A short report on highlights of worldwide development of RIX4414: a Singaporean experience

Vaccine. 2006 May 1;24(18):3782-3. doi: 10.1016/j.vaccine.2006.03.040. Epub 2006 Mar 23.

Abstract

In Singapore, we conducted a phase II randomized, double-blind, placebo-controlled dose ranging study using an attenuated human rotavirus vaccine, RIX4414. Altogether, 2464 healthy infants were recruited. Two oral doses of vaccine at 104.7, 105.2 or 106.1 ffu or placebo were administered with routine immunizations at 3 and 4 months of age. Seroconversion and 'vaccine take' in the vaccine groups 1-month post dose 2 varied from 76 to 91% and 98 to 100% respectively. Vaccine was well tolerated and did not interfere with response of concomitantly administered vaccines.

Publication types

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

MeSH terms

  • Antibodies, Viral / blood
  • Double-Blind Method
  • Humans
  • Infant
  • Rotavirus / immunology
  • Rotavirus Vaccines* / administration & dosage
  • Rotavirus Vaccines* / adverse effects
  • Rotavirus Vaccines* / immunology
  • Singapore
  • Vaccines, Attenuated* / administration & dosage
  • Vaccines, Attenuated* / adverse effects
  • Vaccines, Attenuated* / immunology

Substances

  • Antibodies, Viral
  • RIX4414 vaccine
  • Rotavirus Vaccines
  • Vaccines, Attenuated