NCT02305446已完成3 期
Phase 3b, Open Label, Uncontrolled, Single-arm, Single-centre Study to Evaluate the Safety of Two Doses of Novartis Meningococcal Group B Vaccine When Administered to Healthy Adults From 18 to 50 Years of Age and to Collect Blood Donations to Develop Vaccines Against Neisseria Meningitidis
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Number of Subjects Reporting Unsolicited Adverse Events (AEs).
研究概览
简要总结
The purpose of this trial is to assess the safety of a Meningococcal Group B Vaccine and to collect blood donation. Sera panel obtained from blood donations will be used as a control to measure the immunoresponse to the Meningococcal Group B Vaccine in other studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals of 18 through 50 years of age on the day of informed consent;
- •Individuals who had voluntarily given written informed consent after the nature of the study had been explained according to local regulatory requirements, prior to study entry;
- •Individuals who could comply with study procedures including follow-up;
- •Males, females of non-childbearing potential or females of childbearing potential who are using an effective birth control method.
排除标准
- •Progressive, unstable or uncontrolled clinical conditions;
- •Hypersensitivity, including allergy, to any component of vaccines or medical equipment whose use is foreseen in this study;
- •Abnormal function of the immune system;
- •Chronic clinical significant conditions;
- •Been administered any group B meningococcal vaccine at any time prior to informed consent;
- •Current or previous, confirmed or suspected disease caused by N.meningitidis.
结局指标
主要结局
Number of Subjects Reporting Unsolicited Adverse Events (AEs).
时间窗: From day 1 to day 7 after each vaccination (Vaccination 1: Day 1 to Day 7; Vaccination 2: Day 61 to Day 67)
Safety was assessed as the number of the subjects who reported unsolicited AEs following vaccination.
次要结局
未报告次要终点
研究者
研究点 (1)
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