Infanrix-IPV (GSK, Belgium) is diphtheria, tetanus, acellular pertussis, and inactivated poliovirus (DTaP-IPV) combination vaccination approved in several countries, including Korea. The study conducted post-marketing surveillance (PMS) study in line with Korean laws to assess the safety of DTaP-IPV administered to Korean children in normal vaccination regimens. Children aged 7 years who had received at least one dose of DTaP-IPV as part of a primary (3-dose) vaccination series or as a subsequent booster were included in the study. During the 30-day post-vaccination follow-up period, adverse events (AEs), adverse drug reactions (ADRs), and serious adverse events (SAEs) were documented after each dosage. In a total of 639 children, 289 suffered AEs, the majority of which were deemed unlikely to be connected to the vaccine. ADRs were reported by 13.0% of the participants. Fever was the most frequently reported anticipated AE, as well as the most frequently reported expected ADR. There was no clear relationship between AE incidence and vaccination dosage sequence. Unexpected AEs were observed in 32.9 percent of the youngsters, but unexpected ADRs were considerably less prevalent. Thirty-four SAEs were documented in 26 patients, two of whom had a causal relationship with the vaccination that could not be ruled out, despite the fact that both resolved promptly.
According to the results of this PMS, DTaP-IPV has a satisfactory safety profile when administered to Korean children in line with local prescription standards during regular childhood vaccination. NCT01568060 is the ClinicalTrials.gov identifier.