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.

NCT01250249 | Completed Phase 3 DMC

• 1 other identifier: BCGV/034/08
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

To compare Safety and Reactogenecity of BCG vaccine of Green Signal Biopharma Private Limited with BCG vaccine of serum institute of India limited

Study Arms (1)

BCG Vaccine - Intradermal injection

ACTIVE COMPARATOR

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

Interventions

BCG Vaccine IP - Serum Institute of India BIOLOGICAL

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

Also known as: BCG Vaccine IP (SIIL)

BCG Vaccine - Intradermal injection

Eligibility Criteria

• Age: Up to 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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 -

You may not qualify if:

• 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.

Sponsors & Collaborators

• Green Signal Biopharma Private Limited: lead

Study Sites (1)

Arya vysya maternity home & child welfare centre

Chennai, Tamil Nadu, 600001, India

Location

Study Officials

• SR Lakshimipathy, MBBS, DCH

  KC General Hospital, Malleswaram, Bangalore

  PRINCIPAL INVESTIGATOR

• Mohamed Kizhar Irshat, MBBS, DCH

  Arya vysya maternity home & child welfare centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 26, 2010
• First Posted: November 30, 2010
• Study Start: November 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: November 30, 2010

Record last verified: 2010-11

Locations

IN (1)