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Clinical Trials/CTRI/2012/11/003156
CTRI/2012/11/003156
Recruiting
Phase 1

Phase-I,open,unicentric clinical trial for evaluation of safety of Varicella Vaccine,Live(I.P.)Oka strain in adults.

Biomed P Limited0 sites10 target enrollmentTBD
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Biomed P Limited
Enrollment
10
Status
Recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
Biomed P Limited

Eligibility 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

  • •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.

Outcomes

Primary Outcomes

Not specified

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