An observational study in Pneumococcal Infections, Streptococcal Infections and Bacterial Infections, sponsored by CanSino Biologics Inc.. Not yet recruiting. Open to participants aged 5 Years to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by CanSino Biologics Inc. · Observational
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.
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.
Exclusion Criteria:
Other: Previously vaccinated with PCV13 (CanSino)
Other: Previously vaccinated with PCV13 (Pfizer)
3.0 to 3.5 mL of venous blood will be collected for the immunodynamic study.
3.0 to 3.5 mL of venous blood will be collected for the immunodynamic study.
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
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
No study locations are listed for this record.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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CanSino Biologics Inc.