This clinical trial will enroll 160 participants who previously took part in the Phase I clinical trial of the adsorbed acellular pentavalent (five-component) DTP-polio combination vaccine (for individuals aged 6 years and older) (Protocol No.: CTP-Tdcp-001). Approximately 3-4 mL of venous blood will be collected from each participant 2.5 years, 5 years, and 10 years after vaccination for a study on immune persistence.
Participants in the 6-11-year-old, 12-17-year-old, and ≥18-year-old groups from the Phase I clinical trial of the adsorbed acellular pentavalent (five-component) DTP-polio combined vaccine (for individuals aged 6 and older) (Protocol No.: CTP-Tdcp-001) who were included in the protocol-defined analysis set;
Willingness to provide identification documents;
Informed consent must be obtained from the trial participant and/or guardian and/or authorized representative, and the informed consent form must be signed;
The trial participant and/or guardian and/or authorized representative must be able and willing to comply with the requirements of the clinical study protocol and be able to complete the full course of study follow-up.
Received another DTP-type vaccine after completing the CTP-Tdcp-001 study;
Developed a DTP-related illness since the completion of the CTP-Tdcp-001 study;
Has a coagulation disorder;
In the investigator's judgment, the participant has any other factors that make them unsuitable for participation in the clinical trial.
This clinical trial includes 160 participants who previously took part in the Phase I clinical trial of the adsorbed acellular pentavalent (five-component) DTP-polio combination vaccine (for individuals aged 6 years and older) (Protocol No.: CTP-Tdcp-001). For the immunopersistence study, approximately 3-4 mL of venous blood will be collected from each participant 2.5 years, 5 years, and 10 years after vaccination.
Cohort
Prospective
Previously received the Tdcp vaccine at age 18 and older
Other interventionApproximately 3-4 mL of venous blood will be collected 2.5 years, 5 years, and 10 years after vaccination for a study on immune persistence.
Previously received the Tdcp vaccine at age 12-17
Other interventionApproximately 3-4 mL of venous blood will be collected 2.5 years, 5 years, and 10 years after vaccination for a study on immune persistence.
Previously received the Tdcp vaccine at age 6-11
Other interventionApproximately 3-4 mL of venous blood will be collected 2.5 years, 5 years, and 10 years after vaccination for a study on immune persistence.
Previously received the DT vaccine at age 6-11
Other interventionApproximately 3-4 mL of venous blood will be collected 2.5 years, 5 years, and 10 years after vaccination for a study on immune persistence.
Seropositivity rates of antibodies against DT, TT, PT, FHA, PRN, and FIM 2&3
Geometric mean concentrations (GMC) of antibodies against DT, TT, PT, FHA, PRN, and FIM 2&3
Proportions of serum anti-PRN antibody levels ≥5 and ≥10 IU/mL
Proportions of anti-FIM 2&3 antibody levels ≥5 and ≥10 EU/mL
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