A clinical trial to investigate a plant-derived flu vaccine in adults 65 years of age and older in order to assess efficacy, safety and to see how well it works at generating an immune response.

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 12000

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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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