Vaccination against measles and rubella for child treated with steroid

JRCT ID: jRCTs031190014

Registered date:22/04/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Diseases requiring steroid treatments
• Date of first enrollment: 01/05/2019
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Measles and rubella vaccination for pediatric patients treated with steroid

Outcome(s)

• Primary Outcome: Positive sero-conversion rate of specific virus antibody after vaccination
• Secondary Outcome: Comparison of the specific virus antibody titer before and after vaccination

Key inclusion & exclusion criteria

• Age minimum: >= 5age old
• Age maximum: < 15age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Ishii Taku
• Source(s) of Monetary Support: Japan Society for the Promotion of Science