Efficacy of sequential administration of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine in the adults with immunocompromising conditions-A double blind randomized controlled trial
- Conditions
- immunocompromised patients
- Registration Number
- JPRN-jRCT1090220246
- Lead Sponsor
- ational Hospital Organization Mie National
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2000
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of pneumococcal pneumonia
- Secondary Outcome Measures
Name Time Method 1. Incidence of all cause pneumonia<br>2. Incidence of invasive pneumococcal disease (IPD)<br>3. Incidence of death from pneumococcal pneumonia<br>4. Incidence of death from all cause pneumonia<br>5. Incidence of death from IPD<br>6. Incidence of death from all cause<br>7. Safety of the vaccination<br>8. Immunogenicity of the vaccination