AzTrials
AzTrials

Influenza, HumanPhase 3NCT04120194

Phase 3 Pivotal Trial of NanoFlu™ in Older Adults

A Phase 3 study testing NanoFlu and Fluzone Quadrivalent in people with Influenza, Human, run by Novavax at 19 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Influenza, Human
What is being tested?
NanoFlu and Fluzone Quadrivalent
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,654 participants
Where
19 sitesUnited States
Study dates
14 Oct 2019to 13 Dec 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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.
  • Willing and able to give informed consent prior to trial enrollment, and
  • Living in the community and able to attend trial visits, comply with trial requirements, and provide timely, reliable, and complete reports of adverse events.

Who cannot join

  • Participation in research involving investigational product (drug / biologic / device) within 45 days before planned date of study vaccination.
  • Participation in any previous Novavax influenza vaccine clinical trial(s).
  • History of a serious reaction to prior influenza vaccination, known allergy to constituents of Fluzone Quadrivalent or polysorbate 80.
  • History of Guillain-Barré Syndrome (GBS) within 6 weeks following a previous influenza vaccine.
  • Received any vaccine in the 4 weeks preceding the trial vaccination and any influenza vaccine within 6 months preceding the trial vaccination.
  • Any known or suspected immunosuppressive illness, congenital or acquired, based on medical history and/or physical examination.
Show all 12Show fewer
  • 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.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the trial vaccine.
  • 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).
  • 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).
  • Known disturbance of coagulation.
  • Suspicion or recent history (within 1 year of planned vaccination) of alcohol or other substance abuse.

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

United States19 sites

  • US056

    Binghamton, New York, 13901

  • US030

    Cleveland, Ohio, 44122

  • US050

    Dakota Dunes, South Dakota, 57049

  • US017

    Endwell, New York, 13760

  • US135

    Hollywood, Florida, 33024

  • US003

    Lenexa, Kansas, 66219

  • US012

    Meridian, Idaho, 83642

  • US079

    Mt. Pleasant, South Carolina, 29464

  • US032

    Nampa, Idaho, 83687

  • US029

    Nashville, Tennessee, 37203

  • US025

    Norfolk, Nebraska, 68701

  • US053

    Oklahoma City, Oklahoma, 73112

  • US018

    Omaha, Nebraska, 68134

  • US138

    Rockville, Maryland, 20854

  • US004

    San Antonio, Texas, 78229

  • US045

    Savannah, Georgia, 31406

  • US013

    Stockbridge, Georgia, 30281

  • US073

    Tomball, Texas, 77375

  • US044

    Warwick, Rhode Island, 02886

Other trials in United States

About this study

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

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.

Being tested
NanoFlu, Fluzone Quadrivalent
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NanoFluBiological

    Also called Quad-NIV

    Investigational quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.

  • Fluzone QuadrivalentBiological

    Licensed quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.

Study groups in NCT04120194
Study groupRoleWhat they receive
NanoFluExperimentalNanoFlu will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.
Receives: Biological: NanoFlu
Fluzone QuadrivalentActive comparatorFluzone Quadrivalent will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.
Receives: Biological: Fluzone Quadrivalent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HAI Antibody Responses for Vaccine Homologous Influenza Strains Expressed as Ratio of Geometric Mean Fold Ratio (GMFR)

    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

    Measured: Day 28

  2. Mean Difference in the Seroconversion Rate (SCR) HAI Antibody Responses for Vaccine Homologous Influenza Strains Expressed as a Percentage of Participants

    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

    Measured: Day 0 - Day 28

  3. Number of Subjects With Solicited Local and Systemic Adverse Events (AEs)

    Number of subjects with solicited local and systemic AEs over 7 days post-injection (ie, Day 0 through Day 6, inclusive).

    Measured: Day 0 - Day 6

  4. Number of Subjects With Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), Significant New Medical Conditions (SNMCs)

    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.

    Measured: Day 0 - Day 364

  5. Number of Subjects With MAAEs, SAEs, SNMCs

    Number of subjects with MAEs, SAEs, and SNMCs - including AESIs.

    Measured: Day 0 - Day 27

Secondary outcomes (4)

  1. HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain Expressed as Geometric Mean Titers (GMT)

    Homologous influenza strains and 1 antigenically drifted strain expressed as GMT

    Measured: Day 0 - Day 28

  2. HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain Expressed as Geometric Mean Fold Ratio (GMFR)

    Wild-Type HAI Assay Homologous influenza strains and 1 antigenically drifted strain expressed as GMFR.

    Measured: Day 28 - 364

  3. Subjects Who Seroconverted as Determined by HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain

    Wild-Type HAI Assay Homologous Influenza Strains and at least 1 Antigenically Drifted Strain Expressed as Seroconversion Rate (SCR).

    Measured: Day 28 - Day 364

  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

    Homologous Influenza Strains and at least 1 Antigenically Drifted Strain Expressed as Seroprotection Rate (SPR).

    Measured: Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2019
  2. Study start14 Oct 2019
  3. Primary completion29 Oct 2020
  4. Study completion13 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,654 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04120194
Sponsor's protocol ID
qNIV-E-301
Status last verified
Apr 2023
First submitted
7 Oct 2019
Last updated
6 May 2023
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Shinde V, Cho I, Plested JS, Agrawal S, Fiske J, Cai R, Zhou H, Pham X, Zhu M, Cloney-Clark S, Wang N, Zhou B, Lewis M, Price-Abbott P, Patel N, Massare MJ, Smith G, Keech C, Fries L, Glenn GM. Comparison of the safety and immunogenicity of a novel Matrix-M-adjuvanted nanoparticle influenza vaccine with a quadrivalent seasonal influenza vaccine in older adults: a phase 3 randomised controlled trial. Lancet Infect Dis. 2022 Jan;22(1):73-84. doi: 10.1016/S1473-3099(21)00192-4. Epub 2021 Sep 23.

    PubMed 34563277

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NanoFlu and Fluzone Quadrivalent in people with Influenza, Human, run by Novavax at 19 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HAI Antibody Responses for Vaccine Homologous Influenza Strains Expressed as Ratio of Geometric Mean Fold Ratio (GMFR) (time frame: Day 28). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04120194, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in