CPI study

Phase 4

• Conditions: pneumonia; D011014

• Registration Number: JPRN-jRCTs031180147
• Lead Sponsor: Maruyama Takaya

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2000

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

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
1.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 all pneumococcal disease<br>4.Incidence of vaccine type pneumococcal disease<br>5.Severity of pneumococcal pneumonia <br>6.Severity of all cause pneumonia <br>7.Severity of IPD<br>8.Severity of all pneumococcal disease<br>9.Severity of vaccine type pneumococcal disease<br>10.Incidence of death from pneumococcal pneumonia<br>11.Incidence of death from all cause pneumonia <br>12.Incidence of death from IPD <br>13.Incidence of death from all pneumococcal disease <br>14.Incidence of death from vaccine type pneumococcal disease<br>15. Incidence of death from all causes<br>16.Safety of the vaccination <br>17.Immunogenicity of the vaccination