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Efficacy of a Plant-derived Quadrivalent Virus-like Particle (VLP) Vaccine in the Elderly

NCT03739112 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 12794

Last updated 2023-06-23

Study results available
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Summary

This Phase 3 study was intended to assess the relative efficacy of the Quadrivalent VLP Influenza Vaccine during the 2018-2019 influenza season compared to a licensed vaccine in elderly adults 65 years of age and older. One dose of VLP Influenza Vaccine (30 μg/strain) or of Comparator (15 μg/strain) was to be administered to 12,738 participants.

Conditions

  • Virus Diseases
  • RNA Virus Infections
  • Respiratory Tract Diseases
  • Respiratory Tract Infections

Interventions

BIOLOGICAL

Quadrivalent VLP Vaccine

Single dose of a 30 µg/strain of Quadrivalent VLP Vaccine

BIOLOGICAL

Fluarix Quadrivalent® Comparator Vaccine

Single dose of a 15 μg/strain of Fluarix Quadrivalent® Comparator Vaccine

Sponsors & Collaborators

  • Medicago

    lead INDUSTRY

Principal Investigators

  • Medical Director · Medicago

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-18
Primary Completion
2019-05-17
Completion
2019-07-16
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Finland
  • Germany
  • Thailand

Study Locations

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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 NCT03739112 on ClinicalTrials.gov