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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043588
Receipt No. R000048914
Scientific Title Immunogenicity and safety of mumps vaccine in healthy adults: a single institute based cohort study
Date of disclosure of the study information 2021/03/12
Last modified on 2021/03/11

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Basic information
Public title Immunogenicity and safety of mumps vaccine in healthy adults: a single institute based cohort study
Acronym Immunogenicity and safety of mumps vaccine in healthy adults: a single institute based cohort study
Scientific Title Immunogenicity and safety of mumps vaccine in healthy adults: a single institute based cohort study
Scientific Title:Acronym Immunogenicity and safety of mumps vaccine in healthy adults
Region
Japan

Condition
Condition Mumps virus infection
Classification by specialty
Infectious disease Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the immunogenicity and safety of mumps vaccine in healthy adults
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Antibody
Key secondary outcomes Local reaction

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
20 years-old <=
Age-upper limit
50 years-old >
Gender Male and Female
Key inclusion criteria Person who had not complete 2 dosed of mumps vaccination yet
Key exclusion criteria Person who had completed 2 dosed of mumps vaccination
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Megumi
Middle name
Last name Hara
Organization Saga University
Division name Preventive medicine
Zip code 849-8501
Address Nabeshima 5-1-1, Saga, Japan
TEL 0952-34-2289
Email harameg@cc.saga-u.ac.jp

Public contact
Name of contact person
1st name Megumi
Middle name
Last name Hara
Organization Saga university
Division name Preventive medicine
Zip code 849
Address Nabeshima 5-1-1, Saga, Japan
TEL 0952-34-2289
Homepage URL
Email harameg@cc.saga-u.ac.jp

Sponsor
Institute Saga University
Institute
Department

Funding Source
Organization MLWH
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization ethics committee of Saga University.
Address Nabeshima 5-1-1, Saga, Japan
Tel 0952-34-3400
Email harameg@cc.saga-u.ac.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
2021 Year 03 Month 12 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2020 Year 12 Month 19 Day
Date of IRB
2021 Year 01 Month 10 Day
Anticipated trial start date
2021 Year 01 Month 17 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Antibody after vaccination will be measured

Management information
Registered date
2021 Year 03 Month 11 Day
Last modified on
2021 Year 03 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048914

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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