A senior official from the Indian Council of Medical Research (ICMR) has recently revealed that the third phase trial for a dengue vaccine is going to begin within a few months. The vaccine is being developed by a pharmaceutical firm known as Panacea Biotech. The company is making the dengue vaccine in association with the ICMR. The official has also confirmed that the third phase trial will be a placebo-measured, double-blind randomized trial. Participants of the trial will be allocated randomly to obtain the placebo or dengue shot. Nobody will know who is getting the vaccine and who is getting the placebo.
The chief of the ICMR, Dr. Rajiv Bahl has said that the trials are still in process but trials have not started in full swing as the company is still making the batch of products that were expected to be developed around three months ago. Experts have said that the firm will be able to prepare the products by August this year. Therefore, phase-3 trials of the dengue vaccine are expected to begin within a couple of months.
Third phase trial aims to examine the efficiency of the dengue vaccine shot
The third phase trial aims to examine the efficiency of the shot in averting dengue symptoms. The secondary final points of the trial will assess the safety of the dengue shot. The chief of the communicable diseases division of the ICMR, Dr. Nivedita Gupta has said that the phase 1/2 trials have been completed by Panacea Biotech on healthy Indian adults.
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Some initial immunogenicity findings on the dengue vaccine have been obtained. The documentation of the trials is completed and the Drugs Controller General of India (DCGI) granted approval for the clinical trials in January this year. The trials will assess 10335 healthy adults aged 18-80 years at 20 locations.
Four different types of viruses cause Dengue, a mosquito-borne disease. It can lead to symptoms such as mild to chronic ailments, such as dengue hemorrhagic fever. The disease is a significant cause of concern for many experts.