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.
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.
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.
Parallel
low-dose Tetanus, Diphtheria and Acellular Component Pertussis Vaccine Adsorbed (Reduced Antigens Content)
Biological/VaccineLow-dose vaccine, 0.5ml/dose, one dose at Day 0
high-dose Tetanus, Diphtheria and Acellular Component Pertussis Vaccine Adsorbed (Reduced Antigens Content)
Biological/VaccineHigh-dose vaccine, 0.5ml/dose, one dose at Day 0
Tetanus, Diphtheria and Acellular Pertussis Vaccine
Biological/VaccineDTaP controlled vaccine, 0.5ml/dose, one dose at Day 0
23-valent polysaccharide pneumococcal vaccine
Biological/VaccinePPV23 controlled vaccine, 0.5ml/dose, one dose at Day 0
Safety index - incidence of adverse events
Incidence of adverse events after vaccination
Immunogenicity index - Geometric Mean Concentration (GMC)
The GMC of anti-DT, TT, PT, PRN, FHA antibodies 30 days after vaccination
Immunogenicity index - Seropositive Rate
The seropositve rate of anti-DT, TT, PT, PRN, FHA antibodies 30 days after vaccination
Safety index - incidence of serious adverse events
Incidence of serious adverse events after vaccination
Immunogenicity index - Seroconversion Rate
The seroconversion rate of anti-DT, TT, PT, PRN, FHA antibodies 30 days after vaccination
Immunogenicity index - Geometric mean fold increases (GMFI)
The GMFI of anti-DT, TT, PT, PRN, FHA antibodies 30 days after vaccination
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This trial is not recruiting at the moment. You can still explore other options:
