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
Soon Min Lee
Yonsei University College of Medicine
South Korea
Sung Jin Kim
Sung Jin Kim
Yonsei University Wonju College of Medicine
Jing Chen
Jing Chen
University of Kentucky
Lexington | United States
Rok Song
Rok Song
the Catholic University of Korea
Raghavendra Devadiga
Raghavendra Devadiga
GSK Pharmaceuticals Pvt. Ltd.
Yun-Kyung Kim
Yun-Kyung Kim
Kyung Hee University
South Korea

Hum Vaccin Immunother 2019 19;15(5):1145-1153. Epub 2019 Mar 19.

e Department of Pediatrics , Korea University College of Medicine , Seoul , Republic of Korea.

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.

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http://dx.doi.org/10.1080/21645515.2019.1572406DOI Listing
March 2019
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