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

• Published in: European journal of pediatrics Vol. 161; no. 11; pp. 581 - 587
• Main Authors: Avdicová, Mária, Prikazský, Viktor, Hudecková, Henrieta, Schuerman, Lode, Willems, Paul
• Format: Journal Article
• Language: English
• Published: Heidelberg Springer 01.11.2002; Berlin Springer Nature B.V
• Subjects: Antibodies; Antigens; Bacterial Capsules; Biological and medical sciences; Diphtheria; Diphtheria-Tetanus-acellular Pertussis Vaccines - administration & dosage; Diphtheria-Tetanus-acellular Pertussis Vaccines - adverse effects; Diphtheria-Tetanus-acellular Pertussis Vaccines - immunology; Diphtheria-Tetanus-Pertussis Vaccine; Epidemiology. Vaccinations; General aspects; Haemophilus influenzae; Haemophilus Vaccines - administration & dosage; Haemophilus Vaccines - adverse effects; Haemophilus Vaccines - immunology; Hepatitis B; Hepatitis B Vaccines - administration & dosage; Hepatitis B Vaccines - adverse effects; Hepatitis B Vaccines - immunology; Humans; Immunization; Immunization Schedule; Immunogenicity; Infant; Infants; Infectious diseases; Medical sciences; Pertussis; Poliomyelitis; Poliovirus Vaccine, Inactivated; Polysaccharides, Bacterial - administration & dosage; Polysaccharides, Bacterial - adverse effects; Polysaccharides, Bacterial - immunology; Tetanus; Vaccines; Vaccines, Combined - administration & dosage; Vaccines, Combined - adverse effects; Vaccines, Combined - immunology; Whooping cough; Combined paediatric vaccines; Vaccination; Hepatic disease; Infant; Haemophilus influenzae; Viral hepatitis B; Haemophilus influenzae b; Bacteria; Acellular pertussis; Human; Inactivated polio vaccine; Nervous system diseases; Respiratory disease; Acute anterior poliomyelitis; Vaccine; Mixed vaccine; Diphtheria; Whooping cough; Infection; Pasteurellaceae; Immunogenicity; Viral disease; Central nervous system disease; Bacteriosis; Digestive diseases; Tetanus; Spinal cord disease; Hepatitis B
• ISSN: 0340-6199; 1432-1076
• DOI: 10.1007/s00431-002-1079-5

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. 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.