PMID- 30431387
OWN - NLM
STAT- MEDLINE
DCOM- 20200212
LR  - 20200309
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 15
IP  - 2
DP  - 2019
TI  - Immunogenicity and safety of a combined DTPa-IPV/Hib vaccine administered as a 
      three-dose primary vaccination course in healthy Korean infants: phase III, 
      randomized study.
PG  - 317-326
LID - 10.1080/21645515.2018.1536588 [doi]
AB  - We assessed the immunogenicity and safety of a three-dose primary vaccination 
      schedule with the combined diphtheria-tetanus-acellular pertussis-inactivated 
      poliovirus/Haemophilus influenzae type b vaccine (DTPa-IPV/Hib) in Korean 
      infants. In this phase III open-label, multicenter study (NCT01309646), healthy 
      infants aged 42-69 days (randomized 1:1) received three doses of either 
      pentavalent DTPa-IPV/Hib (DTPa-IPV/Hib group) or DTPa-IPV and Hib vaccines 
      administered separately (DTPa-IPV+Hib group) at 2, 4, 6 months of age. The 
      primary objective was to demonstrate non-inferiority of DTPa-IPV/Hib compared to 
      DTPa-IPV+Hib vaccines in terms of immune responses to all vaccine antigens, 
      1 month post-dose 3. Solicited symptoms (local and general) were recorded during 
      4 days, and unsolicited adverse events (AEs) during 31 days, after each 
      vaccination. Serious AEs (SAEs) were recorded throughout the study duration. The 
      immunogenicity of the pentavalent DTPa-IPV/Hib vaccine was non-inferior compared 
      to concomitant administration of DTPa-IPV+Hib vaccines. One month post-dose 3, 
      nearly all infants had antibody levels above the seroprotective thresholds for 
      anti-diphtheria toxoid, anti-tetanus toxoid, anti-polyribosyl-ribitol phosphate, 
      and anti-poliovirus type 1, 2 and 3, and had antibody levels above the 
      seropositive thresholds for anti-pertussis toxoid (PT), anti-filamentous 
      hemagglutinin (FHA) and anti-pertactin (PRN) antibodies. A vaccine response for 
      PT, FHA and PRN was observed in at least 96.7% of study participants. Anti-PRP 
      geometric mean concentrations appeared lower for the DTPa-IPV/Hib group 
      (8.456 microg/mL) than for the DTPa-IPV+Hib group (18.700 microg/mL). In both groups, the 
      most common solicited symptoms were injection site redness and irritability. 
      Fifty-seven SAEs were reported throughout the study; none were considered to be 
      vaccination related.
FAU - Kim, Ki Hwan
AU  - Kim KH
AD  - a Incheon St. Mary's Hospital, College of Medicine, The Catholic University of 
      Korea Incheon, The Republic of Korea.
FAU - Kim, Chun Soo
AU  - Kim CS
AD  - b Keimyung University School of Medicine , Daegu , The Republic of Korea.
FAU - Kim, Hwang Min
AU  - Kim HM
AUID- ORCID: 0000-0002-0329-1371
AD  - c Yonsei University Wonju College of Medicine , Wonju , The Republic of Korea.
FAU - Kim, Jong-Duck
AU  - Kim JD
AD  - d Wonkwang University Hospital , Iksan , The Republic of Korea.
FAU - Ma, Sang Hyuk
AU  - Ma SH
AD  - e Changwon Fatima Hospital , Changwon , The Republic of Korea.
FAU - Kim, Dong Ho
AU  - Kim DH
AD  - f Korea Cancer Center Hospital , Seoul , The Republic of Korea.
FAU - Hwang, Pyoung-Han
AU  - Hwang PH
AD  - g Chonbuk National University Hospital, Chonbuk National University Medical 
      School , Jeonju , The Republic of Korea.
FAU - Han, Ji-Whan
AU  - Han JW
AD  - h Uijeongbu St. Mary's Hospital , The Catholic University of Korea , Uijeongbu , 
      The Republic of Korea.
FAU - Lee, Taek-Jin
AU  - Lee TJ
AUID- ORCID: 0000-0002-8912-6982
AD  - i Bundang CHA Hospital , Seongnam , The Republic of Korea.
FAU - Kim, Joon Hyung
AU  - Kim JH
AUID- ORCID: 0000-0002-6014-3543
AD  - j GSK , Seoul , The Republic of Korea.
FAU - Karkada, Naveen
AU  - Karkada N
AD  - k GSK , Wavre , Belgium.
FAU - Mesaros, Narcisa
AU  - Mesaros N
AD  - k GSK , Wavre , Belgium.
FAU - Sohn, Woo-Yun
AU  - Sohn WY
AD  - l GSK , Seoul , The Republic of Korea.
FAU - Kim, Jong-Hyun
AU  - Kim JH
AD  - m St. Vincent's Hospital, College of Medicine , The Catholic University of Korea 
      , Suwon , The Republic of Korea.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20181115
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (Antibodies, Bacterial)
RN  - 0 (Antibodies, Viral)
RN  - 0 (DTPP vaccine)
RN  - 0 (Diphtheria-Tetanus-Pertussis Vaccine)
RN  - 0 (Haemophilus Vaccines)
RN  - 0 (Poliovirus Vaccine, Inactivated)
RN  - 0 (Vaccines, Combined)
SB  - IM
MH  - Antibodies, Bacterial/*blood
MH  - Antibodies, Viral/*blood
MH  - Diphtheria-Tetanus-Pertussis Vaccine/administration & dosage/*immunology
MH  - Dose-Response Relationship, Immunologic
MH  - Drug-Related Side Effects and Adverse Reactions
MH  - Female
MH  - Haemophilus Vaccines/administration & dosage/*immunology
MH  - Humans
MH  - *Immunization Schedule
MH  - *Immunogenicity, Vaccine
MH  - Infant
MH  - Male
MH  - Poliovirus Vaccine, Inactivated/administration & dosage/*immunology
MH  - Republic of Korea
MH  - Vaccines, Combined/administration & dosage/immunology
PMC - PMC6422512
OTO - NOTNLM
OT  - type b
OT  - DTPa-IPV/Hib
OT  - acellular pertussis
OT  - diphtheria
OT  - immunogenicity
OT  - infants
OT  - poliovirus
OT  - reactogenicity
OT  - safety
OT  - tetanus
EDAT- 2018/11/16 06:00
MHDA- 2020/02/13 06:00
PMCR- 2018/11/15
CRDT- 2018/11/16 06:00
PHST- 2018/11/16 06:00 [pubmed]
PHST- 2020/02/13 06:00 [medline]
PHST- 2018/11/16 06:00 [entrez]
PHST- 2018/11/15 00:00 [pmc-release]
AID - 1536588 [pii]
AID - 10.1080/21645515.2018.1536588 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2019;15(2):317-326. doi: 10.1080/21645515.2018.1536588. 
      Epub 2018 Nov 15.