Safety and immunogenicity of fully liquid DTaP₅-IPV-Hib pediatric combination vaccine (Pediacel®) compared to DTaP₃-HBV-IPV/Hib (Infanrix® Hexa) when coadministered with heptavalent pneumococcal conjugate vaccine (PCV7) as a booster at 11-18 months of age: a phase III, modified double-blind, randomized, controlled, multicenter study

Reinhard Berner; Florence Boisnard; Stéphane Thomas; Grace Mwawasi; Donna Reynolds

doi:10.1016/j.vaccine.2012.05.064

Safety and immunogenicity of fully liquid DTaP₅-IPV-Hib pediatric combination vaccine (Pediacel®) compared to DTaP₃-HBV-IPV/Hib (Infanrix® Hexa) when coadministered with heptavalent pneumococcal conjugate vaccine (PCV7) as a booster at 11-18 months of age: a phase III, modified double-blind, randomized, controlled, multicenter study

Vaccine. 2012 Jul 27;30(35):5270-7. doi: 10.1016/j.vaccine.2012.05.064. Epub 2012 Jun 9.

Authors

Reinhard Berner¹, Florence Boisnard, Stéphane Thomas, Grace Mwawasi, Donna Reynolds

Affiliation

¹ University Medical Centre Freiburg, Freiburg, Germany. [email protected]

PMID: 22691430
DOI: 10.1016/j.vaccine.2012.05.064

Abstract

This study compared the safety and immunogenicity of DTaP₅-IPV-Hib vaccine (followed by monovalent hepatitis B vaccine [HBV]) and DTaP₃-HBV-IPV/Hib vaccines, both coadministered with PCV7, as a fourth-dose booster in toddlers 11-18 months who had a hexavalent vaccine primary series. The fever rate within 4 days of DTaP₅-IPV-Hib was noninferior to DTaP₃-HBV-IPV/Hib. DTaP₅-IPV-Hib induced a marked immune response and had a similar safety and immunogenicity profile compared with DTaP₃-HBV-IPV/Hib. Fully liquid DTaP₅-IPV-Hib can be used as a booster after a hexavalent vaccine primary series; where required, a fourth dose of monovalent HBV can be administered after DTaP₅-IPV-Hib (NCT ID: NCT00355654).

Publication types

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

MeSH terms

Antibodies, Bacterial / blood
Antibodies, Bacterial / immunology
Antibodies, Viral / blood
Antibodies, Viral / immunology
Diphtheria-Tetanus-Pertussis Vaccine / administration & dosage*
Diphtheria-Tetanus-acellular Pertussis Vaccines / administration & dosage*
Dose-Response Relationship, Drug
Double-Blind Method
Endpoint Determination
Female
Haemophilus Vaccines / administration & dosage*
Heptavalent Pneumococcal Conjugate Vaccine
Humans
Immunization
Immunization, Secondary
Infant
Male
Pneumococcal Vaccines / administration & dosage*
Poliovirus Vaccine, Inactivated / administration & dosage*
Vaccines, Combined / administration & dosage
Vaccines, Combined / immunology
Vaccines, Conjugate / administration & dosage

Substances

Antibodies, Bacterial
Antibodies, Viral
Diphtheria-Tetanus-Pertussis Vaccine
Diphtheria-Tetanus-acellular Pertussis Vaccines
Haemophilus Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Pneumococcal Vaccines
Poliovirus Vaccine, Inactivated
Vaccines, Combined
Vaccines, Conjugate
diphtheria-tetanus-five component acellular pertussis-inactivated poliomyelitis -Haemophilus influenzae type b conjugate vaccine

Associated data

ClinicalTrials.gov/NCT00355654