An Open label, Phase III, Multicentric Randomized controlled study to evaluate the safety and immunogenicity of Single dose Live Attenuated Varicella Vaccine (VR 795 varicella Oka strain) versus Varilrix Vaccine in healthy Indian children
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 254
- 试验地点
- 4
- 主要终点
- The immunogenicity profile of the test will be evaluated and compared with that of the reference (Varilrix) vaccine in the study population by estimation of the:
研究概览
简要总结
Thisis an An open label, Phase III, Multicentric, randomizedcontrolled study to evaluate the safety and immunogenicity of Single dose LiveAttenuated Varicella Vaccine (VR 795 of varicella Oka strain) Versus VarilrixVaccine in healthy Indian children. There will be 268 subjects to be enrolled(134 in each arm) in this trial. THe objective of this trial is Comparative assessmentof the immunogenicity of the test vaccine versus the comparator by estimation of: a) Seroconversion rates in eachtreatment arm at 6 weeks post vaccination.b) Extent of rise of Varicella(VZV) IgG antibody from baseline values at 6 weeks post vaccination. And comparativeassessment of safety and tolerability of the vaccine up to 6 weeks postvaccination
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 12.00 Month(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Healthy children aged 12 months to 12 years of either sex who are baseline VZV IgG antibody negative •Parent/guardian of subject willing to give written informed consent and to comply to all study related procedures.
排除标准
- •â€¢Clinical history of varicella (chicken pox) and herpes zoster natural infection in the past.
- •â€¢History of Varicalla vaccination in the past.
- •â€¢History of household, playmate, school or daycare center exposure to varicella or herpes zoster in the previous 4 weeks prior to vaccination •Presence of any person in close vicinity of the vaccine who is at high risk of developing varicella (like immunocompromised sibling) •Any established or clinically suspected immunosuppressive or immunocompromised disorder / state (congenital or acquired- drug induced, neoplastic, tuberculosis etc) •Any subject who had received parenteral immunoglobulin or any immunosuppressive drugs in the last three months.
- •â€¢Any major congenital abnormality – cardiac, renal, neurological •Any acute dermatological disease such as, allergy and bacterial/viral/ fungal infection •Participant on any dose of oral/parenteral steroids or inhalational steroids >800 mcg of beclomethasone (or its equivalent) in the last 3 months prior to vaccination.
- •â€¢History of any allergic diatheses and those with known hypersensitivity to vaccine or any of its components like gelatin, gentamicin / neomycin/ kanamycin etc.
- •â€¢Febrile (axillary temperature > 37°C) or any systemic illness at the time of vaccination.
- •â€¢History of administration of varicella zoster immune globulin or any blood products in the previous 4 weeks •Subject has received any live vaccine in the last 4 weeks or any killed vaccine in the last 4 weeks prior to this scheduled vaccination.
- •â€¢Subject scheduled to be administered a live vaccine in the next 4 weeks or any killed vaccine in the next 4 weeks.
结局指标
主要结局
The immunogenicity profile of the test will be evaluated and compared with that of the reference (Varilrix) vaccine in the study population by estimation of the:
时间窗: a. Seroconversion rates amongst those who were baseline seronegative for IgG VZV antibody (i.e 100mIU/ml) and had a 6 weeks post-vaccination ELISA varicella IgG antibody level of ( 150mIU/ml) | b. Extent of rise of Varicella (VZV) IgG antibody from baseline values at 6 weeks post vaccination
a)Seroconversion rates amongst those who were baseline seronegative for IgG VZV antibody (i.e 100mIU/ml) and had a 6 weeks post-vaccination ELISA varicella IgG antibody level of ( 150mIU/ml)
时间窗: a. Seroconversion rates amongst those who were baseline seronegative for IgG VZV antibody (i.e 100mIU/ml) and had a 6 weeks post-vaccination ELISA varicella IgG antibody level of ( 150mIU/ml) | b. Extent of rise of Varicella (VZV) IgG antibody from baseline values at 6 weeks post vaccination
b)Extent of rise of Varicella (VZV) IgG antibody from baseline values at 6 weeks post vaccination
时间窗: a. Seroconversion rates amongst those who were baseline seronegative for IgG VZV antibody (i.e 100mIU/ml) and had a 6 weeks post-vaccination ELISA varicella IgG antibody level of ( 150mIU/ml) | b. Extent of rise of Varicella (VZV) IgG antibody from baseline values at 6 weeks post vaccination
次要结局
- The safety of the vaccine in the study population will be evaluated by estimation of incidence of both serious and non-serious adverse events upto 6 weeks post vaccination with an intensive initial monitoring phase of 10 days post vaccination(estimation of incidence of both serious and non-serious adverse events)