A Clinical Trial of the 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (CRM197/Tetanus Toxoid)

NCT07648641 | Not Yet Recruiting

• 1 other identifier: CTP-PCV-003
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Pneumococcal Infections; Streptococcal Infections; Bacterial Infections

Keywords

PCV13; 13 valent Pneumococcal conjugate vaccine; Pneumococcal Infections; Immune persistence

Outcome Measures

Primary Outcomes (2)

• Seropositivity rate for serotype-specific pneumococcal IgG antibodies (antibody concentration ≥ 0.35 μg/ml) among trial participants

  4 years after completion of the full vaccination series

• Geometric mean concentration (GMC) of antibodies among trial participants

  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

  4 years after completion of the full vaccination series

Study Arms (2)

Previously vaccinated with PCV13 (CanSino)

Other: Previously vaccinated with PCV13 (CanSino)

Previously vaccinated with PCV13 (Pfizer)

Other: Previously vaccinated with PCV13 (Pfizer)

Interventions

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 (CanSino)

Previously vaccinated with PCV13 (Pfizer) OTHER

3.0 to 3.5 mL of venous blood will be collected for the immunodynamic study.

Previously vaccinated with PCV13 (Pfizer)

Eligibility Criteria

• Age: 5 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CanSino Biologics Inc.: lead

MeSH Terms

Conditions

Pneumococcal Infections; Streptococcal Infections; Bacterial Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Zhiqiang Xie

  Henan Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiayi Huang

CONTACT

022-58213600-6051; jiayi.huang@cansinotech.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 15, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 15, 2026

Record last verified: 2026-06