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
This trial accepts healthy volunteersQualifiers
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 population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Previously vaccinated with PCV13 (CanSino)
Other intervention3.0 to 3.5 mL of venous blood will be collected for the immunodynamic study.
Previously vaccinated with PCV13 (Pfizer)
Other intervention3.0 to 3.5 mL of venous blood will be collected for the immunodynamic study.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Previously vaccinated with PCV13 (CanSino)1 intervention
Group B: Previously vaccinated with PCV13 (Pfizer)1 intervention
Trial outcomes
Primary outcomes
1
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 series2
Geometric mean concentration (GMC) of antibodies among trial participants
Time frame
4 years after completion of the full vaccination seriesSecondary outcomes
1
Proportion of trial participants with serum-type-specific pneumococcal IgG antibody among trial participants
Time frame
4 years after completion of the full vaccination seriesLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: