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
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
- 是
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
