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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: Completed Phase 1 study of Influenza, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT01317745 record still lists
NCT01317745 is an interventional study that assigns participants to a tested intervention. The registered 270 participants enrollment target is mid-sized for trials with a published cap, below the 36,802-participant average among 156 other Influenza trials with a reported enrollment target (99% lower).
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 lists 5 locations in 4 states (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.
Learn More About Clinical Trials
Similar trials for Influenza
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01317745's enrollment target sits among peer trials
270 73rd of 156 higher than 83 of 156 other Influenza trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Influenza 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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