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

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:

  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 exclusion criteria 2,5,8,9).
  2. Participation in research involving investigational product (drug/ biologic/ device) within 45 days before planned date of first vaccination
  3. History of a serious reaction to prior influenza vaccination, known allergy to constituents of licensed TIV (e.g., egg proteins) or polysorbate-80.
  4. History of Guillain-Barré Syndrome (GBS) within 6 weeks following a previous influenza vaccine.
  5. Received any vaccine in the 4 weeks preceding the study vaccination and any influenza vaccine within six months preceding the study vaccination.
  6. History of receipt of any avian influenza vaccine containing an H5 antigen, or known exposure to birds infected with an H5 virus.
  7. Any known or suspected immunosuppressive illness, congenital or acquired, based on medical history and/or physical examination.
  8. 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.
  9. Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or during the study.
  10. 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.
  11. 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).
  12. Known disturbance of coagulation.
  13. Women who are breastfeeding or plan to become pregnant during the study.
  14. 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

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

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.

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