Choe Young June, Vidor Emmanuel, Manson Christine
Medical Affairs, Sanofi, Seoul, Republic of Korea.
Global Medical Affairs, Sanofi, Lyon, France.
Infect Dis Ther. 2022 Aug;11(4):1479-1492. doi: 10.1007/s40121-022-00650-8. Epub 2022 May 14.
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.
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.
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.
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.
NCT01437423.
百白破-脊髓灰质炎联合疫苗（TETRAXIM™，赛诺菲公司生产）是一种白喉、破伤风、无细胞百日咳和灭活脊髓灰质炎病毒联合疫苗（DTaP-IPV），自2009年起在韩国获得许可。根据食品药品安全部的规定，这项上市后监测（PMS）研究评估了DTaP-IPV疫苗在婴儿和儿童的实际临床实践中的安全性，这些儿童在2、4和6个月时接受了三剂基础免疫系列疫苗中的一剂，或者在4至6岁时接受了入学前加强免疫。
这项多中心、观察性PMS研究在韩国的实际临床实践中进行了6年（2009年至2015年），参与者年龄在2个月至6岁之间。研究结果包括预期反应、非预期不良事件（AE）/药物不良反应（ADR）、意外AE/ADR以及严重AE（SAE）/ADR。
647名参与者的数据纳入了安全性分析。总体而言，181名（28%）参与者报告了268例AE：47例（17.5%）为预期反应，220例（82.1%）为非预期AE，1例（0.4%）为非预期ADR。共有48例AE（包括47例预期反应）被报告与DTaP-IPV疫苗存在因果关系，36名（5.6%）参与者报告了这些AE。152名（23.5%）参与者共报告了212例意外AE，其中无一例与DTaP-IPV疫苗存在因果关系。研究期间未报告即刻AE和SAE。在报告AE的参与者中，220名（34%）正在使用合并用药。大多数AE为轻度，所有参与者均康复。
在韩国人群中，2至6个月接受基础免疫系列疫苗以及4至6岁接受入学前加强免疫剂量的参与者中，未发现与DTaP-IPV疫苗在实际应用中相关的安全问题。DTaP-IPV疫苗耐受性良好，可继续作为婴幼儿常规免疫计划的一部分。
NCT01437423
