UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033094 |
|---|---|
| Receipt number | 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 13:54:20 |
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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
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
ldgproject@merck.com
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
The ethics review board of the Medical Corporation Toukeikai Kitamachi Clinic
Address
Kitamachi 1-1-3, Kichijoji, Musashino-shi, Tokyo, Japan
Tel
07050118550
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037664
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
