About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Previously received the Tdcp vaccine at age 18 and older
- Previously received the Tdcp vaccine at age 12-17
- Previously received the Tdcp vaccine at age 6-11
- Previously received the DT vaccine at age 6-11