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Trial record 5 of 24 for:    Novavax

Quadrivalent Influenza VLP Vaccine Dose Ranging Study in Young Adults

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ClinicalTrials.gov Identifier: NCT02307851
Recruitment Status : Completed
First Posted : December 4, 2014
Last Update Posted : September 23, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

November 17, 2014
December 4, 2014
September 23, 2016
November 2014
June 2015   (Final data collection date for primary outcome measure)
  • 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)

  • 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.
Same as current
Complete list of historical versions of study NCT02307851 on ClinicalTrials.gov Archive Site
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)

Same as current
Not Provided
Not Provided
 
Quadrivalent Influenza VLP Vaccine Dose Ranging Study in Young Adults
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Influenza
  • Biological: Quadrivalent VLP Vaccine
  • Biological: Comparator TIV
  • Experimental: Group A
    Quadrivalent VLP vaccine, low dose, intramuscular injection (0.5mL)
    Intervention: Biological: Quadrivalent VLP Vaccine
  • Experimental: Group B
    Quadrivalent VLP vaccine, high dose, intramuscular injection (0.5mL)
    Intervention: Biological: Quadrivalent VLP Vaccine
  • Experimental: Group C
    Quadrivalent VLP vaccine, medium dose, intramuscular injection (0.5mL)
    Intervention: Biological: Quadrivalent VLP Vaccine
  • Active Comparator: Group D
    Comparator TIV, intramuscular injection (0.5mL)
    Intervention: Biological: Comparator TIV
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
June 2015
June 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 49 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02307851
FLU-SIQ-206
No
Not Provided
Not Provided
Novavax
Novavax
Department of Health and Human Services
Study Director: D Nigel Thomas, Ph.D. Novavax
Novavax
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP