CTRI/2023/12/060869已完成3 期
A Prospective, Randomized, Observer Blind, Parallel, Active Controlled, Multicentre, Non-Inferiority Phase III Study to Evaluate The Immunogenicity And Safety Of Live Attenuated Varicella Vaccine Of Novo Medi Sciences Pvt. Ltd Compared To a Marketed Varicella Vaccine In Healthy Subjects. - NA
ovo Medi Sciences Pvt Ltd.0 个研究点目标入组 424 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 424
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Healthy subjects of either sex aged 1 year to 60 years.
- •2. Informed consent/assent of the subject/parents/LAR and their
- •willingness to be followed up for entire study period.
- •3. Subject/Parents/LAR with adequate literacy to fill the subject diary
- •4. Female participants of reproductive potential must:
- •Have a negative urine pregnancy test prior to each study
- •vaccination (on the day the participant is vaccinated and
- •before vaccine is administered).
- •Agree to remain abstinent, or use (or have their partner use)
- •2 acceptable methods of birth control. Abstinence or 2
- •acceptable methods of birth control must be practiced or
- •used from the day of enrolment, throughout the duration of
- •the study, and continued until 3 months following the last
- •study vaccination.
- •Age of subject should be at least 12 completed months
排除标准
- •1. Subjects with a history of anaphylaxis or serious reactions to other
- •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 hematopoietic
- •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 neighbour) with a diagnosed case of vericella infection
研究者
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