CTRI/2025/07/090136招募中1 期
A randomized, open label clinical trial to evaluate the safety and immunogenicity of varicella-zoster virus (VZV) vaccine in healthy subjects
Cadila Pharmaceutical Limited1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年12月20日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To evaluate the safety and reactogenicity based on Frequency of and percentage AE and SAE for recommendation of dose and dosing regimen for Phase-II clinical trial.
研究概览
简要总结
This Phase-I, prospective, randomized, FIH, open-label, parallel, dose escalation clinical trial will the objective to assess the safety and immunogenicity of the VZV Vaccine in healthy adult human subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy adult subjects of either gender with 18 years or more of age.
- •Subject’s BMI within normal limit of 18.50-30.00 kg/m2 (inclusive both).
- •Subjects in good health at the time of randomization into the study.
- •Subject willing to follow all study requirements.
- •Female subjects of childbearing potential.
排除标准
- •Subject with history of chicken pox /herpes zoster disease.
- •Subjects with history of vaccination with any chicken pox vaccine, varicella or zoster vaccine.
- •Subjects with history of allergy or hypersensitivity reaction to any vaccine component.
- •Subject is having a history of disease or any underlying medical conditions.
- •Subjects using any immunosuppressive therapy, use of nontopical antiviral therapy with activity against herpes virus.
- •Subject is having a history of adverse reactions during previous vaccinations.
- •Any clinically significant abnormal laboratory findings during screening.
- •Any other vaccine administration within the last 30 days or planned to be administered during the study period.
- •Pregnant and lactating girls and female subjects of child bearing age not using acceptable contraceptive measures.
- •Subjects who have received blood transfusion or participated in another clinical trial during past 3 month.
结局指标
主要结局
To evaluate the safety and reactogenicity based on Frequency of and percentage AE and SAE for recommendation of dose and dosing regimen for Phase-II clinical trial.
时间窗: Within 7 days post- each vaccination
次要结局
- To evaluate the immunogenicity results of the test vaccine, based on IgG antibody(response.)
- To evaluate the safety profile of test vaccine(After day 7 of each vaccination)
研究者
Dr Arani Chatterjee
Cadila Pharmaceuticals Limited
研究点 (1)
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