title: Immunogenicity and reactogenicity of a 13-valent-pneumococcal conjugate vaccine administered at 2, 4, and 12 months of age: a double-blind randomized active-controlled trial.
abstract: BACKGROUND
  A 2-, 4-, and 12-month schedule of a novel 13-valent-pneumococcal conjugate vaccine (PCV13), containing serotype 1, 3, 4, 5, 6A, 6B 7F, 9V, 14, 18C, 19A, 19F, and 23F polysaccharides individually conjugated to CRM197 was evaluated in a randomized, double-blind, controlled infant study.
  
  
  METHODS
  Two hundred eighty-six healthy infants received PCV13 or the 7-valent-pneumococcal conjugate vaccine (PCV7) at 2, 4, and 12 months of age, alongside a serogroup C meningococcal (MenC) vaccine (2 and 4 months of age), DTaP-IPV-Hib (2, 3, and 4 months), and a Hib-MenC vaccine (12 months). Specific antibody responses were assessed at age 5, 12, and 13 months.
  
  
  RESULTS
  At 13 months of age, >97% of PCV13 recipients had pneumococcal serotype-specific serum IgG concentrations ≥0.35 µg/mL for each vaccine serotype except serotype 3 (88.2%), and at least 93% of PCV13 recipients had OPA titers ≥1:8 for each serotype. At 5 months, 110/114 (96.5%) of PCV13 recipients and 100/102 (98.0%) of PCV7 recipients had serum anti-PRP (Hib) IgG concentration ≥0.15 µg/mL (difference, 1.5%; CI, -7.1%–3.7%), while 119/120 (99.2%) and 117/118 (99.2%), respectively, had MenC serum bactericidal assay titers of ≥1:8. All PCV13 recipients and 110/113 (97.3%) of PCV7 recipients had IgG concentrations against fimbrial agglutinogens of ≥2.2 EU/mL; IgG concentrations for the remaining pertussis antigens were ≥5 EU/mL for all participants. Local reactions and systemic events were similar in the PCV13 and PCV7 groups.
  
  
  CONCLUSIONS
  A 2-, 4-, and 12-month course of PCV13 was immunogenic for all 13 vaccine serotypes and was well tolerated.
authors.affiliation: Oxford Vaccine Group, Department of Paediatrics, Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, University of Oxford, Headington, United Kingdom.
authors.forename: Matthew D
authors.initials: MD
authors.lastname: Snape
authors.forename: Chaam L
authors.initials: CL
authors.lastname: Klinger
authors.forename: Elvis D
authors.initials: ED
authors.lastname: Daniels
authors.forename: Tessa M
authors.initials: TM
authors.lastname: John
authors.forename: Helen
authors.initials: H
authors.lastname: Layton
authors.forename: Llinos
authors.initials: L
authors.lastname: Rollinson
authors.forename: Sarah
authors.initials: S
authors.lastname: Pestridge
authors.forename: Sandra
authors.initials: S
authors.lastname: Dymond
authors.forename: Eva
authors.initials: E
authors.lastname: Galiza
authors.forename: Susan
authors.initials: S
authors.lastname: Tansey
authors.forename: Daniel A
authors.initials: DA
authors.lastname: Scott
authors.forename: Sherryl A
authors.initials: SA
authors.lastname: Baker
authors.forename: Thomas R
authors.initials: TR
authors.lastname: Jones
authors.forename: Ly-Mee
authors.initials: LM
authors.lastname: Yu
authors.forename: William C
authors.initials: WC
authors.lastname: Gruber
authors.forename: Emilio A
authors.initials: EA
authors.lastname: Emini
authors.forename: Saul N
authors.initials: SN
authors.lastname: Faust
authors.forename: Adam
authors.initials: A
authors.lastname: Finn
authors.forename: Paul T
authors.initials: PT
authors.lastname: Heath
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Pollard
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007117:Immunization, Secondary / Q000379:methods*; D007223:Infant; D008297:Male; D011008:Pneumococcal Infections / Q000276:immunology / Q000517:prevention & control*; D022242:Pneumococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D014611:Vaccination / Q000379:methods*
chemical_list: C538862:13-valent pneumococcal vaccine; D000907:Antibodies, Bacterial; D022242:Pneumococcal Vaccines