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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033094
Receipt No. R000037664
Scientific Title Primary data collection for the coverage rate of pneumococcal vaccines among those having chronic medical conditions (CMCs) in Japan
Date of disclosure of the study information 2018/06/22
Last modified on 2020/02/18

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Basic information
Public title Primary data collection for the coverage rate of pneumococcal vaccines among those having chronic medical conditions (CMCs) in Japan
Acronym Primary data collection for the coverage rate of pneumococcal vaccines among those having chronic medical conditions (CMCs) in Japan
Scientific Title Primary data collection for the coverage rate of pneumococcal vaccines among those having chronic medical conditions (CMCs) in Japan
Scientific Title:Acronym Primary data collection for the coverage rate of pneumococcal vaccines among those having chronic medical conditions (CMCs) in Japan
Region
Japan

Condition
Condition infectious diseases of pneumococci
Classification by specialty
Medicine in general Pneumology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate the vaccination coverage rates of PPSV23 among different age cohort (age cohort 50-59, 60-64 and age 65+) of persons with CMCs
Basic objectives2 Others
Basic objectives -Others To elucidate the vaccination coverage rates of PPSV23 among different age cohort (age cohort 50-59, 60-64 and age 65+) of persons with CMCs (Subjects Panel)
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Subjects' panel
Vaccination coverage rate of PPSV23 among those having CMC in each age group, 50-59, 60-64 years and older age 65 years
Key secondary outcomes Subjects' panel:
1) Vaccination coverage rates of PPSV23 in each CMC cohort
2) Reason for receiving or not receiving PPSV23 among those having CMCs
Doctors' Panel:
1) Reason for recommending or not recommending PPSV23 vaccination to those having CMCs

Base
Study type Observational

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
50 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Subjects

1. Adults 50-64 years old with chronic medical conditions (CMCs) and all older adults (65 years and older)
2. Adults available for Internet based survey

Doctors
1. Internists treating more than 100 subjects of age 50 years+ per month
2. Internists available for Internet based survey
Key exclusion criteria No exclusion criteria
Target sample size 5000

Research contact person
Name of lead principal investigator
1st name Tomoharu
Middle name
Last name Iino
Organization MSD K.K.
Division name Medical Affairs Vaccine
Zip code 102-8667
Address 1-13-12 Kudan-kita Chiyoda Tokyo
TEL 03-6272-2049
Email ldgproject@merck.com

Public contact
Name of contact person
1st name Tomoharu
Middle name
Last name Iino
Organization MSD K.K.
Division name Medical Affairs Vaccine
Zip code 102-8667
Address 1-13-12 Kudan-kita Chiyoda Tokyo
TEL 03-6272-2049
Homepage URL
Email ldgproject@merck.com

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 The ethics review board of the Medical Corporation Toukeikai Kitamachi Clinic
Address Kitamachi 1-1-3, Kichijoji, Musashino-shi, Tokyo, Japan
Tel 07050118550
Email shingo-namiki@j-smo.com

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
2018 Year 06 Month 22 Day

Related information
URL releasing protocol https://www.ncbi.nlm.nih.gov/pubmed/31799889
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/31799889
Number of participants that the trial has enrolled 5078
Results
PPSV23 coverages among chronic patients aged 50-59, 60-64, and 65+ years were respectively 1.3%, 2.9%, and 37.8%. The high disease-specific PPSV23 rates seen in the 65+ group was 50.0% and 49.4%, for chronic liver disease and chronic lung disease, respectively. 
Results date posted
2020 Year 02 Month 17 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The patient survey was administered to 5,078 Japanese men and women 50 years and older located all over Japan, who were able to complete the internet survey.
Participant flow
Eligible patients provided consent electronically. Questionnaire included questions about CMC; pneumonia history, pneumococcal vaccination history, pneumococcal vaccine type (PPSV23/PCV13/Unknown), and count.
Adverse events
No adverse event was reported.
Outcome measures
Outcomes assessed were PPSV23 vaccination coverage rate (primary)
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 05 Month 29 Day
Date of IRB
2018 Year 06 Month 19 Day
Anticipated trial start date
2018 Year 06 Month 22 Day
Last follow-up date
2018 Year 07 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2018 Year 12 Month 03 Day

Other
Other related information Internet based survey
This study is a cross-sectional survey targeting adults eligible for pneumococcal vaccination 'subjects' and 'doctors'

Management information
Registered date
2018 Year 06 Month 21 Day
Last modified on
2020 Year 02 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037664

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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