A Double-Blind, Randomized, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of V211 Administered Concomitantly Versus Nonconcomitantly With Influenza Virus Vaccine (Inactivated)

Merck Sharp & Dohme LLC0 个研究点目标入组 763 人开始时间: 2005年9月最近更新: 2015年9月21日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Merck Sharp & Dohme LLC
入组人数: 763
主要终点: Varicella-zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Antibody Responses

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

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

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

研究者

发起方

Merck Sharp & Dohme LLC

申办方类型

Industry

责任方

Sponsor

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