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Sponsored by: |
AlphaVax, Inc. |
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Information provided by: | AlphaVax, Inc. |
ClinicalTrials.gov Identifier: | NCT00706732 |
The objective of this study is to evaluate the safety of the vaccine and the immune response to the vaccine in healthy adult volunteers 65 years of age or older. Volunteers will be assigned by randomization to receive either the vaccine or an inactive substance (placebo) by injections in the arm on two occasions over one month. The study will last approximately 10 months and will have a total of 7 visits.
Condition | Intervention | Phase |
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Influenza |
Biological: AVX502 Biological: Placebo |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study |
Official Title: | A Single-Site, Phase I/II, Double Blinded, Safety and Immunogenicity Trial of an Alphavirus Replicon Vaccine Expressing Influenza A/Wyoming/03/2003 Hemagglutinin (AVX502) in Adult Volunteers 65 Years of Age or Older |
Estimated Enrollment: | 72 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | March 2009 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
T1: Active Comparator |
Biological: AVX502
2 doses at 2e8 IU given at T=0 and T=4 weeks via the IM route
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T2: Active Comparator |
Biological: AVX502
2 doses at 2e8 IU given at T=0 and T=4 weeks given via the SC route
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C1: Placebo Comparator |
Biological: Placebo
2 doses of placebo given at T=0 and T=4 weeks via the IM route
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C2: Placebo Comparator |
Biological: Placebo
2 doses of placebo given at T=0 and T=4 weeks via the SC route
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Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Alphavax ( Robert Olmsted, Ph.D. ) |
Study ID Numbers: | AVX502-003 |
Study First Received: | June 26, 2008 |
Last Updated: | November 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00706732 |
Health Authority: | United States: Food and Drug Administration |
Influenza Flu A/Wyoming/03/2003 Alphavirus |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |
RNA Virus Infections |