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A Clinical Trial of the 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (CRM197/Tetanus Toxoid)
Sponsor: CanSino Biologics Inc.
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.
Official title: Phase IV Clinical Trial of the 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (CRM197/Tetanus Toxoid)
Key Details
Gender
All
Age Range
5 Years - 5 Years
Study Type
OBSERVATIONAL
Enrollment
100
Start Date
2026-09-01
Completion Date
2027-12-01
Last Updated
2026-08-05
Healthy Volunteers
Yes
Interventions
Previously vaccinated with PCV13 (CanSino)
3.0 to 3.5 mL of venous blood will be collected for the immunodynamic study.
Previously vaccinated with PCV13 (Pfizer)
3.0 to 3.5 mL of venous blood will be collected for the immunodynamic study.