drugset / Trial / NCT00908687

A/H5N1/LT Dose Ranging Study

NCT00908687 ↗

RandomizedParallel-groupTriple-blindTreatment

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).

Timeline

Start
2009-05
Primary completion
2010-01
Completion
2011-07

Drugs

EvaluationDrugModalityDoseRoute
Subject A/H5N1 Vaccine 30 ug Intramuscular
Subject A/H5N1 Vaccine 45 ug Intramuscular
Subject LT Adjuvant Patch Unknown 50 ug —
Subject LT Adjuvant Patch Unknown 100 ug —

Indications