Evaluation of the Safety and Tolerability of a Higher Potency Dose of Varicella Zoster Virus Vaccine Live (Oka/Merck)Among Adults 50 Years of Age or Older
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 695
- 主要终点
- Number of Participants With Vaccine-related Serious Clinical Adverse Experiences (SAEs)
研究概览
简要总结
This study compared the safety and tolerability profile of a higher potency investigational vaccine to that of the investigational vaccine at a lower potency 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy individuals 50 years of age or older with a history of chickenpox who have not had herpes zoster
- •Exclusion Criteria :
- •Preexisting conditions that might affect vaccine safety such as conditions that inhibit an immune response
排除标准
- 未提供
结局指标
主要结局
Number of Participants With Vaccine-related Serious Clinical Adverse Experiences (SAEs)
时间窗: Day 1-42 post vaccination
The incidence of vaccine-related SAEs occurring Day 1 through Day 42 postvaccination. Whether a serious clinical adverse experience occurring Day 1 through Day 42 postvaccination was vaccine-related was determined by the investigator who was a qualified physician . The difference in the risk of developing a vaccine-related SAE between the two groups was compared at the 2-sided 0.05 level.
Number of Participants With Moderate or Severe Injection-site Pain/Tenderness/Soreness or Swelling (> 2 Inches at Largest Diameter)
时间窗: Day 1-5 postvaccination
次要结局
未报告次要终点