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.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 424
- 试验地点
- 7
- 主要终点
- post dose 2 for adolescents/adults in test & reference arm.
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) This will be a prospective, randomized, observer blind, parallel, active controlled, multicenter, non-inferiority, phase III clinical trial in healthy subjects aged 1 to 60 years in India. The study will enroll approximately 424 healthy Indian subjects to receive single dose or two doses of either test Varicella vaccine (live attenuated) of Novo Medi Sciences Pvt. Ltd or VARIPED® Vaccine (Varicella Vaccine Live I.P By MSD Pharmaceuticals Pvt Ltd, India) in 1:1 ratio. The study will be conducted in sequential manner, wherein subject aged 18 - 60 years will be enrolled first followed by subjects aged 13 -17 years, 7-12 years & 1-6 years in sequentially manner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 1.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy subjects of either sex aged 1 year to 60 years.
- •Informed consent/assent of the subject/parents/LAR and their willingness to be followed up for entire study period.
- •Subject/Parents/LAR with adequate literacy to fill the subject diary cards.
- •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
- •Subjects with a history of anaphylaxis or serious reactions to other vaccines,
- •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.
- •Subjects with a history of convulsions, seizures, other central nervous system diseases, severe disease of hematopoietic system, cardiovascular system, liver or kidney
- •Subjects with an acute febrile illness at the time of randomization
- •Any other vaccine administration within 30 days of initiation of the study or planned during the study period.
- •A history of serious chronic illness, major congenital defects, immunosuppression (immunosuppressive illness or therapy)
- •Subjects who have received blood, blood products or immunoglobulins during the preceding 6 months or have planned.
- •during the study period.
- •#Close contact (family member or neighbour) with a diagnosed case of vericella infection.
结局指标
主要结局
post dose 2 for adolescents/adults in test & reference arm.
时间窗: 6 weeks
1.Sero-conversion rate at 6 weeks post vaccination for children & at 6 weeks
时间窗: 6 weeks
2.Geometric mean titre of IgG antibodies to Varicella Zoster virus at 6 weeks
时间窗: 6 weeks
postvaccination for children and at 6 weeks post dose 2 for adolescents/adults in
时间窗: 6 weeks
test and reference arm.
时间窗: 6 weeks
次要结局
- 1.4- Fold Seroconversion (antibody rise) rate at 6 weeks post vaccination for children &(at 6 weeks post dose 2 for adolescents/adults in test and reference arm.)