PMID- 36520326
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230325
IS  - 2193-8229 (Print)
IS  - 2193-6382 (Electronic)
IS  - 2193-6382 (Linking)
VI  - 12
IP  - 2
DP  - 2023 Feb
TI  - Post-Marketing Safety Surveillance of a Childhood Pentavalent 
      Diphtheria-Tetanus-Acellular Pertussis-Polio and Haemophilus influenzae Type B 
      (DTaP-IPV//Hib) Vaccine in South Korea.
PG  - 499-511
LID - 10.1007/s40121-022-00724-7 [doi]
AB  - INTRODUCTION: PENTAXIM (Sanofi), DTaP-IPV//Hib, a pentavalent combination 
      vaccine for protection against diphtheria, tetanus, pertussis, poliomyelitis, and 
      invasive infections caused by Haemophilus influenzae type b, has been licensed in 
      South Korea by the Ministry of Food and Drug Safety (MFDS) on May 9, 2016, and is 
      currently used in routine vaccination. The aim of this phase IV study, conducted 
      as a post-licensure commitment in South Korea, was to evaluate the safety of the 
      DTaP-IPV//Hib vaccine when administered in infants at 2, 4, and 6 months of age 
      in the real-world clinical practice. METHODS: This multicenter, observational, 
      post-marketing surveillance (PMS) study was conducted in real-world practice in 
      South Korea. Infants aged 2 months or older were enrolled across seven centers 
      from July 31, 2018 to February 11, 2020. The study outcomes included occurrence, 
      time to onset, duration, intensity, and causality assessment (for unsolicited 
      adverse events [AEs] only) for several pre-listed solicited injection-site and 
      systemic reactions, unsolicited AEs, and serious adverse events (SAEs). RESULTS: 
      Data from 619 participants were included in the safety analysis. Overall, 618 AEs 
      were reported by 273 (44.1%) participants consisting of 121 solicited 
      injection-site reactions (15.4%), 344 solicited systemic reactions (24.6%), and 
      153 unsolicited AEs (15.7%) of which, 124 were unexpected AEs (12.9%) (regardless 
      of intensity). None of the unsolicited AEs were reported to have a causal 
      relationship with the study vaccine. One SAE of pyrexia (solicited reaction) was 
      reported. Most AEs were of mild intensity, and all participants recovered. 
      CONCLUSION: This PMS study of the DTaP-IPV//Hib vaccine confirmed its safety 
      profile in a real-life setting in South Korea and justified that the vaccine is 
      well tolerated when used in infants aged 2 months or older for the primary 
      series.
CI  - (c) 2022. The Author(s).
FAU - Yang, Kuhyun
AU  - Yang K
AD  - Medical Affairs, Sanofi, Seoul, Republic of Korea.
FAU - Kim, Hyunjung
AU  - Kim H
AD  - Medical Department, Sanofi, Seoul, Republic of Korea.
FAU - Ortiz, Esteban
AU  - Ortiz E
AD  - Pharmacovigilance Department, Sanofi, Lyon, France.
FAU - Huoi, Catherine
AU  - Huoi C
AD  - Global Medical Affairs Department, Sanofi, Lyon, France.
FAU - Kang, Jinhan
AU  - Kang J
AD  - The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, Republic of 
      Korea. kjhan@catholic.ac.kr.
LA  - eng
PT  - Journal Article
DEP - 20221215
PL  - New Zealand
TA  - Infect Dis Ther
JT  - Infectious diseases and therapy
JID - 101634499
PMC - PMC9925623
OTO - NOTNLM
OT  - DTaP-IPV//Hib
OT  - Diphtheria
OT  - Haemophilus influenzae type b
OT  - Hib
OT  - PENTAXIM
OT  - Pertussis
OT  - Polio
OT  - Post-marketing surveillance
OT  - Safety
OT  - Tetanus
OT  - Vaccines
EDAT- 2022/12/16 06:00
MHDA- 2022/12/16 06:01
PMCR- 2022/12/15
CRDT- 2022/12/15 11:19
PHST- 2022/08/30 00:00 [received]
PHST- 2022/11/03 00:00 [accepted]
PHST- 2022/12/16 06:00 [pubmed]
PHST- 2022/12/16 06:01 [medline]
PHST- 2022/12/15 11:19 [entrez]
PHST- 2022/12/15 00:00 [pmc-release]
AID - 10.1007/s40121-022-00724-7 [pii]
AID - 724 [pii]
AID - 10.1007/s40121-022-00724-7 [doi]
PST - ppublish
SO  - Infect Dis Ther. 2023 Feb;12(2):499-511. doi: 10.1007/s40121-022-00724-7. Epub 
      2022 Dec 15.