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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name