immunocompromised patients
Conditions
Interventions
Intervention type:VACCINE
Name of intervention:sequential administration of PCV13 and PPSV23
Dose form / Japanese Medical Device Nomenclature:INJECTION
Route of administration / Site of application:IN
Sponsors
National Hospital Organization Mie National
45 hospitals belonging to National Hospital Organization
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Immunocompromised patients >=19 years based on the recommendation of ACIP in 2012 [3] 1. Patients with human immunodeficiency virus infection 2. Patients with hematologic malignancy (leukemia, lymphoma or multiple myeloma) 3. Patients with generalized malignancy 4. Patients with congenital or acquired immunodeficiency 5. Patients with chronic renal failure needed hemodialysis 6. Patients with solid organ transplant 7. Patients with diseases requiring treatment with systemic corticosteroids >= 14days 8. Patients with diseases requiring treatment with immunosuppressive drugs
Exclusion criteria
Exclusion criteria: 1) Patients given pneumococcal vaccine within 5 years 2) Patients hypersensitive to vaccine components. 3) Patients who had Guillain-Barre syndrome or acute disseminated encephalomyelitis previously 4) Women with pregnancy or lactation 5) Patients judged by the investigator to be inappropriate for inclusion for any other reason including severe disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of pneumococcal pneumonia | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of all cause pneumonia 2. Incidence of invasive pneumococcal disease (IPD) 3. Incidence of death from pneumococcal pneumonia 4. Incidence of death from all cause pneumonia 5. Incidence of death from IPD 6. Incidence of death from all cause 7. Safety of the vaccination 8. Immunogenicity of the vaccination | — |
Countries
Japan
Contacts
Public ContactTakaya Maruyama
National Hospital Organization Mie National
Outcome results
None listed