A Clinical Trial of Adsorbed Cell-free DPT Vaccine (5-component) (for People Aged 6 Years and Above) (NCT06056050) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Clinical Trial of Adsorbed Cell-free DPT Vaccine (5-component) (for People Aged 6 Years and Above)
China180 participantsStarted 2023-12-06
Plain-language summary
Pertussis is an acute respiratory infectious disease caused by Bordetella pertussis, diphtheria is an acute upper respiratory infectious disease caused by Gram-positive Corynebacterium diphtheriae, and tetanus is a highly fatal disease caused by Clostridium tetani infection. Currently, there is no clinical trial registration of Diphtheria, tetanus, and pertussis (DPT) vaccine applicable to ≥6 years of age in China, therefore, the five-component acellular DPT combination vaccine developed by our research has a promising future.
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:
* ≥ 6 years of age.
* Willingness to provide proof of identity.
* The informed consent of the volunteer and/or the guardian and/or the delegate must be obtained and the informed consent form must be signed.
* Volunteers are able and willing to comply with the requirements of the clinical trial protocol and are able to complete the full study follow up.
* Volunteers aged 6-11 years who have completed 4 doses of DPT-containing vaccine, but have not received the 5th dose, and have ≥3 years between the 4th dose.
* Volunteers aged ≥12 years must not have received any of the components of the DPT-containing vaccine within 5 years.
Exclusion Criteria:
* Persons with fever prior to vaccination, with axillary temperature \> 37.0°C.
* A female with a positive urine pregnancy test or a breastfeeding volunteer, where the volunteer or her partner has a plan to become pregnant within 180 days.
* Adults with severe cardiovascular disease, hypertension (systolic blood pressure ≥160mmHg, diastolic blood pressure ≥100mmHg) that cannot be controlled by medication, or other severe chronic diseases.
* Abnormal and clinically significant results of preimmunization blood tests, blood biochemistry and urine tests.
* Persons who have suffered from one of the diseases of diphtheria or tetanus, or who have suffered from whooping cough in the last three years.
* Volunteers ≥12 years of age who have received pneumococcal polysaccharide/conjugate-containing vaccine within 4 years.
*…
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
Incidence of adverse reactions 0-30 days after vaccination