Study of the immunogenicity of 13-valent pneumococcal conjugate vaccine in high-risk patients who were outside recommended ages for routine vaccination

Study of the immunogenicity of 13-valent pneumococcal conjugate vaccine in high-risk patients who were outside recommended ages for routine vaccination - Study of the immunogenicity of PCV13 in high-risk patients

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000038760

Enrollment

Registered

2019-12-02

Start date

2019-11-05

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hematological malignancies and post hematopoietic stem cell transplantations

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients aged 6-64 years old who have underlying diseases such as hematological malignancies, and post hematopoietic stem cell transplantation. Patients with prior written consents of PCV13 vaccination suggested from their attending doctor.

Exclusion criteria

Exclusion criteria: Patients who were determined as unsuitable subjects by investigators.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Countries

Japan

Contacts

Public ContactKenichi Takeshita

Graduate School of Medicine, Chiba University Department of Pediatrics

take1nek@yahoo.co.jp043-226-2144

Outcome results