A Clinical Study on Immunogenicity Persistence of Adsorbed 5-component Acellular Pertussis, Diphtheria and Tetanus Combined Vaccine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 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.
- Who it may be relevant to
- Registry conditions: Diphtheria, Tetanus, Pertussis. Basic parameters: from 6 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Phase I Clinical Study on Immunogenicity Persistence of Adsorbed 5-component Acellular Pertussis, Diphtheria and Tetanus Combined Vaccine
Overview
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.
Interventions
- Other Previously received the Tdcp vaccine at age 18 and older
Approximately 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. - Other Previously received the Tdcp vaccine at age 12-17
Approximately 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. - Other Previously received the Tdcp vaccine at age 6-11
Approximately 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. - Other Previously received the DT vaccine at age 6-11
Approximately 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.
Primary outcome measures
- Seropositivity rates of antibodies against DT, TT, PT, FHA, PRN, and FIM 2&3 [Time frame: 2.5, 5, and 10 years post-vaccination]
- Geometric mean concentrations (GMC) of antibodies against DT, TT, PT, FHA, PRN, and FIM 2&3 [Time frame: 2.5, 5, and 10 years post-vaccination]
- Proportions of serum anti-PRN antibody levels ≥5 and ≥10 IU/mL [Time frame: 2.5, 5, and 10 years post-vaccination]
- Proportions of anti-FIM 2&3 antibody levels ≥5 and ≥10 EU/mL [Time frame: 2.5, 5, and 10 years post-vaccination]
- Proportions of serum anti-DT and anti-TT antibody levels ≥0.1 IU/mL and ≥1.0 IU/mL [Time frame: 2.5, 5, and 10 years post-vaccination]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07744347 · CTP-Tdcp-005