A prospective, randomized, single blind,parallel, active controlled, multicentre, phase II /III clinical study to evaluate the immunogenicityand safety of Measles & Rubella vaccine (Live)I.P. (Freeze Dried) â?? Single Dose and MultiDose formulations of M/s Cadila HealthcareLimited compared to Measles and Rubellavaccine (Live) I.P. (Freeze Dried) of M/s SerumInstitute of India Limited in healthy paediatricsubjects aged 9-12 months

Cadila Healthcare Ltd0 个研究点目标入组 0 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 9 months to 12 months
•2. Informed consent of either parent (mother or father) and their willingness to
•be followed up for at least 6 months after vaccination of their child
•3. Parents with adequate literacy to fill the diary cards

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

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