The Subject Expert Committee (SEC) on Vaccines has asked Zydus Lifesciences Ltd. to revise its Phase III clinical trial protocol for its Measles, Mumps and Rubella (MMR) Vaccine (Live) I.P. (Freeze Dried). The meeting was held on 29 January 2026 in hybrid mode to review biological and PAC proposals and to advise the Drugs Controller General (India).
Zydus presented its Phase III study titled, “A prospective, randomized, parallel, single-blind, five-arm, active-controlled, multicentre, phase III clinical trial to evaluate the immunogenicity and safety of Measles, Mumps and Rubella vaccine (Live) I.P. (Freeze Dried) of M/s. Zydus Lifesciences Ltd. compared to Measles, Mumps and Rubella vaccine (Live) I.P. (Freeze Dried) of M/s. Serum Institute of India Pvt. Ltd. and to evaluate lot-to-lot consistency… in healthy infants aged 9–12 months.”
The proposed study aims to compare the immunogenicity and safety of Zydus’ MMR vaccine with that of Serum Institute of India and also to assess lot-to-lot consistency of Zydus’ vaccine in healthy infants aged 9 to 12 months.
After reviewing the proposal, the committee made several observations. The firm has been asked to include seropositivity rate, seroconversion rate, and Geometric Mean Titers (GMT) as primary endpoints instead of secondary endpoints. The proposed dropout rate should be reduced from 20% to 10%. Accordingly, the company must revise the sample size in all study cohorts. The exclusion criteria should clearly mention weight limits based on WHO age-versus-weight charts, specifically up to minus 2 standard deviation (-2 SD) for weight-for-age.
The committee directed the firm to remove blood sample collection at 180 days and update all related sections of the protocol, including study procedures, assessments, and statistical analysis plan. The protocol should clearly specify that GMTs of all assessed antibodies will be compared between the test and reference groups separately for each batch and also as pooled data.
After detailed discussion, the SEC recommended that Zydus Lifesciences submit a revised clinical trial protocol to the Central Drugs Standard Control Organization (CDSCO) for further consideration.
This development means that India may soon have another MMR (Measles, Mumps and Rubella) vaccine option after proper evaluation. The MMR vaccine is routinely given to children to protect them from three highly contagious viral diseases that can cause serious complications such as pneumonia, brain infection, hearing loss, birth defects, and even death. Measles outbreaks have been reported in different parts of India in recent years, making vaccination very important. If approved after successful trials, Zydus’ vaccine could increase vaccine availability, support the national immunization programme, and help strengthen protection against measles, mumps, and rubella in the Indian population.
