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.

Green Signal Biopharma

Status and phase: Completed; Phase 3

Conditions: Healthy

Treatments: Biological: BCG Vaccine IP - Serum Institute of India

Study type: Interventional

Funder types: Industry

Identifiers

NCT01250249

BCGV/034/08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: Under 14 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. 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 -

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

BCG Vaccine - Intradermal injection

Active Comparator group

Description:

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

Treatment:

Biological: BCG Vaccine IP - Serum Institute of India