- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04120194
Phase 3 Pivotal Trial of NanoFlu™ in Older Adults
April 11, 2023 updated by: Novavax
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
2654
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Hollywood, Florida, United States, 33024
- US135
-
-
Georgia
-
Savannah, Georgia, United States, 31406
- US045
-
Stockbridge, Georgia, United States, 30281
- US013
-
-
Idaho
-
Meridian, Idaho, United States, 83642
- US012
-
Nampa, Idaho, United States, 83687
- US032
-
-
Kansas
-
Lenexa, Kansas, United States, 66219
- US003
-
-
Maryland
-
Rockville, Maryland, United States, 20854
- US138
-
-
Nebraska
-
Norfolk, Nebraska, United States, 68701
- US025
-
Omaha, Nebraska, United States, 68134
- US018
-
-
New York
-
Binghamton, New York, United States, 13901
- US056
-
Endwell, New York, United States, 13760
- US017
-
-
Ohio
-
Cleveland, Ohio, United States, 44122
- US030
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73112
- US053
-
-
Rhode Island
-
Warwick, Rhode Island, United States, 02886
- US044
-
-
South Carolina
-
Mount Pleasant, South Carolina, United States, 29464
- US079
-
-
South Dakota
-
Dakota Dunes, South Dakota, United States, 57049
- US050
-
-
Tennessee
-
Nashville, Tennessee, United States, 37203
- US029
-
-
Texas
-
San Antonio, Texas, United States, 78229
- US004
-
Tomball, Texas, United States, 77375
- US073
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: NanoFlu
NanoFlu will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.
|
Investigational quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.
Other Names:
|
Active Comparator: Fluzone Quadrivalent
Fluzone Quadrivalent will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.
|
Licensed quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Day 28
|
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
|
Day 0 - Day 28
|
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).
|
Day 0 - Day 6
|
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.
|
Day 0 - Day 364
|
Number of Subjects With MAAEs, SAEs, SNMCs
Time Frame: Day 0 - Day 27
|
Number of subjects with MAEs, SAEs, and SNMCs - including AESIs.
|
Day 0 - Day 27
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Day 0 - Day 28
|
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.
|
Day 28 - 364
|
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).
|
Day 28 - Day 364
|
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).
|
Day 28
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cell-mediated immune (CMI) responses
Time Frame: Day 0 - Day 28
|
Counts of peripheral blood effector memory T-cell populations
|
Day 0 - Day 28
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 14, 2019
Primary Completion (Actual)
October 29, 2020
Study Completion (Actual)
December 13, 2020
Study Registration Dates
First Submitted
October 7, 2019
First Submitted That Met QC Criteria
October 7, 2019
First Posted (Actual)
October 9, 2019
Study Record Updates
Last Update Posted (Estimate)
May 4, 2023
Last Update Submitted That Met QC Criteria
April 11, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- qNIV-E-301
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Influenza, Human
-
Novartis VaccinesCompletedInfluenza | Seasonal Influenza | Human Influenza | Influenza Due to Unspecified Influenza VirusBelgium
-
AVIR Green Hills Biotechnology AGCompletedSeasonal Human InfluenzaAustria
-
Fluart Innovative Vaccine Ltd, HungaryCompleted
-
Research Institute for Biological Safety ProblemsResearch Institute of Influenza, Russia; Asfendiyarov Kazakh National Medical...Completed
-
Novartis VaccinesCompleted
-
Novartis VaccinesCompleted
-
Emergent BioSolutionsCompleted
-
Novartis VaccinesCompleted
-
Novartis VaccinesCompleted
-
Novartis VaccinesCompleted
Clinical Trials on NanoFlu
-
NovavaxCompleted
-
NovavaxTerminatedInfluenza, HumanUnited States