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