A Randomized, Blinded, Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of Adsorbed Cell-free DTP Vaccine (Five-component)
This is a randomized, blinded, controlled phase II and III clinical trial evaluating the immunogenicity and safety of adsorbed cell-free DPT vaccine. 320 subjects aged 7 years and older in the phase II were divided into two age groups, the ≥18 years group and the 7-17 years group, and randomized 3:1 to receive the trial vaccine Tdcp versus the control vaccine PPV23. 1500 subjects in the phase III were divided into 3 age subgroups. 780 subjects were planned to be enrolled in the 6-year-old group and randomized 1:1 to receive the experimental vaccine Tdcp versus the control vaccine DTaP, and 360 subjects were planned to be enrolled in each of the 7-17 and ≥18 age groups and randomized 3:1 to receive the experimental vaccine Tdcp versus the control vaccine PPV23.
• Phase II : People ≥ 7 years old
• Phase II : Willing to provide identification documents
• Phase II : Volunteers must obtain informed consent from the volunteers themselves and/or their guardians/ or delegates, sign the informed consent form and be willing to comply with the requirements of the clinical trial protocol, and be able to complete the full study follow-up
• Phase II : Volunteers aged 7\
⁃ 11 years have completed 4 doses of vaccine containing DPT
• Phase II : ≥12 years old volunteers need to have not received any component vaccine containing DPT within 5 years
• Phase III : People ≥6 years old
• Phase III : Willing to provide identification documents
• Phase III : Volunteers must obtain informed consent from themselves and/or their guardians/ or delegates, sign the informed consent form and be willing to comply with the requirements of the clinical trial protocol, and be able to complete the full study follow-up
• Phase III : Volunteers aged 6\
⁃ 11 years old have completed 4 doses of DPT-containing vaccine in the past
• Phase III : Volunteers aged ≥12 years should not have received any vaccine containing any component of DPT within 5 years