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NCT02078674 · ClinicalTrials.gov registry record · Phase 1
A(H7N9) VLP Antigen Dose-Ranging Study With Matrix-M1™ Adjuvant
A Phase 1 study of Influenza, Pandemic, sponsored by Novavax.
- Completed
- Registry status
- Phase 1
- Development phase
- 610
- Enrollment target
- 5
- Study locations
NCT02078674 is a Phase 1 study of Influenza, Pandemic that has completed, run by Novavax. The registered enrollment target is 610 participants. The trial reports 5 study locations across 5 states.
The verdict
NCT02078674, a Phase 1 study of Influenza, Pandemic, has completed, sponsored by Novavax.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 610 participants
- Enrollment target
- 5
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 1. 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 31 total studies on file at ClinicalTrials.gov.
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.
NCT02078674 reports 5 study locations spanning 5 distinct geographic areas - top geographies include California, Florida, Idaho.
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.
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).
Who is sponsoring clinical trial NCT02078674?
This trial is sponsored by Novavax, which has 31 total clinical trials registered on ClinicalTrials.gov.
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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