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Clinical Trials/EUCTR2011-002928-41-AT
EUCTR2011-002928-41-AT
Active, not recruiting
Phase 1

Characterization of humoral and cellular immunity for tick-borne encephalitis (TBE) vaccination in allogeneic blood and marrow graft recipients: a pilot study

Med. Uni. Wien, Klinik für Innere I0 sites52 target enrollmentNovember 23, 2012
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DrugsFSME Immun

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Med. Uni. Wien, Klinik für Innere I
Enrollment
52
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 23, 2012
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Med. Uni. Wien, Klinik für Innere I

Eligibility Criteria

Inclusion Criteria

  • •Adult patients \=18 years who
  • •\-had undergone an allogeneic HSCT 11 to 13 months ago or
  • •\-healthy volunteers without previous TBE vaccination
  • •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 52
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range 0

Exclusion Criteria

  • •\-Previous TBE vaccination following HSCT
  • •\-HSCT patients with extremely severe acute graft versus host disease (receiving prednisone \>0\.5 mg/kg bodyweight as part of a combination therapy or a three agent immunosuppressive treatment)
  • •\-Previous TBE virus infection, previous dengue virus infection or vaccination against yellow fever or Japanese encephalitis
  • •\-Any acute febrile illness in the 2 weeks prior to or at the time of enrolment
  • •\-A history of severe allergic reactions or anaphylaxis after vaccination
  • •\-If female, are pregnant or lactating
  • •\-If belonging to the healthy control group are immunosuppressed

Outcomes

Primary Outcomes

Not specified

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