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Phase 3 Pivotal Trial of NanoFlu™ in Older Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04120194
Recruitment Status : Completed
First Posted : October 9, 2019
Results First Posted : May 6, 2023
Last Update Posted : May 6, 2023
Sponsor:
Information provided by (Responsible Party):
Novavax

Study Description
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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 were formulated with the 4 influenza strains recommended for the 2019-20 Northern hemisphere influenza season. 2654 subjects were enrolled and randomized into 1 of 2 treatment groups to receive either NanoFlu or active comparator. Subjects were followed for approximately 1 year following injection; with primary immunogenicity analyses based on Day 28 sera. This trial was 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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2654 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
Actual Primary Completion Date : October 29, 2020
Actual Study Completion Date : December 13, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot Vaccines

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. HAI Antibody Responses for Vaccine Homologous Influenza Strains Expressed as Ratio of Geometric Mean Fold Ratio (GMFR) [ Time Frame: Day 28 ]
    Egg-Based HAI Assay responses for all 4 vaccine homologous influenza strains (ie, 2 influenza A and 2 influenza B strains) expressed as GMFR on Day 28

  2. Mean Difference in the Seroconversion Rate (SCR) HAI Antibody Responses for Vaccine Homologous Influenza Strains Expressed as a Percentage of Participants [ Time Frame: Day 0 - Day 28 ]
    Egg-Based HAI Assay responses for all 4 vaccine homologous influenza strains (ie, 2 influenza A and 2 influenza B strains) summarized in terms of SCR on Day 28

  3. Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) [ Time Frame: Day 0 - Day 6 ]
    Number of subjects with solicited local and systemic AEs over 7 days post-injection (ie, Day 0 through Day 6, inclusive).

  4. Number of Subjects With Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), Significant New Medical Conditions (SNMCs) [ Time Frame: Day 0 - Day 364 ]
    Number of subjects with Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), Significant New Medical Conditions (SNMCs) - including AESIs - through 1-year post-injection.

  5. Number of Subjects With MAAEs, SAEs, SNMCs [ Time Frame: Day 0 - Day 27 ]
    Number of subjects with MAEs, SAEs, and SNMCs - including AESIs.


Secondary Outcome Measures :
  1. HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain Expressed as Geometric Mean Titers (GMT) [ Time Frame: Day 0 - Day 28 ]
    Homologous influenza strains and 1 antigenically drifted strain expressed as GMT

  2. HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain Expressed as Geometric Mean Fold Ratio (GMFR) [ Time Frame: Day 28 - 364 ]
    Wild-Type HAI Assay Homologous influenza strains and 1 antigenically drifted strain expressed as GMFR.

  3. Subjects Who Seroconverted as Determined by HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain [ Time Frame: Day 28 - Day 364 ]
    Wild-Type HAI Assay Homologous Influenza Strains and at least 1 Antigenically Drifted Strain Expressed as Seroconversion Rate (SCR).

  4. Subjects Who Seroprotected as Determined by HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain Expressed as SPR [ Time Frame: Day 28 ]
    Homologous Influenza Strains and at least 1 Antigenically Drifted Strain Expressed as Seroprotection Rate (SPR).


Eligibility Criteria
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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.
Contacts and Locations
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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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Sponsors and Collaborators
Novavax
Investigators
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Study Director: Clinical Development Novavax, Inc.
  Study Documents (Full-Text)

Documents provided by Novavax:
Study Protocol  [PDF] October 31, 2019
Statistical Analysis Plan  [PDF] November 1, 2019

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Novavax
ClinicalTrials.gov Identifier: NCT04120194    
Other Study ID Numbers: qNIV-E-301
First Posted: October 9, 2019    Key Record Dates
Results First Posted: May 6, 2023
Last Update Posted: May 6, 2023
Last Verified: April 2023
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
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
 RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases