Observation of Immune Persistence in a Phase III Clinical Trial of an Adsorbed Tetanus Vaccine
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Geometric mean concentration (GMC) against tetanus toxoid.
研究概览
简要总结
This study included 240 trial participants who had previously taken part in a Phase III clinical trial of an adsorbed tetanus vaccine (Protocol No.: CTP-TTVA-001), with 120 participants in each of the treatment and control groups. All trial participants were required to provide 3.0-4.0 mL of blood for an immunodurability assessment 2.5 years after vaccination.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals who have previously participated in the Phase III clinical trial of the adsorbed tetanus vaccine (Protocol No.: CTP-TTVA-001).
- •Willing to provide identification documents.
- •Have given informed consent, voluntarily signed the informed consent form, and are able to comply with the requirements of the clinical trial protocol.
- •At least 2.5 years have elapsed since completion of the vaccination series.
排除标准
- •Following vaccination in the Phase III clinical trial (Protocol No.: CTP-TTVA-001), participants who have received tetanus immunoglobulin, tetanus antitoxin, or a vaccine containing tetanus toxoid antigen.
- •Participants in the previous Phase III clinical trial (Protocol No.: CTP-TTVA-001) who did not complete the blood draw 30 days after vaccination.
- •Other circumstances deemed by the investigator to render a participant ineligible for this clinical study.
研究组 & 干预措施
Previously vaccinated with Tetanus Vaccine, Adsorbed (TTVA)
干预措施: Previously vaccinated with TTVA (Other)
Previously vaccinated with Tetanus Vaccine, Adsorbed (TT)
干预措施: Previously vaccinated with TT (Other)
结局指标
主要结局
Geometric mean concentration (GMC) against tetanus toxoid.
时间窗: 2.5 years after vaccination
Positivity rate of IgG antibodies against tetanus toxoid.
时间窗: 2.5 years after vaccination
The proportion of antibody concentrations ≥ 1.0 IU/mL 2.5 years after vaccination.
时间窗: 2.5 years after vaccination
次要结局
未报告次要终点