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Trial record 1 of 1 for:    Novavax NanoFlu | influenza
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Evaluation of the Safety and Immunogenicity of a Recombinant Trivalent Nanoparticle Influenza Vaccine With Matrix M-1 Adjuvant (NanoFlu)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03293498
First Posted: September 26, 2017
Last Update Posted: October 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novavax
  Purpose
This is a Phase 1/2, randomized, observer-blinded, active-controlled trial. Approximately 330 eligible subjects will be enrolled and randomized into 1 of 3 treatment groups as shown in the Trial Design table below. Each group will consist of approximately 110 subjects total, stratified by age, gender, and history of receipt of 2016 - 17 influenza vaccine. On Day 0, subjects in Groups A and B will be administered an IM injection of NanoFlu at one of two dose levels; subjects in Group C will receive the preconfigured comparator (Fluzone HD) at the manufacturer's recommended dose and volume. On Day 21, all Group A and B subjects will be administered a rescue injection with a licensed seasonal influenza vaccine, while all Group C subjects will be administered an injection with sterile saline placebo to maintain trial blind. Trial follow-up for each subject will span approximately 1 year from the Day 0.

Condition Intervention Phase
Influenza Biological: NanoFlu Biological: Fluzone HD - Day 0 Biological: Fluzone HD - Day 21 Other: Saline - Day 21 Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 1/2, Randomized, Observer-Blinded, Active-Controlled Trials to Evaluate the Safety and Immunogenicity of a Recombinant Trivalent Nanoparticle Influenza Vaccine With Matrix-M1 Adjuvant (NanoFlu) in Healthy Older Adults

Resource links provided by NLM:


Further study details as provided by Novavax:

Primary Outcome Measures:
  • Number and percentage of subjects adverse events. [ Time Frame: Day 0 - Day 365 ]
    Solicited local and systemic adverse events over the 7 days post-injection (ie, Day 0 through Day 6 post-dosing); all adverse events (including adverse changes in clinical laboratory parameters) through 21 days post-injection; and MAEs, SAEs, and SNMCs through 1 year post-Day 0 dosing.

  • Geometric Mean Titers (GMT) specific for the HA receptor binding domains of each of the virus strains included in the NanoFlu as measured by the HAI assay. [ Time Frame: Day 0 - Day 21 ]
  • Geometric Mean Ratio (GMR) specific for the HA receptor binding domains of each of the virus strains included in the NanoFlu as measured by the HAI assay. [ Time Frame: Day 0 - Day 21 ]
  • Seroconversion Rate (SCR) specific for the HA receptor binding domains of each of the virus strains included in the NanoFlu as measured by the HAI assay. [ Time Frame: Day 0 - Day 21 ]
  • Seroconversion Rate differences specifically difference of seroconversion rates between each of the NanoFlu vaccine groups and the Fluzone HD group. [ Time Frame: Day 0 - Day 21 ]
  • Seroprotection Rate (SPR) specific for the HA receptor binding domains of each of the virus strains included in the NanoFlu as measured by the HAI assay. [ Time Frame: Day 0 - Day 21 ]

Secondary Outcome Measures:
  • Geometric Mean Titers (GMT) specific for the HA receptor binding domains of at least 2 historic A virus strains (one H1N1 and one H3N2) as measured by the HAI assay [ Time Frame: Day 0 - Day 21 ]
  • Geometric Mean Ratio (GMR) specific for the HA receptor binding domains of at least 2 historic A virus strains (one H1N1 and one H3N2) as measured by the HAI assay [ Time Frame: Day 0 - Day 21 ]
  • Seroconversion Rate (SCR) specific for the HA receptor binding domains of at least 2 historic A virus strains (one H1N1 and one H3N2) as measured by the HAI assay [ Time Frame: Day 0 - Day 21 ]
  • Seroprotection Rate (SPR) specific for the HA receptor binding domains of at least 2 historic A virus strains (one H1N1 and one H3N2) as measured by the HAI assay [ Time Frame: Day 0 - Day 21 ]
  • Geometric Mean Titers (GMT) for neutralizing antibody titers specific for the virus strains included in NanoFlu and the Fluzone HD comparator, as well as selected historical A strains, as measured by a microneutralization assay. [ Time Frame: Day 0 - Day 21 ]
  • Geometric Mean Ratio (GMR) for neutralizing antibody titers specific for the virus strains included in NanoFlu and the Fluzone HD comparator, as well as selected historical A strains, as measured by a microneutralization assay. [ Time Frame: Day 0 - Day 21 ]
  • Seroconversion Rate (SCR) for neutralizing antibody titers specific for the virus strains included in NanoFlu and the Fluzone HD comparator, as well as selected historical A strains, as measured by a microneutralization assay. [ Time Frame: Day 0 - Day 21 ]

Other Outcome Measures:
  • HAI and neutralizing antibody titers specific for a contemporary B/Yamagata virus strain. [ Time Frame: Day 0 - Day 21 ]
  • Levels of antibodies competitive with broadly-neutralizing monoclonal antibodies to HA of varying specificities, as measured by competitive-binding in a biosensor assay. [ Time Frame: Day 0 - Day 21 ]

Enrollment: 330
Actual Study Start Date: September 18, 2017
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Low dose NanoFlu - Day 0; Fluzone HD - Day 21
Biological: NanoFlu
Vaccine
Biological: Fluzone HD - Day 21
Vaccine
Experimental: Group B
High dose NanoFlu - Day 0; Fluzone HD - Day 21
Biological: NanoFlu
Vaccine
Biological: Fluzone HD - Day 21
Vaccine
Active Comparator: Group C
Fluzone HD - Day 0; Saline - Day 21
Biological: Fluzone HD - Day 0
Vaccine
Other: Saline - Day 21
Placebo

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy older adults, male or female,
  2. Willing and able to give informed consent prior to trial enrollment, and
  3. Able to attend trial visits, comply with trial requirements, and provide reliable and complete reports of adverse events.

Exclusion Criteria:

  1. Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care.

    • Asymptomatic chronic conditions or findings (eg, mild hypertension, dyslipidemia) that are not associated with evidence of end-organ damage are not exclusionary provided that they are being appropriately managed and are clinically stable (ie, unlikely to result in symptomatic illness within the time-course of this trial) in the opinion of the investigator.
    • Acute or chronic illnesses or conditions which may be reasonably predicted to become symptomatic if treatment were withdrawn or interrupted are exclusionary, even if stable.
    • Acute or chronic illnesses reasonably expected to be associated with increased risks in the event of influenza infection (eg, cardio-pulmonary diseases, diabetes mellitus, renal or hepatic dysfunction, hemoglobinopathies) are exclusionary, even if stable.
    • Note that illnesses or conditions may be exclusionary, even if otherwise stable, due to therapies used to treat them (see exclusion criteria 2, 5, 8, 9).
  2. Participation in research involving investigational product (drug / biologic / device) within 45 days before planned date of first injection.
  3. History of a serious reaction to prior influenza vaccination, or known allergy to constituents of influenza vaccines - including egg proteins - or polysorbate 80.
  4. History of Guillain-Barré Syndrome (GBS) within 6 weeks following a previous influenza vaccine.
  5. Receipt of 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 or during the trial.
  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 one year of planned vaccination) of alcohol or other substance abuse.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03293498


Locations
United States, North Carolina
Research Site US108
Raleigh, North Carolina, United States, 27609
Research Site US106
Rocky Mount, North Carolina, United States, 27804
Research Site US132
Statesville, North Carolina, United States, 28625
Sponsors and Collaborators
Novavax
Investigators
Study Director: D. Nigel Thomas, Ph.D. Novavax
  More Information

Responsible Party: Novavax
ClinicalTrials.gov Identifier: NCT03293498     History of Changes
Other Study ID Numbers: tNIV-E-101
First Submitted: September 19, 2017
First Posted: September 26, 2017
Last Update Posted: October 9, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs