A clinical trial to evaluate immunogenicity and safety of Live Varicella vaccine (Oka Strain) in Indian children.
- Registration Number
- CTRI/2014/03/004445
- Lead Sponsor
- Biomed Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 252
1.Subject should be a healthy child as assessed by history, physical examination and clinical judgment of the investigator.
2.Age of subject should be between one to twelve years.
3.Subject should be of Indian origin and will remain in the study area for the length of the trial.
4.Subject should give written inform consent.
5.Subject should be aware of full information regarding the vaccine and clinical trial.
1.History of chicken pox disease.
2.Subject is suffering from fever, diarrhoea and sign of acute infection.
3.Subject is having a history of vaccination with chicken pox vaccine.
4.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.
5.Subject is having a history of allergy or hypersensitivity to any component of the vaccine.
6.Subject is having immunodeficiency or an auto-immune disease.
7.Subject is having a history of adverse reactions during previous vaccination.
8.Subject is participating in any other study at the same time or during the past three months.
9.Subject is planning surgery during the study period.
10.Subject is likely to move out of station during the study period.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of seroconversion in subjects (Seroconversion is defined as the rise in post vaccination antibody titre in comparision to the pre-vaccination antibody titre.Timepoint: 42±7 days
- Secondary Outcome Measures
Name Time Method Evaluation of the safety aspects of the vaccineTimepoint: 42±7 days