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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: Completed Phase 1 study of Influenza, Pandemic, sponsored by Novavax.
NCT02078674 is a Phase 1 study of Influenza, Pandemic that has completed, run by Novavax. The registered enrollment target is 610 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (917% higher). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Counts (and percentages) of subjects with solicited local and systemic AEs over the seven days post-injection and all adverse events, solicited and unsolicited, including adverse changes in clinical laboratory parameters, over 42 days post-first injection. In addition, MAEs, SAEs, and SNMCs will be collected for one year.
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 |
What the finished NCT02078674 record still lists
NCT02078674 is an interventional study that assigns participants to a tested intervention. The registered 610 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (917% higher).
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 lists 5 locations in 5 states (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.
Learn More About Clinical Trials
Similar trials for Influenza, Pandemic
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 NCT02078674's enrollment target sits among peer trials
610 25th of 2000 higher than 1,976 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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