CPI study

JRCT ID: jRCTs031180147

Registered date:22/02/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: pneumonia
• Date of first enrollment: 01/11/2016
• Target sample size: 2000
• Study type: Interventional

Intervention(s)

Study Intervention: sequential administration of PCV13 and PPSV23
Control Intervention: single administration of PPSV23

Outcome(s)

• Primary Outcome: 1.Incidence of pneumococcal pneumonia

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 19age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Maruyama Takaya
• Source(s) of Monetary Support: National Hospital Organization
• Secondary ID(s): JMA-IIA00246