Quadrivalent Influenza VLP Vaccine Dose Ranging Study in Young Adults

NCT02307851 | Completed Phase 2

• 1 other identifier: FLU-SIQ-206
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 5

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.

Conditions

Influenza

Outcome Measures

Primary Outcomes (2)

• Immunogenicity of the quadrivalent VLP vaccine using HAI responses.

  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)

  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 Outcomes (1)

• Immunogenicity of each quadrivalent VLP vaccine formulation measured by neuraminidase inhibition (NAI)

  Up to 6 months

Study Arms (4)

Group A

EXPERIMENTAL

Quadrivalent VLP vaccine, low dose, intramuscular injection (0.5mL)

Biological: Quadrivalent VLP Vaccine

Group B

EXPERIMENTAL

Quadrivalent VLP vaccine, high dose, intramuscular injection (0.5mL)

Biological: Quadrivalent VLP Vaccine

Group C

EXPERIMENTAL

Quadrivalent VLP vaccine, medium dose, intramuscular injection (0.5mL)

Biological: Quadrivalent VLP Vaccine

Group D

ACTIVE COMPARATOR

Comparator TIV, intramuscular injection (0.5mL)

Biological: Comparator TIV

Interventions

Quadrivalent VLP Vaccine BIOLOGICAL

Group A; Group B; Group C

Comparator TIV BIOLOGICAL

Group D

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care.
• 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.

Sponsors & Collaborators

• Novavax: lead
• Department of Health and Human Services: collaborator

Study Sites (5)

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Location

Miami Research Associates

Miami, Florida, 33143, United States

Location

Johnson County Clin Trials

Lenexa, Kansas, 66219, United States

Location

Meridian Clinical Research

Omaha, Nebraska, 68134, United States

Location

Clinical Trials of Texas

San Antonio, Texas, 78229, United States

Location

Related Links

• Novavax, Inc.

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• D Nigel Thomas, Ph.D.

  Novavax

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2014
• First Posted: December 4, 2014
• Study Start: November 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: September 23, 2016

Record last verified: 2016-09

Locations

US (5)