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NCT03301051 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Influenza and Respiratory Tract Infections, sponsored by Medicago.

Completed
Registry status
Phase 3
Development phase
10,160
Enrollment target
20
Study locations

NCT03301051 is a Phase 3 study of Influenza and Respiratory Tract Infections that has completed, run by Medicago. The registered enrollment target is 10,160 participants, below the 36,739-participant average among 156 other Influenza trials with a reported enrollment target (72% lower). The trial reports 20 study locations across 13 states.

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The verdict

NCT03301051, a Phase 3 study of Influenza and Respiratory Tract Infections, has completed, sponsored by Medicago.

COMPLETED
Registry status
Phase 3
Development phase
10,160 participants
Enrollment target
20
Study locations

Study 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 Studied

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

Interventions

  • BIOLOGICAL Placebo
  • BIOLOGICAL Quadrivalent VLP Vaccine

Study Locations (20)

Florida

  • Site 217 - Coral Gables
  • Site 220 - Hollywood
  • Site 212 - South Miami

North Carolina

  • Site 216 - Charlotte
  • Site 221 - Charlotte
  • Site 227 - Winston-Salem

Georgia

  • Site 203 - Savannah
  • Site 218 - Stockbridge

Nebraska

  • Site 224 - Norfolk
  • Site 208 - Omaha

New York

  • Site 205 - Binghamton
  • Site 228 - Endwell

Alabama

  • Site 222 - Mobile

California

  • Site 210 - Anaheim

Connecticut

  • Site 223 - Milford

Trial Details

FieldValue
Enrollment Target 10,160 participants
Start Date 2017-08-31
Est. Completion 2018-05-09
Phase Phase 3

Sponsor

Medicago

9 total trials

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What the Registry Record Tells You About NCT03301051

The ClinicalTrials.gov registry entry for NCT03301051 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 10,160 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 36,739-participant average among 156 other Influenza trials with a reported enrollment target (72% lower). The listed sponsor is Medicago, which has 9 total studies on file at ClinicalTrials.gov.

The record links to 5 conditions, with Influenza appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT03301051 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Florida, North Carolina, Georgia.

Frequently Asked Questions

What is clinical trial NCT03301051 about?

NCT03301051 is a clinical study titled "Efficacy, Safety, and Immunogenicity of a Plant-Derived Quadrivalent Virus-Like Particles (VLPs) Influenza Vaccine in Adults". 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 part...

What is the current status of trial NCT03301051?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 10,160 participants. The study started on 2017-08-31. Estimated completion is 2018-05-09.

What conditions does trial NCT03301051 study?

This clinical trial studies the following conditions: Influenza, Respiratory Tract Infections, Respiratory Tract Diseases, Virus Diseases, RNA Virus Infections.

What interventions are being tested in trial NCT03301051?

The interventions under investigation include: Placebo (BIOLOGICAL), Quadrivalent VLP Vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT03301051?

This trial is sponsored by Medicago, which has 9 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03301051 being conducted?

This trial has 20 study locations across Alabama, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.