CDSCO Panel Asks Takeda to Submit Full Phase III Data on Dengue Tetravalent Vaccine
- byDoctor News Daily Team
- 26 September, 2025
- 0 Comments
- 0 Mins

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. Also Read: Takeda Dengue Tetravalent Vaccine QDENGA gets European Commission nod
Disclaimer: This website is designed for healthcare professionals and serves solely for informational purposes.
The content provided should not be interpreted as medical advice, diagnosis, treatment recommendations, prescriptions, or endorsements of specific medical practices. It is not a replacement for professional medical consultation or the expertise of a licensed healthcare provider.
Given the ever-evolving nature of medical science, we strive to keep our information accurate and up to date. However, we do not guarantee the completeness or accuracy of the content.
If you come across any inconsistencies, please reach out to us at
admin@doctornewsdaily.com.
We do not support or endorse medical opinions, treatments, or recommendations that contradict the advice of qualified healthcare professionals.
By using this website, you agree to our
Terms of Use,
Privacy Policy, and
Advertisement Policy.
For further details, please review our
Full Disclaimer.
Recent News
Health Ministry Proposes Barcoding Rule for All Va...
- 23 October, 2025
Boehringer Ingelheim Jascayd gets nod in China for...
- 23 October, 2025
Mizoram reports 121 multidrug-resistant TB Deaths...
- 23 October, 2025
GSK Shingrix new prefilled syringe presentation ge...
- 23 October, 2025
Daily Newsletter
Get all the top stories from Blogs to keep track.
0 Comments
Post a comment
No comments yet. Be the first to comment!