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

Soon Min Lee, Sung Jin Kim, Jing Chen, Rok Song, Joon Hyung Kim, Raghavendra Devadiga, Yun Kyung Kim

    Research output: Contribution to journalArticlepeer-review

    2 Citations (Scopus)

    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.

    Original languageEnglish
    Pages (from-to)1145-1153
    Number of pages9
    JournalHuman Vaccines and Immunotherapeutics
    Volume15
    Issue number5
    DOIs
    Publication statusPublished - 2019 May 4

    Bibliographical note

    Funding Information:
    GlaxoSmithKline Biologicals SA was the funding source, was involved in all stages of the study conduct and analysis (ClinicalTrial.gov identifier: NCT01568060) and funded all costs associated with the development and the publishing of the present manuscript. The authors would like to acknowledge the investigators and their clinical teams for their contribution to the study and their support and care of participants/patients, as well as the children and their parent/guardian for their participation. The authors also would like to thank Business & Decision Life Sciences platform for editorial assistance and publication coordination, on behalf of GSK. Nathalie Arts coordinated manuscript development and editorial support. The authors thank Iain O’Neill (freelance on behalf of GSK) for providing medical writing support.

    Publisher Copyright:
    © 2019, © 2019 GlaxoSmithKline Biologicals SA. Published with license by Taylor & Francis Group, LLC.

    Keywords

    • (5-10): DTaP-IPV
    • Diphtheria
    • Korea
    • Pertussis
    • Poliomyelitis
    • Post-marketing surveillance
    • Safety
    • Tetanus

    ASJC Scopus subject areas

    • Immunology and Allergy
    • Immunology
    • Pharmacology

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