PMID- 32048889
OWN - NLM
STAT- MEDLINE
DCOM- 20210621
LR  - 20220531
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 16
IP  - 9
DP  - 2020 Sep 1
TI  - Immunogenicity and safety of a combined DTPa-IPV/Hib vaccine administered as a 
      three-dose primary vaccination course and a booster dose in healthy children in 
      Russia: a phase III, non-randomized, open-label study.
PG  - 2265-2273
LID - 10.1080/21645515.2020.1720437 [doi]
AB  - We assessed the immunogenicity and safety of the combined 
      diphtheria-tetanus-acellular pertussis-inactivated poliovirus/Haemophilus 
      influenzae type b vaccine (DTPa-IPV/Hib) in children in Russian Federation aiming 
      to support the registration of the vaccine in Russia. In this phase 3, 
      non-randomized, open-label study (NCT02858440), healthy children received three 
      primary doses at 3, 4.5, and 6 months of age (N = 235) and a booster dose at 
      18 months of age (N = 225). Seroprotection rates against diphtheria, tetanus, 
      Hib, and poliovirus 1-3, seropositivity rates against pertussis antigens, and 
      antibody geometric mean concentrations/titers for all antigens were evaluated one 
      month post-primary and post-booster vaccinations. Solicited local and general 
      adverse events (AEs) were collected during a 4-day period and unsolicited AEs 
      during a 31-day period post-vaccination. Serious AEs were recorded throughout the 
      study. At post-primary vaccination, all infants were seroprotected against 
      diphtheria, tetanus, and poliovirus 1 and 2, 99.3% against poliovirus 3, and 
      98.4% against Hib. At least 98.9% of participants were seropositive for the three 
      pertussis antigens. At post-booster vaccination, all toddlers were 
      seroprotected/seropositive against all vaccine components. The most frequent 
      local and general solicited AEs were redness, reported for 52.6% and 44.9% of 
      children, and irritability, reported for 64.7% and 39.1% of children, 
      post-primary and post-booster vaccination, respectively. Unsolicited AEs were 
      reported for 20.4% (post-primary) and 5.8% of children (post-booster 
      vaccination). Most AEs were mild or moderate in intensity. Six serious AEs were 
      reported in three (0.4%) children; none were fatal or assessed as 
      vaccination-related. DTPa-IPV/Hib proved immunogenic and well tolerated in the 
      Russian pediatric population.
FAU - Romanenko, Victor
AU  - Romanenko V
AD  - Children's City Hospital numero sign11 , Ekaterinburg, Russian Federation.
FAU - Osipova, Irina
AU  - Osipova I
AD  - OOO "ASKO-MED-PLUS" , Barnaul, Russian Federation.
FAU - Galustyan, Anna
AU  - Galustyan A
AD  - Medical Technologies Ltd , St. Petersburg, Russian Federation.
FAU - Scherbakov, Michael
AU  - Scherbakov M
AUID- ORCID: 0000-0002-9189-4729
AD  - GSK , Moscow, Russian Federation.
FAU - Baudson, Nathalie
AU  - Baudson N
AD  - GSK , Rixensart, Belgium.
FAU - Farhi, Deborah
AU  - Farhi D
AD  - GSK , Wavre, Belgium.
FAU - Anaya, Luis
AU  - Anaya L
AD  - GSK , Wavre, Belgium.
FAU - Kuriyakose, Sherine O
AU  - Kuriyakose SO
AD  - GSK Asia Private Ltd ., Bengaluru, India.
FAU - Meyer, Nadia
AU  - Meyer N
AD  - GSK , Wavre, Belgium.
FAU - Janssens, Winnie
AU  - Janssens W
AUID- ORCID: 0000-0003-1314-3468
AD  - GSK , Wavre, Belgium.
LA  - eng
SI  - ClinicalTrials.gov/NCT02858440
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20200212
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (Antibodies, Bacterial)
RN  - 0 (Diphtheria-Tetanus-Pertussis Vaccine)
RN  - 0 (Haemophilus Vaccines)
RN  - 0 (Hepatitis B Vaccines)
RN  - 0 (Poliovirus Vaccine, Inactivated)
RN  - 0 (Vaccines, Combined)
RN  - 7A314HQM0I (Pentetic Acid)
SB  - IM
MH  - Antibodies, Bacterial
MH  - Child
MH  - Diphtheria-Tetanus-Pertussis Vaccine/adverse effects
MH  - *Haemophilus Vaccines/adverse effects
MH  - *Haemophilus influenzae type b
MH  - Hepatitis B Vaccines
MH  - Humans
MH  - Immunization, Secondary
MH  - Infant
MH  - Pentetic Acid
MH  - Poliovirus Vaccine, Inactivated/adverse effects
MH  - Russia
MH  - Vaccination
MH  - Vaccines, Combined/adverse effects
PMC - PMC7553713
OTO - NOTNLM
OT  - DTPa-IPV/Hib
OT  - acellular pertussis
OT  - diphtheria
OT  - immunogenicity
OT  - pediatric population
OT  - poliovirus Haemophilus influenzae type b
OT  - reactogenicity
OT  - safety
OT  - tetanus
EDAT- 2020/02/13 06:00
MHDA- 2021/06/22 06:00
PMCR- 2020/02/12
CRDT- 2020/02/13 06:00
PHST- 2020/02/13 06:00 [pubmed]
PHST- 2021/06/22 06:00 [medline]
PHST- 2020/02/13 06:00 [entrez]
PHST- 2020/02/12 00:00 [pmc-release]
AID - 1720437 [pii]
AID - 10.1080/21645515.2020.1720437 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2020 Sep 1;16(9):2265-2273. doi: 
      10.1080/21645515.2020.1720437. Epub 2020 Feb 12.