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Clinical Trials/JPRN-jRCTs031190014
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

Sponsor
Ishii Taku

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