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H5N1 Mix and Match With MF59
NCT01317745 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 270 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01317745 reports 5 study locations spanning 4 distinct geographic areas — top geographies include Georgia, Iowa, Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01317745?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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