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

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

KEYWORDS:

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

Acknowledgments

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.

Author contributions

All authors participated in the study design and/or implementation, analysis, and interpretation of the data. All authors had full access to the data, participated in manuscript development and gave final approval before submission

Disclosure of potential conflicts of interest

SJK, JC, RS, JHK and RD are employees of the GSK group of companies. SJK, JC, RS and JHK hold shares in the GSK group of companies. YKK and SML have nothing to disclose.

Trademark section

Infanrix-IPV is a trade mark owned by or licensed to the GSK group of companies.

Supplementary material

Supplemental data for this article can be accessed on the publisher’s website.

Additional information

Funding

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.