UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001681
Receipt No. R000002029
Scientific Title The medical economic effects of the Pneumococcal vaccine in the elderly.
Date of disclosure of the study information 2009/03/01
Last modified on 2012/08/02

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The medical economic effects of the Pneumococcal vaccine in the elderly.
Acronym Pneumococcal vaccination in the elderly.
Scientific Title The medical economic effects of the Pneumococcal vaccine in the elderly.
Scientific Title:Acronym Pneumococcal vaccination in the elderly.
Region
Japan

Condition
Condition Community-acquired pneumonia in the elderly
Classification by specialty
Pneumology Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Pneumonia is the leading cause of death in the elderly people. Pneumococcal pneumonia infection is about 20 to 30 percent of the causes of pneumonia in the elderly. The pneumococcal vaccine is known to reduce deaths from pneumococcal infection in the elderly and patients with chronic obstructive pulmonary disease (COPD). Based on these findings, pneumococcal vaccination is recommended in the United States and Europe. However, because of the insufficient evidence of the effectiveness of domestic and economic effects of the pneumococcal vaccine in Japan, the rate of pneumonia vaccination is low in the Japanese elderly.
The aim of this study is to clarify the effect of prevention of recurrent pneumonia in elderly patients with Pneumococcal vaccine.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Incidence of pneumonia
Key secondary outcomes Medical costs

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Vaccine
Interventions/Control_1 Pneumococcal vaccination
Interventions/Control_2 without Pneumococcal vaccination
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
65 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria Patients who understand the purpose of this study and give informed consent.
Key exclusion criteria 1) patients who have already received Pneumococcal vaccine.
2) patients who are receiving radiation therapy
3) patients who are given an immunosuppressive drug
4) patients who have fever
5) patients with a malignant neoplasm
6) patients with a severe disease in liver, kidney, heart, or lung
7) when the doctor decides the patient's condition is inappropriate
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mutsuo YAMAYA
Organization Tohoku University School of Medicine
Division name Department of Advanced Preventive Medicine for Infectious Disease
Zip code
Address 2-1 Seiryoumachi, Aobaku, Sendai, JAPAN
TEL 022-717-7184
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi KUBO
Organization Tohoku University School of Medicine
Division name Department of Advanced Preventive Medicine for Infectious Disease
Zip code
Address 2-1 Seiryoumachi, Aobaku, Sendai, JAPAN
TEL 022-717-7184
Homepage URL
Email hkubo@m.tains.tohoku.ac.jp

Sponsor
Institute Department of Advanced Preventive Medicine for Infectious Disease, Tohoku University School of Medicine
Institute
Department

Funding Source
Organization Scholarship donation
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization JAPAN

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
2009 Year 03 Month 01 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
2009 Year 02 Month 28 Day
Date of IRB
Anticipated trial start date
2009 Year 05 Month 01 Day
Last follow-up date
2011 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 02 Month 02 Day
Last modified on
2012 Year 08 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002029

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.