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.

• Authors: Soon Min Lee, Sung Jin Kim, Jing Chen, Rok Song, Joon-Hyung Kim, Raghavendra Devadiga, Yun-Kyung Kim
• Journal: Human vaccines & immunotherapeutics (Hum Vaccin Immunother) Vol. 15 Issue 5 Pg. 1145-1153 ( 2019) ISSN: 2164-554X [Electronic] United States
• PMID: 30668217 (Publication Type: Journal Article, Multicenter Study, Observational Study, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Bacterial
• Antibodies, Viral
• Diphtheria-Tetanus-acellular Pertussis Vaccines
• Poliovirus Vaccine, Inactivated
• Vaccines, Combined

Topics

• Antibodies, Bacterial (blood)
• Antibodies, Viral (blood)
• Child
• Child, Preschool
• Diphtheria (prevention & control)
• Diphtheria-Tetanus-acellular Pertussis Vaccines (administration & dosage, adverse effects)
• Female
• Humans
• Immunization, Secondary
• Infant
• Male
• Poliomyelitis (prevention & control)
• Poliovirus Vaccine, Inactivated (administration & dosage, adverse effects)
• Product Surveillance, Postmarketing
• Prospective Studies
• Republic of Korea
• Tetanus (prevention & control)
• Vaccines, Combined (administration & dosage, adverse effects)
• Whooping Cough (prevention & control)