This is a Phase 1/2, randomized, observer-blind, placebo-controlled clinical trial. A maximum of 500 eligible subjects in 10 groups will be enrolled, randomized and vaccinated in this study. Subjects will receive an intramuscular injection of either the influenza A/H5N1 (low, medium or high dose) or placebo on Day 0 and Day 21 with or without a patch. This study will be performed in two parts. In Part 1, an initial safety evaluation will be performed in 100 randomized subjects. A Safety Review Committee (SRC)will review all safety data, including laboratory values, through the Day 7 visit, and compare those data against Stopping Criteria. If the treatments are considered safe, Part 2 of the study will be initiated and a second vaccination will be administered to subjects in Part 1 on Day 21. In Part 2, the remaining 400 subjects will be randomized, treated, and will follow the same visit structure and protocol-defined requirements as subjects in Part 1, without the additional laboratory safety measurements. An SRC review will also be performed of all safety data through the Day 28 visit for subjects participating in Part 1.
Name: A/H5N1
Description: Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; No LT Patch Day 0 or Day 21Type: BiologicalGroup 1
Name: A/H5N1
Description: Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21Type: BiologicalGroup 2
Name: A/H5N1
Description: Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21Type: BiologicalGroup 3
Name: A/H5N1
Description: Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21Type: BiologicalGroup 4
Name: A/H5N1
Description: Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21Type: BiologicalGroup 5
Name: A/H5N1
Description: Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21Type: BiologicalGroup 6
Name: A/H5N1
Description: High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21Type: BiologicalGroup 7
Name: A/H5N1
Description: High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21Type: BiologicalGroup 8
Name: A/H5N1
Description: High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21Type: BiologicalGroup 9
Name: Placebo
Description: Placebo (0.5ml); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21Type: BiologicalGroup 10
Allocation: Randomized
Parallel Assignment
There is one SNP
Acceptable forms of birth control are: abstinence, hormonal contraceptives (oral, injectable, implant, patch, ring), double-barrier contraceptives (condom or diaphragm, with spermicide), and IUD Exclusion Criteria: - Laboratory abnormalities [as determined by the Toxicity Grading Scale (grade 1 4)] at laboratory screening - Abnormalities at physical examination [as determined by the Toxicity Grading Scale (grade 1-4)] - Known allergies to any component of the vaccine - Known egg protein allergy - Known allergies to adhesives - Known disturbance of coagulation - Participated in research involving investigational product within 45 days before planned date of first vaccination - Donated or received blood or blood products such as plasma within the past 45 days - Received any licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to planned date of first vaccination - Ever received investigational enterotoxigenic E. coli, LT, or LT (R192G) or NasalFlu, Berna Biotech, Ltd - Ever received cholera toxin or vaccine (e.g. --- R192G ---