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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 344
- 试验地点
- 6
- 主要终点
- Immunogenicity: Geometric mean titre of IgG antibodies to Varicella Zoster virus in the two groups at the end of the study
研究概览
简要总结
Varicella (chickenpox) is an acute and highly contagious disease of childhood caused by human (alpha) herpesvirus 3 (Varicella-Zoster virus). It is of widespread distribution, occurs in epidemic waves and affects most people by 20 years of age. This will be a prospective, randomized, single blind, parallel, active controlled, multicenter, non-inferiority, phase III clinical trial in healthy pediatric subjects aged 1 to 12 years in India. The study will enroll approximately 344 healthy Indian subjects to receive single dose of either test Varicella vaccine (live attenuated) of Test or reference vaccine in 1:1 ratio. The study will be conducted in sequential manner wherein subject aged >6-12 years will be enrolled before subjects aged 1-6 years. The immune response will be evaluated at day 42 post vaccination and safety will be evaluated throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 1.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy pediatrics subjects of either sex aged 1 year to 12 years
- •Informed consent of the parents/LAR and their willingness to be followed up for at least 6 weeks after vaccination of their child
- •Parents/LAR with adequate literacy to fill the diary cards Note Age of subject should be at least 12 completed months.
排除标准
- •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.
结局指标
主要结局
Immunogenicity: Geometric mean titre of IgG antibodies to Varicella Zoster virus in the two groups at the end of the study
时间窗: 42 days
Number & severity of solicited local & systemic adverse events during the first 7 days post vaccination
时间窗: 42 days
Number, severity and relatedness of serious adverse events (SAEs)
时间窗: 42 days
Safety, Tolerability: Alone & in comparison.
时间窗: 42 days
Number, severity and relatedness of all unsolicited AEs through study period post vaccination
时间窗: 42 days
次要结局
- Immunogenicity:(Sero-conversion rate at the end of the study for Varicella in the two groups)