A Clinical Trial of the 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (CRM197/Tetanus Toxoid)
Starting soon
Conditions studied: Pneumococcal Infections, Streptococcal Infections, Bacterial Infections
In brief
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.
Key facts
- Study ID
- NCT07648641
- Run by
- CanSino Biologics Inc.
- People needed
- 100
- Starts
- 2026-09-01
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-08-05
Who can join
Age: 5 and older, up to 5. Sex: any. Healthy volunteers: accepted.
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
Full record on ClinicalTrials.gov
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