NCT02180295撤回3 期
A Phase III, Double-Blind, Lot-To-Lot Consistency Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of V212 in Healthy Adults
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Geometric Mean Titer of VZV Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titers
研究概览
简要总结
The study will evaluate the consistency of 3 lots of inactivated VZV vaccine for safety, tolerability, and immunogenicity in healthy adults. The primary hypothesis of the study is that the 3 lots of inactivated vaccine will demonstrate similar immunogenicity at 28 days after the fourth dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Afebrile (<=100.4 °F [<=38.0 °C]) oral or equivalent on Day 1 before the first vaccination
- •Any underlying chronic illness that is not in stable condition
- •History of varicella, antibodies to VZV, or residence (for >=30 years) in a country with endemic VZV infection
- •Female participants of childbearing potential must have a negative pregnancy test. A female not of reproductive potential has reached natural menopause, or is 6-weeks postsurgical bilateral oophorectomy and/or hysterectomy or bilateral tubal ligation
- •Male, or female of childbearing potential who agrees to remain abstinent or use 2 acceptable methods of birth control from 2 weeks before enrollment to 6 months after the last study vaccination
排除标准
- •History of allergic reaction to any vaccine component, or an anaphylactic/anaphylactoid reaction to neomycin (not including contact dermatitis to neomycin)
- •Prior history of herpes zoster
- •History of receipt or expects to receive any varicella or zoster vaccine during the study period
- •Is pregnant or breastfeeding, or expects to conceive from 2 weeks before enrollment to 6 months after the last study vaccination
- •Has received a live virus vaccine or is scheduled to receive any live virus vaccine from 4 weeks before the first dose of study vaccination and throughout the study
- •Has received any inactivated vaccine or is scheduled to receive any inactivated vaccine from 7 days before to 7 days after any study vaccination
- •Received immunoglobulin or any blood products or is scheduled to receive them from 5 months before the first dose of study vaccination and throughout the study
- •Has participated in an investigational drug or vaccine study within 30 days before enrollment
- •Has any acute illness or significant underlying illness that may interfere with interpretation of the study
- •Receiving immunosuppressive therapy (including systemic corticosteroid doses exceeding physiological replacement doses within 14 days prior to the first vaccination), except topical, ophthalmic, or inhaled corticosteroids or intra-articular or soft-tissue injections of steroids
- •Has known or suspected immune dysfunction
结局指标
主要结局
Geometric Mean Titer of VZV Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titers
时间窗: 28 days postdose 4
次要结局
- Percentage of Participants with a Serious Adverse Experience(Up to 28 days postdose 4)
研究者
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