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
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 入组人数
- 256
- 试验地点
- 5
- 主要终点
- 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
This is a randomized, single blind, parallel group, multicentre, non-inferiority phase II / III clinical trial to evaluate the immunogenicity and safety of Varicella vaccine (Live Attenuated, Freeze-dried, IP) of M/s Cadila Healthcare Limited compared to Variped Vaccine Live I.P. (Oka / Merck strain, Manufactured by Merck (USA) in healthy paediatric subjects aged 1-12 years. Two hundred and fifty six subjects will be randomized to receive either Varicella vaccine (Live Attenuated, Freeze-dried, IP) of M/s Cadila Healthcare Limited or Variped Vaccine Live I.P. (Oka / Merck strain, Manufactured by Merck (USA) according to the centralized computer generated randomization plan. A pre vaccination and a post vaccination (day 42) blood sample will be collected to determine IgG antibody titres to Varicella Zoster virus using gpELISA kit manufactured by The Binding Site Group Ltd, UK (VaccZymeTM). The primary efficacy end point will be the Geometric mean titre of IgG antibodies to Varicella Zoster virus in the two groups at the end of the study. The safety of the vaccine will be assessed by recording the adverse events occurring during the entire course of the study. The study will be conducted in sequential manner wherein subject aged >6-12 years will be enrolled before subjects aged 1-6 years.
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
- •Healthy paediatric subjects of either sex aged 1 year to 12 years
- •Informed consent of the parents/guardians and their willingness to be followed up for at least 6 weeks after vaccination of their child
- •Parents/guardians with adequate literacy to fill the diary cards.
排除标准
- •Subjects with a history of anaphylaxis or serious reactions to other vaccines, neomycin, gelatin and / or albumin
- •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 haematopoietic system, cardiovascular system, liver or kidney
- •Subjects with an acute febrile illness at the time of randomization
- •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
- •Subjects with any other clinically significant concurrent illness affecting immune response after vaccination.
结局指标
主要结局
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 following vaccination
次要结局
- Sero-conversion rate at the end of the study for Varicella in the two groups(42 days following vaccination)