A Clinical Study on Immunogenicity Persistence of Adsorbed 5-component Acellular Pertussis, Diphtheria and Tetanus Combined Vaccine | NCT07744347

NCT07744347

Overview

NCT ID: NCT07744347
Lead Sponsor: CanSino Biologics Inc.INDUSTRY
Official Title: Phase I Clinical Study on Immunogenicity Persistence of Adsorbed 5-component Acellular Pertussis, Diphtheria and Tetanus Combined Vaccine
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
Interventions

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Aug 4, 2026Actual
Start Date: Oct 15, 2026Estimated
Primary Completion Date: Oct 15, 2033Estimated

Participation Criteria

Ages Eligible for Study: Child (0-17)Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
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.

Study Plan

Study Type: Observational
Phase: No data available
Enrollment: 160Estimated
Primary Purpose: No data available
Allocation: No data available
Interventional Model: No data available
Masking

Contacts and Locations

Central Contacts: Ying WangContact
ying.wang@cansinotech.com

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