跳至主要内容
临床试验/NCT01324440
NCT01324440已完成1 期

A Randomized, Multicenter, Double-Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Single Dose of Merck 0657nI Staphylococcus Aureus Vaccine With Merck Aluminum Adjuvant or Without Merck Aluminum Adjuvant in Healthy Adults 18 to 70 Years of Age

Merck Sharp & Dohme LLC0 个研究点目标入组 64 人开始时间: 2006年9月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
64
主要终点
Number of Participants With a Positive Immune Response, Defined as a Change in Antibody Level Greater Than or Equal to a 2-fold-rise at Day 14 Compared to Baseline

研究概览

简要总结

The purpose of this study was to evaluate the safety, tolerability, and immunogenicity of the Merck 0657nI S. aureus vaccine (V710) either with or without Merck Aluminum Adjuvant (MAA).

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

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Number of Participants With a Positive Immune Response, Defined as a Change in Antibody Level Greater Than or Equal to a 2-fold-rise at Day 14 Compared to Baseline

时间窗: Baseline and Day 14 postvaccination

Immunoglobulin G (IgG) antibodies were measured by a LUMINEX(TM) assay.

Geometric Mean Antibody Concentrations (GMC)

时间窗: Day 14 postvaccination

Immunoglobulin G (IgG) antibodies were measured by a LUMINEX(TM) assay.

Change in Antibody Concentration (Titer) at Day 14 Compared to Baseline, Expressed as the Geometric Mean Fold-rise (GMFR)

时间窗: Baseline and Day 14 postvaccination

Immunoglobulin G (IgG) antibodies were measured by a LUMINEX(TM) assay. The GMFR is the ratio of the antibody concentration at Day 14 to the antibody concentration at baseline.

Number of Vaccine-related Serious Adverse Experiences

时间窗: Up to Day 360 postvaccination

Investigators were instructed to determine the seriousness and causality (relatedness to test vaccine) of each AE based on criteria defined in the protocol: A serious adverse event (SAE) is any AE that: * results in death, * is life threatening, * results in a persistent or significant disability/incapacity, * results in or prolongs an existing inpatient hospitalization, * is a congenital anomaly/birth defect, * is a cancer, * is an overdose, * or is another important medical event that may require medical or surgical intervention to prevent one of the outcomes listed above.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

相似试验