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NCT00546585 · ClinicalTrials.gov registry record · Phase 1
Safety, Reactogenicity, and Immunogenicity of Inactivated Influenza A/H7/N7 Vaccine in Healthy Adults
A Phase 1 study of Influenza, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 126
- Enrollment target
- 1
- Study location
NCT00546585 is a Phase 1 study of Influenza that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 126 participants, below the 36,803-participant average among 156 other Influenza trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00546585, a Phase 1 study of Influenza, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 126 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the safety, any adverse events or side effects, and the body's immune response to an experimental flu vaccine \[Inactivated Influenza A/H7N7 Vaccine\] being given in increasing doses. Researchers will try to find the smallest dose of flu vaccine needed to cause antibody responses against the flu virus in both single and repeat doses. The study will enroll 125 healthy adults ranging in age from 18 to 40 years old. Subjects will be given 2 doses of the vaccine 28 days apart. Study procedures will include obtaining a medical history, physical exam, blood sample collections, and use of patient memory aids. The volunteers will be in the study for about 7 months.
Conditions Studied
Interventions
- DRUG Placebo
- BIOLOGICAL Influenza A/H7N7 Vaccine
Study Locations (1)
Texas
- Baylor College of Medicine - Department of Molecular Virology and Microbiology - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2008-03 |
| Est. Completion | 2009-02 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00546585
The ClinicalTrials.gov registry entry for NCT00546585 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 126 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 36,803-participant average among 156 other Influenza trials with a reported enrollment target (100% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00546585 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT00546585 about?
NCT00546585 is a clinical study titled "Safety, Reactogenicity, and Immunogenicity of Inactivated Influenza A/H7/N7 Vaccine in Healthy Adults". The purpose of this study is to evaluate the safety, any adverse events or side effects, and the body's immune response to an experimental flu vaccine \[Inactivated Influenza A/H7N7 Vaccine\] being given in increasing doses. Researchers will try to find the smallest dose of flu vaccine needed to cau...
What is the current status of trial NCT00546585?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 126 participants. The study started on 2008-03. Estimated completion is 2009-02.
What conditions does trial NCT00546585 study?
This clinical trial studies the following conditions: Influenza.
What interventions are being tested in trial NCT00546585?
The interventions under investigation include: Placebo (DRUG), Influenza A/H7N7 Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00546585?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00546585 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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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.