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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024860
Receipt No. 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

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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
Email 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
Email yoshitaka.murakami@med.toho-u.ac.jp

Sponsor
Institute MSD K.K.
Institute
Department

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
Email 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
URL(English) https://upload.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
Registered date File name


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