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Efficacy, Safety, and Immunogenicity of a Plant-Derived Quadrivalent Virus-Like Particles (VLPs) Influenza Vaccine in Adults

NCT03301051 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 10160

Last updated 2023-08-14

Study results available
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Summary

This Phase 3 study is intended to assess the efficacy of the Quadrivalent VLP Influenza Vaccine during the 2017-2018 influenza season in healthy adults 18 to 64 years of age. One dose of Quadrivalent VLP Influenza Vaccine (30 μg/strain) or of placebo will be administered to approximately 10,000 participants

Conditions

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

Interventions

BIOLOGICAL

Quadrivalent VLP Vaccine

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

BIOLOGICAL

Placebo

Single dose of a Placebo

Sponsors & Collaborators

  • Medicago

    lead INDUSTRY

Principal Investigators

  • Medical Director · Medicago

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-31
Primary Completion
2018-05-02
Completion
2018-05-09
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Finland
  • Germany
  • Philippines
  • Thailand
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT03301051 on ClinicalTrials.gov