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NCT02768805

Immunogenicity of a Quadrivalent Virus-Like Particles (VLP) Influenza Vaccine in Healthy Adults

Completed Phase 2 Last updated 11 June 2020
What this trial tests

Phase 2 trial testing 15 µg/strain of Quadrivalent VLP Vaccine in Virus Diseases in 900 participants. Completed in 26 November 2016.

Timeline
2 March 2016
Primary endpoint
17 May 2016
26 November 2016

Quick facts

Lead sponsorMedicago
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeprevention
Enrollment900
Start date2 March 2016
Primary completion17 May 2016
Estimated completion26 November 2016
Sites9 locations across Canada, United States

Drugs / interventions tested

Conditions studied

Sponsor

Medicago — full company profile →

Who can join

Adults 18 to 64, any sex, with Virus Diseases or RNA Virus Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 demonstrate that the immunogenicity profile of the Quadrivalent VLP Vaccine meets the US Center for Biologics Evaluation and Research (CBER) licensure criteria. The study will also help to define the optimal dose, establish potential competitive advantages, and support the design of future studies.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Virus-like particle vaccinology, from bench to bedside.
    Mohsen MO, Bachmann MF. · · 2022 · cited 181× · PMID 35962190 · DOI 10.1038/s41423-022-00897-8
  2. Virus-like particle vaccines: immunology and formulation for clinical translation.
    Donaldson B, Lateef Z, Walker GF, Young SL, et al · · 2018 · cited 108× · PMID 30173619 · DOI 10.1080/14760584.2018.1516552
  3. Platforms, advances, and technical challenges in virus-like particles-based vaccines.
    Gupta R, Arora K, Roy SS, Joseph A, et al · · 2023 · cited 80× · PMID 36845125 · DOI 10.3389/fimmu.2023.1123805
  4. Plant Viruses and Bacteriophage-Based Reagents for Diagnosis and Therapy.
    Shukla S, Hu H, Cai H, Chan SK, et al · · 2020 · cited 27× · PMID 32991265 · DOI 10.1146/annurev-virology-010720-052252

Verify or expand the search:

Other recruiting trials for Virus Diseases

Currently open trials in the same condition.

Other Medicago trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02768805.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing