Immunogenicity and safety of combined adsorbed low-dose diphtheria, tetanus and inactivated poliovirus vaccine (REVAXIS (®)) versus combined diphtheria, tetanus and inactivated poliovirus vaccine (DT Polio (®)) given as a booster dose at 6 years of age

Hum Vaccin. 2011 May;7(5):549-56. doi: 10.4161/hv.7.5.14982. Epub 2011 May 1.

Abstract

This randomized, comparative, phase-IIIb study conducted in France aimed to demonstrate whether seroprotection against diphtheria, tetanus and poliomyelitis 1 month after a single dose of REVAXIS (low-dose diphtheria) is non-inferior to seroprotection 1 month after a single dose of DT Polio (standard-dose diphtheria), both vaccines being given as a second booster to healthy children at 6 years of age. Children were randomly assigned to receive a single intramuscular dose of REVAXIS or DT Polio. Primary endpoints were the 1-month post-booster seroprotection rates for diphtheria, tetanus and poliovirus type-1, -2 and -3 antigens. Secondary endpoints were immunogenicity and safety observations. Of 788 children screened, 760 were randomized: REVAXIS group, 384 children; DT Polio group, 376 children. No relevant difference in demographic characteristics at baseline was observed between REVAXIS and DT Polio groups. Non-inferiority of REVAXIS compared with DT Polio for seroprotection was demonstrated against diphtheria (respectively 98.6% and 99.3%), tetanus (respectively 99.6% and 100%), and poliovirus antigens (100% for each types in both groups). No allergic reactions to REVAXIS were reported. A benefit/risk ratio in favor of REVAXIS was suggested by the trend towards a better tolerability of REVAXIS compared with DT Polio regarding the rate of severe solicited injection-site reactions. The results support the use of REVAXIS as a booster at 6 years of age in infants who previously received a three-dose primary series within the first 6 months of life and a first booster including diphtheria, tetanus and poliovirus vaccine(s) given before 2 years of age.

Trial registration: ClinicalTrials.gov NCT00447525.

Publication types

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

MeSH terms

  • Child
  • Diphtheria / prevention & control*
  • Diphtheria Toxoid / administration & dosage
  • Diphtheria Toxoid / adverse effects*
  • Diphtheria Toxoid / immunology*
  • Female
  • France
  • Humans
  • Hypersensitivity
  • Immunization, Secondary / adverse effects*
  • Immunization, Secondary / methods*
  • Incidence
  • Injections, Intramuscular
  • Male
  • Poliomyelitis / prevention & control*
  • Poliovirus Vaccines / administration & dosage
  • Poliovirus Vaccines / adverse effects*
  • Poliovirus Vaccines / immunology*
  • Skin Diseases / chemically induced
  • Tetanus / prevention & control*
  • Tetanus Toxoid / administration & dosage
  • Tetanus Toxoid / adverse effects*
  • Tetanus Toxoid / immunology*
  • Vaccines, Combined / administration & dosage
  • Vaccines, Combined / adverse effects
  • Vaccines, Combined / immunology

Substances

  • DTPolio vaccine
  • Diphtheria Toxoid
  • Poliovirus Vaccines
  • Tetanus Toxoid
  • Vaccines, Combined

Associated data

  • ClinicalTrials.gov/NCT00447525