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.

NCT01250249 Phase 3 COMPLETED

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.

Details

Lead sponsor	Green Signal Biopharma Private Limited
Phase	Phase 3
Status	COMPLETED
Enrolment	120
Start date	2008-11
Completion	2009-06

Conditions

• Healthy

Interventions

• BCG Vaccine IP - Serum Institute of India

Countries

India