A Safety and Immunogenicity Trial in Adults 65 Years of Age or Over to Prevent Influenza
NCT ID: NCT00706732
Last Updated: 2012-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
28 participants
INTERVENTIONAL
2008-06-30
2009-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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T1
AVX502
2 doses at 2e8 IU given at T=0 and T=4 weeks via the IM route
T2
AVX502
2 doses at 2e8 IU given at T=0 and T=4 weeks given via the SC route
C1
Placebo
2 doses of placebo given at T=0 and T=4 weeks via the IM route
C2
Placebo
2 doses of placebo given at T=0 and T=4 weeks via the SC route
Interventions
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AVX502
2 doses at 2e8 IU given at T=0 and T=4 weeks via the IM route
AVX502
2 doses at 2e8 IU given at T=0 and T=4 weeks given via the SC route
Placebo
2 doses of placebo given at T=0 and T=4 weeks via the IM route
Placebo
2 doses of placebo given at T=0 and T=4 weeks via the SC route
Eligibility Criteria
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Inclusion Criteria
* Good general health without significant physical examination findings or clinically significant abnormal laboratory results
* Available to participate for entire study period
* Acceptable laboratory parameters
* Willingness to have blood stored for up to 10 years for use in additional assays to evaluate immune responses to influenza or the alphavirus vector if such assays become available
* Willingness to refrain from donating blood while participating in the study
* Willingness to delay receipt of 2008-2009 licensed influenza vaccination until after completing study visit 6 procedures (study week 8)
* Signed inform consent obtained before screening and before enrollment
Exclusion Criteria
* Receipt of any other vaccine within 30 days prior to enrollment
* Use of any investigational agent within 30 days prior to enrollment
* Receipt of immunoglobulin or other blood products within 60 days prior to enrollment
* Use of cytotoxic medications within 6 months prior to enrollment
* Use of systemic corticosteroids within 6 months prior to enrollment (except that participants who have completed a course of prednisone, at up to 20 mg per day for up to 7 days, at least 1 month prior to enrollment are eligible for enrollment)
* History of serious adverse reactions to any vaccines, including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, or abdominal pain
* History of autoimmune disease or splenectomy
* History of malignancy within the last 3 years (except that participants with a diagnosis of basal cell carcinoma of the skin are eligible for enrollment)
* Psychiatric condition that may interfere with the ability to comply with the protocol requirements or to understand informed consent. Specifically excluded are persons with history of psychosis within the past 3 years or history of suicidal attempt or gesture within the past 3 years.
* History of medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months
* Any condition which leads the investigator to believe that the particpant cannot comply with the protocol requirements or that may place the participant at an unacceptable risk for further participation.
65 Years
ALL
Yes
Sponsors
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AlphaVax, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Olmsted, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
AlphaVax, Inc.
Locations
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Johnson County Clin-Trials
Lenexa, Kansas, United States
Countries
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Related Links
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AlphaVax, Inc.
Johnson County Clin-Trials
Other Identifiers
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AVX502-003
Identifier Type: -
Identifier Source: org_study_id