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

NCT07648641 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-08-05

No results posted yet for this study

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

Interventions

OTHER

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 (Pfizer)

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

Sponsors & Collaborators

  • CanSino Biologics Inc.

    lead INDUSTRY

Principal Investigators

  • Zhiqiang Xie · Henan Provincial Center for Disease Control and Prevention

Eligibility

Min Age
5 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2027-12-01
Completion
2027-12-01

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07648641 on ClinicalTrials.gov