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临床试验/CTRI/2012/11/003156
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

发起方
Biomed P Limited

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