UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014491 |
|---|---|
| Receipt number | R000016858 |
| Scientific Title | Research study of time interval of varicella and mumps live vaccination in post KD IVIG |
| Date of disclosure of the study information | 2014/07/07 |
| Last modified on | 2024/01/15 05:15:19 |
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Basic information
Public title
Research study of time interval of varicella and mumps live vaccination in post KD IVIG
Acronym
KDV2
Scientific Title
Research study of time interval of varicella and mumps live vaccination in post KD IVIG
Scientific Title:Acronym
KDV2
Region
| Japan |
Condition
Condition
Kawasaki Disease
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We are aimed at confirming the vaccination response and the transition of antibody titer in the children who received measles, rubella, mumps and VZV vaccination after IVIG for Kawasaki disease by the method recommended from ACIP in US.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The ratio of acquisition of immunity
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
| 2 | months-old | <= |
Age-upper limit
| 48 | months-old | > |
Gender
Male and Female
Key inclusion criteria
Children who received an IVIG therapy for Kawasaki disease
Children who were not affected mumps and VZV
Children who have not got vaccination of mumps and VZV
Two months to 5 years old.
Written consent from the parents
Key exclusion criteria
Positive one or more of antibody titer of mumps or VZV on the examination at the admission.
Malignancy diseases, immune deficiency disease or chromosomal abnormality.
Received immunosuppressant or systemic steroid within one month to be hospitalized as Kawasaki disease.
Chronic Kidney disease.
Judged inappropriate for this study by the physicians.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | Miura |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Clinical Research Support Center
Zip code
183-8561
Address
2-8-29 Musashidai, Fuchu, Tokyo, Japan
TEL
042-300-5111
yoshihiko_morikawa@tmhp.jp
Public contact
Name of contact person
| 1st name | Yoshihiko |
| Middle name | |
| Last name | Morikawa |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Clinical Research Support Center
Zip code
1838561
Address
2-8-29 Musashidai, Fuchu, Tokyo, Japan
TEL
042-300-5111
Homepage URL
yoshihiko_morikawa@tmhp.jp
Sponsor or person
Institute
Tokyo Metropolitan Chilren's Medical Center
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Government
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the ethics committee of Tokyo Metropolitan Children's Medical Center
Address
2-8-29, Musashidai, Fuchu-shi, Tokyo
Tel
042-300-5111
sn_erb@tmhp.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
| 2014 | Year | 07 | Month | 07 | 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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 12 | Month | 18 | Day |
Date of IRB
| 2013 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2014 | Year | 07 | Month | 07 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluation to antibody titer of mumps and VZV 11 months after IVIG.
Administrate of mumps and VZV 11 months after IVIG, and then evaluate the titers 3 months after vaccination.
Management information
Registered date
| 2014 | Year | 07 | Month | 07 | Day |
Last modified on
| 2024 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016858
