Influenza, HumanPhase 2NCT03658629

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

A Phase 2 study testing NanoFlu (Quad-NIV), Matrix-M Adjuvant and Fluzone HD in people with Influenza, Human, run by Novavax at 14 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for: Influenza, Human
What is being tested?: NanoFlu (Quad-NIV), Matrix-M Adjuvant and Fluzone HD
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,375 participants
Where: 14 sitesUnited States
Study dates: 24 Sep 2018to 26 Apr 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
Healthy volunteers accepted
Older adult

Who may be able to join

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.

Who cannot join

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.

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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.

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

United States14 sites

US078
Cary, North Carolina, 27518
US050
Dakota Dunes, South Dakota, 57049
US135
Hollywood, Florida, 33024
US056
Moncks Corner, South Carolina, 29461
US025
Norfolk, Nebraska, 68701
US018
Omaha, Nebraska, 68134
US108
Raleigh, North Carolina, 27609
US138
Rockville, Maryland, 20854
US137
Salisbury, North Carolina, 28144
US045
Savannah, Georgia, 31406
US132
Statesville, North Carolina, 28625
US013
Stockbridge, Georgia, 30281
US071
Wilmington, North Carolina, 28401
US063
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

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

A total of approximately 1375 subjects were to be randomized to seven treatment groups to receive Quad-NIV or an active comparator.

Read the detailed description

This randomized, observer-blind, active-controlled, Phase 2 trial was conducted at multiple sites. The composition of the Quad-NIV Influenza Vaccines used in this trial included 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 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: Influenza, Human
Being tested: NanoFlu (Quad-NIV), Matrix-M Adjuvant, Placebo, Fluzone HD, Flublok Quadrivalent
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NanoFlu (Quad-NIV)Biological
2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M AdjuvantOther
Adjuvant
PlaceboOther
Placebo
Fluzone HDBiological
2018-2019 Licensed Trivalent Seasonal Influenza Vaccine
Flublok QuadrivalentBiological
2018-2019 Licensed Quadrivalent Seasonal Influenza Vaccine
Influenza VaccineBiological
2018-19 Licensed Seasonal Influenza Vaccine

Study groups in NCT03658629
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Placebo; Biological: Fluzone HD
Dose G	Experimental	Alternating deltoid injections of 2018-2019 Quadrivalent Vaccine on Day 0 and Placebo on Day 28. Receives: Other: Placebo; Biological: Flublok Quadrivalent

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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).
Measured: 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).
Measured: Day 0 - Day 28

Secondary outcomes (8)

HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT
HAI antibody titers specific for the HA receptor binding domains of vaccine-homologous A and B strain(s) expressed as GMT on Day 0,28,56 and 182.
Measured: Day 0 - Day 182
HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR)
HAI antibody titers specific for the HA receptor binding domains of vaccine-homologous A and B strain(s) expressed as GMFR on Day 28,56 and 182.
Measured: Day 28 - Day 182
Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains
HAI antibody titers specific for the HA receptor binding domains of vaccine-homologous A and B strain(s) expressed as SCR on Day 28,56 and 182.
Measured: Day 28 - Day 182
Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains
HAI antibody titers specific for the HA receptor binding domains of vaccine-homologous A and B strain(s) expressed as SPR on Day 28,56 and 182.
Measured: Day 28 - Day 182
HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT
HAI antibody titers specific for antigenically-drifted influenza strains, at Days 0,28, 56 and 182 expressed as geometric man titer (GMT).
Measured: Day 0 - Day 182
HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR
HAI antibody titer responses specific for antigenically-drifted influenza strains, at Days 28, 56, and 182 expressed as Geometric Fold Ratio.
Measured: Day 28 - Day 182
Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains
HAI antibody titers specific for antigenically-drifted influenza strains, at Days 28, 56 and 182 expressed as SCR.
Measured: Day 28 - Day 182
Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains
HAI antibody titers specific for antigenically-drifted influenza strains, at Days 28, 56 and 182 expressed as SPR.
Measured: Day 28 - Day 182

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Sep 201826 Apr 2019

First posted5 Sep 2018
Study start24 Sep 2018
Primary completion26 Apr 2019
Study completion26 Apr 2019

Why it stopped: This study was terminated 182 days after initial dosing.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Influenza, HumanStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,375 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03658629
Sponsor's protocol ID: qNIV-E-201
Status last verified: Nov 2022
First submitted: 31 Aug 2018
Last updated: 4 Nov 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Publications

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.
PubMed 33146720

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03658629
Acronym / sponsor ID: qNIV-E-201
Conditions: Influenza, Human
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: This study was terminated 182 days after initial dosing.
Enrolment: 1,375 participants (actual)
Lead sponsor: NovavaxIndustry (pharma, biotech, devices)
Study start: 24 Sep 2018 (actual)
Primary completion: 26 Apr 2019 (actual)
Study completion: 26 Apr 2019 (actual)
First posted: 5 Sep 2018 (actual)
Results: Posted 4 Nov 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A total of approximately 1375 subjects were to be randomized to seven treatment groups to receive Quad-NIV or an active comparator.

Detailed description

Subjects were followed for safety for approximately 6 months, with primary immunogenicity results at Day 28.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 7

Arm	Type	Receives
Dose A	Experimental	Biological: NanoFlu (Quad-NIV), Other: Matrix-M Adjuvant, Other: PlaceboAlternating 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.
Dose B	Experimental	Biological: NanoFlu (Quad-NIV), Other: Matrix-M Adjuvant, Other: PlaceboAlternating 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.
Dose C	Experimental	Biological: NanoFlu (Quad-NIV), Other: Matrix-M Adjuvant, Other: PlaceboAlternating 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.
Dose D	Experimental	Biological: NanoFlu (Quad-NIV), Other: Matrix-M Adjuvant, Other: PlaceboAlternating 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.
Dose E	Experimental	Biological: NanoFlu (Quad-NIV), Biological: Influenza VaccineAlternating 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.
Dose F	Experimental	Other: Placebo, Biological: Fluzone HDAlternating deltoid injections of 2018-2019 High-Dose Trivalent Vaccine on Day 0 and Placebo on Day 28.
Dose G	Experimental	Other: Placebo, Biological: Flublok QuadrivalentAlternating deltoid injections of 2018-2019 Quadrivalent Vaccine on Day 0 and Placebo on Day 28.

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (6 listed)

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:
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.

Key exclusion criteria (12 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NanoFlu (Quad-NIV)2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine	Biological	Dose A, Dose B, Dose C, Dose D, Dose E
Matrix-M AdjuvantAdjuvant	Other	Dose A, Dose B, Dose C, Dose D
PlaceboPlacebo	Other	Dose A, Dose B, Dose C, Dose D, Dose F, Dose G
Fluzone HD2018-2019 Licensed Trivalent Seasonal Influenza Vaccine	Biological	Dose F
Flublok Quadrivalent2018-2019 Licensed Quadrivalent Seasonal Influenza Vaccine	Biological	Dose G
Influenza Vaccine2018-19 Licensed Seasonal Influenza Vaccine	Biological	Dose E

Primary outcome

Number of Subjects With Adverse Events (AEs)
Time frame: Day 0 - Day 182
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.
Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT)
Time frame: Day 0 - Day 28
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).
HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT
Time frame: Day 0 - Day 28
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).

8 secondary outcomes

HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT
Time frame: Day 0 - Day 182
HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR)
Time frame: Day 28 - Day 182
Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains
Time frame: Day 28 - Day 182
Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains
Time frame: Day 28 - Day 182
HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT
Time frame: Day 0 - Day 182
HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR
Time frame: Day 28 - Day 182
Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains
Time frame: Day 28 - Day 182
Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains
Time frame: Day 28 - Day 182

Results and safety

Results posted to the registry on 4 Nov 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A	158	151
Group B	309	296
Group C	155	149
Group D	133	125
Group E	313	303
Group F	154	151
Group G	153	148

Primary outcome: Number of Subjects With Adverse Events (AEs)

Time frame: Day 0 - Day 182. Number. Unit: participants

Measure	Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A n = 157	Quad-NIV Preformulated With Adjuvant Dose A n = 305	Quad-NIV Preformulated With Adjuvant Dose B n = 156	Quad-NIV Preformulated With Increased B HA Adjuvant Dose A n = 132	Quad-NIV Without Adjuvant n = 311	Licensed High-Dose Trivalent Influenza Vaccine n = 153	Licensed Quadrivalent Influenza Vaccine n = 151
All AE's	100	189	92	71	165	93	87
SAE's	8	16	8	12	6	6	3
MAE's	51	87	29	38	74	34	40
SNMC's	5	18	10	10	15	6	9

Population analysed: Safety Population

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

Time frame: Day 0 - Day 28. Geometric mean (95% Confidence Interval). Unit: titers

Measure	Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A n = 149	Quad-NIV Preformulated With Adjuvant Dose A n = 295	Quad-NIV Preformulated With Adjuvant Dose B n = 147	Quad-NIV Preformulated With Increased B HA Adjuvant Dose A n = 121	Quad-NIV Without Adjuvant n = 290	Licensed High-Dose Trivalent Influenza Vaccine n = 143	Licensed Quadrivalent Influenza Vaccine n = 144
Day 0 (A/Michigan/45/2015 (H1N1))	50.1 (44.6 to 56.4)	47.9 (44.2 to 51.9)	55.3 (49.0 to 62.3)	48.7 (42.6 to 55.8)	48.7 (44.8 to 52.8)	50.5 (45.2 to 56.4)	44.0 (39.5 to 49.1)
Day 28 (A/Michigan/45/2015 (H1N1))	98.9 (86.4 to 113.1)	91.3 (82.5 to 101.0)	99.1 (86.2 to 114.0)	79.5 (68.6 to 92.2)	90.3 (81.0 to 100.5)	96.9 (84.5 to 111.1)	82.1 (71.6 to 94.2)
Day 0 (B/Colorado/06/2017 (Victoria Lineage))	47.6 (43.1 to 52.6)	46.4 (42.8 to 50.2)	48.5 (44.0 to 53.6)	52.7 (46.7 to 59.4)	47.5 (43.9 to 51.3)	52.0 (46.1 to 58.5)	42.9 (38.5 to 47.7)
Day 28 (B/Colorado/06/2017 (Victoria Lineage))	86.8 (77.1 to 97.7)	83.2 (76.0 to 91.0)	89.6 (79.3 to 101.2)	95.5 (82.2 to 110.3)	73.2 (67.6 to 79.3)	93.2 (81.6 to 106.5)	83.3 (73.2 to 94.9)
Day 0 (B/Phuket/3073/2013 (Yamagata Lineage))	50.4 (44.7 to 56.7)	47.7 (44.4 to 51.3)	47.6 (42.9 to 52.9)	53.6 (46.9 to 61.2)	48.8 (45.2 to 52.7)	52.9 (47.3 to 59.1)	46.9 (42.1 to 52.2)
Day 28 (B/Phuket/3073/2013 (Yamagata Lineage))	108.5 (96.2 to 122.4)	101.7 (93.3 to 110.3)	104.9 (92.4 to 119.2)	113.8 (97.6 to 132.6)	87.5 (79.5 to 96.4)	64.5 (57.3 to 72.6)	102.0 (88.6 to 117.4)
Day 0 (A/Singapore/INFIMH-16-0019/2016 (H3N2))	21.4 (18.9 to 24.3)	22.0 (20.0 to 24.1)	22.8 (19.7 to 26.3)	23.4 (20.2 to 27.1)	21.3 (19.3 to 23.5)

Population analysed: Per-Protocol Population for immunogenicity was used for the primary outcome measure and included all randomized subjects that received the assigned dose of the test article according to protocol, had HAI serology results for Day 0 and Day 28, and had no major protocol deviations affecting the primary immunogenicity outcomes.

Primary outcome: HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT

Time frame: Day 0 - Day 28. Geometric mean (95% Confidence Interval). Unit: titers

Measure	Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A n = 149	Quad-NIV Preformulated With Adjuvant Dose A n = 295	Quad-NIV Preformulated With Adjuvant Dose B n = 147	Quad-NIV Preformulated With Increased B HA Adjuvant Dose A n = 121	Quad-NIV Without Adjuvant n = 290	Licensed High-Dose Trivalent Influenza Vaccine n = 143	Licensed Quadrivalent Influenza Vaccine n = 144
Day 0 (A/Switzerland/9715293/2013 (H3N2)))	54.6 (47.8 to 62.4)	60.0 (54.3 to 66.2)	60.9 (52.7 to 70.3)	60.6 (52.1 to 70.5)	58.6 (52.8 to 65.1)	62.3 (54.3 to 71.6)	54.8 (47.8 to 62.9)
Day 28 (A/Switzerland/9715293/2013 (H3N2))	146.8 (124.0 to 173.9)	160.4 (143.9 to 178.7)	154.8 (132.7 to 180.7)	137.9 (117.2 to 162.2)	122.4 (109.1 to 137.3)	133.4 (111.2 to 160.0)	158.8 (132.2 to 190.9)
Day 0 (A/Wisconsin/19/2017 (H3N2))	21.7 (19.2 to 24.6)	23.1 (21.1 to 25.3)	24.0 (20.7 to 27.7)	23.9 (20.9 to 27.3)	22.1 (20.1 to 24.4)	24.5 (21.6 to 27.7)	20.7 (18.1 to 23.6)
Day 28 (A/Wisconsin/19/2017 (H3N2))	61.1 (51.8 to 72.0)	63.2 (56.3 to 70.9)	63.0 (53.5 to 74.2)	58.2 (48.9 to 69.2)	50.1 (44.4 to 56.5)	46.1 (38.7 to 55.1)	64.3 (53.5 to 77.2)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 Months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A	12 of 157 (7.6%)	4 of 157 (2.5%)	1 of 157
Quad-NIV Preformulated With Adjuvant Dose A	21 of 305 (6.9%)	14 of 305 (4.6%)	3 of 305
Quad-NIV Preformulated With Adjuvant Dose B	16 of 156 (10.3%)	7 of 156 (4.5%)	0 of 156
Quad-NIV Preformulated With Increased B HA Adjuvant Dose A	22 of 132 (16.7%)	2 of 132 (1.5%)	2 of 132
Quad-NIV Without Adjuvant	7 of 311 (2.3%)	16 of 311 (5.1%)	0 of 311
Licensed High-Dose Trivalent Influenza Vaccine	8 of 153 (5.2%)	10 of 153 (6.5%)	0 of 153
Licensed Quadrivalent Influenza Vaccine	6 of 151 (4%)	2 of 151 (1.3%)	1 of 151

Limitations and caveats (from the sponsor): This study was terminated at 182 days after initial dosing.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33146720Shinde 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.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Development study director

Novavax

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NanoFlu (Quad-NIV), Matrix-M Adjuvant and Fluzone HD in people with Influenza, Human, run by Novavax at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects With Adverse Events (AEs) (time frame: Day 0 - Day 182). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03658629, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.