Seasonal influenza MedDRA version: 20.0 Level: PT Classification code 10022000 Term: Influenza System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Quadrivalent VLP Influenza Vaccine
Pharmaceutical Form: Suspension for injection in pre-filled syringe
INN or Proposed INN: Quadrivalent VLP Influenza Vac
Sponsors
Medicago R&D Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must have read, understood, and signed the informed consent form (ICF); Subject must have a body mass index (BMI) = 35 kg/m^2; Male and female subjects must be 65 years of age and older at the Screening/Vaccination visit (Visit 1); Subjects must be non-institutionalized (e.g. not living in rehabilitation centres or old-age homes; living in an elderly community is acceptable) and have no acute or evolving medical problems prior to study participation and no clinically relevant abnormalities that could jeopardize subject safety or interfere with study assessments Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12000
Exclusion criteria
Exclusion criteria: According to the Investigator’s opinion, history of an ongoing acute or evolving medical or neuropsychiatric illness (see protocol for definition of 'evolving'); Any autoimmune disease other than hypothyroidism on stable replacement therapy or any confirmed or suspected immunosuppressive condition or immunodeficiency; Any history of status asthmaticus or ongoing serious problems with asthma, hospitalization for asthma control, or recurrent asthma episodes requiring medical attention in the last three years; Administration or planned administration of any non-influenza vaccine within 30 days prior to randomization up to blood sampling on Day 21; Administration of any adjuvanted or investigational influenza vaccine within one year prior to randomization or planned administration prior to the completion of the study; Administration of any ‘standard’, non-adjuvanted influenza vaccine within six months prior to randomization and up to completion of the study (see protocol for definition of 'standard'); Treatment with systemic glucocorticoids at a dose exceeding 10 mg of prednisone (or equivalent) per day for more than seven consecutive days or for ten or more days in total, within one month of study vaccine administration; any other cytotoxic or immunosuppressant drug, or any immunoglobulin preparation within three months of vaccination and until the completion of the study; Any significant disorder of coagulation including, but not limited to, treatment with warfarin derivatives or heparin; History of allergy to any of the constituents of the Quadrivalent VLP Influenza Vaccine, any components of the active comparator quadrivalent vaccine, or tobacco; History of anaphylactic allergic reactions to plants or plants components; Use of antihistamines, prophylactic medications against influenza or antiviral treatment, or have a blood transfusion prior to study vaccination (see protocol for applicable time periods); Daily use of large doses of medication for pain control or inflammation; Have a rash, dermatological condition, tattoos, muscle mass at the injection site; Presence of any febrile illness within 24 hours prior to vaccination; Cancer or treatment for cancer within three years prior to study vaccine administration; Subjects with a history of Guillain-Barré Syndrome.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy, relative to an active comparator, of a single 30 µg/strain dose of the Quadrivalent VLP Influenza Vaccine, protocol-defined influenza-like illness (ILI) caused by any influenza viral types/subtypes (matched, mis-matched and un-typed).;Timepoint(s) of evaluation of this end point: = 14 days post-vaccination; Secondary Objective: Efficacy To evaluate efficacy, relative to active comparator, of a single dose of test IMP (Quadrivalent VLP Influenza Vaccine), against laboratory-confirmed protocol-defined ILI caused by vaccine-matched strains; To evaluate efficacy, relative to active comparator, of a single dose of test IMP, against laboratory-confirmed protocol-defined respiratory illness caused by vaccine-matched strains or any influenza viral types/subtypes (matched, mismatched, and un-typed); To evaluate efficacy, relative to an active comparator, of a single dose of test IMP, as measured by the incidence of subjects presenting with symptoms of protocol-defined ILI, regardless of laboratory results. Safety To assess safety and tolerability, relative to an active comparator, of a single dose of test IMP. Immunogenicity (Subset of subjects) To assess immunogenicity of a single dose of test IMP as measured by HI assay, MN assay & SRH assay against homologous and heterologous (HI only) influenza strains ; Primary end point(s): Vaccine efficacy will be defined as per by the applicable regulatory region-specific case definition as follows: Occurrences of protocol-defined ILI due to laboratory-confirmed influenza (= 14 days post-vaccination) caused by any influenza viral types/subtypes (matched, mismatched and un-typed). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy Occurrences of laboratory-confirmed influenza illnesses (according to protocol defined ILI) caused by influenza viral types/subtypes that are matched (and/or antigenically similar) to the strains covered in the vaccine formulation; Occurrences of laboratory-confirmed influenza illnesses (according to protocol defined respiratory illness) caused by any influenza viral types/subtypes (matched, mismatched, and un-typed); Occurrences of laboratory-confirmed influenza illnesses (according to protocol defined respiratory illness) caused by any influenza viral types/subtypes that are matched (and/or antigenically similar) to the strains covered in the vaccine formulation; Occurrences of protocol-defined ILI (confirmed or not by laboratory testing). Safety Percentage, intensity, and relationship to vaccination of immediate complaints (15 minutes post-vaccination); Percentage, intensity, and relationship to vaccination of solicited local and systemic signs and symptoms (for seven days following study vaccine administration); Percentage, intensity, and relationship of TEAEs for 21 days following study vaccine administration; Occurrences of deaths, SAEs, AEs leading to withdrawal, and NOCDs up to the end of the surveillance period. Immunogenicity (subset of subjects): HI antibody response induced against the homologous and heterologous influenza strains on Days 0 and 21 will be assessed in a subset of 420 subjects (210 from each of the two treatment groups). HI antibody titers will be analyzed using the following parameters: geometric mean titer (GMT), seroconversion (SC) rate, seroprotection (SP) rate, and geometric mean fold rise (GMFR); MN antibody response induced by the Quadrivalent VLP Influenza Vaccine against the homologous influenza strains on | — |
Countries
Canada, Finland, Germany, United States
Contacts
Public ContactDaniel Croteau
Medicago R&D Inc
Outcome results
None listed