Phase 3
N=2,654
Phase 3 Pivotal Trial of NanoFlu™ in Older Adults
Influenza, Human
Bottom Line
View on ClinicalTrials.gov: NCT04120194 ↗Enrolled (actual)
2,654
Serious AEs
9.8%
Results posted
May 2023
Primary outcome: Primary: HAI Antibody Responses for Vaccine Homologous Influenza Strains Expressed as Ratio of Geometric Mean Fold Ratio (GMFR) — 1.9; 1.7; 2.7; 2.3 Geometric Mean Fold Ratio
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- NanoFlu (Biological); Fluzone Quadrivalent (Biological)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Novavax
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HAI Antibody Responses for Vaccine Homologous Influenza Strains Expressed as Ratio of Geometric Mean Fold Ratio (GMFR) |
1.9; 1.7; 2.7; 2.3; 1.6; 1.5 | — |
| PRIMARY Mean Difference in the Seroconversion Rate (SCR) HAI Antibody Responses for Vaccine Homologous Influenza Strains Expressed as a Percentage of Participants |
22.0; 17.0; 41.8; 34.4; 11.2; 10.7 | — |
| PRIMARY Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) |
372; 243; 369; 292 | — |
| PRIMARY Number of Subjects With Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), Significant New Medical Conditions (SNMCs) |
81; 78; 42; 49; 353; 354 | — |
| PRIMARY Number of Subjects With MAAEs, SAEs, SNMCs |
10; 5; 4; 11; 108; 108 | — |
| SECONDARY HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain Expressed as Geometric Mean Titers (GMT) |
26.2; 26.0; 49.3; 45.0; 55.1; 54.7 | — |
| SECONDARY HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain Expressed as Geometric Mean Fold Ratio (GMFR) |
2.4; 1.9; 5.6; 3.4; 2.1; 1.6 | — |
| SECONDARY Subjects Who Seroconverted as Determined by HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain |
32.7; 21.4; 69.8; 49.5; 25.1; 13.5 | — |
| 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 |
69.1; 64.5; 98.8; 98.3; 99.1; 98.7 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04120194). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.