EUCTR2013-003403-19-SE
Active, not recruiting
Phase 1
Study of T- and B-cell immunity after vaccination with a virosomebased influenza vaccine (Inflexal V) in patients who have undergone hematopoietic allogeneic stem cell transplantation.
Karolinska University Hospital0 sites30 target enrollmentAugust 2, 2013
ConditionsAllogeneic stem cell transplantationTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
DrugsInflexal V
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Allogeneic stem cell transplantation
- Sponsor
- Karolinska University Hospital
- Enrollment
- 30
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult allogeneic stem cell transplant patients who has undergone transplant 3\-24 months before transplantation and who shall get influenza vaccine according to national and international guidelines.
- •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 25
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range 5
Exclusion Criteria
- •1\. Patients \< 3 months and \> 24 months after HSCT
- •2\. Patients who has been influenzavaccinated during the actual season.
- •3\. Patients who has been diagnosed with influenza during the actual season.
- •4\. Patients with severe acute GVHD (grade III\-IV)
- •5\. Patienter with extensive or severe chronic GVHD treated with photopheresis or mesenchymal stem cells
- •6\. Patients treated with drugs produced by gene\- or celltherapeutical techniques
- •7\. Patients with relapse of the original disease undergoing or planned to undergo chemotherapy
- •8\. Patients treated with iv or sc immune globulins
- •9\. Patients requiring platelet transfusions
- •10\. Patienter allergic to any of the in the vaccine included substances.
Outcomes
Primary Outcomes
Not specified
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