Phase III 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 (SIIL), India in 120 healthy children.

A randomized,open label,single treatment,single period,controlled multi center phase III 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,India in 120 healthy children. - hase III 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 (SIIL), Indi

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000897

Enrollment

120

Registered

2010-07-23

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: BCG Vaccine of Green Signal Bio Pharma Private Limited: Single Dose: 0.05 mL/ 0.1 mL Control Intervention1: BCG Vaccine Of Serum Institute of India Limited.: Single Dose: 0.05 mL/ 0.1 m

Eligibility

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
To measure the reactogenecity and safety of the vaccineTimepoint: 30 min, 72 hours, 10th day, 30th day, 60th day & 90th day from the time/day of vaccination.	—

Secondary

Measure	Time frame
To check the formation of the Scar on the injected site at different time intervalsTimepoint: 30 min, 72 hrs, 10th day, 30th day, 60th day & 90th day from the time/day of vaccination.	—

Countries

India

Contacts

Public ContactSajjanadhasanVJ

sajjukutta@gmail.com04427922446

Outcome results