CDSCO Panel Asks Takeda to Submit Full Phase III Data on Dengue Tetravalent Vaccine
New Delhi: Reviewing India specific blinded interim safety analysis report of the ongoing Phase III clinical trial of Dengue tetravalent vaccine (live, attenuated), the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organisation (CDSCO) has opined Takeda Biopharmaceuticals India to submit complete Phase III clinical trial report after completion of the on-going study in Indian population for further deliberation.
This came after Takeda Biopharmaceuticals India presented India specific blinded interim safety analysis report of the ongoing Phase III clinical trial titled, "А randomized, double-blind, placebo-controlled, Phase III trial to investigate the safety and immunogenicity of a Dengue Tetravalent Vaccine (live, attenuated) (TDV) administered subcutaneously to healthy subjects aged 4 to 60 years in India"
A dengue tetravalent vaccine (live, attenuated) is a type of vaccine that uses weakened versions of the four dengue virus serotypes to provide protection against dengue disease.
The vaccine contains weakened (attenuated) forms of the dengue viruses, making it live but not capable of causing serious illness. It includes weakened viruses for all four dengue serotypes (1, 2, 3, and 4), providing protection against all. The weakened viruses stimulate the body's immune system to create antibodies, providing immunity against future dengue infections.
At the recent SEC meeting for Vacccines, the expert panel reviewed the India-specific blinded interim safety analysis report of the ongoing Phase III clinical trial titled, "А randomized, double-blind, placebo-controlled, Phase III trial to investigate the safety and immunogenicity of a Dengue Tetravalent Vaccine (live, attenuated) (TDV) administered subcutaneously to healthy subjects aged 4 to 60 years in India"
After detailed deliberation, the committee recommended that the firm should submit a complete Phase III clinical trial report after completion of the ongoing study in the Indian population for further deliberation.
