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Serum Institute of India gets CDSCO Panel nod to study Measles, Mumps, and Rubella Vaccine Live Freeze-Dried

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-10-13T18:00:19+05:30  |  Updated On 13 Oct 2024 6:00 PM IST
Serum Institute of India gets CDSCO Panel nod to study Measles, Mumps, and Rubella Vaccine Live Freeze-Dried
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New Delhi: Vaccine major Serum Institute of India has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct a Phase IV clinical trial titled, “A Phase IV, double-blind, randomized, active control clinical study comparing safety and immunogenicity of SIIMeasles-Mumps-Rubella vaccine with PRIORIX (GSK) in healthy infants in India.

However, this nod is subject to the condition of inclusion of the site from the eastern part of India.

This came after Serum Institute of India presented the revised Phase IV clinical trial protocol titled, “A Phase IV, double blind, randomized, active control clinical study comparing safety and immunogenicity of SII-Measles-Mumps- Rubella vaccine with PRIORIX (GSK) in healthy infants in India.”

Measles-Mumps-Rubella vaccine (Live) I.P. (Freeze-Dried) is indicated for active immunization against Measles and Rubella in infants, children, adolescents, and young adults at risk.

TRESIVAC (Measles, Mumps, and Rubella Virus Vaccine (Live) I.P.) freeze-dried is prepared from the live, attenuated strains of Edmonston-Zagreb Measles virus propagated on human diploid cell culture, L-Zagreb Mumps virus propagated on chick embryo fibroblast cells, and Wistar RA 27/3 Rubella virus propagated on human diploid cell culture.

The vaccine is freeze-dried and is provided with diluent. The product has the appearance of a yellowish-white friable mass that may or may not contain bubbles and/or indentations. The vaccine meets the requirements of I.P. and WHO when tested by the methods outlined in I.P. and WHO, TRS 840 (1994).

At the recent SEC meeting for vaccine held on October 3, 2024, the expert panel reviewed the revised Phase IV clinical trial protocol titled, “A Phase IV, double blind, randomized, active control clinical study comparing safety and immunogenicity of SII-Measles-Mumps- Rubella vaccine with PRIORIX (GSK) in healthy infants in India.”

After detailed deliberation, the committee recommended the approval of the Phase IV clinical trial protocol as presented with the condition of inclusion of a site from the eastern part of India.

Also Read: Pfizer Gets CDSCO Panel Nod to Study PF-06823859

Serum Institute of IndiacdscoMeasles mumps and rubella vaccinephase 4 trial
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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