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 ARTICLE HISTORY

Post-Marketing Surveillance of Tetravalent Diphtheria-Tetanus-Acellular Pertussis and Inactivated Poliovirus (DTaP-IPV) Vaccine in South Korea, 2009 to 2015

“…The occurrence of solicited reactions in this study was consistent with the information on the product label, where redness, pain, and swelling at the injection site were considered to be very common (C 1/10) AEs [42]. Fever was reported as the most common AE (11.9%) in another PMS study that assessed the safety profile of another DTaP-IPV in South Korea [19]. In contrast to this other PMS study and the product label of the study vaccine, which considers a fever C 38 °C as a very common AE, the rate of fever was substantially lower in the current study (1.4%).…”

“…The findings from this study are consistent with the information present on the local product label. They are also in line with the good safety profile of other DTaP-IPV vaccines reported from real-word use [19,43]. Injection site AEs/ADRs are commonly reported for vaccines administered via the intramuscular route [44].…”

“…In 2009, the vaccination schedule recommended by the South Korean National Immunization Program (NIP) included administration of the diphtheria-tetanus-acellular pertussis (DTaP) vaccine as a three-dose primary vaccination series in infants aged 2, 4, and 6 months, with a fourth (booster) dose given at 15--18 months and a fifth (school-entry booster) dose at 4-6 years of age. At that time, the primary vaccination for polio recommended vaccinations at 2, 4, and 6 months of age, with a subsequent fourth (booster) dose at 4-6 years [19,20]. National vaccination data for South Korea indicate successful implementation of the childhood immunization program with an estimated vaccine coverage rate of 98% for DTaP3 in 2019 [21].…”