title: Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in infants and toddlers.
abstract: BACKGROUND
  7-Valent pneumococcal conjugate vaccine (PCV7 [Prevnar, Wyeth Pharmaceuticals Inc, Philadelphia, PA], serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) is effective in preventing vaccine-serotype pneumococcal disease. 13-Valent pneumococcal conjugate vaccine (PCV13) (PCV7 serotypes plus 1, 3, 5, 6A, 7F, and 19A) was designed to provide broader pneumococcal disease coverage. We evaluated the immunogenicity and safety of PCV13 compared with PCV7.
  
  
  METHODS
  Infants received PCV13 or PCV7 at ages 2, 4, 6, and 12 to 15 months with routine pediatric vaccinations. Pneumococcal anticapsular polysaccharide-binding immunoglobulin G responses and functional antipneumococcal opsonophagocytic activity were assessed 1 month after dose 3, before the toddler dose, and 1 month after the toddler dose. Safety and tolerability were also assessed.
  
  
  RESULTS
  For the 7 common serotypes, PCV13-elicited immunoglobulin G titers were noninferior to those elicited by PCV7, although PCV13 responses were generally somewhat lower. PCV13 also elicited functional opsonophagocytic activity comparable with that elicited by PCV7. For the 6 additional serotypes in PCV13, PCV13 elicited binding and functional antibody levels notably greater than those in PCV7 recipients. After PCV13 immunization, concordance between antipolysaccharide and opsonophagocytic responses was noted for all 13 serotypes. The PCV13 toddler dose resulted in higher immune responses compared with infant-series doses. Safety and tolerability were comparable; reactogenicity was generally mild.
  
  
  CONCLUSIONS
  PCV13 will be as effective as PCV7 in the prevention of pneumococcal disease caused by the 7 common serotypes and could provide expanded protection against the 6 additional serotypes. The PCV13 safety profile was comparable to that of PCV7.
authors: Vaccine Research Center, Los Angeles Biomedical Research Institute, Harbor-UCLA Medical Center, 1124 West Carson St, Liu Research Building, Torrance, CA 90502, USA. syeh@uclacvr.labiomed.org
authors: Sylvia H
authors: SH
authors: Yeh
authors: Alejandra
authors: A
authors: Gurtman
authors: David C
authors: DC
authors: Hurley
authors: Stan L
authors: SL
authors: Block
authors: Richard H
authors: RH
authors: Schwartz
authors: Scott
authors: S
authors: Patterson
authors: Kathrin U
authors: KU
authors: Jansen
authors: Jack
authors: J
authors: Love
authors: William C
authors: WC
authors: Gruber
authors: Emilio A
authors: EA
authors: Emini
authors: Daniel A
authors: DA
authors: Scott
mesh_terms: D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D000069443:Heptavalent Pneumococcal Conjugate Vaccine; D006801:Humans; D007223:Infant; D008297:Male; D022242:Pneumococcal Vaccines / Q000009:adverse effects / Q000276:immunology*; D018074:Vaccines, Conjugate / Q000009:adverse effects / Q000276:immunology*
chemical_list: C538862:13-valent pneumococcal vaccine; D000069443:Heptavalent Pneumococcal Conjugate Vaccine; D022242:Pneumococcal Vaccines; D018074:Vaccines, Conjugate