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Clinical trialNCT02233816CompletedPhase 2Interventional

Immunogenicity, Safety and Tolerability of a Plant-Derived Seasonal Virus-Like-Particle Quadrivalent Influenza Vaccine in Adults

SponsorMedicagoEnrollment300RNA Virus InfectionsRespiratory Tract DiseasesRespiratory Tract InfectionsVirus Diseases
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

A phase II trial multicenter, observer-blind, randomized, dose-ranging, placebo-controlled study to evaluate the immunogenicity, safety, and tolerability of a single intramuscular injection of plant-derived Seasonal VLP Quadrivalent Influenza Vaccine administered to healthy adults 18-49 years of age. A total of three hundred subjects will be randomized in four (4) groups of 75 subjects to receive one injection of either a low, a medium, or a high dose level of the quadrivalent VLP influenza vaccine or the placebo preparation (100 millimolar (mM) phosphate buffer + 150 mM sodium chloride (NaCl) + 0.01% Tween 80).
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.

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

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

United States
  • Broward Research Group

    Hollywood, Florida, United States

  • Miami Research Associates

    Miami, Florida, 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.

High dose of quadrivalent VLP vaccineLow dose of quadrivalent VLP vaccineMedium dose of quadrivalent VLP vaccinePlacebo
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
28 Jul 2014
Primary completion
22 Jun 2015
Completion
22 Jun 2015
Last update posted
13 Nov 2019
Registered enrollment
300
Registry id
NCT02233816
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.