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Evaluation of the Safety and Immunogenicity of a Recombinant Trivalent Nanoparticle Influenza Vaccine With Matrix M-1 Adjuvant (NanoFlu)

NCT03293498 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2022-12-21

Study results available
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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

Conditions

Interventions

BIOLOGICAL

NanoFlu

Vaccine

BIOLOGICAL

Fluzone HD - Day 0

Vaccine

BIOLOGICAL

Fluzone HD - Day 21

Vaccine

OTHER

Saline - Day 21

Placebo

Sponsors & Collaborators

  • Novavax

    lead INDUSTRY

Principal Investigators

  • Clinical Development · Novavax

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-18
Primary Completion
2018-03-14
Completion
2018-10-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03293498 on ClinicalTrials.gov