ClinicalTrials.gg
Not yet recruitingNCT07744347Updated Aug 4, 2026

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

An observational study in Diphtheria, Tetanus and Pertussis, sponsored by CanSino Biologics Inc.. Not yet recruiting. Open to participants aged 6 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-04.

Sponsored by CanSino Biologics Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
160
Ages
6 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Diphtheria
  • Tetanus
  • Pertussis

Keywords

  • Vaccine
  • Five Components
  • ≥6 years
  • Immune Persistence
03

In context

Diphtheria

267 studies on the registry are indexed under Diphtheria; 17 are open to participants now.

This study's planned enrollment of 160 is below the median of 970 across 24 observational studies indexed under Diphtheria.

Browse Diphtheria studies →

Lead sponsor

CanSino Biologics Inc. is the lead sponsor of 41 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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;
  • 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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
160 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • 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.

06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Oct 2033, 84 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 30, 2026
First posted
Aug 4, 2026
StartEst.
Oct 15, 2026
Primary completionEst.
Oct 15, 2033
CompletionEst.
Oct 15, 2033
Last update
Aug 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07744347
Responsible party
Sponsor
First posted
Aug 4, 2026
Start date
Oct 15, 2026 (estimated)
Primary completion
Oct 15, 2033 (estimated)
Completion
Oct 15, 2033 (estimated)
Last update
Aug 4, 2026

Study contacts

Ying Wang
Contact
ying.wang@cansinotech.com
022-58213600-6051
Xiaoyu Liu
principal investigator · Center for Disease Prevention and Control, Shaanxi Province

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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