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 |
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dc.contributor.author | Lee, Soon Min | - |
dc.contributor.author | Kim, Sung Jin | - |
dc.contributor.author | Chen, Jing | - |
dc.contributor.author | Song, Rok | - |
dc.contributor.author | Kim, Joon-Hyung | - |
dc.contributor.author | Devadiga, Raghavendra | - |
dc.contributor.author | Kim, Yun-Kyung | - |
dc.date.accessioned | 2021-09-01T15:06:58Z | - |
dc.date.available | 2021-09-01T15:06:58Z | - |
dc.date.created | 2021-06-19 | - |
dc.date.issued | 2019-05-04 | - |
dc.identifier.issn | 2164-5515 | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/65452 | - |
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.language | English | - |
dc.language.iso | en | - |
dc.publisher | TAYLOR & FRANCIS INC | - |
dc.subject | KAWASAKI-DISEASE | - |
dc.subject | IMMUNOGENICITY | - |
dc.subject | IMMUNIZATION | - |
dc.subject | KINRIX(TM) | - |
dc.subject | BOOSTER | - |
dc.subject | AGE | - |
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.affiliatedAuthor | Kim, Yun-Kyung | - |
dc.identifier.doi | 10.1080/21645515.2019.1572406 | - |
dc.identifier.scopusid | 2-s2.0-85063132962 | - |
dc.identifier.wosid | 000461952500001 | - |
dc.identifier.bibliographicCitation | HUMAN VACCINES & IMMUNOTHERAPEUTICS, v.15, no.5, pp.1145 - 1153 | - |
dc.relation.isPartOf | HUMAN VACCINES & IMMUNOTHERAPEUTICS | - |
dc.citation.title | HUMAN VACCINES & IMMUNOTHERAPEUTICS | - |
dc.citation.volume | 15 | - |
dc.citation.number | 5 | - |
dc.citation.startPage | 1145 | - |
dc.citation.endPage | 1153 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Biotechnology & Applied Microbiology | - |
dc.relation.journalResearchArea | Immunology | - |
dc.relation.journalWebOfScienceCategory | Biotechnology & Applied Microbiology | - |
dc.relation.journalWebOfScienceCategory | Immunology | - |
dc.subject.keywordPlus | KAWASAKI-DISEASE | - |
dc.subject.keywordPlus | IMMUNOGENICITY | - |
dc.subject.keywordPlus | IMMUNIZATION | - |
dc.subject.keywordPlus | KINRIX(TM) | - |
dc.subject.keywordPlus | BOOSTER | - |
dc.subject.keywordPlus | AGE | - |
dc.subject.keywordAuthor | (5-10): DTaP-IPV | - |
dc.subject.keywordAuthor | Post-marketing surveillance | - |
dc.subject.keywordAuthor | Safety | - |
dc.subject.keywordAuthor | Korea | - |
dc.subject.keywordAuthor | Diphtheria | - |
dc.subject.keywordAuthor | Tetanus | - |
dc.subject.keywordAuthor | Pertussis | - |
dc.subject.keywordAuthor | Poliomyelitis | - |
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