NCT00908687

A/H5N1/LT Dose Ranging Study

A Randomized Blinded, LT Dose-ranging Study to Assess the Immunogenicity and Safety of Different Doses of LT Adjuvant Patch Administered in Conjunction With Different Doses of Inactivated Influenza A/H5N1 Vaccine in Healthy Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: Intercell USA, Inc. · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 2, randomized, blinded, clinical trial. Up to 500 eligible subjects will be enrolled and randomized in a 1:2:2:1:2:2 ratio into one of six groups, and vaccinated in this study. Subjects will receive an intramuscular injection of the influenza A/H5N1 (low or high dose) on Day 0 with or without a patch (low or high dose).

Conditions

• Pandemic Influenza

Interventions

Type	Name	Description
BIOLOGICAL	A/H5N1	A/H5N1 Low Dose
BIOLOGICAL	A/H5N1	A/H5N1 High Dose
BIOLOGICAL	LT Adjuvant Patch	LT Adjuvant Patch Low Dose
BIOLOGICAL	LT Adjuvant Patch	LT Adjuvant Patch High Dose

Timeline

• Start date: 2009-05-01
• Primary completion: 2010-01-01
• Completion: 2011-07-01
• First posted: 2009-05-27
• Last updated: 2021-12-10
• Results posted: 2014-03-13

Locations

6 sites across 1 country: United States