GSK gets CDSCO panel Nod for Phase III Extension safety follow-up study for trial of RSVPreF3 vaccine
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has granted approval to the drug major GSK to conduct the global Phase III Extension safety follow-up study for the trial of the RSVPreF3 vaccine with protocol no- 219510 (RSVMAT-015).
This came after the firm presented its proposal for a grant of permission for the conduct of a Global Phase III Extension safety follow-up study for the trial of the RSVPreF3 vaccine with protocol no- 219510 (RSV- MAT-015).
RSVPreF3 Vaccine is indicated for Respiratory Syncytial Virus (RSV) in Older Adults. RSV is a frequent cause of respiratory tract disease in adults. Respiratory syncytial virus, or RSV, is a common respiratory virus. It usually causes mild, cold-like symptoms. But it can cause serious lung infections, especially in infants, older adults, and people with serious medical problems.
RSV spreads from person to person through the air by coughing and sneezing Direct contact, such as kissing the face of a child who has RSV.
Respiratory Syncytial Virus Prefusion F (RSVPreF3) vaccine contains a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) combined with GSK's proprietary AS01E adjuvant.
At the recent SEC meeting of vaccine held on 27th June 2023, the expert panel reviewed the proposal presented by GSK for the grant the permission to conduct the global Phase III Extension safety follow-up study for the trial of RSVPreF3 vaccine with the protocol no- 219510 (Rasav-MAT-015)
After detailed deliberation, the committee recommended the grant of permission to conduct the study.
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