A Randomised, Open Label, Single-Period, Single-Treatment, Controlled Study of Comparing Safety and Reactogenecity of Lyophilised Bcg Vaccine Ip (0.1 Mg In 0.1 Ml) of Green Signal Biopharma Private Limited India with Bcg Vaccine (0.1 Mg In 0.1 Ml) of Ser

The study was conducted with the objective to compare the safety and reactogenecity of lyophilized BCG Vaccine of Green Signal Bioharma Private Limited (GSBPL), India (Test) with lyophilized BCG vaccine which was available in the market (of Serum Institute of India (Reference)) in 120 healthy children.
The above study was conducted in two centers (Chennai & Bangalore). The study was conducted as per the protocol approved by DCGI and Madras ethical Committee.
A single dose was administered 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 (Purified protein derivative) 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.