NCT04714229已完成1 期
A Single Center, Randomized, Observer-blinded, Active Comparator Phase I Study to Assess the Safety and Immunogenicity of Meningococcal (Groups A, C, W-135 and Y) Conjugate Vaccine in Healthy Adults Aged 19 to 55 Years Old
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Occurrence of unsolicited adverse events
研究概览
简要总结
Phase I study to evaluate safety and immunogenicity in healthy adult subjects following a single dose administration of Meningococcal (Group A, C, W-135, and Y)-CRM197 Conjugate vaccine
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects 19 to 55 years of age
- •Written informed consent
- •Available for all visits and telephone calls scheduled for the study
排除标准
- •Previous or suspected disease caused by N. meningitidis
- •Household and/or intimate exposure to an individual with culture-proven N. meinigitidis infection within 60 days prior to screening
- •Serious acute, chronic or progressive disease as determined by investigator
- •History of alcohol or substance abuse
研究组 & 干预措施
Menveo
Active Comparator
Healthy adults received 0.5mL single intramuscular dose on Day 0.
干预措施: Meningococcal(Groups A, C, Y, and W-135) Conjugate Vaccine (Biological)
EuMCV4
Experimental
Healthy adults received 0.5mL single intramuscular dose on Day 0.
干预措施: Meningococcal(Groups A, C, W-135, and Y) Conjugate Vaccine (Biological)
结局指标
主要结局
Occurrence of unsolicited adverse events
时间窗: within 28 days post vaccination
Occurrence of solicited adverse events
时间窗: within 7 days post vaccination
local and systemic AEs
Occurrence of serious adverse events
时间窗: within 180 days post vaccination
次要结局
未报告次要终点
研究者
研究点 (1)
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