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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014491
Receipt No. 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 2015/10/31

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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
Middle name
Last name Masaru Miura
Organization Tokyo Metropolitan Children's Medical Center
Division name Clinical Research Support Center
Zip code
Address 2-8-29 Musashidai, Fuchu, Tokyo, Japan
TEL 042-300-5111
Email yoshihiko_morikawa@tmhp.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihiko Morikawa
Organization Tokyo Metropolitan Children's Medical Center
Division name Clinical Research Support Center
Zip code
Address 2-8-29 Musashidai, Fuchu, Tokyo, Japan
TEL 042-300-5111
Homepage URL
Email yoshihiko_morikawa@tmhp.jp

Sponsor
Institute Tokyo Metropolitan Chilren's Medical Center
Institute
Department

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
Address
Tel
Email

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 Open public recruiting
Date of protocol fixation
2013 Year 12 Month 18 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 07 Day
Last follow-up date
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
2015 Year 10 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016858

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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