A Clinical Trial of the 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (CRM197/Tetanus Toxoid)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5-5
SponsorCanSino Biologics Inc.
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Previously vaccinated with PCV13 (CanSino)
- Previously vaccinated with PCV13 (Pfizer)
Treatment groups
100 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov