NCT00921973

Safety of VAX102 Vaccine Given With Seasonal Flu Vaccine in Healthy Adults

A Multicenter, Double-Blinded, Randomized, Placebo Controlled Study to Investigate the Safety and Immunogenicity of VAX102 When Given in the Same Arm With the Standard Influenza Vaccine in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: VaxInnate Corporation · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

The study will assess the safety, reactogenicity, and tolerability of VAX102 when given with Trivalent Inactivated Influenza Vaccine (TIV) delivered in the same arm as two separate IM injections in healthy adults 18 to 49 years. The investigators will measure the immunogenicity of the VAX102 when given with TIV and the antibody response to TIV when given with VAX102 compared to TIV alone.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	VAX102	All subjects receive TIV, one half of the subjects are randomized to receive VAX102 1 ug and one half are randomized to receive placebo
BIOLOGICAL	Placebo	All subjects receive TIV, one half of the subjects are randomized to receive VAX102 1 ug and one half are randomized to receive placebo

Timeline

• Start date: 2009-06-01
• Primary completion: 2009-07-01
• Completion: 2009-09-01
• First posted: 2009-06-17
• Last updated: 2014-09-23

Locations

2 sites across 1 country: United States