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NCT01317745 · ClinicalTrials.gov registry record · Phase 1
H5N1 Mix and Match With MF59
A Phase 1 study of Influenza, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 270
- Enrollment target
- 5
- Study locations
NCT01317745 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 270 participants, below the 36,802-participant average among 156 other Influenza trials with a reported enrollment target (99% lower). The trial reports 5 study locations across 4 states.
The verdict
NCT01317745, 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
- 270 participants
- Enrollment target
- 5
- Study locations
Study Summary
Approximately 216, and up to 270, healthy males and non-pregnant females, 18 to 49 years old, inclusive, will be enrolled over a 5-month period into this multicenter, randomized, double-blinded, controlled Phase I study. Subjects who meet the entry criteria for the study and provide informed consent will be randomized 2:1 between adjuvanted and unadjuvanted vaccine and placed into one of 6 groups (see table) to receive two doses of an intramuscular subvirion inactivated monovalent influenza A/H5N1 virus vaccine at 3.75, 7.5, or 15 mcg given with the adjuvant MF59 or diluent (N=216, up to 270). All eligible subjects will receive 2 doses separated by approximately 21 days.
Conditions Studied
Interventions
- OTHER Phosphate Buffered Saline (PBS) diluent
- DRUG MF59 Adjuvant
- BIOLOGICAL H5N1 Antigen
Study Locations (5)
Georgia
- Emory Children's Center - Division of Pediatric Infectious Diseases - Atlanta
- Emory Vaccine Center - The Hope Clinic - Decatur
Iowa
- University of Iowa - Infectious Disease Clinic - Iowa City
Missouri
- Saint Louis University - Center for Vaccine Development - St Louis
Ohio
- Cincinnati Children's Hospital Medical Center - Infectious Diseases - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 270 participants |
| Start Date | 2011-05 |
| Est. Completion | 2012-09 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01317745
The ClinicalTrials.gov registry entry for NCT01317745 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 270 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 36,802-participant average among 156 other Influenza trials with a reported enrollment target (99% 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 3 interventions - of which Phosphate Buffered Saline (PBS) diluent is the first listed.
NCT01317745 reports 5 study locations spanning 4 distinct geographic areas - top geographies include Georgia, Iowa, Missouri.
Frequently Asked Questions
What is clinical trial NCT01317745 about?
NCT01317745 is a clinical study titled "H5N1 Mix and Match With MF59". Approximately 216, and up to 270, healthy males and non-pregnant females, 18 to 49 years old, inclusive, will be enrolled over a 5-month period into this multicenter, randomized, double-blinded, controlled Phase I study. Subjects who meet the entry criteria for the study and provide informed consent...
What is the current status of trial NCT01317745?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 270 participants. The study started on 2011-05. Estimated completion is 2012-09.
What conditions does trial NCT01317745 study?
This clinical trial studies the following conditions: Influenza.
What interventions are being tested in trial NCT01317745?
The interventions under investigation include: Phosphate Buffered Saline (PBS) diluent (OTHER), MF59 Adjuvant (DRUG), H5N1 Antigen (BIOLOGICAL).
Who is sponsoring clinical trial NCT01317745?
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 NCT01317745 being conducted?
This trial has 5 study locations across Georgia, Iowa, Missouri, Ohio. 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
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