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  • Serum Institute gets...

Serum Institute gets CDSCO Panel nod to conduct phase III clinical trial of Yellow Fever Vaccine

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-01-19T18:00:37+05:30  |  Updated On 19 Jan 2025 6:00 PM IST
Serum Institute gets CDSCO Panel nod to conduct phase III clinical trial of Yellow Fever Vaccine
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New Delhi: Noting the interim results of the Phase II clinical trial of Yellow Fever Vaccine, the Subject Expert Committee (SEC), functional under the Central Drug Standard Control Organization (CDSCO), has recommended the vaccine major Serum Institute for conducting a Phase III clinical trial as per the presented revised protocol.

This came after the firm submitted the interim analysis of the safety and immunogenicity study report (Blinded) (Phase II) along with Data Safety Monitoring Board (DSMB) recommendations and revised Phase III study protocol.

Yellow fever is a viral disease that is transmitted to humans by the bites of infected mosquitoes. It is prone to epidemics and is preventable with a vaccine. The yellow fever vaccine is a live, weakened version of the yellow fever virus that protects against the viral infection. It's recommended for people who are traveling to or living in areas of Africa and South America where the virus is a risk.

At the recent SEC meeting for vaccine, the expert panel observed that permission was granted to conduct Phase II/III clinical trial of Yellow Fever Vaccine as per presented protocol with conditions that

1) The firm should submit a Phase II study report along with DSMB review for approval before initiation of Phase III.

2) Adverse events of special interest (AESI) of the Yellow Fever vaccine to be included in the patient information sheet.

Now, in continuation, the firm has submitted the Interim Analysis of Safety and Immunogenicity Study Report (Blinded) (Phase II) along with DSMB recommendations and a revised Phase III study protocol.

After detailed deliberation, the committee noted the interim results of the Phase II clinical trial and recommended the conduct of the Phase III clinical trial as per the presented revised protocol.

Also Read:Pfizer Gets CDSCO Panel Nod To Study Anti-cancer Drug PF-07220060

cdscoyellow feverYellow Fever Vaccineserum-institutevaccine
Dr. Divya Colin
Dr. Divya Colin

    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.

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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