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A(H7N9) VLP Antigen Dose-Ranging Study With Matrix-M1™ Adjuvant
NCT02078674 · View on ClinicalTrials.gov ↗
Study Summary
This is a randomized, observer-blinded, placebo-controlled trial in adults 18 to 64 years old. Randomization will be stratified by age (18 to 49 years and 50 to 64 years) and by prior influenza immunization within the past three months. Subjects 18 to 49 years of age will comprise \~67% of subjects in each treatment group, and the balance will comprise subjects 50 to 64 years. Each subject will receive two identical IM doses of test article at a 21-day interval (Day 0 and Day 21), in alternate deltoids. For each subject, study follow-up will span approximately 385 days total, or approximately 13 months from the first dose.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Monovalent Avian Influenza VLP (H7N9)
- BIOLOGICAL Matrix-M1™ adjuvant
Study Locations (5)
California
- Diablo Clinical Research — Walnut Creek
Florida
- Miami Research Associates — Miami
Idaho
- Advanced Clinical Research — Meridian
New York
- Regional Clinical Research, Inc. — Endwell
South Carolina
- Coastal Carolina Research — Mt. Pleasant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 610 participants |
| Start Date | 2014-03 |
| Est. Completion | 2015-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02078674
The ClinicalTrials.gov registry entry for NCT02078674 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 610 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novavax, which has 8 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 (Pandemic) appearing as the primary indexed condition, and to 3 interventions — of which Placebo 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: NCT02078674 reports 5 study locations spanning 5 distinct geographic areas — top geographies include California, Florida, Idaho. 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 NCT02078674 about?
NCT02078674 is a clinical study titled "A(H7N9) VLP Antigen Dose-Ranging Study With Matrix-M1™ Adjuvant". This is a randomized, observer-blinded, placebo-controlled trial in adults 18 to 64 years old. Randomization will be stratified by age (18 to 49 years and 50 to 64 years) and by prior influenza immunization within the past three months. Subjects 18 to 49 years of age will comprise \~67% of subjects ...
What is the current status of trial NCT02078674?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 610 participants. The study started on 2014-03. Estimated completion is 2015-07.
What conditions does trial NCT02078674 study?
This clinical trial studies the following conditions: Influenza (Pandemic). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02078674?
The interventions under investigation include: Placebo (BIOLOGICAL), Monovalent Avian Influenza VLP (H7N9) (BIOLOGICAL), Matrix-M1™ adjuvant (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02078674?
This trial is sponsored by Novavax, which has 8 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02078674 being conducted?
This trial has 5 study locations across California, Florida, Idaho, New York, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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