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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032511
Receipt No. R000037066
Scientific Title The study about the efficacy of the 23-valent pneumococcal polysaccharide vaccine among dialysis patients
Date of disclosure of the study information 2018/05/09
Last modified on 2018/05/08

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Basic information
Public title The study about the efficacy of the 23-valent pneumococcal polysaccharide vaccine among dialysis patients
Acronym The study about the efficacy of the 23-valent pneumococcal polysaccharide vaccine among dialysis patients
Scientific Title The study about the efficacy of the 23-valent pneumococcal polysaccharide vaccine among dialysis patients
Scientific Title:Acronym The study about the efficacy of the 23-valent pneumococcal polysaccharide vaccine among dialysis patients
Region
Japan

Condition
Condition chronic renal failure on dialysis
Classification by specialty
Medicine in general Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of the 23-valent pneumococcal polysaccharide vaccine
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes First admission, or deaths due to all-cause pneumonia or cardiac events.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria consecutive patients undergoing dialysis at any one of the study centers between January 1 and December 31, 2010
Key exclusion criteria No regular visits
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nakanobu Azuma
Organization Tokatsu-Clinic Hospital
Division name Director of the Hospital
Zip code
Address 865-2 Hinokuchi; Matsudo-shi, Chiba
TEL 047-364-5121
Email bcj02422@nifty.com

Public contact
Name of contact person
1st name
Middle name
Last name Hiroaki Ihara
Organization Juntendo University, School of Medicine
Division name Respiratory Medicine
Zip code
Address 2-1-1 Hongo; Bunkyo-Ku, Tokyo
TEL 03-3813-3111
Homepage URL
Email h-ihara@juntendo.ac.jp

Sponsor
Institute Tokatsu-Clinic Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 05 Month 09 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 03 Month 22 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Cox proportional hazards models were used to compare hazard ratios between the vaccinated and non-vaccinated groups

Management information
Registered date
2018 Year 05 Month 08 Day
Last modified on
2018 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037066

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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