UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042738 |
|---|---|
| Receipt number | R000048784 |
| Scientific Title | Immunogenicity and safety of the simultaneous administration of MR and yellow fever vaccines among Japanese adults |
| Date of disclosure of the study information | 2021/03/01 |
| Last modified on | 2023/12/16 09:15:46 |
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Basic information
Public title
Immunogenicity and safety of the simultaneous administration of MR and yellow fever vaccines among Japanese adults
Acronym
Immunogenicity and safety of the simultaneous administration of MR and yellow fever vaccines among Japanese adults
Scientific Title
Immunogenicity and safety of the simultaneous administration of MR and yellow fever vaccines among Japanese adults
Scientific Title:Acronym
Immunogenicity and safety of the simultaneous administration of MR and yellow fever vaccines among Japanese adults
Region
| Japan |
Condition
Condition
Yellow fever, Measles and Rubella
Classification by specialty
| Medicine in general | Infectious disease | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the immunogenisity and safety of the simultaneous administration with yelloe fever and MR vaccines.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
Immunogenicity
1)Seroprotection to yellow fever after the simultaneous administration with yelloe fever and MR vaccines
Key secondary outcomes
Safety
1)Adverse events wihin 28 days after the simultaneous administration with yelloe fever and MR vaccines
Immunogenicity
2)Geometric mean titer(GMT) of yellow fever virus titer 4-6 weeks after the simultaneous administration with yelloe fever and MR vaccine
3)Seroconversion and GMTs of measles or rubella virus titers 4-6 weeks after the simultaneous administration with yelloe fever and MR vaccines
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Vaccine |
Interventions/Control_1
Simultaneous administration of MR and yellow fever vaccines
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Japanese healthy adults need MR and yellow fever vaccines
2)20 years old and over and under 60 years old
3)No history of yellow fever
4)No history of immunization of yellow fever vaccine
Key exclusion criteria
1)Manifest fever (37.5 or more temperature)
2)Suffering from severe acute illness
3)History of anaphylaxis
4)Immunodeficiency
5)HIV infection
6)Immunosuppressive and Immunomodulatory Therapies
7)Neurological disorder
8)Thymus Disorder
9)History of hypersensitivity to MR and yellow fever vaccine
10)Other chronic medical conditions
11)Pregnancy
12)Brestfeeding
13)Other inappropriate condition for vaccination
Target sample size
20
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
TEL
0333426111
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
TEL
0333426111
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
The Ministry of Education,Culuture,Sports,Science and Technology (MEXT)
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
Tokyo Medical University
Address
1-1-1 Shinjuku Shinjuku, Tokyo
Tel
0333516141
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
| 2021 | Year | 03 | 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
14
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 12 | Month | 09 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 12 | Month | 13 | Day |
Last modified on
| 2023 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048784
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