UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037773 |
|---|---|
| Receipt number | R000042855 |
| Scientific Title | Human papillomavirus vaccine confidence in Japan: A web-based questionnaire survey of mothers, female adolescents, and health care professionals |
| Date of disclosure of the study information | 2019/08/23 |
| Last modified on | 2024/04/03 17:21:38 |
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Basic information
Public title
Human papillomavirus vaccine confidence in Japan: A web-based questionnaire survey of mothers, female adolescents, and health care professionals
Acronym
Human papillomavirus vaccine confidence in Japan: A web-based questionnaire survey of mothers, female adolescents, and health care professionals
Scientific Title
Human papillomavirus vaccine confidence in Japan: A web-based questionnaire survey of mothers, female adolescents, and health care professionals
Scientific Title:Acronym
Human papillomavirus vaccine confidence in Japan: A web-based questionnaire survey of mothers, female adolescents, and health care professionals
Region
| Japan |
Condition
Condition
Cervical cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Establish levels of self-reported confidence in HPV vaccines of mothers, female adolescents, and health care professionals (HCPs) in Japan
Compare changes in the HPV vaccine confidence of mothers, female adolescents, and HCPs between two surveys
Basic objectives2
Others
Basic objectives -Others
Assess the intention/factores of HPV vaccination and the intention to recommend HPV vaccines
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
HPV vaccine confidence (i.e., importance, effectiveness and safety)
Key secondary outcomes
The intention and the factors of HPV vaccination/recommendation
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Mothers: Females who have at least one daughter of an HPV vaccination-eligible age (12-16 years)
2.Female adolescents: Females aged 15-19 years
3.HCPs: Gynecologists, pediatricians, or internists
Key exclusion criteria
HCPs who did not see any female adolescents aged between 12-19 years in clinical practice within the past year since the time of study participation
Target sample size
3260
Research contact person
Name of lead principal investigator
| 1st name | Kayo |
| Middle name | |
| Last name | Sato |
Organization
MSD K.K.
Division name
Medical Affairs
Zip code
102-8667
Address
1-13-12 Kudan-kita, Chiyoda-ku, Tokyo
TEL
03-6272-0218
ldgproject@merck.com
Public contact
Name of contact person
| 1st name | Kayo |
| Middle name | |
| Last name | Sato |
Organization
MSD K.K.
Division name
Medical Affairs
Zip code
102-8667
Address
1-13-12 Kudan-kita, Chiyoda-ku, Tokyo
TEL
03-6272-0218
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
Kitamachi clinic
Address
1-1-3 Kitamachi, Musashino-city, Tokyo
Tel
070-5011-8550
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
| 2019 | Year | 08 | Month | 23 | Day |
Related information
URL releasing protocol
NA
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1080/21645515.2021.1918042
Number of participants that the trial has enrolled
3127
Results
Levels of HPV vaccine confidence were higher among HCPs than among mothers and female adolescents.
Results date posted
| 2024 | Year | 04 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 06 | Month | 01 | Day |
Baseline Characteristics
1,646 mothers, 562 female adolescents, and 919 HCPs.
Participant flow
A subject of this survey conducted using a physician panel and a general consumer panel: A survey was conducted on 1,646 mothers, 562 female adolescents, and 919 HCPs.
Adverse events
Adverse event was not collected in this study.
Outcome measures
HPV vaccine confidence (i.e., importance, effectiveness, and safety of HPV vaccinces) of mothers, female adolescents, and HCPs
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 07 | Month | 12 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 24 | Day |
Date of closure to data entry
| 2019 | Year | 10 | Month | 28 | Day |
Date trial data considered complete
| 2019 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 04 | Month | 01 | Day |
Other
Other related information
The pilot survey was conducted from Aug 28 to 30 2019.
The first main survey was conducted from Oct 17 to 24 2019.
Management information
Registered date
| 2019 | Year | 08 | Month | 22 | Day |
Last modified on
| 2024 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042855
| Research Plan | |
|---|---|
| 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 |
