A prospective, randomized, single blind, parallel, active controlled, multicentre, non-inferiority clinical study to evaluate the immunogenicity and safety of Varicella vaccine (Live Attenuated, Freeze Dried IP) of M/s Cadila Healthcare Limited compared to a marketed Varicella vaccine in healthy paediatric subjects aged 1 to 12 years

Cadila Healthcare Ltd0 个研究点目标入组 256 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1. Healthy paediatric subjects of either sex aged 1 year to 12 years
•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 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

发起方