A Phase 3 Study to Assess the Efficacy, Safety, and Immunogenicity of a Plant-Derived Quadrivalent VLP Influenza Vaccine in Adults 18-64 Years of Age
- Conditions
- Seasonal influenzaMedDRA version: 20.0Level: PTClassification code 10022000Term: InfluenzaSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2017-001239-38-FI
- Lead Sponsor
- Medicago R&D Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 10000
Subjects must meet all of the following inclusion criteria to be eligible for participation in this
study:
1. Subjects must be able to read, understand, and sign the informed consent form (ICF); complete study-related procedures; and communicate with the study staff at visits and by phone;
2. Subject must have a body mass index (BMI) below 40 kg/m2;
3. Subjects are considered by the Investigator to be reliable and likely to cooperate with the assessment procedures and be available for the duration of the study;
4. Male and female subjects must be 18 to 64 (has not yet had his/her 65th birthday) years of age, inclusive, at the Screening/Vaccination visit (Visit 1);
5. Subjects must be in good general health prior to study participation, with no clinically relevant abnormalities that could jeopardize subject safety or interfere with study assessments, as assessed by the Principal Investigator or sub-Investigator (there after referred as Investigator) and determined by medical history, physical examination, and vital signs;
Note: Subjects with a pre-existing chronic disease will be allowed to participate if the disease is stable and, according to the Investigator’s judgment, the condition is unlikely to confound the results of the study or pose additional risk to the subject by participating in the study. Stable disease is generally defined as no new onset or exacerbation of pre-existing chronic disease three months prior to vaccination. Based on the Investigator’s judgment, a subject with more recent stabilization of a disease could also be eligible.
6. Female subjects must have a negative urine pregnancy test result at the Screening/Vaccination visit (Visit 1);
7. Female subjects of childbearing potential must use an effective method of contraception for one month prior to vaccination and agree to continue employing adequate birth control measures for at least 60 days post-vaccination. Moreover, female subjects must have no plan to become pregnant for at least two months post-vaccination. Abstinent subjects should be asked what method(s) they would use should their circumstances change, and subjects without a well-defined plan should be excluded. The following relationship or methods of contraception are considered to be effective:
- Hormonal contraceptives (e.g. injectable, topical [patch], or estrogenic vaginal ring);
- Intra-uterine device with or without hormonal release;
- Male partner using a condom plus spermicide or sterilized partner (at least one year prior to vaccination);
- Credible self-reported history of heterosexual abstinence until at least 60 days postvaccination;
- Female partner;
8. Non-childbearing females are defined as:
- Surgically-sterile (defined as bilateral tubal ligation, hysterectomy or bilateral oophorectomy performed more than one month prior to vaccination); or
- Post-menopausal (absence of menses for 24 consecutive months and age consistent with natural cessation of ovulation).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10000
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
Subjects who meet any of the following criteria will be excluded from participating in this study:
1. Any subject whose medical condition(s) is sufficiently severe that annual influenza vaccination would be routinely recommended in the jurisdiction of recruitment;
2. According to the Investigator’s opinion, history of significant acute or chronic, uncontrolled medical or neuropsychiatric illness. ‘Uncontrolled’ is defined as:
- Requiring a new medical or surgical treatment during the three months prior to study vaccine administration unless the criteria outlined in inclusion criterion no. 5 can be met (i.e. the Investigator can justify inclusion based upon the innocuous nature of medical/surgical events and/or treatments);
- Requiring any significant change in a chronic medication (i.e. drug, dose, frequency) during the three months prior to study vaccine administration due to uncontrolled symptoms or drug toxicity unless the innocuous nature of the medication change meets the criteria outlined in inclusion criterion no. 5 and is appropriately justified by the Investigator.
3. Any medical or neuropsychiatric condition or any history of excessive alcohol use or drug abuse which, in the Investigator’s opinion, would render the subject unable to provide informed consent or unable to provide valid safety observations and reporting;
4. Any autoimmune disease other than hypothyroidism on stable replacement therapy (including, but not limited to rhematoid arthritis, systemic lupus erythematosus, Crohn’s disease, and inflammatory bowel disease) or any confirmed or suspected immunosuppressive condition or immunodeficiency including known or suspected human immunodeficiency virus (HIV), Hepatitis B or C infection, the presence of lymphoproliferative disease;
5. History of chronic pulmonary (including asthma, bronchopulmonary dysplasia, and cystic fibrosis) or cardiovascular (except isolated hypertension), renal, hepatic, neurologic, hematologic (including anemia and hemoglobinopathy), or metabolic disorders (including diabetes mellitus);
6. Because this is a placebo-controlled study, any subjects in close contact with individuals considered to be at high risk for developing influenza-related complications (individuals considered at high risk for complications include adults and children who have chronic pulmonary or cardiovascular [except isolated hypertension], renal, hepatic, neurologic, hematologic, or metabolic disorders [including diabetes mellitus]);
7. Administration or planned administration of any non-influenza vaccine within 30 days prior to randomization up to blood sampling on Day 21. Immunization on an emergency basis will be evaluated case-by-case by the Investigator;
8. Administration of any adjuvanted or investigational influenza vaccine within one year prior to randomization or planned administration prior to the completion of the study;
9. Administration of any ‘standard’, non-adjuvanted influenza vaccine (e.g. live attenuated trivalent/quadrivalent inactivated influenza vaccine or split trivalent/quadrivalent inactivated influenza vaccine administered by intranasal, intradermal, or IM route) within six months prior to randomization and up to completion of the study;
10. Use of any investigational or non-registered product within 30 days or five half-lives, whichever is longer, prior to randomization or planned use during the study period. Subjects may not participate in any other investigational or marketed drug study while pa
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