Phase I/II Clinical Trial of Diphtheria-Tetanus-Pertussis (Reduced Dose) Vaccine
China660 participantsStarted 2026-03-12
Plain-language summary
This is a randomized, double-blinded, parallel-controlled phase I/II clinical trial to evaluate the safety and preliminary immunogenicity of the Tetanus, Diphtheria and Acellular Component Pertussis Vaccine Adsorbed (reduced antigen content) in subjects aged 6 years and above.
Who can participate
Age range6 Years
SexALL
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Inclusion Criteria:
* Age Requirement: volunteers aged 6 years and above
* Provision of Legal Identification: volunteers and their legal guardians or appointed representatives must provide valid legal identification documents.
* Informed Consent: participants, legal guardians, or appointed representatives of volunteers must have the capacity to understand the informed consent document and the research process, voluntarily participate, sign the informed consent form, and be able to comply with the requirements in the study as well as complete relevant visits on time.
Exclusion Criteria:
* Subjects whose physical examination, vital signs check, or laboratory test results are abnormal and have clinical significance, and are determined by the researcher to be unsuitable for participation in the clinical trial.
* Subjects who have received any vaccine within 30 days (including the 30th day) before enrollment, or those who plan to receive other vaccines within 30 days (including the 30th day) after receiving the investigational vaccine.
* Subjects who have experienced acute diseases (such as fever) or acute exacerbations of chronic diseases within 3 days before enrollment (including the third day).
* Subjects who have had contact with patients clearly diagnosed with pertussis, diphtheria or tetanus within 30 days before enrollment.
* Individuals who have been clinically diagnosed with diphtheria or tetanus within 10 years before enrollment, or with pertussis within 5 years; or t…
What they're measuring
1
Safety index - incidence of adverse events
Timeframe: 0- 30 minutes/Day 0 to 7 days/Day 0 to 28 days after vaccination
2
Immunogenicity index - Geometric Mean Concentration (GMC)
Timeframe: Day 30 after vaccination
3
Immunogenicity index - Seropositive Rate
Timeframe: Day 30 after vaccination
Trial details
NCT IDNCT07418372
SponsorInstitute of Medical Biology, Chinese Academy of Medical Sciences