UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040525 |
|---|---|
| Receipt number | R000046219 |
| Scientific Title | Long-term immunogenicity after rabies vaccination among Japanese people |
| Date of disclosure of the study information | 2020/06/01 |
| Last modified on | 2023/11/29 02:16:38 |
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Basic information
Public title
Long-term immunogenicity after rabies vaccination among Japanese people
Acronym
Long-term immunogenicity after rabies vaccination among Japanese people
Scientific Title
Long-term immunogenicity after rabies vaccination among Japanese people
Scientific Title:Acronym
Long-term immunogenicity after rabies vaccination among Japanese people
Region
| Japan |
Condition
Condition
Rabies
Classification by specialty
| Medicine in general | Infectious disease | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to evaluate the immunogenicity after more than 2 years of rabies vaccination.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Seropositive rate of antibody titers for rabies virus
Key secondary outcomes
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 adults who received with rabies vaccine more than 2 years ago
Key exclusion criteria
no restriction
Target sample size
100
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
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
fuku789@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University Hospital
Travellers' Medical Center
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical University Hospital
Travellers' Medical Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
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 | 06 | 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
Main results already published
Date of protocol fixation
| 2017 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 27 | Day |
Last follow-up date
| 2023 | 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
| 2023 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046219
| 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 |
