NCT02699840已完成不适用
Observational Study of a Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine Menactra® Administered in Individuals 2 Through 55 Years Old Under Standard Health Care Practice in the Russian Federation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- Number of participants reporting solicited injection site and systemic reactions after a single dose of Menactra® vaccine
研究概览
简要总结
The aim of this study is to generate local data on the safety of Menactra® in individuals 2 to 55 years of age in the Russian Federation.
Primary Objective:
- To describe the safety profile after 1 dose of Menactra® administered in individuals 2-55 years of age under standard health care practices.
详细描述
Participants will be enrolled after receipt of one dose of Menactra® during a routine health care visit. They will be monitored for safety throughout the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 2 through 55 years on the day of enrollment "2 through 55 years" means from the day of the 2nd birthday to the day before the 56th birthday
- •For adults (18-55 years old) Informed consent form has been signed and dated by the participant.
- •For minors: Informed consent form has been signed and dated by the parent. In addition, in accordance with the Institution Ethics Committee/Institution Review Board requirements and as appropriate for the age of the participant:
- •participants aged 14 to 17 years are required to sign and date the informed consent form,
- •participants aged 10 to 13 years are required to sign and date the assent form,
- •for participants under 10 years, consent may be asked orally according to participant's age and ability for understanding
- •Receipt of one dose of Menactra® on the day of inclusion and prior to enrollment into the study, in routine practice according to the approved local product insert.
排除标准
- •Participation at the time of study enrollment (or in the 4 weeks preceding the enrollment) or planned participation during the present study period in a clinical study investigating a vaccine, drug, medical device, or medical procedure.
结局指标
主要结局
Number of participants reporting solicited injection site and systemic reactions after a single dose of Menactra® vaccine
时间窗: Day 0 to Day 7 post-vaccination
Solicited injection site: Pain, Erythema and Swelling, Solicited systemic: Fever (Temperature), Headache, Malaise and Myalgia
次要结局
- Number of participants reporting unsolicited adverse events and serious adverse events after a single dose of Menactra® vaccine(Day 0 to Day 28 post-vaccination)
研究者
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