PMID- 21817957
OWN - NLM
STAT- MEDLINE
DCOM- 20120525
LR  - 20111122
IS  - 1532-0987 (Electronic)
IS  - 0891-3668 (Linking)
VI  - 30
IP  - 12
DP  - 2011 Dec
TI  - Response to primary and booster vaccination with 10-valent pneumococcal 
      nontypeable Haemophilus influenzae protein D conjugate vaccine in Korean infants.
PG  - e235-43
LID - 10.1097/INF.0b013e31822a8541 [doi]
AB  - 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 mug/mL after primary vaccination. 
      Postprimary and postbooster, percentages of subjects with antibody concentration 
      >/=0.2 mug/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.
FAU - Kim, Chang-Hwi
AU  - Kim CH
AD  - College of Medicine, Soonchunhyang University, Bucheon, Republic of Korea.
FAU - Kim, Jung Soo
AU  - Kim JS
FAU - Cha, Sung-Ho
AU  - Cha SH
FAU - Kim, Kwang-Nam
AU  - Kim KN
FAU - Kim, Jong-Duck
AU  - Kim JD
FAU - Lee, Kyung Yil
AU  - Lee KY
FAU - Kim, Hwang Min
AU  - Kim HM
FAU - Kim, Jong-Hyun
AU  - Kim JH
FAU - Hyuk, Sang
AU  - Hyuk S
FAU - Hong, Jung-Yun
AU  - Hong JY
FAU - Park, Su Eun
AU  - Park SE
FAU - Kim, Yun-Kyung
AU  - Kim YK
FAU - Kim, Nam Hee
AU  - Kim NH
FAU - Fanic, Aurelie
AU  - Fanic A
FAU - Borys, Dorota
AU  - Borys D
FAU - Ruiz-Guinazu, Javier
AU  - Ruiz-Guinazu J
FAU - Moreira, Marta
AU  - Moreira M
FAU - Schuerman, Lode
AU  - Schuerman L
FAU - Kim, Kyung-Hyo
AU  - Kim KH
LA  - eng
SI  - ClinicalTrials.gov/NCT00680914
SI  - ClinicalTrials.gov/NCT00911144
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Pediatr Infect Dis J
JT  - The Pediatric infectious disease journal
JID - 8701858
RN  - 0 (10-valent pneumococcal vaccine)
RN  - 0 (Antibodies, Bacterial)
RN  - 0 (Bacterial Proteins)
RN  - 0 (Carrier Proteins)
RN  - 0 (Immunoglobulin D)
RN  - 0 (Lipoproteins)
RN  - 0 (Pneumococcal Vaccines)
RN  - EC 3.1.4.46 (glpQ protein, Haemophilus influenzae)
SB  - IM
MH  - Antibodies, Bacterial/*immunology
MH  - Bacterial Proteins/*immunology
MH  - Carrier Proteins/*immunology
MH  - Female
MH  - Humans
MH  - Immunization Schedule
MH  - Immunoglobulin D/*immunology
MH  - Infant
MH  - Lipoproteins/*immunology
MH  - Male
MH  - Meningitis, Haemophilus/immunology/*prevention & control
MH  - Pneumococcal Vaccines/*administration & dosage/adverse effects/immunology
MH  - Republic of Korea
MH  - Single-Blind Method
EDAT- 2011/08/06 06:00
MHDA- 2012/05/26 06:00
CRDT- 2011/08/06 06:00
PHST- 2011/08/06 06:00 [entrez]
PHST- 2011/08/06 06:00 [pubmed]
PHST- 2012/05/26 06:00 [medline]
AID - 10.1097/INF.0b013e31822a8541 [doi]
PST - ppublish
SO  - Pediatr Infect Dis J. 2011 Dec;30(12):e235-43. doi: 10.1097/INF.0b013e31822a8541.