A prospective, randomized, parallel, single-blind, five-arm, activecontrolled, 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 of Measles, Mumps and Rubella vaccine (Live) I.P. (Freeze Dried) of M/s. Zydus Lifesciences Ltd. in healthy infants aged 9-12 months - NIL

Zydus Lifesciences Limited0 个研究点目标入组 3,500 人开始时间: 2026年7月30日最近更新: 2026年8月3日

试验速览

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•Healthy infant participant of either gender aged 9 to 12 months at the time of enrollment
•Participants should be in good health as determined by medical history and physical examination based on clinical judgment of the investigator
•No previous history of vaccination against measles, mumps, and rubella
•Written informed consent from the participants parent (mother or father)
•Participant parent literate enough to fill the diary card
•Participants and parents likely to be available for follow-up for entire duration of the study

•Participant s weight (Z-score) below -2 SD for weight-for-age as per WHO recommended child growth standards
•History of hypersensitivity reaction to any component of the vaccines
•History of hypersensitivity reaction to neomycin, gelatin or albumin
•History of hypersensitivity to egg proteins.
•History of laboratory confirmed or suspected measles, mumps or rubella in past
•Participant exposed to measles, mumps or rubella virus within the past 30 days
•Fever of any origin or infectious disorder of 3 days or more within the past 30 days
•Febrile illness (axillary temperature greater than equal to 37.5 C) at the time of enrollment
•History of any vaccination within the past month
•Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, hematological, immunological, metabolic or major congenital disorder
•Confirmed or suspected immunosuppressive or immunodeficiency disorder; or subjects on any immunosuppressive or immunostimulant therapy
•Known case of thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy.
•Participants administered blood, blood containing products or immunoglobulins within the
•last 3 months or planned administration during the study
•Participation in any clinical study in the past 3 months
•Any other reason for which the investigator feels that participant should not participate

发起方