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A/H5N1 Dose Ranging Study With Adjuvant Patch
NCT00532792 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- BIOLOGICAL A/H5N1
Study Locations (5)
California
- Solano Clinical Research — Vallejo
Florida
- Miami Research Associates — Miami
Kansas
- Quintiles Phase One Services — Kansas City
Utah
- Jean Brown Research — Salt Lake City
Washington
- Northwest Kinetics — Tacoma
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 501 participants |
| Start Date | 2007-08 |
| Est. Completion | 2008-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00532792
The ClinicalTrials.gov registry entry for NCT00532792 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 501 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Intercell USA, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Pandemic Influenza appearing as the primary indexed condition, and to 1 intervention — of which A/H5N1 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00532792 reports 5 study locations spanning 5 distinct geographic areas — top geographies include California, Florida, Kansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00532792 about?
NCT00532792 is a clinical study titled "A/H5N1 Dose Ranging Study With Adjuvant Patch". 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...
What is the current status of trial NCT00532792?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 501 participants. The study started on 2007-08. Estimated completion is 2008-06.
What conditions does trial NCT00532792 study?
This clinical trial studies the following conditions: Pandemic Influenza. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00532792?
The interventions under investigation include: A/H5N1 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00532792?
This trial is sponsored by Intercell USA, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00532792 being conducted?
This trial has 5 study locations across California, Florida, Kansas, Utah, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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