A Clinical Study on Immunogenicity Persistence of Adsorbed 5-component Acellular Pertussis, Diphtheria and Tetanus Combined Vaccine
2026年7月30日 更新者：CanSino Biologics Inc.
Phase I Clinical Study on Immunogenicity Persistence of Adsorbed 5-component Acellular Pertussis, Diphtheria and Tetanus Combined Vaccine
This clinical trial will enroll 160 participants who previously took part in the Phase I clinical trial of the adsorbed acellular pentavalent (five-component) DTP-polio combination vaccine (for individuals aged 6 years and older) (Protocol No.: CTP-Tdcp-001).
Approximately 3-4 mL of venous blood will be collected from each participant 2.5 years, 5 years, and 10 years after vaccination for a study on immune persistence.
研究概览
地位
尚未招聘
研究类型
观察性的
注册 (估计的)
160
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Ying Wang
- 电话号码：022-58213600-6051
- 邮箱：ying.wang@cansinotech.com
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
是的
取样方法
非概率样本
研究人群
This clinical trial includes 160 participants who previously took part in the Phase I clinical trial of the adsorbed acellular pentavalent (five-component) DTP-polio combination vaccine (for individuals aged 6 years and older) (Protocol No.: CTP-Tdcp-001).
For the immunopersistence study, approximately 3-4 mL of venous blood will be collected from each participant 2.5 years, 5 years, and 10 years after vaccination.
描述
Inclusion Criteria:
- Participants in the 6-11-year-old, 12-17-year-old, and ≥18-year-old groups from the Phase I clinical trial of the adsorbed acellular pentavalent (five-component) DTP-polio combined vaccine (for individuals aged 6 and older) (Protocol No.: CTP-Tdcp-001) who were included in the protocol-defined analysis set;
- Willingness to provide identification documents;
- Informed consent must be obtained from the trial participant and/or guardian and/or authorized representative, and the informed consent form must be signed;
- The trial participant and/or guardian and/or authorized representative must be able and willing to comply with the requirements of the clinical study protocol and be able to complete the full course of study follow-up.
Exclusion Criteria:
- Received another DTP-type vaccine after completing the CTP-Tdcp-001 study;
- Developed a DTP-related illness since the completion of the CTP-Tdcp-001 study;
- Has a coagulation disorder;
- In the investigator's judgment, the participant has any other factors that make them unsuitable for participation in the clinical trial.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Previously received the Tdcp vaccine at age 18 and older
|
Approximately 3-4 mL of venous blood will be collected 2.5 years, 5 years, and 10 years after vaccination for a study on immune persistence.
|
|
Previously received the Tdcp vaccine at age 12-17
|
Approximately 3-4 mL of venous blood will be collected 2.5 years, 5 years, and 10 years after vaccination for a study on immune persistence.
|
|
Previously received the Tdcp vaccine at age 6-11
|
Approximately 3-4 mL of venous blood will be collected 2.5 years, 5 years, and 10 years after vaccination for a study on immune persistence.
|
|
Previously received the DT vaccine at age 6-11
|
Approximately 3-4 mL of venous blood will be collected 2.5 years, 5 years, and 10 years after vaccination for a study on immune persistence.
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Seropositivity rates of antibodies against DT, TT, PT, FHA, PRN, and FIM 2&3
大体时间：2.5, 5, and 10 years post-vaccination
|
2.5, 5, and 10 years post-vaccination
|
|
Geometric mean concentrations (GMC) of antibodies against DT, TT, PT, FHA, PRN, and FIM 2&3
大体时间：2.5, 5, and 10 years post-vaccination
|
2.5, 5, and 10 years post-vaccination
|
|
Proportions of serum anti-PRN antibody levels ≥5 and ≥10 IU/mL
大体时间：2.5, 5, and 10 years post-vaccination
|
2.5, 5, and 10 years post-vaccination
|
|
Proportions of anti-FIM 2&3 antibody levels ≥5 and ≥10 EU/mL
大体时间：2.5, 5, and 10 years post-vaccination
|
2.5, 5, and 10 years post-vaccination
|
|
Proportions of serum anti-DT and anti-TT antibody levels ≥0.1 IU/mL and ≥1.0 IU/mL
大体时间：2.5, 5, and 10 years post-vaccination
|
2.5, 5, and 10 years post-vaccination
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Xiaoyu Liu、Center for Disease Prevention and Control, Shaanxi Province
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年10月15日
初级完成 (估计的)
2033年10月15日
研究完成 (估计的)
2033年10月15日
研究注册日期
首次提交
2026年7月30日
首先提交符合 QC 标准的
2026年7月30日
首次发布 (实际的)
2026年8月4日
研究记录更新
最后更新发布 (实际的)
2026年8月4日
上次提交的符合 QC 标准的更新
2026年7月30日
最后验证
2026年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.