UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Research study of time interval of live vaccination in post KD IVIG
Title of the study (Brief title)	Research study of time interval of live vaccination in post KD IVIG
Region	Japan

Condition
Condition	Kawasaki Disease
Classification by specialty	Infectious disease Pediatrics Blood transfusion
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 Ministry of Health, Labor and Welfare in Japan.
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	6 months-old <=
Age-upper limit	72 months-old >
Gender	Male and Female
Key inclusion criteria	Children who received IVIG for Kawasaki disease Children who were not affected measles, rubella, mumps and VZV Children who have not got vaccination of measles, rubella, mumps and VZV Six months to 6 years old. Written consent from the parents
Key exclusion criteria	Positive one or more of antibody titer of measles, rubella, 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	Hiroshi Sakakibara
Organization	Tokyo Metropolitan Children's Medical Center
Division name	Division of General Pediatrics
Address	2-8-29 Musashidai Fuchu-shi Tokyo
TEL	042-300-5111
Email	yoshihiko_morikawa@tmhp.jp

Public contact
Name of contact person	Yoshihiko Morikawa
Organization	Tokyo Metropolitan Children's Medical Center
Division name	Division of clinical research
Address	2-8-29 Musashidai Fuchu-shi Tokyo
TEL	042-300-5111
Homepage URL
Email	yoshihiko_morikawa@tmhp.jp

Sponsor
Institute	Tokyo Metropolitan Children's Medical Center
Institute
Department

Funding Source
Organization	Clinical research of Tokyo metropolitan hospital group
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2012 Year 01 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 11 Month 01 Day
Anticipated trial start date	2012 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Evaluation to antibody titer of measles, rubella, mumps and VZV 3 months and 6 months after IVIG. Administrate of measles, rubella, mumps and VZV 6 months after IVIG, and then evaluate the titers 3 months after vaccination.

Management information
Registered date	2012 Year 01 Month 31 Day
Last modified on	2017 Year 02 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008452