By: IPP Bureau
Last updated : August 15, 2024 4:31 pm
The clinical trial will be conducted at 19 sites with 10,335 participants across India
Panacea Biotec Limited and Indian Council of Medical Research are proud to share that with the approval of the Drugs Controller General of India (DCGI), we have started the Phase III clinical trial of our tetravalent dengue candidate vaccine, DengiALL in India.
The clinical trial will be conducted at 19 sites with 10,335 participants across India. The development of DengiALL was initiated at Panacea Biotec in 2006 with the licensing and transfer of novel attenuated tetravalent strains of dengue virus between Panacea Biotec and National Institutes of Health, USA. Panacea Biotec has undertaken Phase I/II clinical trials in the Indian population with 3 years of safety follow-up completed in 2020. Subsequently, Panacea Biotec and ICMR entered into an MOU in March 2022 for Phase III clinical trials in India.
On the occasion, Dr. Rajesh Jain, Chairman and Managing Director, at Panacea Biotec, said “DengiALL vaccine development has a long way since it was initiated in 2006 in collaboration with the National Institute of Health USA. We are excited to announce that our dengue vaccine candidate has successfully entered the penultimate Phase 3 clinical trials in India in collaboration with the Indian Council of Medical Research. This milestone brings us one step closer to providing a safe and effective solution for preventing dengue fever, a disease that poses a significant public health challenge. We are committed to ensuring that this vaccine meets the highest standards of safety and efficacy, and we are optimistic about its potential to make a meaningful impact on the lives of millions.”
DengiALL is a tetravalent recombinant live attenuated tetravalent candidate vaccine that targets all the 4 serotypes of Dengue that are prevalent across the world.