InfluenzaPhase 1/2NCT03293498

Evaluation of the Safety and Immunogenicity of a Recombinant Trivalent Nanoparticle Influenza Vaccine With Matrix M-1 Adjuvant (NanoFlu)

A Phase 1/2 study testing NanoFlu, Fluzone HD - Day 0 and Fluzone HD - Day 21 in people with Influenza, run by Novavax at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This was a Phase 1/2, randomized, observer-blinded, active-controlled trial to assess the Safety and Tolerability of a Recombinant Trivalent Nanoparticle Influenza Vaccine (Tri-NIV) with Matrix M1™ Adjuvant in Healthy Older Adults ≥ 60 Years of Age Read more about this study

Who is it for?: Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: NanoFlu, Fluzone HD - Day 0 and Fluzone HD - Day 21
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 330 participants
Where: 3 sitesUnited States
Study dates: 18 Sep 2017to 29 Oct 2018
Phase: Phase 1/2
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 60 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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Acute or chronic illnesses or conditions which may be reasonably predicted to become symptomatic if treatment were withdrawn or interrupted are exclusionary, even if stable.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).
Participation in research involving investigational product (drug / biologic / device) within 45 days before planned date of first injection.

Show all 16Show fewer

History of a serious reaction to prior influenza vaccination, or known allergy to constituents of influenza vaccines - including egg proteins - or polysorbate 80.
History of Guillain-Barré Syndrome (GBS) within 6 weeks following a previous influenza vaccine.
Receipt of 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 one year of planned vaccination) of alcohol or other substance abuse.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Research Site US108
Raleigh, North Carolina, 27609
Research Site US106
Rocky Mount, North Carolina, 27804
Research Site US132
Statesville, North Carolina, 28625

Other trials in United States

About this study

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

Read the detailed description

Study tNIV-E-101 a randomized, observer-blinded, active-controlled trial designed to evaluate the safety and immunogenicity of Novavax's insect cell-derived, egg-free, influenza vaccine (Tri-NIV) based on recombinant HA nanoparticle antigens, representing the 3 major influenza types/subtypes recommended for inclusion in the 2017 - 2018 seasonal influenza vaccine by the World Health Organization (WHO) and the Center for Biologics Evaluation and Research (CBER) Approximately 330 eligible subjects were enrolled and randomized into 1 of 3 treatment groups Each group consisted of approximately 110 subjects total, stratified by age, gender, and history of receipt of the 2016 - 17 influenza vaccine. On Day 0, subjects in Groups A and B were administered an IM injection of NanoFlu at one of two dose levels; subjects in Group C received the preconfigured comparator (Fluzone HD) at the manufacturer's recommended dose and volume. On Day 21, all Group A and B subjects were administered a rescue injection with a licensed seasonal influenza vaccine. In contrast, all Group C subjects were administered an injection with a sterile saline placebo to maintain the trial blind. Trial follow-up for each subject spanned approximately 1 year from Day 0.

Conditions: Influenza
Being tested: NanoFlu, Fluzone HD - Day 0, Fluzone HD - Day 21, Saline - Day 21
Medical subject headings: Influenza, Human

What participants receive

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

NanoFluBiological
Vaccine
Fluzone HD - Day 0Biological
Vaccine
Fluzone HD - Day 21Biological
Vaccine
Saline - Day 21Other
Placebo

Study groups in NCT03293498
Study group	Role	What they receive
Group A	Experimental	Low dose NanoFlu - Day 0; Fluzone HD - Day 21 Receives: Biological: NanoFlu; Biological: Fluzone HD - Day 21
Group B	Experimental	High dose NanoFlu - Day 0; Fluzone HD - Day 21 Receives: Biological: NanoFlu; Biological: Fluzone HD - Day 21
Group C	Active comparator	Fluzone HD - Day 0; Saline - Day 21 Receives: Biological: Fluzone HD - Day 0; Other: Saline - Day 21

What is being measured

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

Number of Participants With All Adverse Events (AEs), Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), and Significant New Medical Conditions (SNMCs).
Number of participants that reported all adverse event (AE) profile (including adverse changes in clinical laboratory parameters) ; medically-attended adverse event (MAE), serious adverse event (SAE), and significant new medical condition (SNMC) post dosing.
Measured: Day 0 - Day 21 post dosing
Number of Participants With Solicited Local and Systemic AEs
Number of participants with solicited local and systemic adverse events over the 7 days post-injection
Measured: Day 0 - Day 6 post-dosing
Geometric Mean Titers (GMT) Specific for the Hemagglutinin (HA) Receptor Binding Domains of Each of the Virus Strains Included in the NanoFlu as Measured by the Hemagglutination Inhibition (HAI) Assay.
The immunogenicity of Tri-NIV at 2 different doses, and the licensed comparator Fluzone HD (Sanofi Pasteur), in healthy older adults ≥ 60 years of age, based on hemagglutination inhibition (HAI) responses to vaccine-homologous influenza A and B strains, as recommended for the 2017 - 18 Northern hemisphere vaccine, at Day 21 post-dosing expressed as GMTs.
Measured: Day 0 - Day 21 post dosing
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.
The immunogenicity of Tri-NIV at 2 different doses, and the licensed comparator Fluzone HD (Sanofi Pasteur), in healthy older adults ≥ 60 years of age, based on hemagglutination inhibition (HAI) responses to vaccine-homologous influenza A and B strains, as recommended for the 2017 - 18 Northern hemisphere vaccine, at Day 21 post-dosing expressed as GMR.
Measured: Day 0 - Day 21 post dosing
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.
The immunogenicity of Tri-NIV at 2 different doses, and the licensed comparator Fluzone HD (Sanofi Pasteur), in healthy older adults ≥ 60 years of age, based on hemagglutination inhibition (HAI) responses to vaccine-homologous influenza A and B strains, as recommended for the 2017 - 18 Northern hemisphere vaccine, at Day 21 post-dosing expressed as SCRs.
Measured: Day 0 - Day 21 post dosing
Number of Participants With Seroprotection Specific for the HA Receptor Binding Domains of Each of the Virus Strains Included in the NanoFlu as Measured by the HAI Assay.
The immunogenicity of Tri-NIV at 2 different doses, and the licensed comparator Fluzone HD (Sanofi Pasteur), in healthy older adults ≥ 60 years of age, based on hemagglutination inhibition (HAI) responses to vaccine-homologous influenza A and B strains, as recommended for the 2017 - 18 Northern hemisphere vaccine, at Day 21 post-dosing expressed as SPRs.
Seroprotection rate (SPR) - defined as the number of subjects with an HAI titer ≥ 1:40.
Measured: Day 0 - Day 21 post dosing

Secondary outcomes (7)

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
The immunogenicity of Tri-NIV at 2 different doses and the licensed comparator Fluzone HD (Sanofi Pasteur) based on hemagglutination inhibition (HAI) responses to at least 2 historic and/or drifted A virus strains (one H1N1 and one H3N2) expressed as GMTs.
Measured: 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
The immunogenicity of Tri-NIV at 2 different doses and the licensed comparator Fluzone HD (Sanofi Pasteur) based on hemagglutination inhibition (HAI) responses to at least 2 historic and/or drifted A virus strains (one H1N1 and one H3N2) expressed as GMRs.
Measured: 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
The immunogenicity of Tri-NIV at 2 different doses and the licensed comparator Fluzone HD (Sanofi Pasteur) based on hemagglutination inhibition (HAI) responses to at least 2 historic and/or drifted A virus strains (one H1N1 and one H3N2) expressed as SCRs.
Measured: Day 0 - Day 21
Number of Participants With Seroprotection 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
The immunogenicity of Tri-NIV at 2 different doses and the licensed comparator Fluzone HD (Sanofi Pasteur) based on hemagglutination inhibition (HAI) responses to at least 2 historic and/or drifted A virus strains (one H1N1 and one H3N2) expressed as SPRs.
Seroprotection rate (SPR) - defined as the percentage of subjects with an HAI titer ≥ 1:40.
Measured: 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.
The immunogenicity of Tri-NIV at 2 different doses, and the licensed comparator Fluzone HD (Sanofi Pasteur), based on microneutralization (MN) responses to vaccine-homologous and historic and/or drifted influenza A strains, and the vaccine-homologous B/Victoria lineage strain, at Day 21 post-dosing expressed as GMTs.
Measured: Day 0 - Day 21 post dosing
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.
The immunogenicity of Tri-NIV at 2 different doses, and the licensed comparator Fluzone HD (Sanofi Pasteur), based on microneutralization (MN) responses to vaccine-homologous and historic and/or drifted influenza A strains, and the vaccine-homologous B/Victoria lineage strain, at Day 21 post-dosing expressed as GMRs.
Measured: 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.
The immunogenicity of Tri-NIV at 2 different doses, and the licensed comparator Fluzone HD (Sanofi Pasteur), based on microneutralization (MN) responses to vaccine-homologous and historic and/or drifted influenza A strains, and the vaccine-homologous B/Victoria lineage strain, at Day 21 post-dosing expressed as SPRs.
Measured: Day 0 - Day 21

Timeline

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

18 Sep 201729 Oct 2018

First posted26 Sep 2017
Study start18 Sep 2017
Primary completion14 Mar 2018
Study completion29 Oct 2018

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.
Other trials for InfluenzaStudies 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 1/2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 330 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03293498
Sponsor's protocol ID: tNIV-E-101
Status last verified: Nov 2022
First submitted: 19 Sep 2017
Last updated: 21 Dec 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

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 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03293498
Acronym / sponsor ID: tNIV-E-101
Conditions: Influenza
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 330 participants (actual)
Lead sponsor: NovavaxIndustry (pharma, biotech, devices)
Study start: 18 Sep 2017 (actual)
Primary completion: 14 Mar 2018 (actual)
Study completion: 29 Oct 2018 (actual)
First posted: 26 Sep 2017 (actual)
Results: Posted 21 Dec 2022

Clinical summary

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

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Group A	Experimental	Biological: NanoFlu, Biological: Fluzone HD - Day 21Low dose NanoFlu - Day 0; Fluzone HD - Day 21
Group B	Experimental	Biological: NanoFlu, Biological: Fluzone HD - Day 21High dose NanoFlu - Day 0; Fluzone HD - Day 21
Group C	Active comparator	Biological: Fluzone HD - Day 0, Other: Saline - Day 21Fluzone HD - Day 0; Saline - Day 21

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (16 listed)

Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care.
Participation in research involving investigational product (drug / biologic / device) within 45 days before planned date of first injection.
History of a serious reaction to prior influenza vaccination, or known allergy to constituents of influenza vaccines - including egg proteins - or polysorbate 80.
History of Guillain-Barré Syndrome (GBS) within 6 weeks following a previous influenza vaccine.
Receipt of 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
NanoFluVaccine	Biological	Group A, Group B
Fluzone HD - Day 0Vaccine	Biological	Group C
Fluzone HD - Day 21Vaccine	Biological	Group A, Group B
Saline - Day 21Placebo	Other	Group C

Primary outcome

Number of Participants With All Adverse Events (AEs), Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), and Significant New Medical Conditions (SNMCs).
Time frame: Day 0 - Day 21 post dosing
Number of participants that reported all adverse event (AE) profile (including adverse changes in clinical laboratory parameters) ; medically-attended adverse event (MAE), serious adverse event (SAE), and significant new medical condition (SNMC) post dosing.
Number of Participants With Solicited Local and Systemic AEs
Time frame: Day 0 - Day 6 post-dosing
Number of participants with solicited local and systemic adverse events over the 7 days post-injection
Geometric Mean Titers (GMT) Specific for the Hemagglutinin (HA) Receptor Binding Domains of Each of the Virus Strains Included in the NanoFlu as Measured by the Hemagglutination Inhibition (HAI) Assay.
Time frame: Day 0 - Day 21 post dosing
The immunogenicity of Tri-NIV at 2 different doses, and the licensed comparator Fluzone HD (Sanofi Pasteur), in healthy older adults ≥ 60 years of age, based on hemagglutination inhibition (HAI) responses to vaccine-homologous influenza A and B strains, as recommended for the 2017 - 18 Northern hemisphere vaccine, at Day 21 post-dosing expressed as GMTs.
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 post dosing
The immunogenicity of Tri-NIV at 2 different doses, and the licensed comparator Fluzone HD (Sanofi Pasteur), in healthy older adults ≥ 60 years of age, based on hemagglutination inhibition (HAI) responses to vaccine-homologous influenza A and B strains, as recommended for the 2017 - 18 Northern hemisphere vaccine, at Day 21 post-dosing expressed as GMR.
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 post dosing
The immunogenicity of Tri-NIV at 2 different doses, and the licensed comparator Fluzone HD (Sanofi Pasteur), in healthy older adults ≥ 60 years of age, based on hemagglutination inhibition (HAI) responses to vaccine-homologous influenza A and B strains, as recommended for the 2017 - 18 Northern hemisphere vaccine, at Day 21 post-dosing expressed as SCRs.
Number of Participants With Seroprotection 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 post dosing
The immunogenicity of Tri-NIV at 2 different doses, and the licensed comparator Fluzone HD (Sanofi Pasteur), in healthy older adults ≥ 60 years of age, based on hemagglutination inhibition (HAI) responses to vaccine-homologous influenza A and B strains, as recommended for the 2017 - 18 Northern hemisphere vaccine, at Day 21 post-dosing expressed as SPRs. Seroprotection rate (SPR) - defined as the number of subjects with an HAI titer ≥ 1:40.

7 secondary outcomes

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
Number of Participants With Seroprotection 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 post dosing
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

Results and safety

Results posted to the registry on 21 Dec 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- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21	109	109
Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21	111	111
Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21.	110	110

Primary outcome: Number of Participants With All Adverse Events (AEs), Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), and Significant New Medical Conditions (SNMCs).

Time frame: Day 0 - Day 21 post dosing. Number. Unit: participants

Measure	Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 n = 109	Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 n = 111	Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. n = 110
MAE's	9	6	2
SAE's	0	1	0
SNMC's	0	1	0
All AEs (21 days post-injection)	40	52	51

Population analysed: Group A and B participants received different doses of the Tri-NIV vaccine on Day 0 and Fluzone HD on Day 21. Group C participants received Fluzone HD on Day 0 and Placebo on Day 21.

Primary outcome: Number of Participants With Solicited Local and Systemic AEs

Time frame: Day 0 - Day 6 post-dosing. Number. Unit: participants

Measure	Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 n = 109	Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 n = 111	Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. n = 110
Solicited Local AE's (Day 0 to Day 6)	15	26	30
Solicited Systemic AE's (Day 0 to Day 6)	23	24	20

Primary outcome: Geometric Mean Titers (GMT) Specific for the Hemagglutinin (HA) Receptor Binding Domains of Each of the Virus Strains Included in the NanoFlu as Measured by the Hemagglutination Inhibition (HAI) Assay.

Time frame: Day 0 - Day 21 post dosing. Geometric mean (95% Confidence Interval). Unit: titers

Measure	Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 n = 109	Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 n = 111	Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. n = 110
Day 0 (A/Michigan/45/2015 (H1N1))	39 (31 to 48)	34 (27 to 42)	31 (25 to 38)
Day 21 (A/Michigan/45/2015 (H1N1))	95 (75 to 121)	130 (102 to 166)	139.1 (112 to 174)
Day 0 (A/HongKong/4801/2014 (H3N2) )	26 (21 to 33)	21 (17 to 27)	26 (21 to 33)
Day 21 (A/HongKong/4801/2014 (H3N2) )	62 (48 to 79)	75 (59 to 94)	94 (74 to 119)
Day 0 (B/Brisbane/60/2008 (Victoria Lineage))	19 (15 to 23)	18 (15 to 22)	15 (12 to 17)
Day 21 (B/Brisbane/60/2008 (Victoria Lineage))	24 (20 to 30)	29 (24 to 35)	37 (31 to 46)
Day 0 (A/California/07/2009 (H1N1))	65 (53 to 80)	59 (48 to 73)	52 (42 to 64)
Day 21 (A/California/07/2009 (H1N1) )	143 (116 to 176)	194 (156 to 242)	206 (169 to 222)

Primary outcome: 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 post dosing. Geometric mean (95% Confidence Interval). Unit: Ratio

Measure	Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 n = 109	Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 n = 111	Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. n = 110
Day 21 (A/Michigan/45/2015 (H1N1))	2.47 (2.05 to 2.98)	3.86 (3.07 to 4.85)	4.55 (3.60 to 5.75)
Day 21 (A/HongKong/4801/2014 (H3N2) )	2.35 (1.94 to 2.84)	3.49 (2.78 to 4.37)	3.57 (2.87 to 4.45)
Day 21 (B/Brisbane/60/2008 (Victoria Lineage))	1.30 (1.16 to 1.44)	1.57 (1.39 to 1.78)	2.56 (2.10 to 3.11)
Day 21 (A/California/07/2009 (H1N1) )	2.20 (1.87 to 2.59)	3.29 (2.67 to 4.05)	3.94 (3.16 to 4.92)
Day 21 (A/Texas/50/2012 (H3N2) )	2.17 (1.83 to 2.58)	3.04 (2.48 to 3.72)	2.40 (2.01 to 2.87)
Day 21 (A/Switzerland/9715293/2013 (H3N2))	2.46 (2.04 to 2.95)	3.38 (2.72 to 4.21)	2.51 (2.08 to 3.02)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21	7 of 109 (6.4%)	32 of 109 (29.4%)	0 of 109
Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21	11 of 111 (9.9%)	27 of 111 (24.3%)	0 of 111
Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21.	8 of 110 (7.3%)	28 of 110 (25.5%)	0 of 110

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

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BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
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Influenza
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A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza

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

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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing NanoFlu, Fluzone HD - Day 0 and Fluzone HD - Day 21 in people with Influenza, run by Novavax at 3 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 3 inclusion and 16 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: finished, as of the sponsor's last update on 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 21 Dec 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 Participants With All Adverse Events (AEs), Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), and Significant New Medical Conditions (SNMCs). (time frame: Day 0 - Day 21 post dosing). The study lists 6 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 NCT03293498.

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 21 Dec 2022.