Bacterial Infections, Pneumococcal Infections, Streptococcal Infections
Conditions
Keywords
PCV13, 13 valent Pneumococcal conjugate vaccine, Pneumococcal Infections, Immune persistence
Brief 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.
Interventions
OTHERPreviously vaccinated with PCV13 (CanSino)
3.0 to 3.5 mL of venous blood will be collected for the immunodynamic study.
OTHERPreviously vaccinated with PCV13 (Pfizer)
3.0 to 3.5 mL of venous blood will be collected for the immunodynamic study.
Sponsors
CanSino Biologics Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
5 Years to 5 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seropositivity rate for serotype-specific pneumococcal IgG antibodies (antibody concentration ≥ 0.35 μg/ml) among trial participants | 4 years after completion of the full vaccination series |
| Geometric mean concentration (GMC) of antibodies among trial participants | 4 years after completion of the full vaccination series |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of trial participants with serum-type-specific pneumococcal IgG antibody among trial participants | 4 years after completion of the full vaccination series |
Contacts
CONTACTJiayi Huang
PRINCIPAL_INVESTIGATORZhiqiang Xie
Henan Provincial Center for Disease Control and Prevention
Outcome results
None listed