Immunogenicity and reactogenicity of a novel hexavalent DTPa-HBV-IPV/Hib vaccine compared to separate concomitant injections of DTPa-IPV/Hib and HBV vaccines, when administered according to a 3, 5 and 11 month vaccination schedule.

Abstract

UNLABELLED:

In an open randomised trial, 312 eligible infants were enrolled to receive either a single injection of the hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B virus-inactivated polio/ Haemophilus influenzae b (DTPa-HBV-IPV/Hib) vaccine, or concomitant injections of commercial DTPa-IPV/Hib and HBV vaccines (comparator). Vaccines were administered at 3, 5 and 11 months of age. The statistical approach for non-inferiority showed that the DTPa-HBV-IPV/Hib vaccine was at least as immunogenic as the comparator vaccines in terms of immunogenicity of all antigens 1 month after the 2nd dose. Non-inferiority criteria were also met immediately before and 1 month after the 3rd dose for all antigens except poliovirus type 3 prior to the 3rd dose. The majority of subjects were seroprotected against diphtheria, tetanus, polyribosyl-ribitol-phosphate, hepatitis B and poliovirus after the 2nd dose and maintained seroprotective antibody levels until the 3rd dose. A marked difference was observed in anti-HBs antibody geometric mean antibody concentrations (GMCs) at 1 month after the 2nd dose (higher GMCs in DTPa-HBV-IPV/Hib group). Reactogenicity (incidence of solicited local and general symptoms) was similar between the two study groups and no vaccine-related serious adverse events occurred.

CONCLUSION:

the new diphtheria-tetanus-acellular pertussis-hepatitis B virus-inactivated polio/ Haemophilus influenzae b vaccine administered at 3, 5 and 11 months of age was safe and at least as immunogenic as the comparator vaccines thus providing an effective and more comfortable option for this infant vaccination schedule.

• Authors: Mária Avdicová, Viktor Prikazský, Henrieta Hudecková, Lode Schuerman, Paul Willems
• Journal: European journal of pediatrics (Eur J Pediatr) Vol. 161 Issue 11 Pg. 581-7 (Nov 2002) ISSN: 0340-6199 [Print] Germany
• PMID: 12424582 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• DTPa-HBV-IPV combined vaccine
• Diphtheria-Tetanus-Pertussis Vaccine
• Diphtheria-Tetanus-acellular Pertussis Vaccines
• Haemophilus Vaccines
• Haemophilus influenzae type b polysaccharide vaccine
• Hepatitis B Vaccines
• Poliovirus Vaccine, Inactivated
• Polysaccharides, Bacterial
• Vaccines, Combined

Topics

• Bacterial Capsules
• Diphtheria-Tetanus-Pertussis Vaccine
• Diphtheria-Tetanus-acellular Pertussis Vaccines (administration & dosage, adverse effects, immunology)
• Haemophilus Vaccines (administration & dosage, adverse effects, immunology)
• Hepatitis B Vaccines (administration & dosage, adverse effects, immunology)
• Humans
• Immunization Schedule
• Infant
• Poliovirus Vaccine, Inactivated
• Polysaccharides, Bacterial (administration & dosage, adverse effects, immunology)
• Vaccines, Combined (administration & dosage, adverse effects, immunology)