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April. 22, 2019

Dec. 02, 2021

jRCTs031190014

Effectiveness of the measles and rubella live attenuated vaccination for pediatric patients treated with not high dose corticosteroid (Effectiveness of the measles and rubella live attenuated vaccination for pediatric patients treated with not high dose corticosteroid)

Vaccination against measles and rubella for child treated with steroid (Vaccination against measles and rubella for child treated with steroid)

Mar. 05, 2021

0

Patients treated with corticosteroids

Discontinued before enrolling patients

none

not applicable

This study was discontinued because it has become difficult to enroll patients due to change in social conditions.

Oct. 30, 2021

No

not applicable

https://jrct.mhlw.go.jp/latest-detail/jRCTs031190014

Ishii Taku

Tokyo Medical and Dental University Hospital of Medicine

Bunkyo-ku, Yushima, 1-5-45

+81-3-5803-5249

tishii.ped@tmd.ac.jp

Ishii Taku

Tokyo Medical and Dental University Hospital of Medicine

Bunkyo-ku, Yushima, 1-5-45

+81-3-5803-5249

tishii.ped@tmd.ac.jp

Complete

May. 01, 2019

40

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

prevention purpose

1. Aged from 5 years old to under 15 years old
2. Current treatment with steroids the dose of which satisfies all of the following
2-1. Less than 1mg/kg/day or 2mg/kg/day
2-2. Less than 20mg/day
2-3. No increase in steroids more than 4 weeks or 28 days
3. Patients of inoculation with MR vaccine once at a year old or over

1. Current treatment with high dose immunosuppressive agents
Definition of high dose immunosuppressive agents is as follows
Salazosulfapyridine more than 40mg/kg/day
Leflunomide more than 0.25mg/kg/day
Methotrexate more than 15mg/m2/week
Cyclosporine more than 2.5mg/kg/day
Tacrolimus more than 0.06mg/kg/day
Azathioprine more than 1mg/kg/day
Cyclophosphamide more than 0.5mg/kg/day
6-Mercaptopurine more than 1.5mg/kg/day
2. Cases with side effect requiring treatment at the time of MR vaccination in the past
3. Cases with febrile disease within 4 weeks prior to vaccination
4. Cases receiving transfusion or administration of biological products within 3 months prior to vaccination
5. Cases receiving other live attenuated vaccine within 4 weeks or 28 days
6. Cases receiving inactivated vaccine within 6 days
7. Cases diagnosed as primary immunodeficiency disease
8. Cases likely to require treatment enhancement within 4 weeks after vaccination
9. Cases in whom both of measles and rubella antibody titers were higher than criteria
10. Cases living with a pregnant woman

5age old over
15age old not

Both

Diseases requiring steroid treatments

Measles and rubella vaccination for pediatric patients treated with steroid

Positive sero-conversion rate of specific virus antibody after vaccination

Comparison of the specific virus antibody titer before and after vaccination

Japan Society for the Promotion of Science
Not applicable
Tokyo Medical and Dental University Certified Clinical Reserch Center
Bunkyo-ku, Yushima, 1-5-45, Tokyo

+81-3-5803-4575

mkan-rinsho.adm@cmn.tmd.ac.jp
Approval

Mar. 25, 2019

none

History of Changes

No Publication date
4 Dec. 02, 2021 (this page) Changes
3 Mar. 19, 2021 Detail Changes
2 Aug. 01, 2019 Detail Changes
1 April. 22, 2019 Detail