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Post-marketing surveillance to assess the safety and tolerability of a combined diphtheria, tetanus, acellular pertussis and inactivated poliovirus vaccine (DTaP-IPV) in Korean children

Authors
 Soon Min Lee  ;  Sung Jin Kim  ;  Jing Chen  ;  Rok Song  ;  Joon-Hyung Kim  ;  Raghavendra Devadiga  ;  Yun-Kyung Kim 
Citation
 HUMAN VACCINES & IMMUNOTHERAPEUTICS, Vol.15(5) : 1145-1153, 2019 
Journal Title
HUMAN VACCINES & IMMUNOTHERAPEUTICS
ISSN
 2164-5515 
Issue Date
2019
Keywords
DTaP-IPV ; Diphtheria ; Korea ; Pertussis ; Poliomyelitis ; Post-marketing surveillance ; Safety ; Tetanus
Abstract
Infanrix-IPV (GSK, Belgium) is a diphtheria, tetanus, acellular pertussis, and inactivated poliovirus combination vaccine (DTaP-IPV) licensed in many countries including Korea. In accordance with Korean regulations, we conducted a post-marketing surveillance (PMS) to evaluate the safety of DTaP-IPV administered to Korean children in routine immunization schedules. Children aged <7 years receiving at least one dose of DTaP-IPV either as part of a primary (3-dose) vaccination series or as a subsequent booster were enrolled. Adverse events (AEs), adverse drug reactions (ADRs) and serious AEs (SAEs) were recorded after each dose during the 30-day post-vaccination follow-up period. Among a total of 639 children, 289 subjects (45.2%) experienced AEs, mostly (79.2%) assessed as being unlikely to be related to the vaccination. ADRs were reported in 13.0% of subjects. Fever was the most commonly reported expected AE (11.9% of subjects) and also the most commonly reported expected ADR (8.5% of subjects). No obvious association between AE incidence and vaccine dose sequence was apparent. An unexpected AE was seen in 32.9% of children, and unexpected ADRs were far less common (1.9%). Thirty-four SAEs were recorded in 26 subjects (4.1%), in two of whom a causal association with the vaccine could not be excluded, although both resolved quickly. Data from this PMS indicate that DTaP-IPV has an acceptable safety profile when given to Korean children in accordance with local prescribing recommendations in routine childhood immunization. ClinicalTrials.gov identifier: NCT01568060.
Files in This Item:
T201904633.pdf Download
DOI
10.1080/21645515.2019.1572406
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Pediatrics (소아과학교실) > 1. Journal Papers
Yonsei Authors
Lee, Soon Min(이순민) ORCID logo https://orcid.org/0000-0003-0174-1065
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/173431
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