A Prospective, Randomized, Single Blind, Parallel, Active Controlled, Multicentre, Non-Inferiority Phase III Study to Evaluate The Immunogenicity And Safety Of Live Attenuated Varicella Vaccine Of Sinovac Biotech Ltd, China Compared To VARIPED® Vaccine (Varicella Vaccine Live I.P By MSDPharmaceuticals Pvt Ltd, India) In Healthy Paediatric Subjects In India - NA

Techinvention Lifecare Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年6月24日

试验速览

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•1.Healthy pediatrics subjects of either sex aged 1 year to 12 years
•2. Informed consent of the parents/LAR and their willingness to be followed up for at least 6 weeks after vaccination of their child
•3. Parents/LAR with adequate literacy to fill the diary cards
•Note Age of subject should be at least 12 completed months

•1)Subjects with a history of anaphylaxis or serious reactions to other vaccines,
•2)Subjects with a history of previous varicella infection or vaccination, or if they had been exposed# to the disease within 30 days of trial commencement
•3)Subjects with a history of convulsions, seizures, other central nervous system diseases, severe disease of haematopoietic system, cardiovascular system, liver or kidney
•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 or planned during the study period
•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 6 months
•or have planned during the study period
•8)Subjects with any other clinically significant concurrent illness affecting immune response after vaccination.
•#Close contact (family member or neighbor) with a diagnosed case of varicella infection.

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