GSK pharma Gets CDSCO Panel Nod To study Respiratory Syncytial Virus vaccine RSVPreF3 OA
New Delhi: Advising to include clinical trial sites from various states in the southern part of India, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has given its nod to vaccine major GSK Pharma India to conduct the Phase III clinical trial of the Respiratory Syncytial Virus (RSV) vaccine (recombinant, adjuvanted).
This came after the vaccine major GSK Pharma India presented the revised Phase-III clinical trial protocol titled,
“A Phase III, randomized, placebo-controlled, observer blind study in India to evaluate the 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.”
Respiratory syncytial virus (RSV) belongs to the genus Orthopneumovirus within the family Pneumoviridae and order Mononegavirales. Members of this genus include human RSV, bovine RSV, and murine pneumonia virus. There are two major antigenic subtypes of human RSV (A and B), determined largely by antigenic drift and duplications in RSV-G sequences but accompanied by genome-wide sequence divergence, including within RSV-F.
In May 2023, the FDA approved GSK’s RSV vaccine for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older.
At the recent SEC meeting for vaccine held on May 31, 2024, the expert panel reviewed the revised Phase-III Clinical Trial Protocol titled “A Phase III, randomized, placebo-controlled, observer blind study in India to evaluate the 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.”
After detailed deliberation, the committee recommended the grant of permission to conduct a Phase III clinical trial as per the presented protocol.
In addition, the expert panel suggested that the firm should include clinical trial sites from various states in the southern part of India.
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