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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040526
Receipt No. R000046155
Scientific Title Long-term immunity after Yellow fever vaccination
Date of disclosure of the study information 2020/08/01
Last modified on 2020/05/26

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Basic information
Public title Long-term immunity after Yellow fever vaccination
Acronym Long-term immunity after Yellow fever vaccination
Scientific Title Long-term immunity after Yellow fever vaccination
Scientific Title:Acronym Long-term immunity after Yellow fever vaccination
Region
Japan

Condition
Condition Yellow fever
Classification by specialty
Medicine in general Infectious disease Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate the Long term immunity after Yellow fever vaccination.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes seropositivity rate of neutralizing antibody titers against yellow fever virus
Key secondary outcomes geometric mean titer of neutralizing antibody titers against yellow fever virus

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

Not applicable
Gender Male and Female
Key inclusion criteria Japanese people who received yellow fever vaccine more than 5 years ago
Key exclusion criteria no restriction
Target sample size 50

Research contact person
Name of lead principal investigator
1st name SHINJI
Middle name
Last name FUKUSHIMA
Organization Tokyo Medical University Hospital
Division name Travellers' Medical Center
Zip code 160-0023
Address 6-7-1 Nishishinjuku, Shinjuku, Tokyo, Japan
TEL +81-3-5339-3726
Email fuku789@tokyo-med.ac.jp

Public contact
Name of contact person
1st name SHINJI
Middle name
Last name FUKUSHIMA
Organization Tokyo Medical University Hospital
Division name Travellers' Medical Center
Zip code 160-0023
Address 6-7-1 Nishishinjuku, Shinjuku, Tokyo, Japan
TEL +81-3-5339-3726
Homepage URL
Email fuku789@tokyo-med.ac.jp

Sponsor
Institute Tokyo Medical University Hospital
Travellers' Medical Center
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization Tokyo Medical University, Institutional Review Board
Address 6-7-1 Nishishinjuku, Shinjuku, Tokyo, Japan
Tel 03-3342-6111
Email IRB@tokyo-med.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 東京医科大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2020 Year 08 Month 01 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 Preinitiation
Date of protocol fixation
2020 Year 05 Month 12 Day
Date of IRB
Anticipated trial start date
2020 Year 08 Month 01 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Descriptive study

Management information
Registered date
2020 Year 05 Month 26 Day
Last modified on
2020 Year 05 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046155

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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