NCT00197795已完成2 期
Immunogenicity and Reactogenicity of a Meningococcal B Outer Membrane Vesicle Vaccine Given in a 0,6,12 Month Schedule to Health UK Adults
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
To measure the serum bactericidal antibody levels and cell mediated immune responses before and six weeks after each dose of meningococcal outer membrane vesicle vaccine given at 0,6 and 12 weeks to healthy UK adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed written consent given for three immunizations with MenBVac and five blood tests
- •Between the ages of 18 and 55 years inclusive at recruitment
排除标准
- •Previous history of bacteriologically confirmed meningococcal disease
- •History of clinically significant allergic sensitivity to any vaccine received in the past
- •Immunodeficiency
- •Any other acute or chronic systemic illness or dependence or abuse of drugs or alcohol
- •Language difficulties sufficient to preclude adequate comprehension of the study information
- •Possibility of pregnancy
- •Receipt of any other vaccine in the previous 4 weeks
- •Receipt of any group B vaccine in the past
- •Current participation in any other clinical trial
- •Generalized acute systemic illness and/or temp >38C on day of vaccination deferral
研究者
Prof. Elizabeth Miller
Consultant epidemiologist
Public Health England
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