Phase 3 Pivotal Trial of NanoFlu™ in Older Adults

NCT04120194 | Completed Phase 3 Results FDA Drug

• 1 other identifier: qNIV-E-301
• Study Type: interventional
• Target: 2,654
• Locations: 1 country
• Sites: 19

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.

Conditions

Influenza, Human

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• Number of Subjects With MAAEs, SAEs, SNMCs

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

  Day 0 - Day 27

Secondary Outcomes (4)

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

  Day 28 - 364

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

  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

  Day 28

Study Arms (2)

NanoFlu

EXPERIMENTAL

NanoFlu will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.

Biological: NanoFlu

Fluzone Quadrivalent

ACTIVE COMPARATOR

Fluzone Quadrivalent will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.

Biological: Fluzone Quadrivalent

Interventions

NanoFlu BIOLOGICAL

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

Also known as: Quad-NIV

NanoFlu

Fluzone Quadrivalent BIOLOGICAL

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

Fluzone Quadrivalent

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novavax: lead

Study Sites (19)

US135

Hollywood, Florida, 33024, United States

Location

US045

Savannah, Georgia, 31406, United States

Location

US013

Stockbridge, Georgia, 30281, United States

Location

US012

Meridian, Idaho, 83642, United States

Location

US032

Nampa, Idaho, 83687, United States

Location

US003

Lenexa, Kansas, 66219, United States

Location

US138

Rockville, Maryland, 20854, United States

Location

US025

Norfolk, Nebraska, 68701, United States

Location

US018

Omaha, Nebraska, 68134, United States

Location

US056

Binghamton, New York, 13901, United States

Location

US017

Endwell, New York, 13760, United States

Location

US030

Cleveland, Ohio, 44122, United States

Location

US053

Oklahoma City, Oklahoma, 73112, United States

Location

US044

Warwick, Rhode Island, 02886, United States

Location

US079

Mt. Pleasant, South Carolina, 29464, United States

Location

US050

Dakota Dunes, South Dakota, 57049, United States

Location

US029

Nashville, Tennessee, 37203, United States

Location

US004

San Antonio, Texas, 78229, United States

Location

US073

Tomball, Texas, 77375, United States

Location

Related Publications (1)

• 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.

  PMID: 34563277 DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Novavax Customer Service Center
• Organization: Novavax Inc

Clinicaltrials@novavax.com

1-844-Novavax (668-2829)

Study Officials

• Clinical Development

  Novavax, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: October 9, 2019
• Study Start: October 14, 2019
• Primary Completion: October 29, 2020
• Study Completion: December 13, 2020
• Last Updated: May 6, 2023
• Results First Posted: May 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (19)