NCT00780806已完成1 期
An Open-Label Safety And Blood Collection Study In Mnb Rlp2086 Vaccinated Healthy Adult Volunteers For Immunological Assay Development
Wyeth is now a wholly owned subsidiary of Pfizer4 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2008年10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
- 60
- 试验地点
- 4
- 主要终点
- Safety of 3 doses of MnB rLP2086 vaccine candidate assessed by frequency of solicited local and systemic reactions collected for 7 days after each study vaccination; evaluation of occurrence of AE and SAE during the duration of study
研究概览
简要总结
The purpose of this study is to evaluate the safety of an investigational meningococcal B rLP2086 vaccine in adults and to obtain blood samples from immunized subjects for use in assay development.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female subject between the ages of >=18 and <=40 years
- •Negative urine pregnancy test for all female subjects of childbearing potential prior to test article administration and at the completion of the study.
- •All female or male subjects who are biologically capable of having children must agree to abstinence or commit to the use of a reliable method of birth control during for the duration of the study and for 30 days after early discontinuation.
- •Hemoglobin levels >=12.0 and <=16.5 g/dL for female subjects and >=13.0 and <=18.5 g/dL for male subjects.
- •Blood pressure: Systolic blood pressure >90 and <160 mm Hg; Diastolic blood pressure >60 and <95 mm Hg.
- •Body weight >=45 and <=120 kg.
- •Able to be contacted by telephone during the study period.
排除标准
- •Pregnancy or breastfeeding women
- •Prior vaccination with a serogroup B meningococcal vaccine.
- •A previous anaphylactic or severe vaccine-associated adverse reaction.
- •A known hypersensitivity to any study vaccine components.
- •A known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids (excluding topical, inhalation and intra-articular corticosteroids).
- •Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
- •Receipt of any blood products, including gamma globulin, in the period from 6 months before study vaccination through the study conclusion.
- •Receipt of an inactivated vaccine within 14 days before study vaccinations and live attenuated vaccine within 28 days before study vaccination. This will apply throughout the study until the last vaccination.
- •Any clinically significant chronic disease that, in the investigator's judgment may be worsened by blood draw.
- •Received any investigational drug, vaccine or device within the 30-day period before study visit 1 and during the conduct of the study.
- •History of culture-proven invasive disease caused by N meningitidis or N gonorrhoea.
结局指标
主要结局
Safety of 3 doses of MnB rLP2086 vaccine candidate assessed by frequency of solicited local and systemic reactions collected for 7 days after each study vaccination; evaluation of occurrence of AE and SAE during the duration of study
时间窗: Up to 2 years
次要结局
未报告次要终点
研究者
研究点 (4)
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