A clinical trial to study the safety of Varicella Vaccine in human adults.
- Registration Number
- CTRI/2012/11/003156
- Lead Sponsor
- Biomed P Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 10
•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.
•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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method