A prospective, randomized, single blind, parallel, active controlled, multicentre, non-inferiority, phase III clinical study to evaluate the immunogenicity and safety of single-dose and multi-dose vials of Measles Mumps and Rubella vaccine (Live) (Freeze-dried) of M/s Cadila Healthcare Limited compared to Measles Mumps and Rubella vaccine (Live) (Freeze-dried) of M/s Serum Institute of India Limited in healthy paediatric subjects aged 15-18 months

Cadila Healthcare Ltd0 个研究点目标入组 327 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Healthy paediatric subjects of either sex aged 15 months to 18 months
•2. Informed consent of the parents/guardians and their willingness to be followed up for at least 6 weeks after vaccination of their child
•3. Parents/guardians with adequate literacy to fill the diary cards

•1. Subjects with a history of anaphylaxis or serious reactions to other vaccines, neomycin, gelatin and / or albumin
•2. Subjects with a history of previous measles, mumps or rubella infection or MMR vaccination, or if they had been exposed to any of these three diseases within 30 days of trial commencement
•3. Subjects having received measles vaccine less than 3 months back
•4. Subjects with a history of convulsions, epilepsy, other central nervous system diseases, severe disease of haematopoietic system, decompensated heart disease or impaired renal function
•5. Subjects with an acute febrile illness at the time of randomization
•6. Any other parenteral vaccine administration within 30 days of initiation of the study or during the study
•7. A history of serious chronic illness, major congenital defects, immunosuppression (immunosuppressive illness or therapy)
•8. Subjects who have received blood, blood products or immunoglobulins during the preceding 3 months
•9. Subjects with any other clinically significant concurrent illness affecting immune response after vaccination

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