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.
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