- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02307851
Quadrivalent Influenza VLP Vaccine Dose Ranging Study in Young Adults
September 20, 2016 updated by: Novavax
A Phase 2 Randomized, Observer-Blind, Dose-Ranging Study to Evaluate the Immunogenicity and SAfety of Quadrivalent Seasonal Virus-Like Particle (VLP) Influenza Vaccine (Recombinant) in Healthy Young (18-49) Adults
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
400
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Anaheim, California, United States, 92801
- Anaheim Clinical Trials
-
-
Florida
-
Miami, Florida, United States, 33143
- Miami Research Associates
-
-
Kansas
-
Lenexa, Kansas, United States, 66219
- Johnson County Clin Trials
-
-
Nebraska
-
Omaha, Nebraska, United States, 68134
- Meridian Clinical Research
-
-
Texas
-
San Antonio, Texas, United States, 78229
- Clinical Trials of Texas
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 49 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy adult male or female, 18-49 years of age
- Willing and able to give informed consent prior to study enrollment
- Able to comply with study requirements
- 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:
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 exclusion criteria 2,5,8,9).
- Participation in research involving investigational product (drug/ biologic/ device) within 45 days before planned date of first vaccination
- History of a serious reaction to prior influenza vaccination, known allergy to constituents of licensed TIV (e.g., egg proteins) or polysorbate-80.
- History of Guillain-Barré Syndrome (GBS) within 6 weeks following a previous influenza vaccine.
- Received any vaccine in the 4 weeks preceding the study vaccination and any influenza vaccine within six months preceding the study vaccination.
- History of receipt of any avian influenza vaccine containing an H5 antigen, or known exposure to birds infected with an H5 virus.
- Any known or suspected immunosuppressive illness, congenital or acquired, based on medical history and/or physical examination.
- Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine. An immunosuppressant dose of glucocorticoid will be defined as a systemic dose greater or equal to 10mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted.
- Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or during the study.
- Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature >38.0°C on the planned day of vaccine administration.
- Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled or could interfere with evaluation of the vaccine or interpretation of study results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting).
- Known disturbance of coagulation.
- Women who are breastfeeding or plan to become pregnant during the study.
- Suspicion or recent history (within one year of planned vaccination) of alcohol or other substance abuse.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A
Quadrivalent VLP vaccine, low dose, intramuscular injection (0.5mL)
|
|
Experimental: Group B
Quadrivalent VLP vaccine, high dose, intramuscular injection (0.5mL)
|
|
Experimental: Group C
Quadrivalent VLP vaccine, medium dose, intramuscular injection (0.5mL)
|
|
Active Comparator: Group D
Comparator TIV, intramuscular injection (0.5mL)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immunogenicity of the quadrivalent VLP vaccine using HAI responses.
Time Frame: Up to 6 months
|
Derived/calculated endpoints based on: Seroconversion rate (SCR) Seroprotection rate (SPR) Geometric mean titer (GMT) Geometric mean ratio (GMR) |
Up to 6 months
|
Safety of three quadrivalent VLP vaccine formulations. adverse events, Medically Attended Events (MAEs), Serious Adverse Events (SAEs), and Significant New medical Conditions (SNMCs)
Time Frame: 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.
|
Up to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immunogenicity of each quadrivalent VLP vaccine formulation measured by neuraminidase inhibition (NAI)
Time Frame: 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) |
Up to 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: D Nigel Thomas, Ph.D., Novavax
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2014
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
November 17, 2014
First Submitted That Met QC Criteria
December 1, 2014
First Posted (Estimate)
December 4, 2014
Study Record Updates
Last Update Posted (Estimate)
September 23, 2016
Last Update Submitted That Met QC Criteria
September 20, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FLU-SIQ-206
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Influenza
-
Novartis VaccinesCompletedInfluenza | Seasonal Influenza | Human Influenza | Influenza Due to Unspecified Influenza VirusBelgium
-
Gamaleya Research Institute of Epidemiology and...CompletedInfluenza A | Influenza A Virus Infection | Influenza Epidemic | Influenza H5N1Russian Federation
-
Vanderbilt University Medical CenterHuman Vaccines ProjectCompletedVaccine Reaction | Influenza | Influenza, Human | Influenza A | Influenza Type B | Influenza A H3N2 | Influenza A H1N1United States
-
National Institute of Allergy and Infectious Diseases...Completed
-
National Institute of Allergy and Infectious Diseases...Completed
-
National Institute of Allergy and Infectious Diseases...CompletedInfluenza Immunisation | Avian InfluenzaUnited States
-
National Institute of Allergy and Infectious Diseases...CompletedInfluenza | Influenza Immunisation | Avian InfluenzaUnited States
-
National Institute of Allergy and Infectious Diseases...CompletedInfluenza Immunisation | Avian InfluenzaUnited States
-
National Institute of Allergy and Infectious Diseases...National Institutes of Health (NIH)CompletedInfluenza AUnited States
-
National Institute of Allergy and Infectious Diseases...CompletedInfluenza Immunisation | Avian InfluenzaUnited States
Clinical Trials on Quadrivalent VLP Vaccine
-
MedicagoCompletedRNA Virus Infections | Virus Diseases | Respiratory Tract Infections | Respiratory Tract DiseasesCanada
-
MedicagoCompletedRNA Virus Infections | Virus Diseases | Respiratory Tract Infections | Respiratory Tract DiseasesUnited States
-
MedicagoCompletedRNA Virus Infections | Virus Diseases | Respiratory Tract Infections | Respiratory Tract DiseasesUnited States
-
MedicagoCompletedRNA Virus Infections | Virus Diseases | Respiratory Tract Infections | Respiratory Tract Diseases | InfluenzaUnited States, Canada, Finland, Germany, Philippines, Thailand, United Kingdom
-
MedicagoCompletedRNA Virus Infections | Virus Diseases | Respiratory Tract Infections | Influenza | Respiratory Tract DiseaseCanada
-
Cancer Institute and Hospital, Chinese Academy...UnknownCervical Cancer | HPV Infections | Precancerous Disease of the Cervix | HPV Related Diseases
-
MedicagoCompletedRNA Virus Infections | Virus Diseases | Respiratory Tract Infections | Respiratory Tract DiseasesUnited States, Canada
-
MedicagoCompletedRNA Virus Infections | Virus Diseases | Respiratory Tract Infections | Respiratory Tract DiseasesUnited States, Canada, Finland, Germany, Thailand
-
Merck Sharp & Dohme LLCCompletedPapillomavirus Infections | Genital Diseases, Female
-
MedicagoCompletedRNA Virus Infections | Virus Diseases | Respiratory Tract Infections | Respiratory Tract DiseasesUnited States, Canada