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