None listed
Conditions
Interventions
Intervention1: Varicella Vaccine LIVE (I.P.)Oka strain: Dose-The Vaccine contains per 0.5mlâ?¥2000 PFU of live attenuated Varicella virus(Oka strain) propagated in MRC-5 human diploid cell culture.
Fr
Sponsors
Biomed P Limited
Eligibility
Inclusion criteria
Inclusion criteria: •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.
Exclusion criteria
Exclusion criteria: •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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety of the live varicella vaccine will be evaluated.Timepoint: 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of the vaccine will be evaluated.Timepoint: 30 days. | — |
Countries
India
Contacts
Public ContactDr S P Garg
Biomed Private Limited
Outcome results
None listed