NCT00706732

A Safety and Immunogenicity Trial in Adults 65 Years of Age or Over to Prevent Influenza

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: AlphaVax, Inc. · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	AVX502	2 doses at 2e8 IU given at T=0 and T=4 weeks via the IM route
BIOLOGICAL	AVX502	2 doses at 2e8 IU given at T=0 and T=4 weeks given via the SC route
BIOLOGICAL	Placebo	2 doses of placebo given at T=0 and T=4 weeks via the IM route
BIOLOGICAL	Placebo	2 doses of placebo given at T=0 and T=4 weeks via the SC route

Timeline

• Start date: 2008-06-01
• Primary completion: 2008-09-01
• Completion: 2009-03-01
• First posted: 2008-06-30
• Last updated: 2012-07-12

Locations

1 site across 1 country: United States