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 journalArticle

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
JournalHuman Vaccines and Immunotherapeutics
DOIs
Publication statusPublished - 2019 Jan 1

Fingerprint

Inactivated Poliovirus Vaccine
Marketing
Drug-Related Side Effects and Adverse Reactions
Safety
Vaccination
Diphtheria-Tetanus-acellular Pertussis Vaccines
Vaccines
Immunization Schedule
Combined Vaccines
Diphtheria
Whooping Cough
Belgium
Tetanus
Korea
Immunization
Fever
DTPP vaccine
Incidence

Keywords

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

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Pharmacology

Cite this

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

In: Human Vaccines and Immunotherapeutics, 01.01.2019.

Research output: Contribution to journalArticle

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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.",
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AU - Lee, Soon Min

AU - Kim, Sung Jin

AU - Chen, Jing

AU - Song, Rok

AU - Kim, Joon Hyung

AU - Devadiga, Raghavendra

AU - Kim, Yun Kyung

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KW - (5-10): DTaP-IPV

KW - Diphtheria

KW - Korea

KW - Pertussis

KW - Poliomyelitis

KW - Post-marketing surveillance

KW - Safety

KW - Tetanus

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