title: Comparative immunogenicity and safety of different multivalent component pertussis vaccine formulations and a 5-component acellular pertussis vaccine in infants and toddlers: a randomized, controlled, open-label, multicenter study.
abstract: BACKGROUND
  Pentavalent and quadrivalent combination vaccine formulations from the same manufacturer (DTaP-IPV/Hib [PENTA], DTaP-IPV [QUAD]) were investigated as to whether they were sufficiently interchangeable to tailor use to local preference or availability.
  
  
  METHODS
  A randomized, controlled, open-label, 4-armed, multicenter study in healthy, full-term infants (42-89 days of age) was conducted in 38 centers across the United States. Participants were randomized 1:1:1:1 to a control vaccine group (3 doses DTaP, IPV, and Hib and at Dose 4 DTaP and Hib) and 3 combination vaccine groups: (1) 3 doses PENTA, then Dose 4 DTaP and Hib; (2) 4 QUAD doses and Hib; (3) 4 PENTA doses. Participants (N=2167) were immunized at 2, 4, and 6 months of age, Dose 4 participants (N=1832) at 15 months of age. Immunogenicity was assessed before Doses 1 and 4 and after Doses 3 and 4. Safety was assessed 30 days after each dose and through 180 days Post-Dose 4.
  
  
  RESULTS
  Antibody responses and geometric mean concentrations/geometric mean titers (GMCs/GMTs) elicited by each combination vaccine were noninferior (upper-bound 90% confidence interval of GMC/GMT ratios <1.5) to control vaccines except pertactin GMCs were higher after 4 control DTaP doses (157.46 EU/mL) than after Dose 4 with DTaP and Hib (after a PENTA infant series) (111.70 EU/mL) and after 4 PENTA doses (98.00 EU/mL). Fever rates in the combination vaccine groups were noninferior (upper bound 95% CI of combination vaccine group fever rate minus control vaccine group fever rate <10%) to the control vaccine group except the rate after 4 QUAD and Hib doses (23.5%) was higher than after 4 control DTaP doses (13.9%).
  
  
  CONCLUSIONS
  PENTA and QUAD had similar safety profiles and no clinically important differences in immunogenicity compared with separately administered control vaccines. ClinicalTrials.gov (NCT ID: NCT00255047).
authors.affiliation: Creighton University School of Medicine, Omaha, NE 68131, USA. achatter@creighton.edu
authors.forename: Archana
authors.initials: A
authors.lastname: Chatterjee
authors.forename: Catherine
authors.initials: C
authors.lastname: O'Keefe
authors.forename: Meera
authors.initials: M
authors.lastname: Varman
authors.forename: Nicola P
authors.initials: NP
authors.lastname: Klein
authors.forename: Stephen
authors.initials: S
authors.lastname: Luber
authors.forename: Antigona
authors.initials: A
authors.lastname: Tomovici
authors.forename: Fernando
authors.initials: F
authors.lastname: Noriega
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D010567:Pertussis Vaccine / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D014481:United States; D014611:Vaccination / Q000009:adverse effects* / Q000379:methods*; D022282:Vaccines, Acellular / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D017778:Vaccines, Combined / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D000907:Antibodies, Bacterial; D010567:Pertussis Vaccine; D022282:Vaccines, Acellular; D017778:Vaccines, Combined