Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 1 study of Pandemic Influenza that has completed, run by Intercell USA. The registered enrollment target is 501 participants. The trial reports 5 study locations across 5 states.
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 |
Interested in This Trial?
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, categorized as Phase 1. 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 7 total studies on file at ClinicalTrials.gov.
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 reports 5 study locations spanning 5 distinct geographic areas - top geographies include 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
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.