Pneumococcal InfectionsNCT07648641
A Clinical Trial of the 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (CRM197/Tetanus Toxoid)
An observational study of Pneumococcal Infections and Streptococcal Infections, run by CanSino Biologics Inc..
Trial summary
This clinical study will enroll 100 participants from the 2-month-old (minimum 6 weeks) group who previously participated in the Phase III clinical trial of the 13-valent pneumococcal polysaccharide conjugate vaccine (CRM197, TT vector) (Protocol No.: CS-CTP-PCV), with 50 participants in each of the treatment and… Read more about this study
- Who is it for?
- Ages 5 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Infections, Streptococcal Infections, Bacterial Infections
- What is being tested?
- Previously vaccinated with PCV13 (CanSino) and Previously vaccinated with PCV13 (Pfizer)
- Type of treatment
- Vaccines
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: This clinical study enrolled 100 participants from the 2-month-old (minimum 6 weeks) group who had previously participated in the Phase III clinical trial of the 13-valent pneumococcal polysaccharide conjugate vaccine (CRM197, TT vector) (Protocol No.: CS-CTP-PCV), with 50 participants in each of the treatment and control groups, and who had completed blood sample collection at 1 and 2 years post-vaccination to assess immunogenicity.
Who may be able to join
- Participants in the 2-month-old (minimum 6 weeks) group from the previous Phase III clinical trial of the 13-valent pneumococcal polysaccharide conjugate vaccine (CRM197, TT vector) (Protocol No.: CS-CTP-PCV)
- The legal guardian or authorized representative is willing to provide identification documents
- The legal guardian or authorized representative has provided informed consent, voluntarily signed the informed consent form, and is able to comply with the requirements of the clinical study protocol
- The interval since the last dose of the primary vaccination series is ≥4 years
Who cannot join
- Failure to complete blood draws at 1 and 2 years post-vaccination
- Administration of any pneumonia vaccine after completion of the full vaccination series
- Body temperature ≥37.3°C
- Any other factors deemed by the investigator to render the participant unsuitable for participation in the clinical trial
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Phase IV Clinical Trial of the 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (CRM197/Tetanus Toxoid)
This clinical study will enroll 100 participants from the 2-month-old (minimum 6 weeks) group who previously participated in the Phase III clinical trial of the 13-valent pneumococcal polysaccharide conjugate vaccine (CRM197, TT vector) (Protocol No.: CS-CTP-PCV), with 50 participants in each of the treatment and control groups, and who have completed blood sample collection for the 1-year and 2-year immunogenicity studies. All participants will have 3.0-3.5 mL of venous blood collected for the immunogenicity study.
- Being tested
- Previously vaccinated with PCV13 (CanSino), Previously vaccinated with PCV13 (Pfizer)
- Keywords
- PCV13, 13 valent Pneumococcal conjugate vaccine, Pneumococcal Infections, Immune persistence
- Medical subject headings
- Pneumococcal Infections, Streptococcal Infections, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Previously vaccinated with PCV13 (CanSino)Other
3.0 to 3.5 mL of venous blood will be collected for the immunodynamic study.
Previously vaccinated with PCV13 (Pfizer)Other
3.0 to 3.5 mL of venous blood will be collected for the immunodynamic study.
| Study group | Role | What they receive |
|---|---|---|
| Previously vaccinated with PCV13 (CanSino) | Not described Receives: Other: Previously vaccinated with PCV13 (CanSino) | |
| Previously vaccinated with PCV13 (Pfizer) | Not described Receives: Other: Previously vaccinated with PCV13 (Pfizer) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seropositivity rate for serotype-specific pneumococcal IgG antibodies (antibody concentration ≥ 0.35 μg/ml) among trial participants
Measured: 4 years after completion of the full vaccination series
Geometric mean concentration (GMC) of antibodies among trial participants
Measured: 4 years after completion of the full vaccination series
Secondary outcomes (1)
Proportion of trial participants with serum-type-specific pneumococcal IgG antibody among trial participants
Measured: 4 years after completion of the full vaccination series
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CanSino Biologics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhiqiang Xie, Principal investigator, Henan Provincial Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07648641
- Sponsor's protocol ID
- CTP-PCV-003
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Clinical Trial of the 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (CRM197/Tetanus Toxoid)
- ClinicalTrials.gov ID
- NCT07648641
- Acronym / sponsor ID
- CTP-PCV-003
- Keywords
- PCV13, 13 valent Pneumococcal conjugate vaccine, Pneumococcal Infections, Immune persistence
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- CanSino Biologics Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical study will enroll 100 participants from the 2-month-old (minimum 6 weeks) group who previously participated in the Phase III clinical trial of the 13-valent pneumococcal polysaccharide conjugate vaccine (CRM197, TT vector) (Protocol No.: CS-CTP-PCV), with 50 participants in each of the treatment and control groups, and who have completed blood sample collection for the 1-year and 2-year immunogenicity studies. All participants will have 3.0-3.5 mL of venous blood collected for the immunogenicity study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Previously vaccinated with PCV13 (CanSino) | – | Other: Previously vaccinated with PCV13 (CanSino) |
| Previously vaccinated with PCV13 (Pfizer) | – | Other: Previously vaccinated with PCV13 (Pfizer) |
Who may qualify
- Ages
- 5 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- This clinical study enrolled 100 participants from the 2-month-old (minimum 6 weeks) group who had previously participated in the Phase III clinical trial of the 13-valent pneumococcal polysaccharide conjugate vaccine (CRM197, TT vector) (Protocol No.: CS-CTP-PCV), with 50 participants in each of the treatment and control groups, and who had completed blood sample collection at 1 and 2 years post-vaccination to assess immunogenicity.
Key inclusion criteria (4 listed)
- Participants in the 2-month-old (minimum 6 weeks) group from the previous Phase III clinical trial of the 13-valent pneumococcal polysaccharide conjugate vaccine (CRM197, TT vector) (Protocol No.: CS-CTP-PCV)
- The legal guardian or authorized representative is willing to provide identification documents
- The legal guardian or authorized representative has provided informed consent, voluntarily signed the informed consent form, and is able to comply with the requirements of the clinical study protocol
- The interval since the last dose of the primary vaccination series is ≥4 years
Key exclusion criteria (4 listed)
- Failure to complete blood draws at 1 and 2 years post-vaccination
- Administration of any pneumonia vaccine after completion of the full vaccination series
- Body temperature ≥37.3°C
- Any other factors deemed by the investigator to render the participant unsuitable for participation in the clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Previously vaccinated with PCV13 (CanSino)3.0 to 3.5 mL of venous blood will be collected for the immunodynamic study. | Other | Previously vaccinated with PCV13 (CanSino) |
| Previously vaccinated with PCV13 (Pfizer)3.0 to 3.5 mL of venous blood will be collected for the immunodynamic study. | Other | Previously vaccinated with PCV13 (Pfizer) |
Primary outcome
Seropositivity rate for serotype-specific pneumococcal IgG antibodies (antibody concentration ≥ 0.35 μg/ml) among trial participants
Time frame: 4 years after completion of the full vaccination series
Geometric mean concentration (GMC) of antibodies among trial participants
Time frame: 4 years after completion of the full vaccination series
1 secondary outcome
Proportion of trial participants with serum-type-specific pneumococcal IgG antibody among trial participants
Time frame: 4 years after completion of the full vaccination series
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhiqiang Xie principal investigator
Henan Provincial Center for Disease Control and Prevention
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumococcal Infections and Streptococcal Infections, run by CanSino Biologics Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiayi Huang (022-58213600-6051, jiayi.huang@cansinotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seropositivity rate for serotype-specific pneumococcal IgG antibodies (antibody concentration ≥ 0.35 μg/ml) among trial participants (time frame: 4 years after completion of the full vaccination series). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.