UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007174
Receipt number R000008452
Scientific Title Research study of time interval of live vaccination in post KD IVIG
Date of disclosure of the study information 2012/01/31
Last modified on 2017/02/03 10:49:16

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Basic information

Public title

Research study of time interval of live vaccination in post KD IVIG

Acronym

Research study of time interval of live vaccination in post KD IVIG

Scientific Title

Research study of time interval of live vaccination in post KD IVIG

Scientific Title:Acronym

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

1st name
Middle name
Last name Hiroshi Sakakibara

Organization

Tokyo Metropolitan Children's Medical Center

Division name

Division of General Pediatrics

Zip code


Address

2-8-29 Musashidai Fuchu-shi Tokyo

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

Division of clinical research

Zip code


Address

2-8-29 Musashidai Fuchu-shi Tokyo

TEL

042-300-5111

Homepage URL


Email

yoshihiko_morikawa@tmhp.jp


Sponsor or person

Institute

Tokyo Metropolitan Children's Medical Center

Institute

Department

Personal name



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)



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

2012 Year 01 Month 31 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

Completed

Date of protocol fixation

2011 Year 11 Month 01 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008452


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name