Phase 2 Dose and Formulation Confirmation of Quad-NIV in Older Adults

NCT03658629 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: qNIV-E-201
• Study Type: interventional
• Target: 1,375
• Locations: 1 country
• Sites: 14

Brief Summary

A Phase 2 trial to confirm the dose and formulation, demonstrate adjuvant effect, and evaluate the safety and tolerability of a single intramuscular injection of Quad-NIV with or without Matrix-M1 adjuvant in healthy adults ≥ 65 years of age. A total of approximately 1375 subjects were to be randomized to seven treatment groups to receive Quad-NIV or an active comparator.

Conditions

Influenza, Human

Outcome Measures

Primary Outcomes (3)

• Number of Subjects With Adverse Events (AEs)

  Adverse Events over the 7 days post-injection; all adverse events (including adverse changes in clinical laboratory parameters) through 21 days post-injection; and Medically Attended Adverse Events (MAEs), Serious Adverse Events (SAEs), and Significant New Medical Conditions (SNMCs) through 6 months post-injection.

  Day 0 - Day 182

• Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT)

  HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B strain(s) at Days 0 and Day 28 post-vaccination expressed as geometric man titer (GMT).

  Day 0 - Day 28

• HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT

  HAI antibody titers specific for at least 2 antigenically-drifted influenza strains, at Days 0 and 28 post-vaccination expressed as geometric man titer (GMT).

  Day 0 - Day 28

Secondary Outcomes (8)

• HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT

  Day 0 - Day 182

• HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR)

  Day 28 - Day 182

• Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains

  Day 28 - Day 182

• Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains

  Day 28 - Day 182

• HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT

  Day 0 - Day 182

Study Arms (7)

Dose A

EXPERIMENTAL

Alternating deltoid injections of Quad-NIV (60 µg HA per A strain and B strain; in-clinic mix with 50 µg of Matrix-M1) on Day 0 and Placebo on Day 28.

Biological: NanoFlu (Quad-NIV); Other: Matrix-M Adjuvant; Other: Placebo

Dose B

EXPERIMENTAL

Alternating deltoid injections of Quad-NIV (60 µg HA per A strain and B strain; co-formulated with 50 µg of Matrix-M1) on Day 0 and Placebo on Day 28.

Biological: NanoFlu (Quad-NIV); Other: Matrix-M Adjuvant; Other: Placebo

Dose C

EXPERIMENTAL

Alternating deltoid injections of Quad-NIV (60 µg HA per A strain and B strain; co-formulated with 75 µg of Matrix-M1) on Day 0 and Placebo on Day 28.

Biological: NanoFlu (Quad-NIV); Other: Matrix-M Adjuvant; Other: Placebo

Dose D

EXPERIMENTAL

Alternating deltoid injections of Quad-NIV (60 µg HA per A strain and 90 µg HA per B strain; co-formulated with 50 µg of Matrix-M1) on Day 0 and Placebo on Day 28.

Biological: NanoFlu (Quad-NIV); Other: Matrix-M Adjuvant; Other: Placebo

Dose E

EXPERIMENTAL

Alternating deltoid injections of Quad-NIV (60 µg HA per A and B strain without adjuvant) on Day 0 and Licensed 2018-2019 Influenza vaccine on Day 28.

Biological: NanoFlu (Quad-NIV); Biological: Influenza Vaccine

Dose F

EXPERIMENTAL

Alternating deltoid injections of 2018-2019 High-Dose Trivalent Vaccine on Day 0 and Placebo on Day 28.

Other: Placebo; Biological: Fluzone HD

Dose G

EXPERIMENTAL

Alternating deltoid injections of 2018-2019 Quadrivalent Vaccine on Day 0 and Placebo on Day 28.

Other: Placebo; Biological: Flublok Quadrivalent

Interventions

NanoFlu (Quad-NIV) BIOLOGICAL

2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine

Dose A; Dose B; Dose C; Dose D; Dose E

Matrix-M Adjuvant OTHER

Adjuvant

Dose A; Dose B; Dose C; Dose D

Placebo OTHER

Placebo

Dose A; Dose B; Dose C; Dose D; Dose F; Dose G

Fluzone HD BIOLOGICAL

2018-2019 Licensed Trivalent Seasonal Influenza Vaccine

Dose F

Flublok Quadrivalent BIOLOGICAL

2018-2019 Licensed Quadrivalent Seasonal Influenza Vaccine

Dose G

Influenza Vaccine BIOLOGICAL

2018-19 Licensed Seasonal Influenza Vaccine

Dose E

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:
• 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 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 first injection.
• Participation in any previous Novavax's influenza vaccine clinical trial(s).
• History of a serious reaction to prior influenza vaccination, known allergy to constituents of licensed comparator vaccines 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 or during the trial.
• 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 (14)

US135

Hollywood, Florida, 33024, United States

Location

US045

Savannah, Georgia, 31406, United States

Location

US013

Stockbridge, Georgia, 30281, United States

Location

US138

Rockville, Maryland, 20854, United States

Location

US025

Norfolk, Nebraska, 68701, United States

Location

US018

Omaha, Nebraska, 68134, United States

Location

US078

Cary, North Carolina, 27518, United States

Location

US108

Raleigh, North Carolina, 27609, United States

Location

US137

Salisbury, North Carolina, 28144, United States

Location

US132

Statesville, North Carolina, 28625, United States

Location

US071

Wilmington, North Carolina, 28401, United States

Location

US063

Winston-Salem, North Carolina, 27103, United States

Location

US056

Moncks Corner, South Carolina, 29461, United States

Location

US050

Dakota Dunes, South Dakota, 57049, United States

Location

Related Publications (1)

• Shinde V, Cai R, Plested J, Cho I, Fiske J, Pham X, Zhu M, Cloney-Clark S, Wang N, Zhou H, Zhou B, Patel N, Massare MJ, Fix A, Spindler M, Thomas DN, Smith G, Fries L, Glenn GM. Induction of Cross-Reactive Hemagglutination Inhibiting Antibody and Polyfunctional CD4+ T-Cell Responses by a Recombinant Matrix-M-Adjuvanted Hemagglutinin Nanoparticle Influenza Vaccine. Clin Infect Dis. 2021 Dec 6;73(11):e4278-e4287. doi: 10.1093/cid/ciaa1673.

  PMID: 33146720 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Limitations and Caveats

This study was terminated at 182 days after initial dosing.

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

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: August 31, 2018
• First Posted: September 5, 2018
• Study Start: September 24, 2018
• Primary Completion: April 26, 2019
• Study Completion: April 26, 2019
• Last Updated: November 4, 2022
• Results First Posted: November 4, 2022

Record last verified: 2022-11

Locations

US (14)