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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04120194
Other study ID # qNIV-E-301
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 14, 2019
Est. completion date December 13, 2020

Study information

Verified date April 2023
Source Novavax
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 2654
Est. completion date December 13, 2020
Est. primary completion date October 29, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
NanoFlu
Investigational quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.
Fluzone Quadrivalent
Licensed quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.

Locations

Country Name City State
United States US056 Binghamton New York
United States US030 Cleveland Ohio
United States US050 Dakota Dunes South Dakota
United States US017 Endwell New York
United States US135 Hollywood Florida
United States US003 Lenexa Kansas
United States US012 Meridian Idaho
United States US079 Mount Pleasant South Carolina
United States US032 Nampa Idaho
United States US029 Nashville Tennessee
United States US025 Norfolk Nebraska
United States US053 Oklahoma City Oklahoma
United States US018 Omaha Nebraska
United States US138 Rockville Maryland
United States US004 San Antonio Texas
United States US045 Savannah Georgia
United States US013 Stockbridge Georgia
United States US073 Tomball Texas
United States US044 Warwick Rhode Island

Sponsors (1)

Lead Sponsor Collaborator
Novavax

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Day 28
Primary 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 Day 0 - Day 28
Primary 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). Day 0 - Day 6
Primary 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. Day 0 - Day 364
Primary Number of Subjects With MAAEs, SAEs, SNMCs Number of subjects with MAEs, SAEs, and SNMCs - including AESIs. Day 0 - Day 27
Secondary 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 Day 0 - Day 28
Secondary 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. Day 28 - 364
Secondary 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). Day 28 - Day 364
Secondary 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). Day 28
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