Diphtheria, Pertussis, Tetanus
Conditions
Keywords
Vaccine, Five Components, ≥6 years, Immune Persistence
Brief summary
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
OTHERPreviously 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.
OTHERPreviously 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.
OTHERPreviously 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.
OTHERPreviously 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.
Sponsors
CanSino Biologics Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seropositivity rates of antibodies against DT, TT, PT, FHA, PRN, and FIM 2&3 | 2.5, 5, and 10 years post-vaccination |
| Geometric mean concentrations (GMC) of antibodies against DT, TT, PT, FHA, PRN, and FIM 2&3 | 2.5, 5, and 10 years post-vaccination |
| Proportions of serum anti-PRN antibody levels ≥5 and ≥10 IU/mL | 2.5, 5, and 10 years post-vaccination |
| Proportions of anti-FIM 2&3 antibody levels ≥5 and ≥10 EU/mL | 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 | 2.5, 5, and 10 years post-vaccination |
Contacts
CONTACTYing Wang
PRINCIPAL_INVESTIGATORXiaoyu Liu
Center for Disease Prevention and Control, Shaanxi Province
Outcome results
None listed