Immunogenicity of Infanrix™ hexa administered at 3, 5 and 11 months of age

• Published in: Vaccine Vol. 30; no. 17; pp. 2710 - 2714
• Main Authors: Van Der Meeren, Olivier, Kuriyakose, Sherine, Kolhe, Devayani, Hardt, Karin
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Ltd 05.04.2012
• Subjects: Age; Allergy and Immunology; Antibodies; Antibodies, Bacterial - blood; Antibodies, Bacterial - immunology; Antibodies, Viral - blood; Antibodies, Viral - immunology; antigens; Booster; Combination vaccines; Data processing; Diphtheria; Diphtheria - immunology; Diphtheria - prevention & control; Diphtheria-Tetanus-acellular Pertussis Vaccines - administration & dosage; Diphtheria-Tetanus-acellular Pertussis Vaccines - adverse effects; Diphtheria-Tetanus-acellular Pertussis Vaccines - immunology; Europe; Female; Haemophilus Infections - immunology; Haemophilus Infections - prevention & control; Haemophilus Vaccines - administration & dosage; Haemophilus Vaccines - adverse effects; Haemophilus Vaccines - immunology; Hepatitis B; Hepatitis B - immunology; Hepatitis B - prevention & control; Humans; Immune response; Immunogenicity; Infant; Infants; Male; Pertussis; Polio; Poliomyelitis - immunology; Poliomyelitis - prevention & control; Poliovirus; Poliovirus Vaccine, Inactivated - administration & dosage; Poliovirus Vaccine, Inactivated - adverse effects; Poliovirus Vaccine, Inactivated - immunology; seroprevalence; Tetanus; Tetanus - immunology; Tetanus - prevention & control; Time Factors; Vaccination; Vaccine; Vaccines; Vaccines, Combined - administration & dosage; Vaccines, Combined - adverse effects; Vaccines, Combined - immunology; Europe; DTPa–HBV–IPV/Hib; PT; CI; Booster; Polio; Vaccine; μg/ml; EL.U/ml; PRN; IU/ml; Combination vaccines; GMT; PRP; SD; Immunogenicity; mIU/ml; GMC; VR; ATP; SP; FHA; ELISA; geometric mean antibody concentration; diphtheria–tetanus–acellular pertussis, hepatitis B, inactivated poliovirus and Haemophilus influenzae type b vaccine; milli-international units per millilitre; seroprotection; ELISA units per millilitre; geometric mean antibody titre; according to protocol; micrograms per millilitre; filamentous haemagglutinin; pertactin; international units per millilitre; pertussis toxoid; enzyme-linked immunosorbent assay; confidence interval; vaccine response; polyribosylribitol phosphate; standard deviation
• ISSN: 0264-410X; 1873-2518; 1873-2518
• DOI: 10.1016/j.vaccine.2012.02.024

A pooled analysis of data from four vaccination studies conducted in Europe was undertaken to assess the immunogenicity of Infanrix™ hexa (DTPa–HBV–IPV/Hib, GlaxoSmithKline Biologicals) when administered in a total of 702 healthy infants at 3, 5 and 11–12 months of age. One month after dose 2, between 96.3% and 100% of subjects had seroprotective antibodies against diphtheria, tetanus, hepatitis B and poliovirus types 1, 2 and 3; 91.7% against Hib and ≥99.0% were seropositive for each pertussis antigen. One month after the third dose, 98.9–100% of subjects were seroprotected/seropositive for all vaccine antigens. Geometric mean antibody concentrations/titres for each vaccine antigen increased by 6.7–52.9 fold after the third vaccine dose. No serious adverse events in DTPa–HBV–IPV/Hib recipients were vaccine related. Infanrix™ hexa induces an adequate immune response after 2-dose primary plus booster doses when administered according to a 3, 5 and 11 months schedule.