UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048747 |
|---|---|
| Receipt number | R000055535 |
| Scientific Title | Pneumococcal vaccination in elderly care facilities in Japan: A Cross-sectional web-based survey |
| Date of disclosure of the study information | 2022/08/24 |
| Last modified on | 2025/06/23 16:04:22 |
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Basic information
Public title
Pneumococcal vaccination in elderly care facilities in Japan: A Cross-sectional web-based survey
Acronym
Pneumococcal vaccination in elderly care facilities in Japan: A Cross-sectional web-based survey
Scientific Title
Pneumococcal vaccination in elderly care facilities in Japan: A Cross-sectional web-based survey
Scientific Title:Acronym
Pneumococcal vaccination in elderly care facilities in Japan: A Cross-sectional web-based survey
Region
| Japan |
Condition
Condition
Pneumococcal disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate vaccination rates of pneumococcal vaccines among residents of the elderly care facilities in Japan.
Basic objectives2
Others
Basic objectives -Others
Actual use conditions
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Vaccination rate of pneumococcal vaccine among residents of the elderly care facilities
Key secondary outcomes
1) Status of recommendation of pneumococcal revaccination for residents of the elderly care facilities
2) Vaccination rate of influenza vaccine (2021/2022) among residents of the elderly care facilities
3) Vaccination rate of COVID-19 vaccine among residents of the elderly care facilities
4) Awareness and willingness to recommend pneumococcal vaccine, influenza vaccine and COVID-19 vaccine among managing directors of the elderly care facilities
5) Pneumococcal vaccination plans and infectious disease prevention measures for residents of the elderly care facilities and the impact of COVID-19 on them
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
1) Current managing director of elderly care facility of the questionnaire panel
2) Managing director who has been working in the current facility for 6 months or more
3) Managing director who has given informed consent for participation in this study
Key exclusion criteria
None
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Youngju |
| Middle name | |
| Last name | Kim |
Organization
MSD K.K.
Division name
Medical Affairs
Zip code
102-8667
Address
KITANOMARU SQUARE,1-13-12 Kudan-kita, Chiyoda-ku, Tokyo
TEL
0362721000
ldgproject@merck.com
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Mizukami |
Organization
Mebix, Inc.
Division name
Research Promotion Division and Research Planning Group
Zip code
105-0001
Address
Toranomon 33 Mori Building, 3-8-21 Toranomon, Minato-ku, Tokyo, Japan
TEL
03-4362-4500
Homepage URL
mizukami@mebix.co.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
Takahashi Clinic Ethics Committee
Address
Medicalhat 1F, 5-1-31, kitamachi, iwaya, nada-ku, kobe-shi, Hyogo
Tel
078-882-6432
kishimoto.satoshi@neues.co.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
| 2022 | Year | 08 | Month | 24 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1080/21645515.2025.2461814
Number of participants that the trial has enrolled
450
Results
Among facilities who kept pneumococcal vaccination records (n = 42), the mean pneumococcal vaccination rate was 31.1%, with the rate being higher for the influenza (93.1%; n = 234) and COVID-19 (94.3%; n = 285) vaccines.
Results date posted
| 2025 | Year | 06 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 02 | Month | 07 | Day |
Baseline Characteristics
The questionnaire was emailed to a total of 1,313 managing directors of elderly care facilities, of whom 450 provided responses; 445 of these were evaluable responses. Five responses were excluded from the dataset due to duplication.
Participant flow
This cross-sectional, web-based questionnaire survey was conducted via e-mail distribution, targeting the managing directors in elderly care facilities in Japan between September 5, 2022, and November 25, 2022.
Adverse events
N/A
Outcome measures
Among facilities who kept pneumococcal vaccination records (n = 42), the mean pneumococcal vaccination rate was 31.1%, with the rate being higher for the influenza (93.1%; n = 234) and COVID-19 (94.3%; n = 285) vaccines.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 07 | Month | 19 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 23 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 05 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 25 | Day |
Date of closure to data entry
| 2022 | Year | 11 | Month | 26 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 15 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
1. Study design
Web-based questionnaire survey
2. Research subject
Managing directors in elderly care facilities in Japan
3. Collection items
Length of time the managing director has worked at that facility, Job title(s)/role(s) of the facility staff(s) who helped managing director to answer the questionnaire (Only if the managing director confirmed with facility staff(s) to answer the questionnaire), Length of time of each of the facility staff has worked at that facility (Only if the managing director confirmed with facility staff(s) to answer the questionnaire), Presence/absence of pneumococcal vaccination recipients, Existence of recorded data of their residents' pneumococcal vaccination, Vaccination rate of pneumococcal vaccine among residents, Status of recommendation of pneumococcal vaccine revaccination for residents, Presence/absence of pneumococcal vaccine revaccination recipients, Presence/absence of influenza vaccine (2021/2022) recipients, Existence of recorded data of their residents' influenza vaccination (2021/2022), Influenza vaccine vaccination rate (2021/2022) among residents of the elderly care facility, Presence/absence of COVID-19 vaccination recipients, Existence of recorded data of their residents' COVID-19 vaccination, COVID-19 vaccine vaccination rate among residents of the elderly care facility, Awareness of vaccines, Vaccine related information sources, Willingness to recommend vaccination for residents of the elderly care facilities, Reasons to recommend/not recommend vaccination for residents of the elderly care facilities, Frequency of programs such as group exercise and recreation for residents, Place of meal for residents, Request from residents or residents' family for the pneumococcal vaccination for the resident, Existence/absent of documented vaccination policy in the facility, The way to obtain informed consent when the resident cannot confirm his or her intention to get vaccinated
Management information
Registered date
| 2022 | Year | 08 | Month | 24 | Day |
Last modified on
| 2025 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055535
