Phase 3 Pivotal Trial of NanoFlu™ in Older Adults

Influenza, Human Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04120194
• Other study ID #: qNIV-E-301
• Status: Completed
• Phase: Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Influenza, Human

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