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Clinical Trials/EUCTR2022-003041-35-BE
EUCTR2022-003041-35-BE
Active, not recruiting
Phase 1

Impact of the immune system on response to inactivated influenza vaccine (IIV) in allogeneic stem cell recipients - Flu-Allo

CHU de Liège0 sites100 target enrollmentSeptember 8, 2022
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DrugsAlpharix-Tetra

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
CHU de Liège
Enrollment
100
Status
Active, not recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 8, 2022
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
CHU de Liège

Eligibility Criteria

Inclusion Criteria

  • •\- prior allogeneic hematopoietic stem cell transplantation 3 months to 5 years earlier (any donor type except cord blood transplantation); patients \> 5 years are also eligible if they are still on systemic immunosuppressive treatment for chronic GVHD.
  • •\- age\> or \= 18 years at inclusion.
  • •\- written informed consent
  • •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 85
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 15

Exclusion Criteria

  • •\- HIV seropositivity
  • •\- Pregnancy
  • •\- Active malignant disease
  • •\- Current grade III\-IV acute GVHD
  • •\- In vitro T\-cell depletion of the graft if vaccination within 6 months after transplantation.
  • •\- Rituximab administration in the 6 months prior to inclusion
  • •\- IVIg in the 3 months before vaccination.
  • •\- Prior post\-transplant IIV vaccination in the 9 months prior inclusion

Outcomes

Primary Outcomes

Not specified

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