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Efficacy of 23-valent pneumococcal polysaccharide vaccine in nursinghome residents- A double blind, randomized and placebo controlled trial

Phase 4
Completed
Conditions
Pneumococcal pneumonia in nursinghome residents
Registration Number
JPRN-jRCT1090220024
Lead Sponsor
Mie University Graduate School of Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1000
Inclusion Criteria

1.Japanese nursinghome residents
2.Signed informed consent from the patient or atorney.
3. The patient or atorney is able to comply with the study protocol for the duration of the study; available to undergo physical examinations as required by the protocol; and able to report on their health conditions such as symptoms.

Exclusion Criteria

1. Patients previously given pneumococcal vaccine.
2. Patients hypersensitive to vaccine components.
3. Immunocompromised people with presumed poor response to the vaccine
(such as patients with myeloma or active malignant disease, neutrophils <1.0x109/L, hypogammmaglobulinaemia, human immunodeficiency virus (HIV) infection, solid-organ or bone-marrow transplantation or those under dialysis)
4. Patients judged by the investigator to be inappropriate for inclusion for any other reason.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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