Study of the immunogenicity of 13-valent pneumococcal conjugate vaccine in high-risk patients who were outside recommended ages for routine vaccinatio
Not Applicable
- Conditions
- hematological malignancies and post hematopoietic stem cell transplantations
- Registration Number
- JPRN-UMIN000038760
- Lead Sponsor
- Chiba university
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 42
Inclusion Criteria
Not provided
Exclusion Criteria
Patients who were determined as unsuitable subjects by investigators.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method We investigate the following three immunological markers before and 1 month, 6 months, 12 months after PCV13 vaccinations. 1. pneumococcal serotype specific IgG concentrations against serotypes which are present in PCV13. 2. pneumococcal serotype specific opsonophagocytic killing assay titers against serotypes which are present in PCV13. 3. the number of pneumococcal serotype specific memory B cells against serotypes which are present in PCV13.
- Secondary Outcome Measures
Name Time Method 1. the number of leukocyte and lymphocyte (before and 1 month, 6 months, 12 months after PCV13 vaccinations) 2. serum IgG consentrations and IgG subclasses (before and 12 months after PCV13 vaccinations) 3. pneumococcal detection from nasopharyngeal swab or saliva (before and 12 months after PCV13 vaccinations) 4. the incidence of adverse effects (1 month after PCV13 vaccinations) 5. the incidence of invasive pneumococcal diseases (12 months after PCV13 vaccinations)