Unknown

Dataset Information

0

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


ABSTRACT:

Introduction

TETRAXIM™ (Sanofi), a combined diphtheria, tetanus, acellular pertussis, and inactivated poliovirus (DTaP-IPV) vaccine, has been licensed in South Korea since 2009. In accordance with the Ministry of Food and Drug Safety regulations, this post-marketing surveillance (PMS) study evaluated the safety of the DTaP-IPV vaccine in real-world clinical practice in infants and children who received it as either a part of the three-dose primary series dose at 2, 4, and 6 months or school entry booster between 4 and 6 years of age.

Methods

This multicenter, observational, PMS study was conducted in real-world practice in South Korea for 6 years (2009-2015) in participants aged between 2 months and 6 years. The study outcomes included solicited reactions, unsolicited adverse events (AEs)/adverse drug reactions (ADRs), unexpected AEs/ADRs, and serious AEs (SAEs)/ADRs.

Results

Data from 647 participants was included in the safety analysis. Overall, 268 AEs were reported by 181 (28%) participants: 47 (17.5%) solicited reactions, 220 (82.1%) unsolicited AEs, and 1 (0.4%) unsolicited ADR. A total of 48 AEs (including 47 solicited reactions) were reported to have a causal relationship with the DTaP-IPV vaccine and were reported by 36 (5.6%) participants. A total of 212 unexpected AEs were reported by 152 (23.5%) participants, none of which had a causal relationship with the DTaP-IPV vaccine. Neither immediate AEs nor SAEs were reported during the study. Among the participants who reported AEs, 220 (34%) were on concomitant medications. Most AEs were of mild intensity, and all participants recovered.

Conclusion

No safety concerns related to the DTaP-IPV vaccine in a real-world setting were raised in participants aged 2-6 months for the primary series and 4-6 years for the school-entry booster dose in the Korean population. The DTaP-IPV vaccine was well tolerated and can be continued as part of routine immunization programs in infants and children.

Trial registration

NCT01437423.

SUBMITTER: Choe YJ 

PROVIDER: S-EPMC9334467 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature

altmetric image

Publications

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

Choe Young June YJ   Vidor Emmanuel E   Manson Christine C  

Infectious diseases and therapy 20220514 4


<h4>Introduction</h4>TETRAXIM™ (Sanofi), a combined diphtheria, tetanus, acellular pertussis, and inactivated poliovirus (DTaP-IPV) vaccine, has been licensed in South Korea since 2009. In accordance with the Ministry of Food and Drug Safety regulations, this post-marketing surveillance (PMS) study evaluated the safety of the DTaP-IPV vaccine in real-world clinical practice in infants and children who received it as either a part of the three-dose primary series dose at 2, 4, and 6 months or sch  ...[more]

Similar Datasets

| S-EPMC6605835 | biostudies-literature
| S-EPMC5489296 | biostudies-literature
| S-EPMC9361845 | biostudies-literature
| S-EPMC4514255 | biostudies-literature
| S-EPMC4964705 | biostudies-literature
| S-EPMC4288310 | biostudies-literature
| S-EPMC7055925 | biostudies-literature
| S-EPMC5360111 | biostudies-literature
| S-EPMC6963843 | biostudies-literature
| S-EPMC7004397 | biostudies-literature