title: Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine in healthy infants and toddlers given with routine pediatric vaccinations in Canada.
abstract: BACKGROUND
  The global distribution of pneumococcal disease and emergence of nonvaccine pneumococcal serotypes prompted the development of a 13-valent pneumococcal conjugate vaccine (PCV13), with broader coverage than 7-valent PCV (PCV7). This study compared compatibility of PCV13 and PCV7 with concurrently administered diphtheria, tetanus, acellular pertussis, inactivated poliovirus, Haemophilus influenzae type b vaccine, and meningococcal C conjugate vaccine (menC), and assessed the safety and immunogenicity of PCV13.
  
  
  METHODS
  In this double-blind, randomized trial, children received PCV7 or PCV13 at 2, 4, 6, and 12 months with routine vaccinations. One month following the infant series and toddler dose, the responses to Hib, pertussis, menC, and specific pneumococcal serotypes were measured. Safety and tolerability were assessed daily for 4 days by parents.
  
  
  RESULTS
  Subjects received PCV13 (n = 300) or PCV7 (n = 303); immunogenicity assessment was completed in 265 and 268 subjects, respectively. There were no statistically significant differences between the groups in responses to Hib, pertussis, or menC after primary or booster vaccinations. More than 95% of subjects in the PCV13 group produced >0.35 μg/mL antibody to each pneumococcal serotype 1 month after the third dose, except with serotypes 23F (90%), 3 (80%), and 5 (87%). After the fourth dose, 98% to 100% of subjects achieved serotype-specific antibody concentrations >0.35 μg/mL, except for serotype 3 (85%). Safety and tolerability did not differ between groups with respect to local or systemic side effects.
  
  
  CONCLUSIONS
  Responses to routine childhood vaccines did not differ with PCV7 or PCV13 coadministration. Serotype-specific pneumococcal antibody concentrations were protective. The safety profile of PCV13 was favorable.
authors.affiliation: Department of Pediatrics, University of Calgary & Alberta Health Services - Calgary Zone, Calgary, Alberta.
authors.forename: Otto G
authors.initials: OG
authors.lastname: Vanderkooi
authors.forename: David W
authors.initials: DW
authors.lastname: Scheifele
authors.forename: Douglas
authors.initials: D
authors.lastname: Girgenti
authors.forename: Scott A
authors.initials: SA
authors.lastname: Halperin
authors.forename: Scott D
authors.initials: SD
authors.lastname: Patterson
authors.forename: William C
authors.initials: WC
authors.lastname: Gruber
authors.forename: Emilio A
authors.initials: EA
authors.lastname: Emini
authors.forename: Daniel A
authors.initials: DA
authors.lastname: Scott
authors.forename: James D
authors.initials: JD
authors.lastname: Kellner
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood*; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D004311:Double-Blind Method; D005260:Female; D018073:Haemophilus Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D000069443:Heptavalent Pneumococcal Conjugate Vaccine; D006801:Humans; D007115:Immunization Schedule; D007223:Infant; D008297:Male; D022401:Meningococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D011008:Pneumococcal Infections / Q000276:immunology / Q000517:prevention & control; D022242:Pneumococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D011054:Poliovirus Vaccine, Inactivated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D013296:Streptococcus pneumoniae / Q000276:immunology*; D016896:Treatment Outcome; D014611:Vaccination; D018074:Vaccines, Conjugate / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*
chemical_list: C538862:13-valent pneumococcal vaccine; D000907:Antibodies, Bacterial; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D018073:Haemophilus Vaccines; D000069443:Heptavalent Pneumococcal Conjugate Vaccine; D022401:Meningococcal Vaccines; D022242:Pneumococcal Vaccines; D011054:Poliovirus Vaccine, Inactivated; D018074:Vaccines, Conjugate; C541234:diphtheria-tetanus-five component acellular pertussis-inactivated poliomyelitis -Haemophilus influenzae type b conjugate vaccine; C410218:serogroup C meningococcal conjugate vaccine