NCT01626794撤回3 期
A Phase III Double Blind, Randomized, Multicenter, Controlled Study to Evaluate the Immunogenicity, Safety and Tolerability of VARIVAX Made With the Varicella Enhanced Process (VEP)
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Percent of Participants with VZV antibody levels ≥5 glycoprotein enzyme-linked immunosorbent assay (gpELISA) units/mL
研究概览
简要总结
This study will test the immunogenicity, safety, and tolerability of VARIVAX™ manufactured with the Varicella Enhanced Process (VEP) compared with the VARIVAX™ 2007 Process. The primary hypotheses being tested are 1)VARIVAX™ VEP will induce varicella-zoster virus (VZV) antibody responses that are non-inferior to those induced by VARIVAX™ 2007 process at 6 weeks after vaccination 1, and 2) VARIVAX™ VEP will induce an acceptable anti-VZV antibody response rate at 6 weeks after vaccination 1.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Months 至 23 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •negative clinical history of measles, mumps, rubella, varicella, and zoster
排除标准
- •received any measles, mumps, rubella, or varicella vaccine at any time prior to the study, or is anticipated to receive any of these vaccines outside the study
- •any congenital or acquired immune deficiency, neoplastic disease, or depressed immunity
- •received systemic immunomodulatory steroids within 3 months prior to entering the study or is expected to require them throughout the study
- •history of allergy or anaphylactoid reaction to neomycin, gelatin, sorbital, egg proteins, chicken proteins, or any components of M-M-R™ II or VARIVAX™
- •received salicylates within 14 days prior to study vaccination
- •exposed to measles, mumps, rubella, varicella, or zoster in the 4 weeks prior to study vaccination
- •received any non-live vaccine within 14 days prior to any study vaccination or is expected to received such vaccine during the 42-day period after each study vaccination
- •received any live vaccine within 30 days prior to any study vaccination or is expected to received such vaccine during the 42-day period after each study vaccination
- •received immune globulin, a blood transfusion, or blood-derived products within 5 months prior to any study vaccination
- •fever illness (≥102.2°F [39.0°C]) within 72 hours prior to study vaccination
- •born to a human immunodeficiency virus (HIV)-infected mother
- •participated in any other clinical trial (other than a surveillance study) within 30 days prior to study enrollment
研究组 & 干预措施
VARIVAX™ VEP
Experimental
干预措施: VARIVAX™ VEP (Biological)
VARIVAX™ VEP
Experimental
干预措施: M-M-R™ II (Biological)
VARIVAX™ 2007 Process
Active Comparator
干预措施: VARIVAX™ 2007 Process (Biological)
VARIVAX™ 2007 Process
Active Comparator
干预措施: M-M-R™ II (Biological)
结局指标
主要结局
Percent of Participants with VZV antibody levels ≥5 glycoprotein enzyme-linked immunosorbent assay (gpELISA) units/mL
时间窗: Six weeks (43 days) after vaccination 1
次要结局
- Percent of participants with fever (≥102.2°F [39.0°C] oral equivalent)(Days 1 to 42 after each vaccination)
- Percent of participants with injection-site reactions(Days 1 to 5 after each vaccination)
- Percent of participants with measles-like, rubella-like, varicella-like, or zoster-like rash and mumps-like symptoms(Days 1 to 42 after each vaccination)
研究者
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