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.
A Randomized, Open Label, Single-period, Single-treatment, Controlled Multi Center Phase Iii Study of Comparing Safety and Reactogenecity of Lyophilized BCG Vaccine ip (0.1 mg in 0.1 ml) of Green Signal Bio Pharma Private Limited India With BCG Vaccine (0.1 mg in 0.1 ml) of Serum Institute of India Limited (SIIL),India in 120 Healthy Children.
Study Overview
Status
Conditions
Intervention / Treatment
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(Reference) in 120 healthy children.
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Tamilnadu
-
Chennai, Tamilnadu, India, 600001
- Arya vysya maternity home & child welfare centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
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.
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 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 |
0.1 ml for adults and children aged 1 month and over 0.05 ml for infants under 1 month of age
Other Names:
|
Collaborators and Investigators
Investigators
- Principal Investigator: SR Lakshimipathy, MBBS, DCH, KC General Hospital, Malleswaram, Bangalore
- Principal Investigator: Mohamed Kizhar Irshat, MBBS, DCH, Arya vysya maternity home & child welfare centre
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BCGV/034/08
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.