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NCT03293498 · ClinicalTrials.gov registry record · Phase 1
Evaluation of the Safety and Immunogenicity of a Recombinant Trivalent Nanoparticle Influenza Vaccine With Matrix M-1 Adjuvant (NanoFlu)
A Phase 1 study, sponsored by Novavax.
- Completed
- Registry status
- Phase 1
- Development phase
- 330
- Enrollment target
NCT03293498: Completed Phase 1 study, sponsored by Novavax.
NCT03293498 is a Phase 1 study that has completed, run by Novavax. The registered enrollment target is 330 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (450% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03293498, a Phase 1 study, has completed, sponsored by Novavax.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 330 participants
- Enrollment target
Study Summary
This was a Phase 1/2, randomized, observer-blinded, active-controlled trial to assess the Safety and Tolerability of a Recombinant Trivalent Nanoparticle Influenza Vaccine (Tri-NIV) with Matrix M1™ Adjuvant in Healthy Older Adults ≥ 60 Years of Age
Primary Outcome
Number of participants that reported all adverse event (AE) profile (including adverse changes in clinical laboratory parameters) ; medically-attended adverse event (MAE), serious adverse event (SAE), and significant new medical condition (SNMC) post dosing.
Interventions
- BIOLOGICAL NanoFlu
- BIOLOGICAL Fluzone HD - Day 0
- BIOLOGICAL Fluzone HD - Day 21
- OTHER Saline - Day 21
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 330 participants |
| Start Date | 2017-09-18 |
| Est. Completion | 2018-10-29 |
| Phase | Phase 1 |
What the finished NCT03293498 record still lists
NCT03293498 is an interventional study that assigns participants to a tested intervention. The registered 330 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 (450% higher).
The record links to 0 conditions, and to 4 interventions - of which NanoFlu is the first listed.
NCT03293498 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03293498 about?
NCT03293498 is a clinical study titled "Evaluation of the Safety and Immunogenicity of a Recombinant Trivalent Nanoparticle Influenza Vaccine With Matrix M-1 Adjuvant (NanoFlu)". This was a Phase 1/2, randomized, observer-blinded, active-controlled trial to assess the Safety and Tolerability of a Recombinant Trivalent Nanoparticle Influenza Vaccine (Tri-NIV) with Matrix M1™ Adjuvant in Healthy Older Adults ≥ 60 Years of Age
What is the current status of trial NCT03293498?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 330 participants. The study started on 2017-09-18. Estimated completion is 2018-10-29.
What interventions are being tested in trial NCT03293498?
The interventions under investigation include: NanoFlu (BIOLOGICAL), Fluzone HD - Day 0 (BIOLOGICAL), Fluzone HD - Day 21 (BIOLOGICAL), Saline - Day 21 (OTHER).
Who is sponsoring clinical trial NCT03293498?
This trial is sponsored by Novavax, which has 31 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03293498's enrollment target sits among peer trials
330 110th of 2000 higher than 1,890 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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