Status:
COMPLETED
A Study of Comparing Safety and Reactogenicity, of Lyophilized BCG Vaccine IP of Green Signal Bio Pharma Private Limited, India With BCG Vaccine of Serum Institute of India Limited in 120 Healthy Children.
Lead Sponsor:
Green Signal Biopharma Private Limited
Conditions:
Healthy
Eligibility:
All Genders
Up to 14 years
Phase:
PHASE3
Brief Summary
To compare Safety and Reactogenecity of BCG vaccine of Green Signal Biopharma Private Limited India with BCG vaccine of serum institute of India limited (SIIL), India in 120 healthy children.
Detailed Description
The study was conducted in the objective to compare the safety and reactogenecity of BCG Vaccine of Green Signal Bio pharma Private Limited India(Test) with BCG vaccine of Serum Institute of India(Ref...
Eligibility Criteria
Inclusion
- Subjects must be in the age group of 0 - 14 years of age.
- Subject's parent should be able to understand and have to sign the informed consent form after being explained by the investigator. They must be aware of the experimental nature of the therapy, its potential benefits, side effects and risks.
- Ability to comply with the schedule of treatment and follow-up.
- Absence of BCG scar
- Tuberculin negative
- No evidence of any other infection
- No evidence of skin disease -
Exclusion
- History or presence of significant:
- Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrinal, immunologic, dermatologic, neurological or psychiatric disease.
- More specifically, history or presence of significant:
- Low birth weight babies (\<2.5 Kg),
- Malignancy,
- Tuberculin positive,
- Hodgkin's disease,
- Corticosteroid therapy,
- Generalised Eczema,
- Infective dermatosis,
- Hypogammaglobulinemia,
- Immunosuppressed,
- Above 14 years of age,
- On anti-tubercular drugs,
- Chest X ray evidence of TB.
- \-
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01250249
Start Date
November 1 2008
End Date
June 1 2009
Last Update
November 30 2010
Active Locations (1)
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1
Arya vysya maternity home & child welfare centre
Chennai, Tamil Nadu, India, 600001