UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024860 |
|---|---|
| Receipt number | R000028611 |
| Scientific Title | A Survey Of PPV23 Vaccine Coverage And Community-Based Interventions To Improve Vaccine Uptake In Adults 65 Years In Japanese Municipalities, 2016 |
| Date of disclosure of the study information | 2016/11/16 |
| Last modified on | 2019/08/07 11:58:41 |
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Basic information
Public title
A Survey Of PPV23 Vaccine Coverage And Community-Based Interventions To Improve Vaccine Uptake In Adults 65 Years In Japanese Municipalities, 2016
Acronym
PPV23 Japan survey
Scientific Title
A Survey Of PPV23 Vaccine Coverage And Community-Based Interventions To Improve Vaccine Uptake In Adults 65 Years In Japanese Municipalities, 2016
Scientific Title:Acronym
PPV23 Japan survey
Region
| Japan |
Condition
Condition
pneumonia
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A cross-sectional, ecological study is conducted in all 1,741 municipalities of Japan to estimate PPV23 vaccine coverage in adults aged 65 years and to describe municipality-level
interventions implemented during fiscal Year 2015.
Basic objectives2
Others
Basic objectives -Others
Description of characteristics among municipalities
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
PPV23 vaccine coverage rate
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All municipalities in Japan
Key exclusion criteria
Non
Target sample size
1741
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Murakami |
Organization
Toho University
Division name
Department of Medical Statistics
Zip code
143-8540
Address
Department of Medical Statistics
TEL
+819099717736
yoshitaka.murakami@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Murakami |
Organization
Prof
Division name
Department of Medical Statistics
Zip code
143-8540
Address
Department of Medical Statistics
TEL
+819099717736
Homepage URL
yoshitaka.murakami@med.toho-u.ac.jp
Sponsor or person
Institute
MSD K.K.
Institute
Department
Personal name
Funding Source
Organization
MSD K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toho University Ethics Committee
Address
Omori-Nishi 5-21-16
Tel
+819099717736
yoshitaka.murakami@med.toho-u.ac.jp
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
| 2016 | Year | 11 | Month | 16 | Day |
Related information
URL releasing protocol
.
Publication of results
Published
Result
URL related to results and publications
https://bmjopen.bmj.com/content/9/7/e030197.info
Number of participants that the trial has enrolled
950
Results
The median PPSV23 coverage among responding municipalities was 41.8%. Vaccine coverage increased by 18.7% in municipalities that sent a direct mail notification to the target population of adults compared with municipalities that did not send any notification. Vaccine coverage decreased by 3.02% for every 1000 JPY increase in out-ofpocket costs. Municipality-level unemployment rates and average per capita income were negatively associated with PPSV23 coverage.
Results date posted
| 2019 | Year | 08 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Municipal vaccination officers
Participant flow
Community-based national survey. A postal
and web-based nationwide survey was sent to all
municipalities in Japan in June 2016 (n=1741). The
survey included questions regarding PPSV23 coverage,
out-of-pocket costs by individuals for vaccination and
community-level activities implemented to improve
and promote PPSV23 uptake. Municipality-level and
prefecture-level variables (eg, unemployment rates,
average per capita income) retrieved from published
sources were also incorporated to explore the impact of
social determinants on vaccine uptake.
Adverse events
none
Outcome measures
The primary study outcome was PPSV23 coverage among adults aged 65 years in Japanese municipalities
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 03 | Month | 17 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 16 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
A survey of all municipalities in Japan
Management information
Registered date
| 2016 | Year | 11 | Month | 16 | Day |
Last modified on
| 2019 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028611
| 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 |
