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.
NCT ID: NCT01250249
Last Updated: 2010-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
120 participants
INTERVENTIONAL
2008-11-30
2009-06-30
Brief Summary
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Detailed Description
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The above study was conducted in multi centers(2 centers - Chennai \& Bangalore). The study was conducted as per the protocol approved by DCGI and Madras ethical Committee.
A single dose was administedred to all the subjects and it was inferred that all the 120 subjects vaccinated were safe. Further, the reactogenecity was confirmed after 90th day by PPD administration to all the subjects. Based on the above observations it was well identified that test vaccine can be safely administered to children and it is well tolerated and accepted by the subjects. More over statistically it is inferred that there is no significant variation between the test and reference vaccine.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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BCG Vaccine - Intradermal injection
Subjects must be in the age group of 0 - 14 years of age.
2\. 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.
3\. Ability to comply with the schedule of treatment and follow-up.
4\. Absence of BCG scar
5\. Tuberculin negative
6\. No evidence of any other infection
7\. No evidence of skin disease
Skin testing with tuberculin is not generally carried out before giving BCG but when performed, those who are found to be positive reactors need not to be immunized
BCG Vaccine IP - Serum Institute of India
0.1 ml for adults and children aged 1 month and over 0.05 ml for infants under 1 month of age
Interventions
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BCG Vaccine IP - Serum Institute of India
0.1 ml for adults and children aged 1 month and over 0.05 ml for infants under 1 month of age
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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.
3. Ability to comply with the schedule of treatment and follow-up.
4. Absence of BCG scar
5. Tuberculin negative
6. No evidence of any other infection
7. No evidence of skin disease -
Exclusion Criteria
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.
\-
14 Years
ALL
Yes
Sponsors
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Green Signal Biopharma Private Limited
INDUSTRY
Responsible Party
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Green Signal Biopharma Private Limited
Principal Investigators
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SR Lakshimipathy, MBBS, DCH
Role: PRINCIPAL_INVESTIGATOR
KC General Hospital, Malleswaram, Bangalore
Mohamed Kizhar Irshat, MBBS, DCH
Role: PRINCIPAL_INVESTIGATOR
Arya vysya maternity home & child welfare centre
Locations
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Arya vysya maternity home & child welfare centre
Chennai, Tamil Nadu, India
Countries
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Other Identifiers
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BCGV/034/08
Identifier Type: -
Identifier Source: org_study_id