Phase 3 Pivotal Trial of NanoFlu™ in Older Adults

NCT ID: NCT04120194

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 2654 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-14
• Study Completion Date: 2020-12-13

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

NanoFlu

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

Group Type: EXPERIMENTAL

NanoFlu

Intervention Type: BIOLOGICAL

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

Fluzone Quadrivalent

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

Group Type: ACTIVE_COMPARATOR

Fluzone Quadrivalent

Intervention Type: BIOLOGICAL

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

Interventions

NanoFlu

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

Intervention Type: BIOLOGICAL

Fluzone Quadrivalent

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

Intervention Type: BIOLOGICAL

Other Intervention Names

Quad-NIV

Eligibility 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:

• 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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novavax

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Development

Role: STUDY_DIRECTOR

Novavax, Inc.

Locations

US135

Hollywood, Florida, United States

US045

Savannah, Georgia, United States

US013

Stockbridge, Georgia, United States

US012

Meridian, Idaho, United States

US032

Nampa, Idaho, United States

US003

Lenexa, Kansas, United States

US138

Rockville, Maryland, United States

US025

Norfolk, Nebraska, United States

US018

Omaha, Nebraska, United States

US056

Binghamton, New York, United States

US017

Endwell, New York, United States

US030

Cleveland, Ohio, United States

US053

Oklahoma City, Oklahoma, United States

US044

Warwick, Rhode Island, United States

US079

Mt. Pleasant, South Carolina, United States

US050

Dakota Dunes, South Dakota, United States

US029

Nashville, Tennessee, United States

US004

San Antonio, Texas, United States

US073

Tomball, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34563277 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

qNIV-E-301

Identifier Type: -

Identifier Source: org_study_id