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 Private Limited120 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

120

Conditions

Healthy

Interventions

BCG Vaccine IP - Serum Institute of IndiaBIOLOGICAL

0.1 ml for adults and children aged 1 month and over 0.05 ml for infants under 1 month of age

Eligibility

Sex: ALLMax age: 14 YearsHealthy volunteers:

Medical Language ↔ Plain English

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. \-

Locations (1)

Arya vysya maternity home & child welfare centre

Chennai, Tamil Nadu, India

Data from ClinicalTrials.gov

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