PMID- 35575974
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220801
IS  - 2193-8229 (Print)
IS  - 2193-6382 (Electronic)
IS  - 2193-6382 (Linking)
VI  - 11
IP  - 4
DP  - 2022 Aug
TI  - Post-Marketing Surveillance of Tetravalent Diphtheria-Tetanus-Acellular Pertussis 
      and Inactivated Poliovirus (DTaP-IPV) Vaccine in South Korea, 2009 to 2015.
PG  - 1479-1492
LID - 10.1007/s40121-022-00650-8 [doi]
AB  - INTRODUCTION: TETRAXIM (Sanofi), a combined diphtheria, tetanus, acellular 
      pertussis, and inactivated poliovirus (DTaP-IPV) vaccine, has been licensed in 
      South Korea since 2009. In accordance with the Ministry of Food and Drug Safety 
      regulations, this post-marketing surveillance (PMS) study evaluated the safety of 
      the DTaP-IPV vaccine in real-world clinical practice in infants and children who 
      received it as either a part of the three-dose primary series dose at 2, 4, and 
      6 months or school entry booster between 4 and 6 years of age. METHODS: This 
      multicenter, observational, PMS study was conducted in real-world practice in 
      South Korea for 6 years (2009-2015) in participants aged between 2 months and 
      6 years. The study outcomes included solicited reactions, unsolicited adverse 
      events (AEs)/adverse drug reactions (ADRs), unexpected AEs/ADRs, and serious AEs 
      (SAEs)/ADRs. RESULTS: Data from 647 participants was included in the safety 
      analysis. Overall, 268 AEs were reported by 181 (28%) participants: 47 (17.5%) 
      solicited reactions, 220 (82.1%) unsolicited AEs, and 1 (0.4%) unsolicited ADR. A 
      total of 48 AEs (including 47 solicited reactions) were reported to have a causal 
      relationship with the DTaP-IPV vaccine and were reported by 36 (5.6%) 
      participants. A total of 212 unexpected AEs were reported by 152 (23.5%) 
      participants, none of which had a causal relationship with the DTaP-IPV vaccine. 
      Neither immediate AEs nor SAEs were reported during the study. Among the 
      participants who reported AEs, 220 (34%) were on concomitant medications. Most 
      AEs were of mild intensity, and all participants recovered. CONCLUSION: No safety 
      concerns related to the DTaP-IPV vaccine in a real-world setting were raised in 
      participants aged 2-6 months for the primary series and 4-6 years for the 
      school-entry booster dose in the Korean population. The DTaP-IPV vaccine was well 
      tolerated and can be continued as part of routine immunization programs in 
      infants and children. TRIAL REGISTRATION: NCT01437423.
CI  - (c) 2022. The Author(s).
FAU - Choe, Young June
AU  - Choe YJ
AD  - Medical Affairs, Sanofi, Seoul, Republic of Korea. choey@korea.ac.kr.
FAU - Vidor, Emmanuel
AU  - Vidor E
AD  - Global Medical Affairs, Sanofi, Lyon, France.
FAU - Manson, Christine
AU  - Manson C
AD  - Global Pharmacovigilance, Sanofi, Lyon, France.
LA  - eng
SI  - ClinicalTrials.gov/NCT01437423
PT  - Journal Article
DEP - 20220514
PL  - New Zealand
TA  - Infect Dis Ther
JT  - Infectious diseases and therapy
JID - 101634499
PMC - PMC9334467
OTO - NOTNLM
OT  - DTaP-IPV
OT  - Diphtheria
OT  - Pertussis
OT  - Polio
OT  - Post-marketing surveillance
OT  - Safety
OT  - TETRAXIM
OT  - Tetanus
OT  - Vaccines
EDAT- 2022/05/17 06:00
MHDA- 2022/05/17 06:01
PMCR- 2022/05/14
CRDT- 2022/05/16 13:18
PHST- 2022/03/11 00:00 [received]
PHST- 2022/04/22 00:00 [accepted]
PHST- 2022/05/17 06:00 [pubmed]
PHST- 2022/05/17 06:01 [medline]
PHST- 2022/05/16 13:18 [entrez]
PHST- 2022/05/14 00:00 [pmc-release]
AID - 10.1007/s40121-022-00650-8 [pii]
AID - 650 [pii]
AID - 10.1007/s40121-022-00650-8 [doi]
PST - ppublish
SO  - Infect Dis Ther. 2022 Aug;11(4):1479-1492. doi: 10.1007/s40121-022-00650-8. Epub 
      2022 May 14.