Immune Responses in Adults to Revaccination With Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (ADACEL®) 10 Years After a Previous Dose
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 769
- 试验地点
- 7
- 主要终点
- Percentage of Participants With Seroprotection Against Tetanus and Diphtheria Before and After Revaccination With ADACEL® 10 Years After a Previous Dose
研究概览
简要总结
The purpose of this study is to collect additional immunogenicity and safety data on re-dosing with Tdap vaccine (ADACEL®) in a continuing effort to address the public health need to establish broader population immunity against pertussis, as well as diphtheria and tetanus.
Primary Objective:
- To assess immune response to Tdap vaccine (ADACEL®) one month after booster vaccination.
详细描述
This is an open-label, multicenter study to describe the immunological response and safety of repeat administration of an adolescent/adult-formulation tetanus-diphtheria-acellular pertussis Tdap vaccine (ADACEL®), 10 years following initial administration of Tdap vaccine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（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
Percentage of Participants With Seroprotection Against Tetanus and Diphtheria Before and After Revaccination With ADACEL® 10 Years After a Previous Dose
时间窗: Day 0 (pre-vaccination) and 30 post-vaccination
Diphtheria concentrations were determined by neutralization assay; tetanus concentrations were determined by enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined as anti-tetanus or anti-diphtheria concentrations ≥ 0.1 IU/mL.
Anti-Pertussis Geometric Mean Concentrations Post-vaccination With ADACEL® 10 Years After a Previous Dose
时间窗: Day 30 post-vaccination
Post-vaccination geometric mean concentrations (GMCs) for pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA).
次要结局
未报告次要终点