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Clinical trialNCT02831751CompletedPhase 2Interventional

Immunogenicity, Safety, and Tolerability of a Plant-Derived Quadrivalent VLP Influenza Vaccine in Elderly Adults

SponsorMedicagoEnrollment1,001RNA Virus InfectionsRespiratory Tract DiseasesRespiratory Tract InfectionsVirus Diseases
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This Phase 2 Quadrivalent VLP Vaccine study is intended to replicate and extend the immunogenicity and safety results obtained in earlier Phase 1-2 and Phase 2 studies. The study is being conducted to evaluate that the immunogenicity profile of the Quadrivalent VLP Vaccine meets the US Center for Biologics Evaluation and Research (CBER) licensure criteria and to evaluate if the immunogenicity and the safety profile of the Quadrivalent VLP Vaccine is acceptable and comparable to that of the FluLaval® Tetra and Fluzone® High-Dose (HD). The study will also help to define the optimal dose in this population, establish potential competitive advantages, and support the design of future studies.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

  • Brandon J Essink, MD

    Meridian Clinical Research, Omaha (NE), USA

    Principal Investigator
    clinicaltrials.gov ↗
  • David J Seiden, MD

    Broward Research Group (BRG), Hollywood (FL), USA

    Principal Investigator
    clinicaltrials.gov ↗
  • Deepen Patel, MD

    Topstone Research, Toronto, Canada

    Principal Investigator
    clinicaltrials.gov ↗
  • Diane R Krieger, MD

    Miami Research Associates (MRA), Miami (FL), USA

    Principal Investigator
    clinicaltrials.gov ↗
  • Ginette Girard, MD

    Diex Research Sherbrooke, Sherbrooke, Canada

    Principal Investigator
    clinicaltrials.gov ↗
  • Guy Tellier, MD

    Omnispec Clinical Research Inc, Mirabel, Canada

    Principal Investigator
    clinicaltrials.gov ↗
  • Gérald Vallières, MD

    Manna Research, Lévis, Canada

    Principal Investigator
    clinicaltrials.gov ↗
  • Jamshid Saleh, MD

    Paradigm Research, Redding (CA), USA

    Principal Investigator
    clinicaltrials.gov ↗
  • Luis Robles, MD

    INC Research Toronto, Inc., Toronto, Canada

    Principal Investigator
    clinicaltrials.gov ↗
  • Marc Dionne, MD

    Équipe de recherche en vaccination du CHU de Québec-Université Laval (CHU), Quebec, Quebec, Canada

    Principal Investigator
    clinicaltrials.gov ↗
  • Michael Libman, MD

    McGill University Health Center - Vaccine Study Center (MUHC), Montreal, Canada

    Principal Investigator
    clinicaltrials.gov ↗
  • Paul Bradley, MD

    Meridian Clinical Research, Savannah (GA), USA

    Principal Investigator
    clinicaltrials.gov ↗
  • Pierre Lachance, MD

    Centre de Recherche St-Louis, Quebec, Quebec, Canada

    Principal Investigator
    clinicaltrials.gov ↗
  • Suchet R Patel, MD

    Regional Clinical Research (RCR), Endwell (NY), USA

    Principal Investigator
    clinicaltrials.gov ↗
  • Trevor Wesson, MD

    Diex Research Montreal, Montreal, Canada

    Principal Investigator
    clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

15 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada
  • Inc Research Toronto

    Toronto, Ontario, Canada

  • Topstone Research

    Toronto, Ontario, Canada

  • Manna Research

    Lévis, Quebec, Canada

  • Omnispec Clinical Research

    Mirabel, Quebec, Canada

  • Diex Research Montreal

    Montreal, Quebec, Canada

  • Mcgill University Health Center - Vaccine Study Center (muhc)

    Pierrefonds, Quebec, Canada

  • Diex Research Sherbroooke

    Sherbroooke, Quebec, Canada

  • Centre de Recherche St-Louis

    Québec, Canada

  • Équipe de Recherche En Vaccination Du Chu de Québec-Université Laval (chu)

    Québec, Canada

United States
  • Paradigm Research - Redding

    Redding, California, United States

  • Broward Research Group (brg)

    Hollywood, Florida, United States

  • Miami Research Associates (mra)

    South Miami, Florida, United States

  • Meridian Clinical Research - Savannah

    Savannah, Georgia, United States

  • Meridian Clinical Research - Omaha

    Omaha, Nebraska, United States

  • Regional Clinical Research (rcr)

    Endwell, New York, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

30 µg/strain of Quadrivalent VLP Vaccine60 µg/strain of Quadrivalent VLP VaccineFluLaval® TetraFluzone® High-Dose
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Apr 2016
Primary completion
31 Jul 2016
Completion
31 Jan 2017
Last update posted
25 Oct 2019
Registered enrollment
1,001
Registry id
NCT02831751
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.