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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6+
SponsorCanSino Biologics Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • 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

Treatment groups

160 Participants
are divided into 4 treatment groups

Locations

This trial has no locations

Sponsors and collaborators