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.

This study has been completed.
Sponsor:
Information provided by:
Green Signal Biopharma Private Limited
ClinicalTrials.gov Identifier:
NCT01250249
First received: November 26, 2010
Last updated: November 29, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
Healthy
Biological: BCG Vaccine IP - Serum Institute of India
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Green Signal Biopharma Private Limited:

Enrollment: 120
Study Start Date: November 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: BCG Vaccine IP (SIIL)

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.

  Eligibility

Ages Eligible for Study:   up to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01250249

Locations
India
Arya vysya maternity home & child welfare centre
Chennai, Tamilnadu, India, 600001
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Mr.Sajjanadhasan.VJ, Green Signal Biopharma Private Limited
ClinicalTrials.gov Identifier: NCT01250249     History of Changes
Other Study ID Numbers: BCGV/034/08
Study First Received: November 26, 2010
Last Updated: November 29, 2010
Health Authority: India: Drugs Controller General of India
India: Ministry of Health

Keywords provided by Green Signal Biopharma Private Limited:
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:
BCG Vaccine
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014