NCT01782066已完成1 期
Dose Finding and Reactogenicity of Reduced-dose Intradermal Administration of Two Quadrivalent Meningococcal Conjugate Vaccines (Menveo® and Nimenrix®) in Healthy Adults (MENID-1).
Leiden University Medical Center2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2013年1月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Seroprotection rate against meningococcal serogroups ACYW135 (anti-meningococcal antibody titre at baseline and 28 days after vaccination)
研究概览
简要总结
Invasive meningococcal disease is a worldwide problem with serious repercussions for those affected. Vaccination is recognized as the best way to combat it. The cost of vaccination is prohibitive in many low-resource settings at home and abroad. By harnessing the special immunologic properties of the skin, a dose reduction may be achieved by intradermal administration of the vaccine. The cost savings associated with dose reduction will increase availability of the 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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Meningococcal C naive subjects are required to fulfill all of the following criteria:
- •Age ≥ 30 years
- •Good health according to the investigator
- •Willingness and ability to adhere to the study regimen
- •Able to give informed consent
- •Meningococcal C experienced subjects are required to fulfill all of the following criteria:
- •Age ≥ 18 years
- •Good health according to the investigator
- •Willingness and ability to adhere to the study regimen
- •Able to give informed consent
排除标准
- •Meningococcal C naïve subjects should not have:
- •Known previous invasive meningococcal infection
- •Known or suspected previous vaccination against meningococcal disease
- •Known or suspected allergy against any of the vaccine components
- •Close contact in the last 60 days with a person known to be Neisseria positive
- •History of unusual or severe reactions to any previous vaccination
- •Family history of Guillain-Barré Syndrome
- •Known or suspected immune deficiency, either congenital or acquired
- •Administration of plasma or blood products less than three months prior to inclusion in the study
- •Pregnancy (breastfeeding is allowed)
- •Fertile female not conforming to prescribed contraceptive use (await first menstruation after vaccination before getting pregnant)
- •Any infectious disease
- •Bleeding disorders or use of anticoagulants
- •Participation as a subject in another trial in the last 3 months
- •Meningococcal C experienced subjects should not have:
- •Known or suspected allergy against any of the vaccine components
- •Known previous vaccination with a quadrivalent meningococcal vaccine (either conjugate or polysaccharide)
- •Close contact in the last 60 days with a person known to be Neisseria positive
- •History of unusual or severe reactions to any previous vaccination
- •Family history of Guillain-Barré Syndrome
- •Known or suspected immune deficiency, either congenital or acquired
- •Administration of plasma or blood products less than three months prior to inclusion in the study
- •Pregnancy (breastfeeding is allowed)
- •Fertile female not conforming to prescribed contraceptive use (await first menstruation after vaccination before getting pregnant)
- •Any infectious disease
- •Bleeding disorders or use of anticoagulants
- •Participation as a subject in another trial in the last 3 months
结局指标
主要结局
Seroprotection rate against meningococcal serogroups ACYW135 (anti-meningococcal antibody titre at baseline and 28 days after vaccination)
时间窗: 28 days
次要结局
- Local and systemic adverse events (subject log and investigator inspection).(28 days)
研究者
L.G. Visser, MD, PhD
Associate professor of Internal Medicine, Senior Consultant Infectious Diseases
Leiden University Medical Center
研究点 (2)
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