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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002189
Receipt No. R000002686
Scientific Title Research on the usefulness of pneumococcal polysaccharide vaccine for elderly in the nursing home
Date of disclosure of the study information 2009/07/17
Last modified on 2009/07/13

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Basic information
Public title Research on the usefulness of pneumococcal polysaccharide vaccine for elderly in the nursing home
Acronym Pneumococcal vaccine study for elderly in the nursing home
Scientific Title Research on the usefulness of pneumococcal polysaccharide vaccine for elderly in the nursing home
Scientific Title:Acronym Pneumococcal vaccine study for elderly in the nursing home
Region
Japan

Condition
Condition Pneumonia in the nursing home
Classification by specialty
Pneumology Infectious disease Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine whether the clinical efficacy and cost-effectiveness of pneumococcal polysaccharide vaccine for elderly at the nursing home
Basic objectives2 Others
Basic objectives -Others Relationship between clinical efficacy for pneumonia and immune response in serum by pneumococcal vaccine
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Incidence of pneumonia and admission due to pneumonia
Key secondary outcomes Medical cost due to pneumonia

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Vaccine
Interventions/Control_1 23-valent pneumococcal polysaccharide vaccine
Interventions/Control_2 Sterile saline
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Influenza vaccination before enrollment
2. No previous immunization with 23-valent pneumococcal polysaccharide vaccine
3. elderly utilizing the nursing home
4. With written informed consent
Key exclusion criteria 1. person who have malignancy
2. person under dialysis
3. person who are taking food non-orally
4. person who had infectious diseases including pneumonia during last one month
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazunori Oishi
Organization Research Institute for Microbial Diseases, Osaka University
Division name International Center for Infectious Diseases
Zip code
Address 3-1 Yamadaoka, Suita, Osaka Prefecture
TEL 06-6879-4253
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazunori Oishi
Organization Research Institute for Microbial Diseases, Osaka University
Division name International Center for Infectious Diseases
Zip code
Address 3-1 Yamadaoka, Suita, Osaka Prefecture
TEL 06-6879-4253
Homepage URL
Email oishik@biken.osaka-u.ac.jp

Sponsor
Institute Research Institute for Microbial Diseases, Osaka University
Institute
Department

Funding Source
Organization Ministry of Healthy, Labor and Welfare of Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Japan Association of Geriatric Health Services Facilities, National Institute for Infectious Diseases
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 07 Month 17 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
No significant difference was found on the demographic data (age, female ratio, ADL) between the pneumococcal vaccine group and the saline group.
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 No longer recruiting
Date of protocol fixation
2008 Year 03 Month 13 Day
Date of IRB
Anticipated trial start date
2008 Year 03 Month 01 Day
Last follow-up date
2010 Year 03 Month 01 Day
Date of closure to data entry
2010 Year 03 Month 01 Day
Date trial data considered complete
2010 Year 04 Month 01 Day
Date analysis concluded
2010 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 07 Month 13 Day
Last modified on
2009 Year 07 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002686

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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