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Trial record 1 of 1 for:    NCT04120194
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Phase 3 Pivotal Trial of NanoFlu™ in Older Adults

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ClinicalTrials.gov Identifier: NCT04120194
Recruitment Status : Active, not recruiting
First Posted : October 9, 2019
Last Update Posted : October 30, 2019
Sponsor:
Information provided by (Responsible Party):
Novavax

Brief Summary:
A Phase 3, randomized, observer-blinded, active-controlled trial to evaluate the immunogenicity and safety of a recombinant quadrivalent nanoparticle influenza vaccine with Matrix-M1 adjuvant (NanoFlu) compared with a licensed quadrivalent inactivated influenza vaccine in adults ≥ 65 years of age. Both vaccines will be formulated with the 4 influenza strains recommended for the 2019-20 Northern hemisphere influenza season. Approximately 2650 subjects (1325 subjects/group) will be enrolled and randomized into 1 of 2 treatment groups to receive either NanoFlu or active comparator. Subjects will be followed for approximately 1 year following injection; with primary immunogenicity analyses based on Day 28 sera. This trial will be conducted in the United States at approximately 19 clinical sites.

Condition or disease Intervention/treatment Phase
Influenza, Human Biological: NanoFlu Biological: Fluzone Quadrivalent Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2650 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 3, Randomized, Observer-blinded, Active-controlled Trial to Evaluate Immunogenicity & Safety of a Recombinant Quadrivalent Nanoparticle Influenza Vaccine (Quad-NIV) With Matrix-M1™ Adjuvant Against Fluzone® Quadrivalent in Clinically Stable Adults ≥ 65 Years of Age
Actual Study Start Date : October 14, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: NanoFlu
NanoFlu will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.
Biological: NanoFlu
Investigational quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.
Other Name: Quad-NIV

Active Comparator: Fluzone Quadrivalent
Fluzone Quadrivalent will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.
Biological: Fluzone Quadrivalent
Licensed quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.




Primary Outcome Measures :
  1. Hemagglutination inhibition (HAI) titers of vaccine homologous influenza strains [ Time Frame: Day 0 - Day 28 ]
    Comparative HAI responses by ratio of geometric mean titers (GMTs) and seroconversion rate (SCR) difference

  2. Number of adverse events (AEs) [ Time Frame: Day 0 - Day 364 ]
    Solicited local and systemic AEs over 7 days post-injection; all AEs through 28 days post-injection; and medically-attended events (MAEs), serious adverse events (SAEs), and significant new medical conditions (SNMCs) though 1 year post-injection


Secondary Outcome Measures :
  1. HAI titers to all vaccine homologous influenza strains and at least 1 antigenically drifted strain [ Time Frame: Day 0 - Day 28 ]
    GMT, geometric mean ratio (GMR), SCR, seroprotection rate (SPR)


Other Outcome Measures:
  1. Cell-mediated immune (CMI) responses [ Time Frame: Day 0 - Day 28 ]
    Counts of peripheral blood effector memory T-cell populations



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Clinically-stable adult male or female, ≥ 65 years of age. Subjects may have 1 or more chronic medical diagnoses, but should be clinically stable as assessed by:

    • Ambulatory status, living independently in the community or in a residential facility providing minimal assistance (eg, meal preparation and transport),
    • Absence of changes in medical therapy within 1 month due to treatment failure or toxicity,
    • Absence of medical events qualifying as serious adverse events within the prior 2 months, and
    • Absence of known, current, and life-limiting diagnoses which render survival to completion of the protocol unlikely in the opinion of the investigator.
  2. Willing and able to give informed consent prior to trial enrollment, and
  3. Living in the community and able to attend trial visits, comply with trial requirements, and provide timely, reliable, and complete reports of adverse events.

Exclusion Criteria:

  1. Participation in research involving investigational product (drug / biologic / device) within 45 days before planned date of study vaccination.
  2. Participation in any previous Novavax influenza vaccine clinical trial(s).
  3. History of a serious reaction to prior influenza vaccination, known allergy to constituents of Fluzone Quadrivalent 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 trial vaccination and any influenza vaccine within 6 months preceding the trial vaccination.
  6. Any known or suspected immunosuppressive illness, congenital or acquired, based on medical history and/or physical examination.
  7. 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 trial 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.
  8. Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the trial vaccine.
  9. 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).
  10. 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 trial results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting).
  11. Known disturbance of coagulation.
  12. Suspicion or recent history (within 1 year of planned vaccination) of alcohol or other substance abuse.

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): NCT04120194


Locations
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United States, Florida
US135
Hollywood, Florida, United States, 33024
United States, Georgia
US045
Savannah, Georgia, United States, 31406
US013
Stockbridge, Georgia, United States, 30281
United States, Idaho
US012
Meridian, Idaho, United States, 83642
US032
Nampa, Idaho, United States, 83687
United States, Kansas
US003
Lenexa, Kansas, United States, 66219
United States, Maryland
US138
Rockville, Maryland, United States, 20854
United States, Nebraska
US025
Norfolk, Nebraska, United States, 68701
US018
Omaha, Nebraska, United States, 68134
United States, New York
US056
Binghamton, New York, United States, 13901
US017
Endwell, New York, United States, 13760
United States, Ohio
US030
Cleveland, Ohio, United States, 44122
United States, Oklahoma
US053
Oklahoma City, Oklahoma, United States, 73112
United States, Rhode Island
US044
Warwick, Rhode Island, United States, 02886
United States, South Carolina
US079
Mount Pleasant, South Carolina, United States, 29464
United States, South Dakota
US050
Dakota Dunes, South Dakota, United States, 57049
United States, Tennessee
US029
Nashville, Tennessee, United States, 37203
United States, Texas
US004
San Antonio, Texas, United States, 78229
US073
Tomball, Texas, United States, 77375
Sponsors and Collaborators
Novavax
Investigators
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Study Director: Vivek Shinde, MD Novavax, Inc.

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Responsible Party: Novavax
ClinicalTrials.gov Identifier: NCT04120194     History of Changes
Other Study ID Numbers: qNIV-E-301
First Posted: October 9, 2019    Key Record Dates
Last Update Posted: October 30, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs