Safety and Immunogenicity of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (ADACEL®) in Persons ≥65 Years of Age
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 1,564
- 试验地点
- 19
- 主要终点
- Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine
研究概览
简要总结
It is well recognized that older adults can contract pertussis, suffer its complications, and unwittingly transmit it to close contacts, which may well include infants too young to have received their primary series of DTaP vaccinations. ADACEL® vaccine is currently licensed in the US for persons 11 - 64 years of age, but no pertussis vaccine is yet approved for administration to older adults. The most widely used Td vaccine in the US, DECAVAC®, has no upper limit on its age indication.
The purpose of this trial is to describe the safety and immunogenicity of ADACEL® vaccine among individuals ≥ 65 years of age.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（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
Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine
时间窗: Day 35 post-vaccination
Percentage of Participants With Post-vaccination Tetanus and Diphtheria Concentrations ≥0.10 IU/mL (Seroprotection) ADACEL® or DECAVAC®.
时间窗: Day 35 post-vaccination
Seroprotection was defined as a post-vaccination Concentrations of ≥0.10 IU/mL.
Percentage of Participants With Booster Response to Tetanus and Diphtheria Post-vaccination With ADACEL® or DECAVAC® Vaccine.
时间窗: Day 35 post-vaccination
Booster response was defined as a minimum rise in antibody concentration from pre- to post-vaccination. The minimum rise is at least 2 times, if pre-vaccination concentration is above the the cutoff value (Tetanus 5.47 IU/mL; Diphtheria 1.28 IU/mL) or at least 4 times it it is at or below the cutoff value.
次要结局
未报告次要终点