Kim Hee Soo, Engel Solene, Neveu David, Thollot Yael, Oster Philipp, Yang Kuhyun
Sanofi Pasteur, Seoul, South Korea.
Sanofi Pasteur, Montpellier, France.
Infect Dis Ther. 2021 Mar;10(1):399-409. doi: 10.1007/s40121-020-00393-4. Epub 2021 Jan 13.
Invasive meningococcal disease is a notifiable disease in the Republic of Korea. The meningococcal (groups A, C, Y, and W) polysaccharide diphtheria toxoid conjugate vaccine (MenACWY-DT, Menactra) was licensed in the Republic of Korea in 2014. This post-marketing surveillance (PMS) observational study aims to assess the safety of MenACWY-DT administration of routine clinical care to individuals aged 9-23 months as a two-dose series at least 3 months apart and to individuals 2-55 years as a single dose.
The PMS observational study (NCT02864927) included participants aged 9 months to 55 years and who were given MenACWY-DT during routine healthcare visits. The study participants were followed-up for up to 30 days following vaccination (additional time was allowed for the visit or phone call to be conducted). Study outcomes included solicited and unsolicited adverse reactions, unexpected adverse events, and serious adverse events (SAEs).
A total of 640 participants 9-23 months of age and 671 participants 2-55 years of age were eligible for safety analysis. Overall, AEs were reported by 35.3% of participants aged < 2 years and 45% of participants aged 2-55 years. Solicited adverse reactions were reported by 21.4% and 17.4% of participants aged < 2 years and 2-55 years, respectively. Unsolicited adverse reactions were reported by 26.1% and 37.9%, respectively. No vaccine-related SAEs occurred during the study. The AEs reported in Korean population were consistent with the known safety profile of MenACWY-DT, and most were of grade 1-2 in severity.
This study did not detect any unanticipated or new safety findings of concern with MenACWY-DT in either of the study age groups, and provides reassurance that MenACWY-DT can be used as part of routine immunization care for the prevention of invasive meningococcal disease.
ClinicalTrials.gov Identifier, NCT02864927.
侵袭性脑膜炎球菌病在大韩民国属于法定报告疾病。脑膜炎球菌（A、C、Y和W群）多糖白喉类毒素结合疫苗（MenACWY-DT，Menactra）于2014年在大韩民国获得许可。这项上市后监测（PMS）观察性研究旨在评估在常规临床护理中，9至23个月大的个体按两剂接种、间隔至少3个月，以及2至55岁的个体按单剂接种MenACWY-DT的安全性。
PMS观察性研究（NCT02864927）纳入了年龄在9个月至55岁之间、在常规医疗就诊期间接种MenACWY-DT的参与者。研究参与者在接种疫苗后随访长达30天（允许额外时间进行就诊或电话随访）。研究结果包括预期和非预期不良反应、意外不良事件和严重不良事件（SAE）。
共有640名9至23个月大的参与者和671名2至55岁的参与者符合安全性分析条件。总体而言，年龄小于2岁的参与者中有35.3%报告了不良事件，2至55岁的参与者中有45%报告了不良事件。年龄小于2岁和2至55岁的参与者中，分别有21.4%和17.4%报告了预期不良反应。分别有26.1%和37.9%报告了非预期不良反应。研究期间未发生与疫苗相关的严重不良事件。韩国人群中报告的不良事件与MenACWY-DT已知的安全性特征一致，且大多数严重程度为1-2级。
本研究在两个研究年龄组中均未发现与MenACWY-DT相关的任何意外或新的安全性问题，这为MenACWY-DT可作为预防侵袭性脑膜炎球菌病的常规免疫护理的一部分提供了保证。
ClinicalTrials.gov标识符，NCT02864927。
