An active post-marketing surveillancestudy to evaluate the safety of Measles& Rubella vaccine (Live) I.P. (FreezeDried) of M/s Zydus Lifesciences Limitedin healthy subjects aged 9-12 months

Zydus Lifesciences Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年5月1日

试验速览

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•1. Healthy paediatric subjects of either sex aged 9 months to 12 months (Age of subject should be at least 9 completed 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 hematopoietic system, decompensated heart
•disease or impaired renal function
•4. Subjects with an acute febrile illness at the time of enrolment
•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 with any other clinically significant concurrent / past illness for which
•the investigator feels that subject should not participate
•#Close contact (family member or neighbor) with a diagnosed case of
•measles / rubella

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