A Phase 1, Placebo-controlled, Randomized, Observer-blinded Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of An Adjuvanted Clostridium Difficile Vaccine Administered As A 3-dose Regimen In Healthy Adults Aged 50 To 85 Years
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 184
- 试验地点
- 20
- 主要终点
- Proportion of subjects reporting local reactions (pain, erythema, and induration) and their severity, as self reported on e-diaries.
研究概览
简要总结
This study will investigate a clostridium difficile vaccine in healthy adults aged 50 to 85 years, who will each receive 3 doses of vaccine. Subjects will receive their vaccine doses at either months 0, 1, and 3 or days 1, 8, and 30. Subjects will be divided into 2 age groups (50-64 and 65-85 years of age). The study will assess how safe and tolerable the vaccine is, and also look at subjects' immune response to the vaccine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female adults aged 50 to 85 years at enrollment
排除标准
- •Proven or suspected prior episode of Clostridium difficile associated diarrhea.
- •Unstable chronic medical condition or disease requiring significant change in therapy or hospitalization for worsening disease within 8 weeks before receipt of study vaccine.
- •Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components
研究组 & 干预措施
Arm Label: Month 0, 1 and 3 Schedule
干预措施: C. difficile vaccine with adjuvant (Biological)
Arm Label: Month 0, 1 and 3 Schedule
干预措施: Placebo (Biological)
Day 1, 8, and 30 Schedule
干预措施: C. difficile vaccine with adjuvant (Biological)
Day 1, 8, and 30 Schedule
干预措施: placebo (Biological)
结局指标
主要结局
Proportion of subjects reporting local reactions (pain, erythema, and induration) and their severity, as self reported on e-diaries.
时间窗: 7 days after vaccination
Proportion of subjects reporting systemic events (fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, and new or worsening joint pain) and their severity, as self reported on e-diaries.
时间窗: 7 days after vaccination
次要结局
- Proportion of subjects in each vaccine group with a greater than or equal to 4 and higher fold-rises in neutralizing antibody levels (in Neut units/mL).(Up to 12 months post-dose 3)
- Proportion of subjects in each vaccine group with neutralizing antibody levels, expressed as geometric mean concentrations (GMCs) (in Neut units/mL).(Up to 12 months post-dose 3)
- Proportion of subjects in each vaccine group with neutralizing antibody levels (in Neut units/mL) greater than or equal to specified threshold(s).(Up to 12 months post-dose 3)