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NOT YET RECRUITING
NCT07648641

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

Sponsor: CanSino Biologics Inc.

View on ClinicalTrials.gov

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

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.