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Not Yet Recruiting NCT07648641

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

Conditions: Pneumococcal Infections, Streptococcal Infections, Bacterial Infections

Sex: All
Ages: 5 Years – 5 Years
Healthy volunteers: Yes
Enrollment: 100
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.

Eligibility Criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07648641). StuddyBuddy aggregates publicly available trial information.