A Double-Blind, Randomized, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of V211 Administered Concomitantly Versus Nonconcomitantly With Influenza Virus Vaccine (Inactivated)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 763
- 主要终点
- Varicella-zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Antibody Responses
研究概览
简要总结
The purpose of this study is to determine whether the investigational zoster vaccine has a comparable immune response (the body's ability to protect against disease) and safety profile when given concomitantly with another vaccine.
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
- •Adults 50 years of age or older
排除标准
- •Prior history of Herpes Zoster (shingles)
- •Prior receipt of varicella or zoster vaccine
- •Immunosuppressed
研究组 & 干预措施
Nonconcomitant
Influenza vaccine and Zostavax placebo on Day 1, Zostavax at week 4
干预措施: Comparator: Influenza Vaccine (Biological)
Nonconcomitant
Influenza vaccine and Zostavax placebo on Day 1, Zostavax at week 4
干预措施: ZOSTAVAX™ (Nonconcomitant) (Biological)
Concomitant
Zostavax concomitantly with influenza vaccine on Day 1, placebo at week 4
干预措施: ZOSTAVAX™ (concomitant) (Biological)
Concomitant
Zostavax concomitantly with influenza vaccine on Day 1, placebo at week 4
干预措施: Comparator: Influenza Vaccine (Biological)
结局指标
主要结局
Varicella-zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Antibody Responses
时间窗: 4 weeks
The Geometric mean titer (GMT) of the VZV glycoprotein enzyme-linked immunosorbent assay (gpELISA) antibody responses at Week 4 postvaccination in participants who received ZOSTAVAX™ concomitantly with influenza vaccine was compared to that in subjects who received influenza vaccine and ZOSTAVAX™ nonconcomitantly.
次要结局
未报告次要终点