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Sponsors and Collaborators: |
Intercell USA, Inc. Department of Health and Human Services |
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Information provided by: | Intercell USA, Inc. |
ClinicalTrials.gov Identifier: | NCT00532792 |
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.
Condition | Intervention | Phase |
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Pandemic Influenza |
Biological: A/H5N1 Biological: Placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Observer-Blind, Placebo-Controlled Study to Assess the Safety and Immunogenicity of Intramuscular Inactivated Influenza A/H5N1 Vaccine Administered With and Without an Adjuvant Patch in Healthy Adults |
Enrollment: | 501 |
Study Start Date: | August 2007 |
Study Completion Date: | June 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group 1: Experimental |
Biological: A/H5N1
Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; No LT Patch Day 0 or Day 21
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Group 2: Experimental |
Biological: A/H5N1
Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21
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Group 3: Experimental |
Biological: A/H5N1
Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21
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Group 4: Experimental |
Biological: A/H5N1
Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21
|
Group 5: Experimental |
Biological: A/H5N1
Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21
|
Group 6: Experimental |
Biological: A/H5N1
Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21
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Group 7: Experimental |
Biological: A/H5N1
High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21
|
Group 8: Experimental |
Biological: A/H5N1
High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21
|
Group 9: Experimental |
Biological: A/H5N1
High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21
|
Group 10: Placebo Comparator |
Biological: Placebo
Placebo (0.5ml); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21
|
Ages Eligible for Study: | 18 Years to 49 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Solano Clinical Research | |
Vallejo, California, United States, 94589 | |
United States, Florida | |
Miami Research Associates | |
Miami, Florida, United States, 33143 | |
United States, Kansas | |
Quintiles Phase One Services | |
Kansas City, Kansas, United States, 66211 | |
United States, Utah | |
Jean Brown Research | |
Salt Lake City, Utah, United States, 84124 | |
United States, Washington | |
Northwest Kinetics | |
Tacoma, Washington, United States, 98418 |
Principal Investigator: | Philip Leese, MD | Quintiles Phase One Services |
Responsible Party: | IOMAI Corporation ( Sarah Frech, DVM / VP Clinical Development ) |
Study ID Numbers: | PLA101, HHSSO100200700031C |
Study First Received: | September 19, 2007 |
Last Updated: | September 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00532792 |
Health Authority: | United States: Food and Drug Administration |
Avian Pandemic Influenza A/H5N1 |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections Influenza, Human |
Influenza in Birds Healthy Orthomyxoviridae Infections |
RNA Virus Infections |