PMID- 25830489
OWN - NLM
STAT- MEDLINE
DCOM- 20160204
LR  - 20190108
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 11
IP  - 4
DP  - 2015
TI  - Immunogenicity and safety of the 10-valent pneumococcal nontypeable Haemophilus 
      influenzae protein D conjugate vaccine (PHiD-CV) co-administered with DTPa 
      vaccine in Japanese children: A randomized, controlled study.
PG  - 826-37
LID - 10.1080/21645515.2015.1012019 [doi]
AB  - This phase III, randomized, open-label, multicenter study (NCT01027845) conducted 
      in Japan assessed the immunogenicity, safety, and reactogenicity of 10-valent 
      pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine 
      (PHiD-CV, given intramuscularly) co-administered with 
      diphtheria-tetanus-acellular pertussis vaccine (DTPa, given subcutaneously). 
      Infants (N=360 ) were randomized (2:1) to receive either PHiD-CV and DTPa 
      (PHiD-CV group) or DTPa alone (control group) as 3-dose primary vaccination 
      (3-4-5 months of age) and booster vaccination (17-19 months of age). Immune 
      responses were measured before and one month after primary/booster vaccination 
      and adverse events (AEs) were recorded. Post-primary immune responses were 
      non-inferior to those in pivotal/efficacy European or Latin American pneumococcal 
      protein D-conjugate vaccine studies. For each PHiD-CV serotype, at least 92.6% of 
      infants post-primary vaccination and at least 97.7% of children post-booster had 
      pneumococcal antibody concentrations >/=0.2 mug/ml, and at least 95.4% post-primary 
      and at least 98.1% post-booster had opsonophagocytic activity (OPA) titers >/=8 . 
      Geometric mean antibody concentrations and OPA titers (except OPA titer for 6B) 
      were higher post-booster than post-priming for each serotype. All 
      PHiD-CV-vaccinated children had anti-protein D antibody concentrations >/=100 
      EL.U/ml one month post-primary/booster vaccination and all were 
      seroprotected/seropositive against each DTPa antigen. Redness and irritability 
      were the most common solicited AEs in both groups. Incidences of unsolicited AEs 
      were comparable between groups. Serious AEs were reported for 47 children (28 in 
      PHiD-CV group); none were assessed as vaccine-related. In conclusion, PHiD-CV 
      induced robust immune responses and was well tolerated when co-administered with 
      DTPa in a 3-dose priming plus booster regimen to Japanese children.
FAU - Iwata, Satoshi
AU  - Iwata S
AD  - a Department of Infectious Diseases ; School of Medicine; Keio University ; 
      Shinjuku-ku , Tokyo , Japan.
FAU - Kawamura, Naohisa
AU  - Kawamura N
FAU - Kuroki, Haruo
AU  - Kuroki H
FAU - Tokoeda, Yasunobu
AU  - Tokoeda Y
FAU - Miyazu, Mitsunobu
AU  - Miyazu M
FAU - Iwai, Asayuki
AU  - Iwai A
FAU - Oishi, Tomohiro
AU  - Oishi T
FAU - Sato, Tomohide
AU  - Sato T
FAU - Suyama, Akari
AU  - Suyama A
FAU - Francois, Nancy
AU  - Francois N
FAU - Shafi, Fakrudeen
AU  - Shafi F
FAU - Ruiz-Guinazu, Javier
AU  - Ruiz-Guinazu J
FAU - Borys, Dorota
AU  - Borys D
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (10-valent pneumococcal conjugate vaccine)
RN  - 0 (Diphtheria-Tetanus-acellular Pertussis Vaccines)
RN  - 0 (PHiD-CV vaccine)
RN  - 0 (Pneumococcal Vaccines)
SB  - IM
MH  - Adolescent
MH  - Child
MH  - Child, Preschool
MH  - Diphtheria-Tetanus-acellular Pertussis Vaccines/*immunology/*therapeutic use
MH  - Female
MH  - Haemophilus influenzae/immunology/pathogenicity
MH  - Humans
MH  - Male
MH  - Pneumococcal Infections/immunology/*prevention & control
MH  - Pneumococcal Vaccines/*immunology/*therapeutic use
MH  - Young Adult
PMC - PMC4514407
OTO - NOTNLM
OT  - 7vCRM, 7-valent pneumococcal CRM-conjugate vaccine
OT  - AE, adverse event
OT  - AOM, acute otitis media
OT  - ATP, according-to-protocol
OT  - CAP, community-acquired pneumonia
OT  - CI, confidence interval
OT  - COMPAS, Clinical Otitis Media and PneumoniA Study
OT  - DTPa, diphtheria-tetanus-acellular pertussis
OT  - ELISA, enzyme-linked immunosorbent assay
OT  - GMC, geometric mean concentration
OT  - GMT, geometric mean titer
OT  - HBV, hepatitis B virus
OT  - Hib, Haemophilus influenzae type b
OT  - IPD, invasive pneumococcal disease
OT  - Japan
OT  - NTHi, nontypeable Haemophilus influenzae
OT  - OPA, opsonophagocytic activity
OT  - PCV, pneumococcal conjugate vaccine
OT  - PHiD-CV, 10-valent pneumococcal nontypeable Haemophilus influenzae protein D 
      conjugate vaccine
OT  - POET, Pneumococcal Otitis Efficacy Trial
OT  - SAE, serious adverse event
OT  - SAS, Statistical Analysis System
OT  - SDD, SAS Drug and Development
OT  - WHO, World Health Organization
OT  - children
OT  - co-administration
OT  - immunogenicity
OT  - pneumococcal conjugate vaccine
OT  - safety
EDAT- 2015/04/02 06:00
MHDA- 2016/02/06 06:00
PMCR- 2016/02/03
CRDT- 2015/04/02 06:00
PHST- 2015/04/02 06:00 [entrez]
PHST- 2015/04/02 06:00 [pubmed]
PHST- 2016/02/06 06:00 [medline]
PHST- 2016/02/03 00:00 [pmc-release]
AID - 1012019 [pii]
AID - 10.1080/21645515.2015.1012019 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2015;11(4):826-37. doi: 10.1080/21645515.2015.1012019.