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NCT00532792 · ClinicalTrials.gov registry record · Phase 1
A/H5N1 Dose Ranging Study With Adjuvant Patch
A Phase 1 study of Pandemic Influenza, sponsored by Intercell USA.
- Completed
- Registry status
- Phase 1
- Development phase
- 501
- Enrollment target
- 5
- Study locations
NCT00532792: Completed Phase 1 study of Pandemic Influenza, sponsored by Intercell USA.
NCT00532792 is a Phase 1 study of Pandemic Influenza that has completed, run by Intercell USA. The registered enrollment target is 501 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (735% higher). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00532792, a Phase 1 study of Pandemic Influenza, has completed, sponsored by Intercell USA.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 501 participants
- Enrollment target
- 5
- Study locations
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 |
What the finished NCT00532792 record still lists
NCT00532792 is an interventional study that assigns participants to a tested intervention. The registered 501 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (735% higher).
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.
NCT00532792 lists 5 locations in 5 states (California, Florida, Kansas).
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.
What interventions are being tested in trial NCT00532792?
The interventions under investigation include: A/H5N1 (BIOLOGICAL).
Who is sponsoring clinical trial NCT00532792?
This trial is sponsored by Intercell USA, which has 7 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00532792's enrollment target sits among peer trials
501 44th of 2000 higher than 1,957 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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