Simplified basic immunisation after transplantation of stem cells
- Conditions
- Patients undergoing stem cell transplantation loose their protection from basic vaccinations done during childhood and need to be immunised again to be protected from diphteria, tetanus, polio and haemophilus influenza. Improved protection against pertussis will also be studied.Therapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2014-005077-36-SE
- Lead Sponsor
- Örebro Läns Landsting
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
• Patients who have undergone allogeneic or autologous stem cell transplantation
• Male or female > 18 years old
• Patients who have given written consent to participate in the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
• Pregnancy confirmed / suspected by the patient upon request.
• Allergy or hypersensitivity to any of the vaccine constituents.
• Ongoing acute illness (temperature >38 degrees celsius).
• Other immunosuppressive disease or ongoing immunosuppressive therapy for other disease than GVH.
• Recurrence of malignancy.
• Treatment with rituximab in the last 6 months.
• Alcohol abuse.
• Mental retardation
• If the investigator for any other reason determines that the patient is not suitable to be included.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method