Cited 2 times in
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
DC Field | Value | Language |
---|---|---|
dc.contributor.author | 이순민 | - |
dc.date.accessioned | 2019-12-18T01:14:18Z | - |
dc.date.available | 2019-12-18T01:14:18Z | - |
dc.date.issued | 2019 | - |
dc.identifier.issn | 2164-5515 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/173431 | - |
dc.description.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. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | Taylor & Francis | - |
dc.relation.isPartOf | HUMAN VACCINES & IMMUNOTHERAPEUTICS | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.title | 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 | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Pediatrics (소아청소년과학교실) | - |
dc.contributor.googleauthor | Soon Min Lee | - |
dc.contributor.googleauthor | Sung Jin Kim | - |
dc.contributor.googleauthor | Jing Chen | - |
dc.contributor.googleauthor | Rok Song | - |
dc.contributor.googleauthor | Joon-Hyung Kim | - |
dc.contributor.googleauthor | Raghavendra Devadiga | - |
dc.contributor.googleauthor | Yun-Kyung Kim | - |
dc.identifier.doi | 10.1080/21645515.2019.1572406 | - |
dc.contributor.localId | A02905 | - |
dc.relation.journalcode | J01014 | - |
dc.identifier.eissn | 2164-554X | - |
dc.identifier.pmid | 30668217 | - |
dc.subject.keyword | DTaP-IPV | - |
dc.subject.keyword | Diphtheria | - |
dc.subject.keyword | Korea | - |
dc.subject.keyword | Pertussis | - |
dc.subject.keyword | Poliomyelitis | - |
dc.subject.keyword | Post-marketing surveillance | - |
dc.subject.keyword | Safety | - |
dc.subject.keyword | Tetanus | - |
dc.contributor.alternativeName | Lee, Soon Min | - |
dc.contributor.affiliatedAuthor | 이순민 | - |
dc.citation.volume | 15 | - |
dc.citation.number | 5 | - |
dc.citation.startPage | 1145 | - |
dc.citation.endPage | 1153 | - |
dc.identifier.bibliographicCitation | HUMAN VACCINES & IMMUNOTHERAPEUTICS, Vol.15(5) : 1145-1153, 2019 | - |
dc.identifier.rimsid | 64255 | - |
dc.type.rims | ART | - |
Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.