Evaluation of the Safety and Immunogenicity of a Recombin... | NCT03293498

NCT03293498

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Experimental	Low dose NanoFlu - Day 0; Fluzone HD - Day 21	Biological: NanoFlu Biological: Fluzone HD - Day 21
Group B	Experimental	High dose NanoFlu - Day 0; Fluzone HD - Day 21	Biological: NanoFlu Biological: Fluzone HD - Day 21
Group C	Active Comparator	Fluzone HD - Day 0; Saline - Day 21	Biological: Fluzone HD - Day 0 Other: Saline - Day 21

Name	Type	Description	Arm Group Labels	Other Names
NanoFlu	Biological	Vaccine	Group A Group B
Fluzone HD - Day 0

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	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	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.	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.	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.

Secondary Outcomes

Measure	Description	Time Frame
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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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.

Contacts/Locations Module

Name	Affiliation	Role
Clinical Development	Novavax	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site US108		Raleigh	North Carolina	27609	United States
Research Site US106

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21	Participants received 15 µg in a 0.3 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.
FG001	Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Nov 13, 2017	Aug 1, 2022

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

330 participants were randomized to 1 of 3 treatment groups based on age, gender, and history of receipt of the 2016 - 17 influenza vaccine.

Arm/Group Information

ID	Title	Description
BG000	Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21	Participants received 15 µg in a 0.3 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.
BG001	Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21	Participants received 60 µg in a 0.8 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.
BG002	Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21.	Participants received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 0 and received 60 µg in a 0.5 mL dose of Placebo, intramuscularly, at Day 21.
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG000109 BG001111 BG002110 BG003330

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Count of Participants

Participants

Title

Denominators

Categories

60 to < 75 years

Title	Measurements
	BG00090 BG00191 BG00290 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00058 BG00160 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0001 BG0011 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0001 BG0010 BG002

History of Prior Flu Vaccinations

Number

participants

Title

Denominators

Categories

Receipt of 2016 - 17 Flu Vaccine

Title	Measurements
	BG00095 BG00194 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

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.

Posted

Number

participants

Day 0 - Day 21 post dosing

ID	Title	Description
OG000	Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21	Participants received 15 µg in a 0.3 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.
OG001	Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21	Participants received 60 µg in a 0.8 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.
OG002	Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21.	Participants received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 0 and received 60 µg in a 0.5 mL dose of Placebo, intramuscularly, at Day 21.

Units	Counts
Participants	OG000109 OG001111 OG002110

Title

Denominators

Categories

MAE's

Title	Measurements
	OG0009 OG0016 OG0022

SAE's

Primary

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

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.

Posted

Number

participants

Day 0 - Day 6 post-dosing

ID	Title	Description
OG000	Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21	Participants received 15 µg in a 0.3 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.
OG001	Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21	Participants received 60 µg in a 0.8 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.
OG002	Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21.	Participants received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 0 and received 60 µg in a 0.5 mL dose of Placebo, intramuscularly, at Day 21.

Primary

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.

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.

Posted

Geometric Mean

95% Confidence Interval

titers

Day 0 - Day 21 post dosing

ID	Title	Description
OG000	Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21	Participants received 15 µg in a 0.3 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.
OG001	Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21	Participants received 60 µg in a 0.8 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.

Primary

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.

Posted

Geometric Mean

95% Confidence Interval

Ratio

Day 0 - Day 21 post dosing

ID	Title	Description
OG000	Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21	Participants received 15 µg in a 0.3 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.
OG001	Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21	Participants received 60 µg in a 0.8 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.
OG002	Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21.

Primary

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.

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.

Posted

Number

participants

Day 0 - Day 21 post dosing

ID	Title	Description
OG000	Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21	Participants received 15 µg in a 0.3 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.
OG001	Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21	Participants received 60 µg in a 0.8 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.
OG002

Primary

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.

Seroprotection rate (SPR) - defined as the number of subjects with an HAI titer ≥ 1:40.

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.

Posted

Number

participants

Day 0 - Day 21 post dosing

ID	Title	Description
OG000	Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21	Participants received 15 µg in a 0.3 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.
OG001	Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21	Participants received 60 µg in a 0.8 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.

Secondary

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.

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.

Posted

Geometric Mean

95% Confidence Interval

titers

Day 0 - Day 21

ID	Title	Description
OG000	Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21	Participants received 15 µg in a 0.3 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.
OG001	Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21	Participants received 60 µg in a 0.8 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.
OG002	Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21.

Secondary

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

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.

Posted

Geometric Mean

95% Confidence Interval

Ratio

Day 0 - Day 21

ID	Title	Description
OG000	Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21	Participants received 15 µg in a 0.3 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.
OG001	Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21	Participants received 60 µg in a 0.8 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.
OG002	Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21.

Secondary

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

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.

Posted

Number

95% Confidence Interval

participants

Day 0 - Day 21

ID	Title	Description
OG000	Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21	Participants received 15 µg in a 0.3 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.
OG001	Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21	Participants received 60 µg in a 0.8 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.
OG002	Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21.

Secondary

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

Seroprotection rate (SPR) - defined as the percentage of subjects with an HAI titer ≥ 1:40.

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.

Posted

Number

95% Confidence Interval

percentage of participants

Day 0 - Day 21

ID	Title	Description
OG000	Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21	Participants received 15 µg in a 0.3 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.
OG001	Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21	Participants received 60 µg in a 0.8 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.

Secondary

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.

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.

Posted

Geometric Mean

95% Confidence Interval

titers

Day 0 - Day 21 post dosing

ID	Title	Description
OG000	Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21	Participants received 15 µg in a 0.3 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.
OG001	Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21	Participants received 60 µg in a 0.8 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.

Secondary

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.

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.

Posted

Geometric Mean

95% Confidence Interval

Ratio

Day 0 - Day 21

ID	Title	Description
OG000	Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21	Participants received 15 µg in a 0.3 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.
OG001	Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21	Participants received 60 µg in a 0.8 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.

Secondary

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.

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.

Posted

Number

95% Confidence Interval

participants

Day 0 - Day 21

ID	Title	Description
OG000	Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21	Participants received 15 µg in a 0.3 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.
OG001	Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21	Participants received 60 µg in a 0.8 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21	Participants received 15 µg in a 0.3 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.	109	7	109	32	109
EG001	Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21	Participants received 60 µg in a 0.8 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.	111	11	111	27	111
EG002	Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21.	Participants received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 0 and received 60 µg in a 0.5 mL dose of Placebo, intramuscularly, at Day 21.	110	8	110	28	110

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
ATRIAL FIBRILLATION	Cardiac disorders	Systematic Assessment	EG0001 events1 affected109 at risk EG0010 events0 affected111 at risk EG0022 events1 affected110 at risk
COLITIS MICROSCOPIC	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected109 at risk EG0011 events1 affected111 at risk EG0020 events0 affected110 at risk
CHEST DISCOMFORT	General disorders	Systematic Assessment	EG0001 events1 affected109 at risk EG0010 events0 affected111 at risk EG0020 events0 affected110 at risk
CHEST PAIN	General disorders	Systematic Assessment	EG0000 events0 affected109 at risk EG0011 events1 affected111 at risk EG0020 events0 affected110 at risk
PYREXIA	General disorders	Systematic Assessment	EG0000 events0 affected109 at risk EG0010 events0 affected111 at risk EG0021 events1 affected110 at risk
BETA HAEMOLYTIC STREPTOCOCCAL INFECTION	Infections and infestations	Systematic Assessment	EG0000 events0 affected109 at risk EG0010 events0 affected111 at risk EG0021 events1 affected110 at risk
PELVIC ABSCESS	Infections and infestations	Systematic Assessment	EG0001 events1 affected109 at risk EG0010 events0 affected111 at risk EG0020 events0 affected110 at risk
PNEUMONIA	Infections and infestations	Systematic Assessment	EG0000 events0 affected109 at risk EG0011 events1 affected111 at risk EG0020 events0 affected110 at risk
OVERDOSE	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected109 at risk EG0010 events0 affected111 at risk EG0021 events1 affected110 at risk
SEROMA	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected109 at risk EG0010 events0 affected111 at risk EG0020 events0 affected110 at risk
UPPER LIMB FRACTURE	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected109 at risk EG0011 events1 affected111 at risk EG0020 events0 affected110 at risk
ADENOCARCINOMA GASTRIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected109 at risk EG0011 events1 affected111 at risk EG0020 events0 affected110 at risk
ADENOCARCINOMA OF COLON	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected109 at risk EG0010 events0 affected111 at risk EG0021 events1 affected110 at risk
ADENOCARCINOMA PANCREAS	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected109 at risk EG0010 events0 affected111 at risk EG0021 events1 affected110 at risk
BLADDER TRANSITIONAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected109 at risk EG0010 events0 affected111 at risk EG0021 events1 affected110 at risk
METASTASES TO MENINGES	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected109 at risk EG0011 events1 affected111 at risk EG0020 events0 affected110 at risk
PROSTATE CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected109 at risk EG0010 events0 affected111 at risk EG0020 events0 affected110 at risk
PROSTATE CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected109 at risk EG0011 events1 affected111 at risk EG0020 events0 affected110 at risk
CEREBROVASCULAR ACCIDENT	Nervous system disorders	Systematic Assessment	EG0000 events0 affected109 at risk EG0012 events2 affected111 at risk EG0020 events0 affected110 at risk
CERVICAL RADICULOPATHY	Nervous system disorders	Systematic Assessment	EG0000 events0 affected109 at risk EG0011 events1 affected111 at risk EG0020 events0 affected110 at risk
SYNCOPE	Nervous system disorders	Systematic Assessment	EG0001 events1 affected109 at risk EG0010 events0 affected111 at risk EG0020 events0 affected110 at risk
TRANSIENT ISCHAEMIC ATTACK	Nervous system disorders	Systematic Assessment	EG0000 events0 affected109 at risk EG0010 events0 affected111 at risk EG0021 events1 affected110 at risk
DEVICE DISLOCATION	Product Issues	Systematic Assessment	EG0000 events0 affected109 at risk EG0011 events1 affected111 at risk EG0020 events0 affected110 at risk
NEPHROLITHIASIS	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected109 at risk EG0010 events0 affected111 at risk EG0020 events0 affected110 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
BRONCHITIS	Infections and infestations	Systematic Assessment	EG00011 events11 affected109 at risk EG00110 events9 affected111 at risk EG0026 events6 affected110 at risk
SINUSITIS	Infections and infestations	Systematic Assessment	EG0004 events4 affected109 at risk EG0015 events5 affected111 at risk EG0027 events7 affected110 at risk
BLOOD PRESSURE SYSTOLIC INCREASED	Investigations	Systematic Assessment	EG00011 events11 affected109 at risk EG0014 events4 affected111 at risk EG0028 events8 affected110 at risk
HEADACHE	Nervous system disorders	Systematic Assessment	EG0003 events2 affected109 at risk EG0018 events7 affected111 at risk EG0021 events1 affected110 at risk
HYPERTENSION	Vascular disorders	Systematic Assessment	EG0004 events4 affected109 at risk EG0012 events2 affected111 at risk EG0026 events6 affected110 at risk

First MCP Posted Date

ID	Term
D007251	Influenza, Human

Title	Measurements
	OG0000 OG0011 OG0020

Participants received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 0 and received 60 µg in a 0.5 mL dose of Placebo, intramuscularly, at Day 21.

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D012140	Respiratory Tract Diseases