Safety and Immune Response to Adjuvanted A(H1N1)v Influenza Vaccine in HIV-1 Infected and Immunosuppressed Adult Patients
NCT01017172 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 500
Last updated 2009-11-20
Summary
The purpose of this study is to evaluate the immunogenicity and safety of an adjuvanted A(H1N1)v influenza vaccine in HIV-infected and immunosuppressed patients after one and two injections.
Conditions
- HIV-1 Infection
- Cancer
- Immunosuppression
Interventions
- OTHER
-
serologic testing
Serologic testing will be performed baseline, day 21 and day 42
Sponsors & Collaborators
-
HIVCENTER
collaborator UNKNOWN -
Goethe University
lead OTHER
Principal Investigators
-
Markus Bickel, MD · JW Goethe University Clinic
-
Christoph Stephan, MD · JW Goethe University Clinic
-
Hans R Brodt, MD · JW Goethe University Clinic
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-11-30
- Primary Completion
- 2010-03-31
- Completion
- 2010-03-31
Countries
- Germany
Study Locations
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