title: Immunogenicity and safety of an acellular pertussis, diphtheria, tetanus, inactivated poliovirus, Hib-conjugate combined vaccine (Pentaxim) and monovalent hepatitis B vaccine at 6, 10 and 14 weeks of age in infants in South Africa.
abstract: OBJECTIVE
  To assess the immunogenicity and safety data for a pentavalent combination vaccine containing acellular pertussis, inactivated poliovirus, and Haemophilus influenzae (Hib) polysaccharide-conjugate antigens.
  
  
  METHODS
  A DTaP-IPV//PRP T vaccine (Pentaxim) was given at 6, 10 and 14 weeks of age to 212 infants in South Africa. Monovalent hepatitis B vaccine was given concomitantly. Immunogenicity was assessed using seroprotection and seroconversion rates; safety was assessed by monitoring for solicited injection site and systemic adverse events, and follow-up monitoring for unsolicited adverse events and serious adverse events.
  
  
  RESULTS
  Immunogenicity was high for each vaccine antigen, and similar to a reference study done in France using a similar (2, 3 and 4 months of age) administration schedule. After the third dose, 94.6% of participants had anti-PRP > or = 0.15 microg/ml. The anti-PRP geometric mean antibody titre (GMT) was 2.0 microg/ml. The seroprotection rates for diphtheria and tetanus (> or = 0.01 IU/ml), poliovirus types 1, 2 and 3 (> or = 8 1/dil U) and hepatitis B were all 100%. Anti-polio GMTs were very high, 1 453, 1 699 and 2 398 (1/dil U) for types 1, 2 and 3, respectively. The seroconversion/vaccine response rates to pertussis antigens (4-fold increase in antibody concentration) were 97.5% for PT and 83.9% for FHA.
  
  
  CONCLUSIONS
  The DTaP-IPV//PRP T vaccine was highly immunogenic at 6, 10 and 14 weeks of age in infants in South Africa, was compatible with the monovalent hepatitis B vaccine, and was well tolerated.
authors.affiliation: Vaccine Preventable Diseases, Department of Science and Technology/National Research Foundation, Johannesburg.
authors.forename: Shabir Ahmed
authors.initials: SA
authors.lastname: Madhi
authors.forename: Clare
authors.initials: C
authors.lastname: Cutland
authors.forename: Stephanie
authors.initials: S
authors.lastname: Jones
authors.forename: Michelle
authors.initials: M
authors.lastname: Groome
authors.forename: Esteban
authors.initials: E
authors.lastname: Ortiz
mesh_terms: D004165:Diphtheria / Q000453:epidemiology / Q000517:prevention & control*; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines / Q000008:administration & dosage; D005260:Female; D005500:Follow-Up Studies; D006509:Hepatitis B / Q000453:epidemiology / Q000517:prevention & control*; D017325:Hepatitis B Vaccines / Q000008:administration & dosage*; D006801:Humans; D015994:Incidence; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D011379:Prognosis; D013019:South Africa / Q000453:epidemiology; D013742:Tetanus / Q000453:epidemiology / Q000517:prevention & control*; D014611:Vaccination / Q000379:methods*; D018074:Vaccines, Conjugate / Q000008:administration & dosage*; D014917:Whooping Cough / Q000453:epidemiology / Q000517:prevention & control*
chemical_list: D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines; D017325:Hepatitis B Vaccines; D018074:Vaccines, Conjugate