title: A randomized, controlled trial to assess the immunogenicity and safety of a heptavalent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, hib and meningococcal serogroup C combination vaccine administered at 2, 3, 4 and 12-18 months of age.
abstract: BACKGROUND
  Combination vaccines offer protection against multiple diseases with fewer injections. This study evaluated the immunogenicity and safety of an investigational diphtheria, tetanus, acellular pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type b (Hib) and meningococcal serogroup C (MenC) heptavalent combination vaccine (heptavalent vaccine) given as 4 doses at 2, 3, 4 and 12-18 months of age.
  
  
  METHODS
  In this randomized, open, phase II study (NCT00970307/NCT01171989) conducted in Poland, 421 infants were enrolled to receive the heptavalent vaccine or licensed comparator vaccines. Immunogenicity against study vaccine antigens was measured prior to and 1 month after primary and booster vaccinations. Safety and reactogenicity of the vaccines were also evaluated.
  
  
  RESULTS
  The primary noninferiority objectives of the MenC and Hib immune responses induced by the heptavalent vaccine versus comparator vaccines were reached after primary vaccination, but no statistical conclusion could be drawn after booster dose. One month after primary and booster vaccinations, ≥98.4% of the heptavalent vaccine recipients were seroprotected for MenC and Hib. Exploratory analyses indicated that the heptavalent vaccine induced higher postprimary vaccination antibody geometric mean concentrations against Hib, but lower postprimary and postbooster vaccinations geometric mean titers against MenC compared with the relevant comparator vaccines. The reactogenicity profiles of the vaccines were acceptable, although 1 infant vaccinated with the heptavalent vaccine experienced a serious adverse event (thrombocytopenia) considered possibly related to vaccination.
  
  
  CONCLUSIONS
  The heptavalent vaccine was immunogenic and had a clinically acceptable safety profile when administered to infants and toddlers.
authors.affiliation: Department of Pediatric Infectious Diseases, Medical University Wroclaw, Wroclaw, Poland. leszek.szenborn@am.wroc.pl
authors.forename: Leszek
authors.initials: L
authors.lastname: Szenborn
authors.forename: Hanna
authors.initials: H
authors.lastname: Czajka
authors.forename: Jerzy
authors.initials: J
authors.lastname: Brzostek
authors.forename: Ryszard
authors.initials: R
authors.lastname: Konior
authors.forename: Magalie
authors.initials: M
authors.lastname: Caubet
authors.forename: Liliana
authors.initials: L
authors.lastname: Ulianov
authors.forename: Maarten
authors.initials: M
authors.lastname: Leyssen
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood; D001770:Blood Bactericidal Activity; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D004797:Enzyme-Linked Immunosorbent Assay; D018073:Haemophilus Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D017325:Hepatitis B Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D006801:Humans; D007223:Infant; D008297:Male; D022401:Meningococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D011044:Poland; D011054:Poliovirus Vaccine, Inactivated / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D014611:Vaccination / Q000009:adverse effects* / Q000379:methods*; D017778:Vaccines, Combined / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D000907:Antibodies, Bacterial; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D018073:Haemophilus Vaccines; D017325:Hepatitis B Vaccines; D022401:Meningococcal Vaccines; D011054:Poliovirus Vaccine, Inactivated; D017778:Vaccines, Combined; C541235:diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine; C410218:serogroup C meningococcal conjugate vaccine