title: Immunogenicity and reactogenicity of four doses of diphtheria-tetanus-three-component acellular pertussis-hepatitis B-inactivated polio virus-Haemophilus influenzae type b vaccine coadministered with 7-valent pneumococcal conjugate Vaccine.
abstract: BACKGROUND
  The 7-valent pneumococcal (7vPn) conjugate vaccine is licensed for primary and booster vaccination according to the same immunization schedules as routinely recommended diphtheria-tetanus-pertussis-based childhood vaccines and can be coadministered during the same vaccination visit.
  
  
  METHODS
  An open, randomized study evaluated the immunogenicity and safety of a hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio virus-Haemophilus influenzae type b (DTPa-HBV-IPV/Hib) vaccine and a 7vPn conjugate vaccine when coadministered at 2, 3 and 4 months and 12-23 months of age, compared with the administration of the hexavalent DTPa-HBV-IPV/Hib vaccine given alone. Serum antibody titers were measured before and 1 month after the primary course and before and 1 month after the booster dose. Solicited local and general adverse events were recorded for 4 days and unsolicited adverse events were recorded for 30 days after each vaccine dose.
  
  
  RESULTS
  A total of 345 subjects were enrolled for primary vaccination with the hexavalent vaccine (170 without and 175 with the 7vPn vaccine coadministered) and 266 returned for booster vaccination (122 without and 144 with coadministration of the 7vPn vaccine). After primary vaccination, antibody responses against the common antigens were similar in both groups, with seroprotection rates of 93.6-100% and with similar antibody decay before booster vaccination. The fourth dose induced a vigorous booster response, with seroprotection/vaccine response rates of 96.8-100%. Response to the 7vPn primary and booster vaccination was within previously reported ranges. Differences in reactogenicity resulted from higher incidences of symptoms after concomitant vaccination. Rectal temperature >39.5 degrees C was observed after 1.2% of the coadministered vaccine doses during primary vaccination and after 2.8% of the booster vaccine doses.
  
  
  CONCLUSIONS
  Coadministration of the DTPa-HBV-IPV/Hib and 7vPn vaccines at separate injection sites during the same vaccination visit was effective and safe.
authors.affiliation: Medical Practice, Munich, Germany.
authors.forename: Irmingard
authors.initials: I
authors.lastname: Tichmann-Schumann
authors.forename: Peter
authors.initials: P
authors.lastname: Soemantri
authors.forename: Ulrich
authors.initials: U
authors.lastname: Behre
authors.forename: Johann
authors.initials: J
authors.lastname: Disselhoff
authors.forename: Hans
authors.initials: H
authors.lastname: Mahler
authors.forename: Gudrun
authors.initials: G
authors.lastname: Maechler
authors.forename: Roland
authors.initials: R
authors.lastname: Sänger
authors.forename: Jeanne-Marie
authors.initials: JM
authors.lastname: Jacquet
authors.forename: Lode
authors.initials: L
authors.lastname: Schuerman
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood*; D000914:Antibodies, Viral / Q000097:blood*; D015331:Cohort Studies; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D018073:Haemophilus Vaccines; D017325:Hepatitis B Vaccines; D000069443:Heptavalent Pneumococcal Conjugate Vaccine; D006801:Humans; D007115:Immunization Schedule; D007117:Immunization, Secondary; D007223:Infant; D022401:Meningococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D022242:Pneumococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D011054:Poliovirus Vaccine, Inactivated; D014611:Vaccination; D017778:Vaccines, Combined / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*
chemical_list: D000907:Antibodies, Bacterial; D000914:Antibodies, Viral; C451839:DTPa-HBV-IPV combined vaccine; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D018073:Haemophilus Vaccines; D017325:Hepatitis B Vaccines; D000069443:Heptavalent Pneumococcal Conjugate Vaccine; D022401:Meningococcal Vaccines; D022242:Pneumococcal Vaccines; D011054:Poliovirus Vaccine, Inactivated; D017778:Vaccines, Combined