UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002189 |
|---|---|
| Receipt number | 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 12:04:51 |
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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
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
oishik@biken.osaka-u.ac.jp
Sponsor or person
Institute
Research Institute for Microbial Diseases, Osaka University
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
