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A Study to Evaluate the Immune Response and Safety of a Seasonal Virus-Like Particle Influenza Vaccine in Healthy Young Adults

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ClinicalTrials.gov Identifier: NCT01561768
Recruitment Status : Completed
First Posted : March 23, 2012
Last Update Posted : July 18, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine the immune response of three dose levels of the Novavax Quadrivalent vaccine in healthy young adults (18-64). The study is broken down into 5 treatment groups. Each group will enroll 100 subjects, for a total of 500 subjects. Group 1-3 will receive one of three dose levels of the Novavax Quadrivalent vaccine, Group 4 will receive a dose of the Novavax Trivalent vaccine, and Group 5 will receive a commercially available trivalent influenza vaccine (TIV). The study will also evaluate the safety and tolerability of the Novavax Quadrivalent vaccine.

Condition or disease Intervention/treatment Phase
Influenza Biological: Novavax Quadrivalent vaccine Biological: Novavax Trivalent vaccine Biological: cTIV Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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 (18-64) Adults
Study Start Date : March 2012
Primary Completion Date : January 2013
Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Group 1 Biological: Novavax Quadrivalent vaccine
Quadrivalent VLP vaccine: low dose; intramuscular injection, deltoid
Experimental: Group 2 Biological: Novavax Quadrivalent vaccine
Quadrivalent VLP vaccine: medium dose; intramuscular injection, deltoid
Experimental: Group 3 Biological: Novavax Quadrivalent vaccine
Quadrivalent VLP vaccine: high dose; intramuscular injection, deltoid
Experimental: Group 4 Biological: Novavax Trivalent vaccine
Trivalent Dose; intramuscular injection, deltoid
Experimental: Group 5 Biological: cTIV
Preconfigured dose; intramuscular injection, deltoid

Outcome Measures

Primary Outcome Measures :
  1. Immunogenicity of 3 dose levels of the Novavax Quadrivalent vaccine based on HAI responses [ Time Frame: Day 21 ]
  2. Number of Solicited and Unsolicited Adverse Events for the Novavax Quadrivalent vaccine [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Estimate capacity of the Novavax Quadrivalent vaccines to fulfill FDA criteria (immunogenicity) for all strains in healthy, young adults [ Time Frame: Day 21 ]
    Based on criteria of greater than or equal to 40% HAI seroconversion and greater than or equal to 70% of subjects with HAI titers greater than or equal to 1:40 post-vaccination.

  2. Impact of including a fourth strain in the Novavax Quadrivalent vaccine on immune responses to other three strains [ Time Frame: Day 21 ]
    Based on comparison to a trivalent NovaFlu formulation tested at the 22.5ug of HA (per strain) dose level.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Healthy adult male or females, 18-64 years of age
  2. Willing and able to give informed consent prior to study enrollment
  3. Able to comply with study requirements
  4. Women who are not post-menopausal (≥ 50 years of age and at least one year post last menses) or surgically sterile 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 abstinence from heterosexual activity, hormonal contraceptives (oral, injectable, implant, patch, ring), double-barrier contraceptives (condom or diaphragm, with spermicide), and intrauterine device (IUD)

Exclusion Criteria:

  1. Participation in research involving investigational product (drug/biologic/device) within 45 days before planned date of first vaccination
  2. History of a serious reaction to prior influenza vaccination, known allergy to constituents of licensed TIV (e.g., egg proteins) or polysorbate-80
  3. History of Guillain-Barré Syndrome (GBS) within 6 weeks following a previous influenza vaccine
  4. Received any vaccine in the 4 weeks preceding the study vaccination and any influenza vaccine within six months preceding the study vaccination
  5. Any know or suspected immunosuppressive illness, congenital or acquired, based on medical history and/or physical examination
  6. 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 ≥10 mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted.
  7. Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study
  8. 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)
  9. Presence of chronic pulmonary (including asthma), cardiovascular (except hypertension), renal, hepatic, neurologic, hematologic or metabolic (including diabetes mellitus) disorders, which would include the potential subject in a "high-risk" category for influenza and/or its complications
  10. Known disturbance of coagulation
  11. Women who are breastfeeding or plan to become pregnant during the study
  12. Suspicion or recent history (within one year of planned vaccination) of alcohol or other substance abuse
  13. 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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01561768

Adelaide, Australia
Emeritus Research
Melbourne, Australia
Linear Clinical Research
Perth, Australia
Holdsworth House
Sydney, Australia
Sponsors and Collaborators
Department of Health and Human Services
Study Director: Nigel Thomas, Ph.D. Novavax
More Information

Additional Information:
Responsible Party: Novavax
ClinicalTrials.gov Identifier: NCT01561768     History of Changes
Other Study ID Numbers: NVX 778.S205
First Posted: March 23, 2012    Key Record Dates
Last Update Posted: July 18, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs