Influenza
Conditions
Brief summary
The purpose of this study is to determine the immune response of three dose levels of the Quadrivalent VLP vaccine in healthy young (18-49) adults. The study is broken down into four treatment groups. Each group will enroll 100 subjects, for a total of 400 subjects. Groups A-C will receive one of three dose levels of the Quadrivalent VLP vaccine, and Group D will receive a commercially available trivalent influenza vaccine (TIV). The study will also evaluate the safety and tolerability of the Quadrivalent VLP vaccine formulations.
Interventions
BIOLOGICALQuadrivalent VLP Vaccine
BIOLOGICALComparator TIV
Sponsors
Department of Health and Human Services
Novavax
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy adult male or female, 18-49 years of age 2. Willing and able to give informed consent prior to study enrollment 3. Able to comply with study requirements 4. Women of child-bearing potential must have a negative urine pregnancy test at vaccination, will be advised through the Informed Consent process to avoid becoming pregnant over the duration of the study, and must assert that they will employ an effective form of birth control for the duration of the study. Acceptable forms of birth control are: credible history of continuous abstinence from heterosexual activity, or prior surgical sterilization, hormonal contraceptives (oral, injectable, implant, patch, ring), barrier contraceptives (condom or diaphragm), and intrauterine device (IUD). Women with an adequately documented history of surgical sterility are exempt from urine pregnancy testing.
Exclusion criteria
1. Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care. * Asymptomatic conditions or findings (e.g., mild hypertension, dyslipidemia) that are not associated with evidence of end-organ damage are not exclusionary provided that they are being appropriately managed and are clinically stable (i.e., unlikely to result in symptomatic illness within the time-course of this study) in the opinion of the investigator. * Acute or chronic illnesses or conditions which may be reasonably predicted to become symptomatic if treatment were withdrawn or interrupted are exclusionary, even if stable. * Acute or chronic illnesses reasonably expected to be associated with increased risks associated with influenza (e.g., cardio-pulmonary diseases, diabetes mellitus, renal or hepatic dysfunction, hemoglobinopathies) are exclusionary, even if stable. * Note that illnesses or conditions may be exclusionary, even if otherwise stable, due to therapies used to treat them (see
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity of the quadrivalent VLP vaccine using HAI responses. | Up to 6 months | Derived/calculated endpoints based on: Seroconversion rate (SCR) Seroprotection rate (SPR) Geometric mean titer (GMT) Geometric mean ratio (GMR) |
| Safety of three quadrivalent VLP vaccine formulations. adverse events, Medically Attended Events (MAEs), Serious Adverse Events (SAEs), and Significant New medical Conditions (SNMCs) | Up to 6 months | Number and percentage of subjects with solicited local and systemic adverse events over the seven days post-injections; all adverse events (including adverse changes in clinical laboratory parameters) over 21 days post-injections; and Medically Attended Events (MAEs), Serious Adverse Events (SAEs), and Significant New medical Conditions (SNMCs) through six months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity of each quadrivalent VLP vaccine formulation measured by neuraminidase inhibition (NAI) | Up to 6 months | Derived/calculated endpoints based on: Two fold and four fold increases in NAI titer Geometric mean titer (GMT) Geometric mean ratio (GMR) |
Countries
United States
Outcome results
None listed