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 range6 Years
SexALL
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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.
*…
What they're measuring
1
Incidence of adverse reactions 0-30 days after vaccination