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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033095
Receipt No. R000037670
Scientific Title Estimated revaccination coverage rate of pneumococcal vaccines among adults aged 65 years or older 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 Estimated revaccination coverage rate of pneumococcal vaccines among adults aged 65 years or older in Japan
Acronym Estimated revaccination coverage rate of pneumococcal vaccines among adults aged 65 years or older in Japan
Scientific Title Estimated revaccination coverage rate of pneumococcal vaccines among adults aged 65 years or older in Japan
Scientific Title:Acronym Estimated revaccination coverage rate of pneumococcal vaccines among adults aged 65 years or older in Japan
Region
Japan

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

Objectives
Narrative objectives1 To assess PPSV23 revaccination coverage rate among primary vaccinated aged 65 years or older in Japan
Basic objectives2 Others
Basic objectives -Others To assess PPSV23 revaccination coverage rate among primary vaccinated aged 65 years or older in Japan
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Subjects' panel:
-Revaccination coverage rate of the PPSV23 in primary vaccinated older adults (aged 65+)
Key secondary outcomes Subjects' panel:
-Reasons for receiving or not receiving the PPSV23 revaccination in older adults (aged 65+)
-Predictors of the PPSV23 revaccination in older adults (aged 65+)
-Revaccination coverage rate of the PPSV23 in older adults (aged 65+)
(Revaccinated: two times of receiving the PPSV23)
(Revaccination coverage rate: Number of revaccinated subjects devided by all replied subjects)
Doctors' panel
-Reasons for recommending or not recommending the PPSV23 revaccination to older adults

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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Subjects criteria:
Provide completed informed consent
Aged 65 years and older
Available for internet based survey

Doctors criteria:
Provide completed informed consent
Treating more than 100 subjects of aged 65 years and older per month
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 ino
Organization MSD K.K.
Division name Medical Affairs Vaccine
Zip code 1028667
Address 1-13-12 Kudan-kita Chitaku 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 1028667
Address 1-13-12 Kudan-kita Chitaku 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 070-5011-8550
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/32045317
Publication of results Partially published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/32045317
Number of participants that the trial has enrolled 5085
Results
In total, 1,648 elderly adults had received at least one PPSV23 dose; of these, 58 had received it at least twice (revaccination coverage rate: 3.5%). The most commonly cited justification for revaccination with PPSV23 among the surveyed physicians was that the benefits of revaccination exceed the risks of revaccination.
Results date posted
2020 Year 02 Month 18 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We asked an array of questions related to PPSV23 revaccination to Elderly adults and doctors across Japan via Web-based surveys in June 2018.
Participant flow
The sampled population consisted of 5,085 men and women aged 65 and older.400 internal medicine physicians were surveyed and asked about their reasons for recommending PPSV23 revaccination to elderly patients.
Adverse events
No adverse event was reported.
Outcome measures
Outcomes assessed were PPSV23 revaccination coverage rate (primary), first-dose coverage rate, and the interval between primary vaccination and revaccination.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 06 Month 01 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 pneumoco
ccal vaccination 'subjects' and 'doctor
s'

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=R000037670

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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