CTRI/2012/11/003156招募中1 期
Phase-I,open,unicentric clinical trial for evaluation of safety of Varicella Vaccine,Live(I.P.)Oka strain in adults.
Biomed P Limited0 个研究点目标入组 10 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
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
- •Subject should be a healthy adult as assessed by history, physical examination and clinical judgement of the investigator.
- •Age of subject should be between 18 to 55 years.
- •Subject is of Indian origin and will remain in the study area for the length of the trial.
- •Subject should give written inform consent.
- •Subject is aware of full information regarding the vaccine and clinical trial.
排除标准
- •Subject is having a history of vaccination with chicken pox vaccine.
- •Subject is suffering from fever, diarrhoea and sign of acute infection.
- •Subject is having a history of disease, drug intake (like anti-malarial, steroids, phenytoin, anti-inflammatory drugs or immunosuppressive drugs) in the past two weeks of proposed vaccination date.
- •Subject is having a history of allergy or hypersensitivity to any component of the vaccine.
- •Subject is having immunodeficiency or an auto-immune disease.
- •Subject is having a history of adverse reactions during previous vaccination.
- •Subject is participating in any other study at the same time or during the past three months.
- •Subject is planning surgery during the study period.
- •Subject is likely to move out of station during the study period.
- •Subject is having a history of chicken pox /herpes zoster disease.
研究者
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