A Clinical Study on Immunogenicity Persistence of Adsorbed 5-component Acellular Pertussis, Dipht… (NCT07744347) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Clinical Study on Immunogenicity Persistence of Adsorbed 5-component Acellular Pertussis, Diphtheria and Tetanus Combined Vaccine
160 participantsStarted 2026-10-15
Plain-language summary
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.
Who can participate
Age range
6 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Seropositivity rates of antibodies against DT, TT, PT, FHA, PRN, and FIM 2&3
Timeframe: 2.5, 5, and 10 years post-vaccination
2
Geometric mean concentrations (GMC) of antibodies against DT, TT, PT, FHA, PRN, and FIM 2&3
Timeframe: 2.5, 5, and 10 years post-vaccination
3
Proportions of serum anti-PRN antibody levels ≥5 and ≥10 IU/mL
Timeframe: 2.5, 5, and 10 years post-vaccination
4
Proportions of anti-FIM 2&3 antibody levels ≥5 and ≥10 EU/mL
Timeframe: 2.5, 5, and 10 years post-vaccination
5
Proportions of serum anti-DT and anti-TT antibody levels ≥0.1 IU/mL and ≥1.0 IU/mL