- Home
- Medical news & Guidelines
- Anesthesiology
- Cardiology and CTVS
- Critical Care
- Dentistry
- Dermatology
- Diabetes and Endocrinology
- ENT
- Gastroenterology
- Medicine
- Nephrology
- Neurology
- Obstretics-Gynaecology
- Oncology
- Ophthalmology
- Orthopaedics
- Pediatrics-Neonatology
- Psychiatry
- Pulmonology
- Radiology
- Surgery
- Urology
- Laboratory Medicine
- Diet
- Nursing
- Paramedical
- Physiotherapy
- Health news
- AYUSH
- State News
- Andaman and Nicobar Islands
- Andhra Pradesh
- Arunachal Pradesh
- Assam
- Bihar
- Chandigarh
- Chattisgarh
- Dadra and Nagar Haveli
- Daman and Diu
- Delhi
- Goa
- Gujarat
- Haryana
- Himachal Pradesh
- Jammu & Kashmir
- Jharkhand
- Karnataka
- Kerala
- Ladakh
- Lakshadweep
- Madhya Pradesh
- Maharashtra
- Manipur
- Meghalaya
- Mizoram
- Nagaland
- Odisha
- Puducherry
- Punjab
- Rajasthan
- Sikkim
- Tamil Nadu
- Telangana
- Tripura
- Uttar Pradesh
- Uttrakhand
- West Bengal
- Medical Education
- Industry
Revise phase III CT protocol of Recombinant Rabies G Protein Vaccine to add safety: CDSCO Panel tells Cadila
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended the vaccine maker Cadila Pharmaceuticals that Phase III clinical trial protocol for the Recombinant Rabies G Protein Vaccine should be revised for inclusion of safety as study objectives and accordingly sample size should be increased and should be...
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended the vaccine maker Cadila Pharmaceuticals that Phase III clinical trial protocol for the Recombinant Rabies G Protein Vaccine should be revised for inclusion of safety as study objectives and accordingly sample size should be increased and should be statistically significant for safety & immunogenicity.
This came after the firm presented its proposal for a grant of permission to conduct Phase III clinical trial in the pediatric population in the age group of 1 year to <18 years.
Rabies virus (RABV) infection leads to rabies in warm-blooded animals, including humans, and is characterized by acute encephalitis at the early phase and fatality at the later stage without postexposure treatment. Approximately,55,000 human deaths caused by rabies are reported annually, with most of these cases occurring in developing countries. Stray dogs, wild carnivores, and bats are the natural reservoirs of field RABV, and these rabid carriers are a public health risk to humans and domestic animals.
At the recent SEC meeting for vaccines held on 21 November 2022, the expert panel reviewed the proposal for a grant of permission to conduct a Phase III clinical trial in the pediatric population in the age group of 1 year to <18 years.
Doctor of Pharmacy
Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.