from two weeks post-Dose 2 until the children were two and three years of age. Anti-rotavirus IgA seroconversion rate was calculated pre-vaccination and 1-2 months post-Dose 2 using ELISA (cut-off=20 U/mL) for 100 infants. Safety was assessed until the children were two years of age; serious adverse events (SAEs) were recorded throughout the study period.

Results: In children aged two and three years of life, vaccine efficacy against severe rotavirus gastroenteritis was 95.6% (95% CI: 73.1%-99.9%) and 96.1% (95% CI: 76.5%-99.9%), respectively. The seroconversion rate 1-2 months after the second dose of RIX4414 was 97.5% (95% CI: 86.8%-99.9%). At least one SAE was recorded in 439 and 477 infants who were administered RIX4414 and placebo, respectively (p-value=0.130). Six intussusception cases were reported (RIX4414=4; placebo=2) and none was assessed to be vaccine-related.

Conclusion: RIX4414 was efficacious, immunogenic and safe in the prevention of rotavirus gastroenteritis for at least two years post-vaccination in Hong Kong children.

Trial registration: ClinicalTrials.gov NCT00197210.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Antibodies, Viral / blood
  • Antibodies, Viral / immunology
  • Child, Preschool
  • Double-Blind Method
  • Gastroenteritis / immunology
  • Gastroenteritis / prevention & control*
  • Gastroenteritis / virology
  • Hong Kong
  • Humans
  • Immunization Schedule
  • Immunoglobulin A / blood
  • Immunoglobulin A / immunology
  • Infant
  • Intussusception / chemically induced
  • Rotavirus
  • Rotavirus Infections / immunology
  • Rotavirus Infections / prevention & control*
  • Rotavirus Vaccines / administration & dosage
  • Rotavirus Vaccines / adverse effects
  • Rotavirus Vaccines / therapeutic use*

Substances

  • Antibodies, Viral
  • Immunoglobulin A
  • Rotavirus Vaccines

Associated data

  • ClinicalTrials.gov/NCT00197210