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A randamised, open label, single-period, single-treatment, controlled study of comparing safety and reactogenecity of lyopholised BCG Vaccine IP(0.1 mg in 0.1 ml) of Green Signal Bio Pharma Pvt . Ltd., India with a reference BCG vaccine(0.1 mg in 0.1ml) of another reputed brand in india was conducted in accordance with ethical principles that have their origins in the declaration of Helsinki.
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Adverse Events:
No adverse reations were fond during the study period pertaining to the administered GSBPL's vaccine.
Safety conclusions:
All subjects were safe and well tolerated with both investigational products(GSBPL's BCG-10 as well as the reference vaccine). No death was reported. No serious adverse events were noticed. No other significant adverse events were experienced.
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