Phase 3 Pivotal Trial of NanoFlu™ in Older Adults

• Sponsor: Novavax (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT04120194
• Collaborator: (none)
• Enrollment: 2,650
• Locations: 19
• Arms: 2
• Anticipated Duration (Months): 12.6
• Patients Per Site: 139.5
• Patients Per Site Per Month: 11.1

Study Details

Study Description

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 will be formulated with the 4 influenza strains recommended for the 2019-20 Northern hemisphere influenza season. Approximately 2650 subjects (1325 subjects/group) will be enrolled and randomized into 1 of 2 treatment groups to receive either NanoFlu or active comparator. Subjects will be followed for approximately 1 year following injection; with primary immunogenicity analyses based on Day 28 sera. This trial will be conducted in the United States at approximately 19 clinical sites.

Condition or Disease	Intervention/Treatment	Phase
Influenza, Human	Biological: NanoFlu; Biological: Fluzone Quadrivalent	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 2650 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: Oct 14, 2019
• Actual Primary Completion Date: Mar 16, 2020
• Anticipated Study Completion Date: Nov 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NanoFlu NanoFlu will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.	Biological: NanoFlu; Investigational quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.; Other Names: Quad-NIV
Active Comparator: Fluzone Quadrivalent Fluzone Quadrivalent will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.	Biological: Fluzone Quadrivalent; Licensed quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.

Outcome Measures

Primary Outcome Measures

1. Hemagglutination inhibition (HAI) titers of vaccine homologous influenza strains [Day 0 - Day 28]

   Comparative HAI responses by ratio of geometric mean titers (GMTs) and seroconversion rate (SCR) difference

2. Number of adverse events (AEs) [Day 0 - Day 364]

   Solicited local and systemic AEs over 7 days post-injection; all AEs through 28 days post-injection; and medically-attended events (MAEs), serious adverse events (SAEs), and significant new medical conditions (SNMCs) though 1 year post-injection

Secondary Outcome Measures

1. HAI titers to all vaccine homologous influenza strains and at least 1 antigenically drifted strain [Day 0 - Day 28]

   GMT, geometric mean ratio (GMR), SCR, seroprotection rate (SPR)

Other Outcome Measures

1. Cell-mediated immune (CMI) responses [Day 0 - Day 28]

   Counts of peripheral blood effector memory T-cell populations

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

1. Willing and able to give informed consent prior to trial enrollment, and

2. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	US135	Hollywood	Florida	United States	33024
2	US045	Savannah	Georgia	United States	31406
3	US013	Stockbridge	Georgia	United States	30281
4	US012	Meridian	Idaho	United States	83642
5	US032	Nampa	Idaho	United States	83687
6	US003	Lenexa	Kansas	United States	66219
7	US138	Rockville	Maryland	United States	20854
8	US025	Norfolk	Nebraska	United States	68701
9	US018	Omaha	Nebraska	United States	68134
10	US056	Binghamton	New York	United States	13901
11	US017	Endwell	New York	United States	13760
12	US030	Cleveland	Ohio	United States	44122
13	US053	Oklahoma City	Oklahoma	United States	73112
14	US044	Warwick	Rhode Island	United States	02886
15	US079	Mount Pleasant	South Carolina	United States	29464
16	US050	Dakota Dunes	South Dakota	United States	57049
17	US029	Nashville	Tennessee	United States	37203
18	US004	San Antonio	Texas	United States	78229
19	US073	Tomball	Texas	United States	77375

Sponsors and Collaborators

• Novavax

Investigators

• Study Director: Vivek Shinde, MD, Novavax, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novavax
• ClinicalTrials.gov Identifier: NCT04120194
• Other Study ID Numbers: qNIV-E-301
• First Posted: Oct 9, 2019
• Last Update Posted: Apr 17, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Influenza, Human

Study Results

No Results Posted as of Apr 17, 2020