Postmarketing Surveillance Study for Use of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) in the Republic of Korea
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,311
- 试验地点
- 1
- 主要终点
- Number of Participants Reporting Solicited Injection-Site Reactions and Systemic Reactions Following Vaccination with Menactra®
研究概览
简要总结
The purpose of the study is to perform the re-examination of Menactra® administered in the routine clinical settings in accordance with the Ministry of Food and Drug Safety regulation.
Primary objective:
- To describe the safety profile after 1 dose of Menactra® administered from 9 months to 55 years of age under standard health care practice.
详细描述
Subjects aged 9 months through 55 years and who are given study vaccine during routine health-care visits will be enrolled in the study.
They will be followed-up for up to Day 42 following vaccination.
No study vaccine will be supplied or administered as part of this study, subjects will be monitored following routine vaccine administration in clinical settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 9 Months 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed consent form signed by the subject (for subjects from 19 to 55 years of age) or the parent(s) or other legal representative (for subjects from 9 months to 18 years of age)
- •Receipt of one dose of Menactra® (on the day of inclusion) according to approved local product insert paper .
排除标准
- •Participation at the time of study enrollment (or in the 4 weeks preceding the study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or a medical procedure
- •Subjects who already participated in this study.
结局指标
主要结局
Number of Participants Reporting Solicited Injection-Site Reactions and Systemic Reactions Following Vaccination with Menactra®
时间窗: Day 0 up to Day 30 post-vaccination
Solicited injection-site reactions: Tenderness/Pain, Erythema, and Swelling. Solicited systemic reactions: infants and toddlers (9 to 23 months) Fever (temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite and Irritability; Subjects aged 2 to 55 years, Fever (temperature), Headache, Malaise, and Myalgia
Number of Participants Reporting Unsolicited Adverse Events Following Vaccination with Menactra®
时间窗: Day 0 up to Day 30 post-vaccination
次要结局
未报告次要终点