Modify CT Protocol: CDSCO Panel Tells GSK on Respiratory Syncytial Virus(RSV) Vaccine
New Delhi: Reviewing the Phase III clinical trial protocol presented by the drug major GSK for the Respiratory Syncytial Virus (RSV) vaccine (Recombinant Adjuvanted), the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to submit revised clinical trial protocol with an increased sample size for both cohorts of more than 60 years and 50-59 years.
In addition, the committee asked the firm to submit a detailed clinical study report for the age group 50-59 years from all the clinical trials conducted globally and current regulatory status.
Furthermore, the expert panel advised to include more clinical trial sites from the southern part of India in the revised clinical trial protocol.
This came after the drug maker GlaxoSmithKline Pharmaceuticals presented the Phase III clinical trial protocol titled “A Phase III randomized, placebo-controlled, observer-blind study in India to evaluate immune response, reactogenicity and safety of a single intramuscular dose of RSVPreF3 OA investigational vaccine when administered to older adults ≥60 years of age and adults 50‑59 years of age at increased risk of respiratory syncytial virus lower respiratory tract disease of Respiratory Syncytial Virus (RSV) vaccine (Recombinant Adjuvanted)."
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.