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.

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Biological: BCG Vaccine IP - Serum Institute of India

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: Interventional
• Enrollment (Actual): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• India
  • Tamilnadu
    • Chennai, Tamilnadu, India, 600001
      • Arya vysya maternity home & child welfare centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

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

Biological: 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 Names: BCG Vaccine IP (SIIL)

Collaborators and Investigators

• Sponsor: Green Signal Biopharma Private Limited
• 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: November 1, 2008
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: November 26, 2010
• First Submitted That Met QC Criteria: November 29, 2010
• First Posted (Estimate): November 30, 2010

Study Record Updates

• Last Update Posted (Estimate): November 30, 2010
• Last Update Submitted That Met QC Criteria: November 29, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Keywords: To compare Safety and Reactogenecity of BCG vaccine of Green Signal Biopharma Private Limited with BCG vaccine of serum institute of India limited
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Adjuvants, Immunologic; Vaccines; BCG Vaccine
• Other Study ID Numbers: BCGV/034/08