Phase 2 Dose and Formulation Confirmation of Quad-NIV in Older Adults
NCT ID: NCT03658629
Last Updated: 2022-11-04
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
1375 participants
INTERVENTIONAL
2018-09-24
2019-04-26
Brief Summary
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A total of approximately 1375 subjects were to be randomized to seven treatment groups to receive Quad-NIV or an active comparator.
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Detailed Description
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Approximately 1375 healthy male and female subjects ≥ 65 years were randomized into 7 treatment groups (group A to group G), receiving various formulations of Quad-NIV, with or without Matrix-M1 adjuvant or one of two active comparator influenza vaccines. Within each site, randomization was stratified by history of receipt of 2017-2018 influenza vaccine. Subjects received two injections 28 days apart. On Day 0, subjects received one of the five Quad-NIV formulations or one of the two comparator influenza vaccines. On Day 28, subjects received either placebo or a licensed influenza vaccine rescue dose, depending on his or her initial randomization.
Subjects were followed for safety for approximately 6 months, with primary immunogenicity results at Day 28.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Dose A
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.
NanoFlu (Quad-NIV)
2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant
Adjuvant
Placebo
Placebo
Dose B
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.
NanoFlu (Quad-NIV)
2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant
Adjuvant
Placebo
Placebo
Dose C
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.
NanoFlu (Quad-NIV)
2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant
Adjuvant
Placebo
Placebo
Dose D
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.
NanoFlu (Quad-NIV)
2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant
Adjuvant
Placebo
Placebo
Dose E
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.
NanoFlu (Quad-NIV)
2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Influenza Vaccine
2018-19 Licensed Seasonal Influenza Vaccine
Dose F
Alternating deltoid injections of 2018-2019 High-Dose Trivalent Vaccine on Day 0 and Placebo on Day 28.
Placebo
Placebo
Fluzone HD
2018-2019 Licensed Trivalent Seasonal Influenza Vaccine
Dose G
Alternating deltoid injections of 2018-2019 Quadrivalent Vaccine on Day 0 and Placebo on Day 28.
Placebo
Placebo
Flublok Quadrivalent
2018-2019 Licensed Quadrivalent Seasonal Influenza Vaccine
Interventions
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NanoFlu (Quad-NIV)
2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant
Adjuvant
Placebo
Placebo
Fluzone HD
2018-2019 Licensed Trivalent Seasonal Influenza Vaccine
Flublok Quadrivalent
2018-2019 Licensed Quadrivalent Seasonal Influenza Vaccine
Influenza Vaccine
2018-19 Licensed Seasonal Influenza Vaccine
Eligibility Criteria
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Inclusion Criteria
* 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
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.
65 Years
ALL
Yes
Sponsors
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Novavax
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Development
Role: STUDY_DIRECTOR
Novavax
Locations
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US135
Hollywood, Florida, United States
US045
Savannah, Georgia, United States
US013
Stockbridge, Georgia, United States
US138
Rockville, Maryland, United States
US025
Norfolk, Nebraska, United States
US018
Omaha, Nebraska, United States
US078
Cary, North Carolina, United States
US108
Raleigh, North Carolina, United States
US137
Salisbury, North Carolina, United States
US132
Statesville, North Carolina, United States
US071
Wilmington, North Carolina, United States
US063
Winston-Salem, North Carolina, United States
US056
Moncks Corner, South Carolina, United States
US050
Dakota Dunes, South Dakota, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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qNIV-E-201
Identifier Type: -
Identifier Source: org_study_id
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