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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.

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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

FieldValue
Enrollment Target 330 participants
Start Date 2017-09-18
Est. Completion 2018-10-29
Phase Phase 1
Novavax

31 total trials

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.

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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Source: ClinicalTrials.gov NCT03293498, the US trial registry maintained by the National Library of Medicine. NCT03293498 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.