CTRI/2020/09/027594已完成1 期
An Open-Label, Randomized, Active Controlled, Phase I Clinical Study to Assess the Safety and Tolerability of SII Yellow Fever Vaccine in Healthy Adults.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
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
入选标准
- •1.Healthy adult male or non-pregnant female participants aged between 18-45 years.
- •2.Normal health as determined by medical history, clinical examination and laboratory assessment.
- •3.Participants willing to adhere to the protocol requirements and to provide written informed consent
- •4.Availability for clinical follow up through period of the study.
- •5.Female participants with negative pregnancy test during screening and prior to vaccine administration and agree to avoid pregnancy during participation in the study.
排除标准
- •1.Fever or any acute infection at time of immunization(Temporary exclusion criteria).
- •2.A known hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances.
- •3.Travel to a YF endemic area [Africa or South America including participants who plan to travel to these areas prior to completion of the study].
- •4.Known history of infection with YF, dengue fever, TBE, JE, or West e Virus (WNV)
- •5. Positive ELISA for YF virus antibodies.
- •6. Woman who is pregnant or breast feeding.
研究者
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