A Clinical Trial of the 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (CRM197/Tetanus Toxoid)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Previously vaccinated with PCV13 (CanSino), Previously vaccinated with PCV13 (Pfizer).
- Who it may be relevant to
- Registry conditions: Pneumococcal Infections, Streptococcal Infections, Bacterial Infections. Basic parameters: 5 years — 5 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Phase IV Clinical Trial of the 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (CRM197/Tetanus Toxoid)
Overview
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.
Interventions
- Other Previously vaccinated with PCV13 (CanSino)
3.0 to 3.5 mL of venous blood will be collected for the immunodynamic study. - Other Previously vaccinated with PCV13 (Pfizer)
3.0 to 3.5 mL of venous blood will be collected for the immunodynamic study.
Primary outcome measures
- 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 series]
- Geometric mean concentration (GMC) of antibodies among trial participants [Time frame: 4 years after completion of the full vaccination series]
Secondary outcome measures (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 series]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07648641 · CTP-PCV-003