New Delhi: Expert Committee The Central Drugs Regulatory Authority has recommended continuation of this Phase-II clinical trials of Serum Institute of India ,SIIGiven the promising results of the Phase-I interim clinical trial of the vaccine against dengue, the Serum Institute conducted a Phase-I, double-blind, randomised, placebo-controlled trial on 60 healthy individuals aged 18 to 45 years in Australia to assess the safety and immunogenicity of the tetravalent live attenuated vaccine. Dengue Vaccine,
A tetravalent live attenuated dengue vaccine was manufactured in India after receipt of the vaccine strain from NIAID, NIH, USA.
In light of the Subject Expert Committee’s recommendation dated July 18, 2023, SII submitted the Phase-I interim clinical trial report of Dengue Tetravalent Vaccine (Live, Attenuated), which was discussed by the panel on May 31.
The SEC recommendations said, “After detailed deliberations, the Committee noted the results of Phase I interim clinical trial and recommended continuation of Phase II clinical trial as per the approved protocol.”
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