title: 13-Valent pneumococcal conjugate vaccine in older children and adolescents either previously immunized with or naïve to 7-valent pneumococcal conjugate vaccine.
abstract: BACKGROUND
  The 13-valent pneumococcal conjugate vaccine (PCV13) has been demonstrated to be immunogenic and safe for administration to infants and children aged <5 years. PCV13 recently was approved for children and adolescents aged up to 17 years as the vaccine may be of benefit to some in this older age group.
  
  
  METHODS
  In this open-label study, healthy children aged ≥5 to <10 years (ie, the younger age group) previously vaccinated (≥1 dose) with 7-valent PCV (PCV7) and pneumococcal vaccine-naïve children aged ≥10 to <18 years (ie, the older age group) received 1 dose of PCV13. For the younger group, antipneumococcal immunoglobulin (Ig) G geometric mean concentrations 1 month postvaccination were compared with posttoddler dose (PCV13 or PCV7) levels from a historical control study. Opsonophagocytic activity geometric mean titers 1 month postvaccination for the older group were compared with the younger age group. Safety data were collected.
  
  
  RESULTS
  Five hundred and ninety-eight children were enrolled, 299 in each age group. For PCV7 serotypes, IgG geometric mean concentrations in the younger group were 8.23-53.56 μg/mL, ≥2.5-fold greater than historical posttoddler dose values. For the 6 additional serotypes, IgG geometric mean concentrations in the younger group were 2.38-21.51 μg/mL, ≥1.2-fold greater than historical posttoddler dose values. Opsonophagocytic activity geometric mean titers were similar in the older and younger age groups, except for serotype 3 which was lower in the older group. Safety was comparable in both groups.
  
  
  CONCLUSIONS
  PCV13 was immunogenic and safe when administered to older children and adolescents, regardless of prior PCV7 vaccination.
authors.affiliation: From the *Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, OH; †Pfizer Inc, Pearl River, NY; ‡Senders Pediatrics, Cleveland, OH; §Alpha Clinical Research, Clarksville, TN; ¶Edinger Medical Group, Fountain Valley, CA; and ‖Pfizer Inc, Collegeville, PA.
authors.forename: Robert
authors.initials: R
authors.lastname: Frenck
authors.forename: Allison
authors.initials: A
authors.lastname: Thompson
authors.forename: Shelly
authors.initials: S
authors.lastname: Senders
authors.forename: Laurie
authors.initials: L
authors.lastname: Harris-Ford
authors.forename: Malcolm
authors.initials: M
authors.lastname: Sperling
authors.forename: Scott
authors.initials: S
authors.lastname: Patterson
authors.forename: Carmel
authors.initials: C
authors.lastname: Devlin
authors.forename: Kathrin U
authors.initials: KU
authors.lastname: Jansen
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: Alejandra
authors.initials: A
authors.lastname: Gurtman
mesh_terms: D000293:Adolescent; D000367:Age Factors; D002648:Child; D002675:Child, Preschool; D005260:Female; D000069443:Heptavalent Pneumococcal Conjugate Vaccine; D006801:Humans; D007223:Infant; D008297:Male; D011008:Pneumococcal Infections / Q000517:prevention & control; D022242:Pneumococcal Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D011446:Prospective Studies; D013296:Streptococcus pneumoniae / Q000276:immunology; D014481:United States; D018074:Vaccines, Conjugate / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: C538862:13-valent pneumococcal vaccine; D000069443:Heptavalent Pneumococcal Conjugate Vaccine; D022242:Pneumococcal Vaccines; D018074:Vaccines, Conjugate