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Trial record 2 of 25 for:    Novavax

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

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ClinicalTrials.gov Identifier: NCT03658629
Recruitment Status : Not yet recruiting
First Posted : September 5, 2018
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Novavax

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 will be randomized to seven treatment groups to receive Quad-NIV or an active comparator.


Condition or disease Intervention/treatment Phase
Influenza, Human Biological: 2018-2019 Investigational Seasonal Influenza Vaccine Biological: 2018-2019 Licensed Seasonal Influenza Vaccine Other: Placebo Phase 2

Detailed Description:

This randomized, observer-blind, active-controlled, Phase 2 trial will be conducted at multiple sites. The composition of the Quad-NIV Influenza Vaccines to be used in this trial includes recombinant H1, H3, and two B hemagglutinin proteins for the 2018-2019 Northern Hemisphere influenza virus strains.

Approximately 1375 healthy male and female subjects ≥ 65 years will be randomized into 7 treatment groups, receiving various formulations of Quad-NIV, with or without Matrix-M1 adjuvant or one of two active comparator influenza vaccines. Within each site, randomization will be stratified by history of receipt of 2017-2018 influenza vaccine. Subjects will receive two injections 28 days apart. On Day 0, subjects will receive one of the five Quad-NIV formulations or one of the two comparator influenza vaccines. On Day 28, subjects will receive either placebo or a licensed influenza vaccine rescue dose, depending on his or her initial randomization.

Subjects will be followed for safety for approximately one year, with primary immunogenicity results at Day 28.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1375 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase 2 Clinical Trial to Confirm the Dose and Formulation of a Recombinant Quadrivalent Nanoparticle Influenza Vaccine (Quad-NIV) With or Without Matrix-M1™ Adjuvant in Healthy Adults ≥ 65 Years of Age
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: Quad-NIV-1
Alternating deltoid injections of 2018-2019 Quad-NIV-1 (Day 0) and Placebo (Day 28)
Biological: 2018-2019 Investigational Seasonal Influenza Vaccine
2018-2019 Investigational Seasonal Influenza Vaccine

Other: Placebo
Placebo

Experimental: Quad-NIV-2
Alternating deltoid injections of 2018-2019 Quad-NIV-2 (Day 0) and Placebo (Day 28)
Biological: 2018-2019 Investigational Seasonal Influenza Vaccine
2018-2019 Investigational Seasonal Influenza Vaccine

Other: Placebo
Placebo

Experimental: Quad-NIV-3
Alternating deltoid injections of 2018-2019 Quad-NIV-3 (Day 0) and Placebo (Day 28)
Biological: 2018-2019 Investigational Seasonal Influenza Vaccine
2018-2019 Investigational Seasonal Influenza Vaccine

Other: Placebo
Placebo

Experimental: Quad-NIV-4
Alternating deltoid injections of 2018-2019 Quad-NIV-4 (Day 0) and Placebo (Day 28)
Biological: 2018-2019 Investigational Seasonal Influenza Vaccine
2018-2019 Investigational Seasonal Influenza Vaccine

Other: Placebo
Placebo

Experimental: Quad-NIV-5
Alternating deltoid injections of 2018-2019 Quad-NIV-5 (Day 0) and Licensed 2018-2019 Influenza vaccine (Day 28)
Biological: 2018-2019 Investigational Seasonal Influenza Vaccine
2018-2019 Investigational Seasonal Influenza Vaccine

Biological: 2018-2019 Licensed Seasonal Influenza Vaccine
2018-2019 Licensed Seasonal Influenza Vaccine

Active Comparator: Licensed High-Dose Trivalent Influenza Vaccine
Alternating deltoid injections of 2018-2019 High-Dose Trivalent Vaccine (Day 0) and Placebo (Day 28)
Biological: 2018-2019 Licensed Seasonal Influenza Vaccine
2018-2019 Licensed Seasonal Influenza Vaccine

Other: Placebo
Placebo

Active Comparator: Licensed Quadrivalent Influenza Vaccine
Alternating deltoid injections of 2018-2019 Quadrivalent Vaccine (Day 0) and Placebo (Day 28)
Biological: 2018-2019 Licensed Seasonal Influenza Vaccine
2018-2019 Licensed Seasonal Influenza Vaccine

Other: Placebo
Placebo




Primary Outcome Measures :
  1. Number of adverse events [ Time Frame: Day 0 - Day 364 ]
    Solicited local and systemic adverse events over the 7 days post-injection; all adverse events (including adverse changes in clinical laboratory parameters) through 21 days post-injection; and MAEs, SAEs, and SNMCs through 1 year post-injection.

  2. Hemagglutination Inhibition (HAI) Titers of vaccine homologous A and B influenza strains [ Time Frame: Day 0 - Day 28 ]
  3. HAI titers of antigenically -drifted influenza strains [ Time Frame: Day 0 - Day 28 ]

Secondary Outcome Measures :
  1. HAI titers of vaccine-homologous A and B influenza strains [ Time Frame: Day 0 - Day 364 ]
  2. HAI titers of antigenically-drifted influenza strains [ Time Frame: Day 0 - Day 364 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

    • 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.
  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 first injection.
  2. Participation in any previous Novavax's influenza vaccine clinical trial(s).
  3. History of a serious reaction to prior influenza vaccination, known allergy to constituents of licensed comparator vaccines 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 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 1 year of planned vaccination) of alcohol or other substance abuse.

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): NCT03658629


Contacts
Contact: Nigel Thomas, PhD 240-268-2023 nthomas@novavax.com

Locations
United States, Florida
US135 Not yet recruiting
Hollywood, Florida, United States, 33024
United States, Georgia
US045 Not yet recruiting
Savannah, Georgia, United States, 31406
US013 Not yet recruiting
Stockbridge, Georgia, United States, 30281
United States, Maryland
US138 Not yet recruiting
Rockville, Maryland, United States, 20854
United States, Nebraska
US025 Not yet recruiting
Norfolk, Nebraska, United States, 68701
US018 Not yet recruiting
Omaha, Nebraska, United States, 68134
United States, North Carolina
US078 Not yet recruiting
Cary, North Carolina, United States, 27518
US108 Not yet recruiting
Raleigh, North Carolina, United States, 27609
US137 Not yet recruiting
Salisbury, North Carolina, United States, 28144
US132 Not yet recruiting
Statesville, North Carolina, United States, 28625
US071 Not yet recruiting
Wilmington, North Carolina, United States, 28401
US063 Not yet recruiting
Winston-Salem, North Carolina, United States, 27103
United States, South Carolina
US056 Not yet recruiting
Moncks Corner, South Carolina, United States, 29461
United States, South Dakota
US050 Not yet recruiting
Dakota Dunes, South Dakota, United States, 57049
Sponsors and Collaborators
Novavax
Investigators
Study Director: Vivek Shinde, MD Novavax

Additional Information:
Responsible Party: Novavax
ClinicalTrials.gov Identifier: NCT03658629     History of Changes
Other Study ID Numbers: qNIV-E-201
First Posted: September 5, 2018    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: August 2018
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