JPRN-jRCTs031190014CompletedPhase 1
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
Ishii Taku0 sites0 target enrollmentStarted: April 22, 2019Last updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
Study Overview
Brief Summary
This study was discontinued because it has become difficult to enroll patients due to change in social conditions.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 5age old to < 15age old (—)
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
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