A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of a Single Dose of the Lyophilized Formulation of Merck Staphylococcus Aureus Vaccine (V710) in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 51
- 主要终点
- Geometric Mean Fold-rise (GMFR) After the Administration of the Lyophilized Formulation of V710 (60 mcg).
研究概览
简要总结
This study is being performed to evaluate a single 60 Mcg dose of lyophilized formulation of Merck Staphylococcus aureus vaccine (V710) in healthy subjects. This study is intended to provide necessary safety and immunogenicity data for the lyophilized formulation of V710 prior to its subsequent evaluation in patients at risk for developing serious S. aureus infections.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 to 80 years of age
- •Good physical health based upon medical history and physical examination
- •Willing and able to participate in the entire study duration
- •Female subject with a negative urine pregnancy test immediately prior to study vaccination
排除标准
- •Chronic skin infections or a chronic skin condition (e.g. psoriasis)
- •Serious S. aureus infection in the last 12 months
- •Allergy to aluminum-containing substance taken in the body or to any other vaccine component
- •Oral temperature equal to or greater than 100.4ºF (38.0ºC), within the past 2 days
- •Participation in a prior V710 vaccine clinical study
- •Participation in any other clinical study in the past 4 weeks, or during the 3-month study duration
结局指标
主要结局
Geometric Mean Fold-rise (GMFR) After the Administration of the Lyophilized Formulation of V710 (60 mcg).
时间窗: Prevaccination to 14 days postvaccination
Participants whose geometric mean fold-rise (GMFR) in anti-0657n IgG was measured 14 days after a single dose of the lyophilized formulation of V710 (60 mcg) by a LUMINEX™ assay for IgG antibodies directly binding to the 0651nI S. aureus antigen. The calculation of GMFR is based on the ratio of IgG Titers (geometric mean concentrations in which the units of measure are µg/mL) prevaccination (pre)/14 days postvaccination (postvac).
次要结局
未报告次要终点