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Plant-Derived Quadrivalent VLP Influenza Vaccine in Adults
NCT02768805Phase 2
Key facts
- Status
- Completed
- Start
- Mar 2016
- Primary completion
- May 2016
- Countries
- 2
- Sponsor
- Medicago Inc.
- Modality
- Recombinant Protein Vaccines
- Conditions
- influenza
01
Overview
Phase 2, randomised, single-blind trial of Quadrivalent VLP Vaccine in influenza (3 arms), sponsored by Medicago Inc. Primary endpoint: Geometric Mean Titers of Hemagglutination Inhibition Antibody against Homologous Influenza Strains at 21 days. Started Mar 2016; status: completed.
02
Design
3 arms- Study design
- RandomizedSingle-blind
15 µg VLP
15 µg/strain of Quadrivalent VLP Vaccine
30 µg VLP
30 µg/strain of Quadrivalent VLP Vaccine
FluLaval Tetra
15 µg/strain of licensed quadrivalent vaccine
03
Who it enrols
Healthy adults aged 18-64 with BMI 18.0-32.4 kg/m2. Excludes those with significant acute or chronic uncontrolled illness, autoimmune disease, immunosuppression, recent vaccination, or history of Guillain-Barre Syndrome.
04
Endpoints
Primary
Geometric Mean Titers of Hemagglutination Inhibition Antibody against Homologous Influenza Strains
Secondary
Geometric Mean Titers of Hemagglutination Inhibition Antibody against Heterologous Influenza Strains
Geometric Mean Titers of Microneutralization Antibody
Geometric Mean Titers of Single Radial Hemolysis Antibody
Cell-Mediated Immune Response
Incidence of Solicited Local and Systemic Reactions
Incidence of Treatment-Emergent Adverse Events
Incidence of Abnormal Clinical Laboratory Tests
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