A Clinical Study on Immunogenicity Persistence of Adsorbed 5-component Acellular Pertussis, Diphtheria and Tetanus Combined Vaccine

NCT07744347 | Not Yet Recruiting

• 1 other identifier: CTP-Tdcp-005
• Study Type: observational
• Target: 160
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diphtheria; Tetanus; Pertussis

Keywords

Vaccine; Five Components; ≥6 years; Immune Persistence

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (4)

Previously received the Tdcp vaccine at age 18 and older

Other: Previously received the Tdcp vaccine at age 18 and older

Previously received the Tdcp vaccine at age 12-17

Other: Previously received the Tdcp vaccine at age 12-17

Previously received the Tdcp vaccine at age 6-11

Other: Previously received the Tdcp vaccine at age 6-11

Previously received the DT vaccine at age 6-11

Other: Previously received the DT vaccine at age 6-11

Interventions

Previously received the Tdcp vaccine at age 12-17 OTHER

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.

Previously received the Tdcp vaccine at age 12-17

Previously received the DT vaccine at age 6-11 OTHER

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.

Previously received the DT vaccine at age 6-11

Previously received the Tdcp vaccine at age 6-11 OTHER

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.

Previously received the Tdcp vaccine at age 6-11

Previously received the Tdcp vaccine at age 18 and older OTHER

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.

Previously received the Tdcp vaccine at age 18 and older

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CanSino Biologics Inc.: lead

MeSH Terms

Conditions

Diphtheria; Tetanus; Whooping Cough

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Clostridium Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Respiratory Tract Infections; Respiratory Tract Diseases

Study Officials

• Xiaoyu Liu

  Center for Disease Prevention and Control, Shaanxi Province

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Wang

CONTACT

022-58213600-6051; ying.wang@cansinotech.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 4, 2026
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): October 15, 2033
• Study Completion (Estimated): October 15, 2033
• Last Updated: August 4, 2026

Record last verified: 2026-07