Immunogenicity and safety of a low-dose diphtheria, tetanus and acellular pertussis combination vaccine with either inactivated or oral polio vaccine as a pre-school booster in UK children

C L Collins; P Salt; N McCarthy; T Chantler; L Lane; F Hemme; L Diggle; J Buttery; N R E Kitchin; E R Moxon; A J Pollard

doi:10.1016/j.vaccine.2004.04.027

Immunogenicity and safety of a low-dose diphtheria, tetanus and acellular pertussis combination vaccine with either inactivated or oral polio vaccine as a pre-school booster in UK children

Vaccine. 2004 Oct 22;22(31-32):4262-9. doi: 10.1016/j.vaccine.2004.04.027.

Authors

C L Collins¹, P Salt, N McCarthy, T Chantler, L Lane, F Hemme, L Diggle, J Buttery, N R E Kitchin, E R Moxon, A J Pollard

Affiliation

¹ Oxford Vaccine Group, Centre for Clinical Vaccinology & Tropical Medicine, University of Oxford, Churchill Hospital, Old Road, Headington, Oxford OX3 7LJ, UK.

PMID: 15474717
DOI: 10.1016/j.vaccine.2004.04.027

Abstract

This open, randomised controlled trial studied the immunogenicity and reactogenicity of two combined low-dose diphtheria, tetanus and acellular pertussis vaccines (Td5aP-IPV, REPEVAX, Aventis Pasteur MSD; and Td5aP, COVAXIS, Aventis Pasteur MSD + OPV, GlaxoSmithKline) in comparison with a standard dose diphtheria pre-school booster vaccine (DT2aP-IPV, TETRAVAC, Aventis Pasteur MSD) in a population of 3.5-5-year-old children administered concomitantly with measles, mumps and rubella vaccine (M-M-R II, Aventis Pasteur MSD). A linked sub-study aimed to evaluate the immunogenicity and reactogenicity of Td5aP-IPV in a population of younger children, aged 3-3.5 years. This study demonstrated non-inferiority of seroprotection rates for diphtheria and tetanus for the study vaccines and comparable immunogenicity for pertussis and polio components of the vaccines. Reactogenicity was similar for all three vaccines. The study vaccines containing low-dose diphtheria antigen (Td5aP-IPV and Td5aP + OPV) are immunogenic and have acceptable reactogenicity for use as a pre-school booster vaccine administered concomitantly with MMR.

Publication types

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

MeSH terms

Antitoxins / analysis
Antitoxins / biosynthesis
Child, Preschool
Diphtheria / immunology
Diphtheria / prevention & control
Diphtheria-Tetanus-Pertussis Vaccine / administration & dosage
Diphtheria-Tetanus-Pertussis Vaccine / adverse effects
Diphtheria-Tetanus-Pertussis Vaccine / immunology*
Diphtheria-Tetanus-acellular Pertussis Vaccines / administration & dosage
Diphtheria-Tetanus-acellular Pertussis Vaccines / adverse effects
Diphtheria-Tetanus-acellular Pertussis Vaccines / immunology*
Dose-Response Relationship, Immunologic
Female
Humans
Immunization, Secondary
Male
Patient Compliance
Poliovirus Vaccines / administration & dosage
Poliovirus Vaccines / adverse effects
Poliovirus Vaccines / immunology*
Sample Size
Tetanus / immunology
Tetanus / prevention & control
United Kingdom / epidemiology
Vaccines, Combined / administration & dosage
Vaccines, Combined / adverse effects
Vaccines, Combined / immunology

Substances

Antitoxins
Diphtheria-Tetanus-Pertussis Vaccine
Diphtheria-Tetanus-acellular Pertussis Vaccines
Poliovirus Vaccines
Vaccines, Combined