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Phase 2 Dose and Formulation Confirmation of Quad-NIV in Older Adults

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ClinicalTrials.gov Identifier: NCT03658629
Recruitment Status : Terminated (This study was terminated 182 days after initial dosing.)
First Posted : September 5, 2018
Results First Posted : November 4, 2022
Last Update Posted : November 4, 2022
Sponsor:
Information provided by (Responsible Party):
Novavax

Study Description
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Brief Summary:

A Phase 2 trial to confirm the dose and formulation, demonstrate adjuvant effect, and evaluate the safety and tolerability of a single intramuscular injection of Quad-NIV with or without Matrix-M1 adjuvant in healthy adults ≥ 65 years of age.

A total of approximately 1375 subjects were to be randomized to seven treatment groups to receive Quad-NIV or an active comparator.


Condition or disease Intervention/treatment Phase
Influenza, Human Biological: NanoFlu (Quad-NIV) Other: Matrix-M Adjuvant Other: Placebo Biological: Fluzone HD Biological: Flublok Quadrivalent Biological: Influenza Vaccine Phase 2

Detailed Description:

This randomized, observer-blind, active-controlled, Phase 2 trial was conducted at multiple sites. The composition of the Quad-NIV Influenza Vaccines used in this trial included recombinant H1, H3, and two B hemagglutinin proteins for the 2018-2019 Northern Hemisphere influenza virus strains.

Approximately 1375 healthy male and female subjects ≥ 65 years were randomized into 7 treatment groups (group A to group G), receiving various formulations of Quad-NIV, with or without Matrix-M1 adjuvant or one of two active comparator influenza vaccines. Within each site, randomization was stratified by history of receipt of 2017-2018 influenza vaccine. Subjects received two injections 28 days apart. On Day 0, subjects received one of the five Quad-NIV formulations or one of the two comparator influenza vaccines. On Day 28, subjects received either placebo or a licensed influenza vaccine rescue dose, depending on his or her initial randomization.

Subjects were followed for safety for approximately 6 months, with primary immunogenicity results at Day 28.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1375 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase 2 Clinical Trial to Confirm the Dose and Formulation of a Recombinant Quadrivalent Nanoparticle Influenza Vaccine (Quad-NIV) With or Without Matrix-M1™ Adjuvant in Healthy Adults ≥ 65 Years of Age
Actual Study Start Date : September 24, 2018
Actual Primary Completion Date : April 26, 2019
Actual Study Completion Date : April 26, 2019

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: Dose A
Alternating deltoid injections of Quad-NIV (60 µg HA per A strain and B strain; in-clinic mix with 50 µg of Matrix-M1) on Day 0 and Placebo on Day 28.
 Biological: NanoFlu (Quad-NIV)
2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine

Other: Matrix-M Adjuvant
Adjuvant

Other: Placebo
Placebo
Experimental: Dose B
Alternating deltoid injections of Quad-NIV (60 µg HA per A strain and B strain; co-formulated with 50 µg of Matrix-M1) on Day 0 and Placebo on Day 28.
 Biological: NanoFlu (Quad-NIV)
2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine

Other: Matrix-M Adjuvant
Adjuvant

Other: Placebo
Placebo
Experimental: Dose C
Alternating deltoid injections of Quad-NIV (60 µg HA per A strain and B strain; co-formulated with 75 µg of Matrix-M1) on Day 0 and Placebo on Day 28.
 Biological: NanoFlu (Quad-NIV)
2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine

Other: Matrix-M Adjuvant
Adjuvant

Other: Placebo
Placebo
Experimental: Dose D
Alternating deltoid injections of Quad-NIV (60 µg HA per A strain and 90 µg HA per B strain; co-formulated with 50 µg of Matrix-M1) on Day 0 and Placebo on Day 28.
 Biological: NanoFlu (Quad-NIV)
2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine

Other: Matrix-M Adjuvant
Adjuvant

Other: Placebo
Placebo
Experimental: Dose E
Alternating deltoid injections of Quad-NIV (60 µg HA per A and B strain without adjuvant) on Day 0 and Licensed 2018-2019 Influenza vaccine on Day 28.
 Biological: NanoFlu (Quad-NIV)
2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine

Biological: Influenza Vaccine
2018-19 Licensed Seasonal Influenza Vaccine
Experimental: Dose F
Alternating deltoid injections of 2018-2019 High-Dose Trivalent Vaccine on Day 0 and Placebo on Day 28.
 Other: Placebo
Placebo

Biological: Fluzone HD
2018-2019 Licensed Trivalent Seasonal Influenza Vaccine
Experimental: Dose G
Alternating deltoid injections of 2018-2019 Quadrivalent Vaccine on Day 0 and Placebo on Day 28.
 Other: Placebo
Placebo

Biological: Flublok Quadrivalent
2018-2019 Licensed Quadrivalent Seasonal Influenza Vaccine


Outcome Measures
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Primary Outcome Measures :
  1. Number of Subjects With Adverse Events (AEs) [ Time Frame: Day 0 - Day 182 ]
    Adverse Events over the 7 days post-injection; all adverse events (including adverse changes in clinical laboratory parameters) through 21 days post-injection; and Medically Attended Adverse Events (MAEs), Serious Adverse Events (SAEs), and Significant New Medical Conditions (SNMCs) through 6 months post-injection.

  2. Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) [ Time Frame: Day 0 - Day 28 ]
    HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B strain(s) at Days 0 and Day 28 post-vaccination expressed as geometric man titer (GMT).

  3. HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT [ Time Frame: Day 0 - Day 28 ]
    HAI antibody titers specific for at least 2 antigenically-drifted influenza strains, at Days 0 and 28 post-vaccination expressed as geometric man titer (GMT).


Secondary Outcome Measures :
  1. HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT [ Time Frame: Day 0 - Day 182 ]
    HAI antibody titers specific for the HA receptor binding domains of vaccine-homologous A and B strain(s) expressed as GMT on Day 0,28,56 and 182.

  2. HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) [ Time Frame: Day 28 - Day 182 ]
    HAI antibody titers specific for the HA receptor binding domains of vaccine-homologous A and B strain(s) expressed as GMFR on Day 28,56 and 182.

  3. Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains [ Time Frame: Day 28 - Day 182 ]
    HAI antibody titers specific for the HA receptor binding domains of vaccine-homologous A and B strain(s) expressed as SCR on Day 28,56 and 182.

  4. Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains [ Time Frame: Day 28 - Day 182 ]
    HAI antibody titers specific for the HA receptor binding domains of vaccine-homologous A and B strain(s) expressed as SPR on Day 28,56 and 182.

  5. HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT [ Time Frame: Day 0 - Day 182 ]
    HAI antibody titers specific for antigenically-drifted influenza strains, at Days 0,28, 56 and 182 expressed as geometric man titer (GMT).

  6. HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR [ Time Frame: Day 28 - Day 182 ]
    HAI antibody titer responses specific for antigenically-drifted influenza strains, at Days 28, 56, and 182 expressed as Geometric Fold Ratio.

  7. Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains [ Time Frame: Day 28 - Day 182 ]
    HAI antibody titers specific for antigenically-drifted influenza strains, at Days 28, 56 and 182 expressed as SCR.

  8. Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains [ Time Frame: Day 28 - Day 182 ]
    HAI antibody titers specific for antigenically-drifted influenza strains, at Days 28, 56 and 182 expressed as SPR.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

    • 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 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 first injection.
  2. Participation in any previous Novavax's influenza vaccine clinical trial(s).
  3. History of a serious reaction to prior influenza vaccination, known allergy to constituents of licensed comparator vaccines 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 or during the trial.
  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): NCT03658629


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, Maryland
US138
Rockville, Maryland, United States, 20854
United States, Nebraska
US025
Norfolk, Nebraska, United States, 68701
US018
Omaha, Nebraska, United States, 68134
United States, North Carolina
US078
Cary, North Carolina, United States, 27518
US108
Raleigh, North Carolina, United States, 27609
US137
Salisbury, North Carolina, United States, 28144
US132
Statesville, North Carolina, United States, 28625
US071
Wilmington, North Carolina, United States, 28401
US063
Winston-Salem, North Carolina, United States, 27103
United States, South Carolina
US056
Moncks Corner, South Carolina, United States, 29461
United States, South Dakota
US050
Dakota Dunes, South Dakota, United States, 57049
Sponsors and Collaborators
Novavax
Investigators
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Study Director: Clinical Development Novavax
  Study Documents (Full-Text)

Documents provided by Novavax:
Study Protocol  [PDF] August 21, 2018
Statistical Analysis Plan  [PDF] March 4, 2020

More Information
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Additional Information:

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

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Responsible Party: Novavax
ClinicalTrials.gov Identifier: NCT03658629    
Other Study ID Numbers: qNIV-E-201
First Posted: September 5, 2018    Key Record Dates
Results First Posted: November 4, 2022
Last Update Posted: November 4, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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