UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047238 |
|---|---|
| Receipt number | R000053670 |
| Scientific Title | Multicenter prospective cohort study of vaccine safety for infants with tuberous sclerosis during evelolimus treatment |
| Date of disclosure of the study information | 2022/05/01 |
| Last modified on | 2023/09/21 13:51:27 |
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Basic information
Public title
Multicenter prospective cohort study of vaccine safety for infants with tuberous sclerosis during evelolimus treatment
Acronym
VaSITE study
Scientific Title
Multicenter prospective cohort study of vaccine safety for infants with tuberous sclerosis during evelolimus treatment
Scientific Title:Acronym
VaSITE study
Region
| Japan |
Condition
Condition
tuberous sclerosis
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigatete immunological effects and safty of vaccines on tuberous sclerosis infants during everolimus treatment
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of seroconversion for Rota virus, pertussis, measles, rubella, and varicella virus at two years of age
Key secondary outcomes
Adverse events
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
live attenuated vaccine
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
| 1 | months-old | <= |
Age-upper limit
| 7 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Tuberous sclerosis infants under two years of age who full filled either one of (1)(2)(3) and (4), and who will have everolimus and vaccine.
(1) subependymal giant cell astrocytoma
(2) cardiac rhabdomyoma
(3) paroxysmal EEG abnormalities
(4) written informed consent form the parents
Key exclusion criteria
(1) Interstitial shadows on the chest X-ray
(2) infected patients
(3) Liver dysfunction with 100 IU/L < of AST or ALT.
(4) Patients who were judged inadequet for registration by a doctor -in-charge.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Muneaki |
| Middle name | |
| Last name | Matsuo |
Organization
Saga University
Division name
Faculty of Medicine, Department of Pediatrics
Zip code
849-8501
Address
5-1-1 Nabeshima, Saga
TEL
0952242314
matsuo@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Obuchi |
Organization
Saga University
Division name
Faculty of Medicine, Department of Pediatrics
Zip code
849-8501
Address
5-1-1 Nabeshima, Saga
TEL
0952242314
Homepage URL
obuchin@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
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
Clinical research center, Saga university hospital
Address
5-1-1 Nabeshima, Saga
Tel
0952-34-3400
clinstudycenter@mail.admin.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
| 2022 | Year | 05 | 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
| 2022 | Year | 03 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 21 | Day |
Last modified on
| 2023 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053670
| 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 |
