Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07744347

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Diphtheria Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Bordetella Infections Clostridium Infections Corynebacterium Infections Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Infections Pertussis Respiratory Tract Diseases Respiratory Tract Infections Tetanus Whooping Cough

Age range

6 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 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 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

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.

Primary outcomes

  1. Seropositivity rates of antibodies against DT, TT, PT, FHA, PRN, and FIM 2&3

    Time frame: 2.5, 5, and 10 years post-vaccination

  2. 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

  3. Proportions of serum anti-PRN antibody levels ≥5 and ≥10 IU/mL

    Time frame: 2.5, 5, and 10 years post-vaccination

  4. Proportions of anti-FIM 2&3 antibody levels ≥5 and ≥10 EU/mL

    Time frame: 2.5, 5, and 10 years post-vaccination

  5. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ying Wang

CONTACT

[email protected]

022-58213600-6051

Sponsors and collaborators

Lead sponsor

CanSino Biologics Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2033
Study completion
2033
First posted
Aug 4, 2026
Registry last updated
Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.