PACTR201506001147964已完成未知
A Staged Phase 3 Study, Including a Double-blind controlled stage to evaluate the safety and immunogenicity of Ad26 ZEBOV and MVA-BN-Filo as candidate prophylactic vaccines for Ebola
Janssen Vaccines and Prevention B.V.0 个研究点目标入组 1,020 人开始时间: 2015年5月25日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 1,020
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 1 Month(s) 至 23 Month(s)（—）
- 性别
- All
入选标准
- •Inclusion criteria Stage 1 and 2
- •- Documented community engagement from community leader and a signed inform consent form (ICF) from each participant must be available - Participant must be 18 years or older at screening and be resident in selected study community with no intention to move from study area within the next 5 months (or during the entire study duration for stage 2)
- •- Participant must be healthy with no abnormalities in laboratory screening tests within 28 days before prime vaccination
- •- Female subjects of childbearing potential must use adequate birth control measures and must have a negative pregnancy test at screening and immediately prior to each study vaccination
- •- Participant must pass the test of understanding (TOU) Additional Inclusion criteria Stage 2
- •- One year or older at screening (children of enrolled parents are eligible)
- •- Parent/legal guardian (for children) must pass the TOU before signing the ICF
- •- Subjects aged 7 years and older will be asked to give positive assent in the presence of a witness
排除标准
- •Exclusion criteria Stage 1 and 2
- •- Diagnosed with EVD or under quarantine/exposed to Ebola or body temperature equal of greater than 38.00C (fever)
- •- Having an acute illness (mild in nature that can be treated at home) or any clinically significant acute/chronic medical condition or having a decreased number of red blood cells/hemoglobin in the blood (anemia)
- •- Previously participated in another Ebola interventional study or received any Ad26/MVA-based candidate vaccine
- •- Vaccinated with live attenuated vaccines within 30 days or with inactivated vaccines 15 days before prime vaccination
- •- Treated with an immunosuppressive drug at the time of screening
- •Additional exclusion criteria for stage 2
- •-Children up to 5 years of age with severe malnutrition (underweight or Z-score weight <2)
研究者
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