title: Response to primary and booster vaccination with 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine in Korean infants.
abstract: BACKGROUND
  This randomized single-blind study in Korea evaluated noninferiority of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) versus the 7-valent pneumococcal conjugate vaccine (7vCRM) when both were coadministered with H. influenzae type b (Hib) conjugate vaccine, as opposed to coadministration with diphtheria-tetanus-acellular pertussis-based combination vaccines in previous studies.
  
  
  METHODS
  Infants received 3 primary doses at 2, 4, and 6 months and a booster dose at 12 to 18 months of PHiD-CV (N = 374) or 7vCRM (N = 129), both coadministered with Hib vaccine. Immune responses were measured 1 month postdose 3 and postbooster using 22F-inhibition enzyme-linked immunosorbent assay and functional opsonophagocytic activity assay.
  
  
  RESULTS
  PHiD-CV-induced antibody responses against each of the vaccine pneumococcal serotypes and protein D. Noninferiority to 7vCRM was demonstrated for all 10 PHiD-CV serotypes in terms of percentages of subjects reaching an antibody concentration ≥0.2 μg/mL after primary vaccination. Postprimary and postbooster, percentages of subjects with antibody concentration ≥0.2 μg/mL or opsonophagocytic activity titer ≥8 were generally consistent between groups for each pneumococcal serotype common to both vaccines. The safety and reactogenicity profiles of PHiD-CV and 7vCRM were generally comparable after both primary and booster vaccination.
  
  
  CONCLUSIONS
  In this Korean study, 3-dose PHiD-CV priming followed by a booster dose was immunogenic for all 10 vaccine pneumococcal serotypes and protein D. Noninferiority to 7vCRM in terms of enzyme-linked immunosorbent assay threshold responses postpriming was demonstrated. The safety and reactogenicity profiles of both vaccines when coadministered with Hib vaccine were generally comparable.
authors.affiliation: College of Medicine, Soonchunhyang University, Bucheon, Republic of Korea.
authors.forename: Chang-Hwi
authors.initials: CH
authors.lastname: Kim
authors.forename: Jung Soo
authors.initials: JS
authors.lastname: Kim
authors.forename: Sung-Ho
authors.initials: SH
authors.lastname: Cha
authors.forename: Kwang-Nam
authors.initials: KN
authors.lastname: Kim
authors.forename: Jong-Duck
authors.initials: JD
authors.lastname: Kim
authors.forename: Kyung Yil
authors.initials: KY
authors.lastname: Lee
authors.forename: Hwang Min
authors.initials: HM
authors.lastname: Kim
authors.forename: Jong-Hyun
authors.initials: JH
authors.lastname: Kim
authors.forename: Sang
authors.initials: S
authors.lastname: Hyuk
authors.forename: Jung-Yun
authors.initials: JY
authors.lastname: Hong
authors.forename: Su Eun
authors.initials: SE
authors.lastname: Park
authors.forename: Yun-Kyung
authors.initials: YK
authors.lastname: Kim
authors.forename: Nam Hee
authors.initials: NH
authors.lastname: Kim
authors.forename: Aurélie
authors.initials: A
authors.lastname: Fanic
authors.forename: Dorota
authors.initials: D
authors.lastname: Borys
authors.forename: Javier
authors.initials: J
authors.lastname: Ruiz-Guiñazù
authors.forename: Marta
authors.initials: M
authors.lastname: Moreira
authors.forename: Lode
authors.initials: L
authors.lastname: Schuerman
authors.forename: Kyung-Hyo
authors.initials: KH
authors.lastname: Kim
mesh_terms: D000907:Antibodies, Bacterial / Q000276:immunology*; D001426:Bacterial Proteins / Q000276:immunology*; D002352:Carrier Proteins / Q000276:immunology*; D005260:Female; D006801:Humans; D007115:Immunization Schedule; D007072:Immunoglobulin D / Q000276:immunology*; D007223:Infant; D008074:Lipoproteins / Q000276:immunology*; D008297:Male; D008583:Meningitis, Haemophilus / Q000276:immunology / Q000517:prevention & control*; D022242:Pneumococcal Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D056910:Republic of Korea; D016037:Single-Blind Method
chemical_list: C538863:10-valent pneumococcal vaccine; D000907:Antibodies, Bacterial; D001426:Bacterial Proteins; D002352:Carrier Proteins; D007072:Immunoglobulin D; D008074:Lipoproteins; D022242:Pneumococcal Vaccines; C067989:glpQ protein, Haemophilus influenzae