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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 is a Phase 1 study that has completed, run by Novavax. The registered enrollment target is 330 participants.

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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

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

Sponsor

Novavax

31 total trials

What the Registry Record Tells You About NCT03293498

The ClinicalTrials.gov registry entry for NCT03293498 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 330 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 0 conditions, and to 4 interventions - of which NanoFlu is the first listed.

NCT03293498 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.