Influenza
Conditions
Brief 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
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.
Interventions
BIOLOGICALNanoFlu
Vaccine
BIOLOGICALFluzone HD - Day 0
Vaccine
BIOLOGICALFluzone HD - Day 21
Vaccine
OTHERSaline - Day 21
Placebo
Sponsors
Novavax
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Healthy older adults, male or female, 2. Willing and able to give informed consent prior to trial enrollment, and 3. Able to attend trial visits, comply with trial requirements, and provide reliable and complete reports of adverse events.
Exclusion criteria
1. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With All Adverse Events (AEs), Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), and Significant New Medical Conditions (SNMCs). | 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 | 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. | 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. | 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. | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Day 0 - Day 21 | 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. |
| 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. | Day 0 - Day 21 | 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. |
| 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 | Day 0 - Day 21 | 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. |
| 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 | Day 0 - Day 21 | 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. |
| 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 | Day 0 - Day 21 | 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. |
| 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. | Day 0 - Day 21 post dosing | 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. |
| 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. | Day 0 - Day 21 | 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. |
Countries
United States
Participant flow
Recruitment details
Participants took part in a study conducted at 3 different clinical sites from September 18, 2017 to October 29, 2018.
Pre-assignment details
Healthy older adults (≥ 60 years of age) were enrolled in the study and divided into 3 treatment groups based on gender, age, and history of 2016-17 influenza vaccine. Participants were treated with different doses of Tri-NIV Vaccine (0.3 mL,0.8mL), Fluzone HD (0.8 mL), and Placebo (0.5 mL) as Intramuscular (IM) injection into the deltoid muscle.
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| 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 |
| 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 |
| Total | 330 |
Baseline characteristics
| Characteristic | Total | Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. |
|---|---|---|---|---|
| Age, Customized 60 to < 75 years | 271 Participants | 90 Participants | 91 Participants | 90 Participants |
| Age, Customized ≥ 75 years | 59 Participants | 19 Participants | 20 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 1 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 327 Participants | 108 Participants | 110 Participants | 109 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| History of Prior Flu Vaccinations Receipt of 2016 - 17 Flu Vaccine | 282 participants | 95 participants | 94 participants | 93 participants |
| History of Prior Flu Vaccinations Receipt of Flu Vaccine in Past 3 Years | 305 participants | 102 participants | 101 participants | 102 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 39 Participants | 17 Participants | 13 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 288 Participants | 91 Participants | 98 Participants | 99 Participants |
| Sex: Female, Male Female | 175 Participants | 58 Participants | 60 Participants | 57 Participants |
| Sex: Female, Male Male | 155 Participants | 51 Participants | 51 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 109 | 0 / 111 | 0 / 110 |
| other Total, other adverse events | 32 / 109 | 27 / 111 | 28 / 110 |
| serious Total, serious adverse events | 7 / 109 | 11 / 111 | 8 / 110 |
Outcome results
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.
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.
Time frame: Day 0 - Day 21 post dosing
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (A/Michigan/45/2015 (H1N1)) | 2.47 Ratio |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (A/California/07/2009 (H1N1) ) | 2.20 Ratio |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (A/Texas/50/2012 (H3N2) ) | 2.17 Ratio |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (A/Switzerland/9715293/2013 (H3N2)) | 2.46 Ratio |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (A/HongKong/4801/2014 (H3N2) ) | 2.35 Ratio |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (B/Brisbane/60/2008 (Victoria Lineage)) | 1.30 Ratio |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (A/Switzerland/9715293/2013 (H3N2)) | 3.38 Ratio |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (B/Brisbane/60/2008 (Victoria Lineage)) | 1.57 Ratio |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (A/California/07/2009 (H1N1) ) | 3.29 Ratio |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (A/Michigan/45/2015 (H1N1)) | 3.86 Ratio |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (A/HongKong/4801/2014 (H3N2) ) | 3.49 Ratio |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (A/Texas/50/2012 (H3N2) ) | 3.04 Ratio |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | 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. | Day 21 (A/Switzerland/9715293/2013 (H3N2)) | 2.51 Ratio |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | 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. | Day 21 (A/Texas/50/2012 (H3N2) ) | 2.40 Ratio |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | 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. | Day 21 (A/Michigan/45/2015 (H1N1)) | 4.55 Ratio |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | 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. | Day 21 (A/HongKong/4801/2014 (H3N2) ) | 3.57 Ratio |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | 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. | Day 21 (B/Brisbane/60/2008 (Victoria Lineage)) | 2.56 Ratio |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | 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. | Day 21 (A/California/07/2009 (H1N1) ) | 3.94 Ratio |
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.
Time frame: Day 0 - Day 21 post dosing
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 0 (A/HongKong/4801/2014 (H3N2) ) | 26 titers |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (A/Switzerland/9715293/2013 (H3N2)) | 159 titers |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 0 (A/Michigan/45/2015 (H1N1)) | 39 titers |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 0 (A/California/07/2009 (H1N1)) | 65 titers |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (A/HongKong/4801/2014 (H3N2) ) | 62 titers |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (B/Brisbane/60/2008 (Victoria Lineage)) | 24 titers |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (A/California/07/2009 (H1N1) ) | 143 titers |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 0 (A/Texas/50/2012 (H3N2) ) | 197 titers |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 0 (A/Switzerland/9715293/2013 (H3N2)) | 65 titers |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 0 (B/Brisbane/60/2008 (Victoria Lineage)) | 19 titers |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (A/Texas/50/2012 (H3N2) ) | 429 titers |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (A/Michigan/45/2015 (H1N1)) | 95 titers |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 0 (A/Michigan/45/2015 (H1N1)) | 34 titers |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 0 (A/Texas/50/2012 (H3N2) ) | 160 titers |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (A/Texas/50/2012 (H3N2) ) | 485 titers |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (A/Michigan/45/2015 (H1N1)) | 130 titers |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 0 (A/HongKong/4801/2014 (H3N2) ) | 21 titers |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (A/HongKong/4801/2014 (H3N2) ) | 75 titers |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 0 (B/Brisbane/60/2008 (Victoria Lineage)) | 18 titers |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (B/Brisbane/60/2008 (Victoria Lineage)) | 29 titers |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 0 (A/California/07/2009 (H1N1)) | 59 titers |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (A/California/07/2009 (H1N1) ) | 194 titers |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 0 (A/Switzerland/9715293/2013 (H3N2)) | 55 titers |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (A/Switzerland/9715293/2013 (H3N2)) | 187 titers |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | 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. | Day 0 (A/California/07/2009 (H1N1)) | 52 titers |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | 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. | Day 21 (A/Texas/50/2012 (H3N2) ) | 470 titers |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | 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. | Day 21 (B/Brisbane/60/2008 (Victoria Lineage)) | 37 titers |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | 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. | Day 0 (A/HongKong/4801/2014 (H3N2) ) | 26 titers |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | 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. | Day 21 (A/Michigan/45/2015 (H1N1)) | 139.1 titers |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | 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. | Day 0 (A/Switzerland/9715293/2013 (H3N2)) | 60 titers |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | 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. | Day 0 (A/Michigan/45/2015 (H1N1)) | 31 titers |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | 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. | Day 21 (A/Switzerland/9715293/2013 (H3N2)) | 151 titers |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | 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. | Day 21 (A/HongKong/4801/2014 (H3N2) ) | 94 titers |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | 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. | Day 0 (A/Texas/50/2012 (H3N2) ) | 196 titers |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | 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. | Day 21 (A/California/07/2009 (H1N1) ) | 206 titers |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | 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. | Day 0 (B/Brisbane/60/2008 (Victoria Lineage)) | 15 titers |
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.
Time frame: Day 0 - Day 21 post dosing
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | Number of Participants With All Adverse Events (AEs), Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), and Significant New Medical Conditions (SNMCs). | MAE's | 9 participants |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | Number of Participants With All Adverse Events (AEs), Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), and Significant New Medical Conditions (SNMCs). | All AEs (21 days post-injection) | 40 participants |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | Number of Participants With All Adverse Events (AEs), Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), and Significant New Medical Conditions (SNMCs). | SAE's | 0 participants |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | Number of Participants With All Adverse Events (AEs), Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), and Significant New Medical Conditions (SNMCs). | SNMC's | 0 participants |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | Number of Participants With All Adverse Events (AEs), Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), and Significant New Medical Conditions (SNMCs). | MAE's | 6 participants |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | Number of Participants With All Adverse Events (AEs), Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), and Significant New Medical Conditions (SNMCs). | SAE's | 1 participants |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | Number of Participants With All Adverse Events (AEs), Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), and Significant New Medical Conditions (SNMCs). | SNMC's | 1 participants |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | Number of Participants With All Adverse Events (AEs), Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), and Significant New Medical Conditions (SNMCs). | All AEs (21 days post-injection) | 52 participants |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | Number of Participants With All Adverse Events (AEs), Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), and Significant New Medical Conditions (SNMCs). | MAE's | 2 participants |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | Number of Participants With All Adverse Events (AEs), Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), and Significant New Medical Conditions (SNMCs). | SNMC's | 0 participants |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | Number of Participants With All Adverse Events (AEs), Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), and Significant New Medical Conditions (SNMCs). | SAE's | 0 participants |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | Number of Participants With All Adverse Events (AEs), Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), and Significant New Medical Conditions (SNMCs). | All AEs (21 days post-injection) | 51 participants |
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.
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.
Time frame: Day 0 - Day 21 post dosing
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 0 (A/Texas/50/2012 (H3N2) ) | 98 participants |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (A/HongKong/4801/2014 (H3N2) ) | 76 participants |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 0 (A/HongKong/4801/2014 (H3N2) ) | 51 participants |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (A/California/07/2009 (H1N1) ) | 98 participants |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 0 (B/Brisbane/60/2008 (Victoria Lineage)) | 31 participants |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (A/Michigan/45/2015 (H1N1)) | 93 participants |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 0 (A/Michigan/45/2015 (H1N1)) | 65 participants |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 0 (A/Switzerland/9715293/2013 (H3N2)) | 79 participants |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (B/Brisbane/60/2008 (Victoria Lineage)) | 42 participants |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (A/Switzerland/9715293/2013 (H3N2)) | 101 participants |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 0 (A/California/07/2009 (H1N1) ) | 80 participants |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (A/Texas/50/2012 (H3N2) ) | 109 participants |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (A/Michigan/45/2015 (H1N1)) | 96 participants |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 0 (A/Michigan/45/2015 (H1N1)) | 63 participants |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 0 (A/HongKong/4801/2014 (H3N2) ) | 45 participants |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 0 (B/Brisbane/60/2008 (Victoria Lineage)) | 30 participants |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (B/Brisbane/60/2008 (Victoria Lineage)) | 53 participants |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 0 (A/Texas/50/2012 (H3N2) ) | 96 participants |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 0 (A/Switzerland/9715293/2013 (H3N2)) | 71 participants |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (A/HongKong/4801/2014 (H3N2) ) | 79 participants |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 0 (A/California/07/2009 (H1N1) ) | 77 participants |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (A/California/07/2009 (H1N1) ) | 102 participants |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (A/Texas/50/2012 (H3N2) ) | 110 participants |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (A/Switzerland/9715293/2013 (H3N2)) | 103 participants |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | 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. | Day 0 (B/Brisbane/60/2008 (Victoria Lineage)) | 19 participants |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | 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. | Day 0 (A/California/07/2009 (H1N1) ) | 74 participants |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | 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. | Day 0 (A/Switzerland/9715293/2013 (H3N2)) | 73 participants |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | 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. | Day 0 (A/HongKong/4801/2014 (H3N2) ) | 45 participants |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | 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. | Day 0 (A/Texas/50/2012 (H3N2) ) | 98 participants |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | 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. | Day 21 (A/California/07/2009 (H1N1) ) | 104 participants |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | 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. | Day 21 (A/Switzerland/9715293/2013 (H3N2)) | 100 participants |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | 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. | Day 21 (A/Michigan/45/2015 (H1N1)) | 98 participants |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | 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. | Day 21 (A/Texas/50/2012 (H3N2) ) | 108 participants |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | 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. | Day 21 (A/HongKong/4801/2014 (H3N2) ) | 89 participants |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | 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. | Day 0 (A/Michigan/45/2015 (H1N1)) | 57 participants |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | 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. | Day 21 (B/Brisbane/60/2008 (Victoria Lineage)) | 57 participants |
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
Time frame: Day 0 - Day 6 post-dosing
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | Number of Participants With Solicited Local and Systemic AEs | Solicited Local AE's (Day 0 to Day 6) | 15 participants |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | Number of Participants With Solicited Local and Systemic AEs | Solicited Systemic AE's (Day 0 to Day 6) | 23 participants |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | Number of Participants With Solicited Local and Systemic AEs | Solicited Local AE's (Day 0 to Day 6) | 26 participants |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | Number of Participants With Solicited Local and Systemic AEs | Solicited Systemic AE's (Day 0 to Day 6) | 24 participants |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | Number of Participants With Solicited Local and Systemic AEs | Solicited Local AE's (Day 0 to Day 6) | 30 participants |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | Number of Participants With Solicited Local and Systemic AEs | Solicited Systemic AE's (Day 0 to Day 6) | 20 participants |
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.
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.
Time frame: Day 0 - Day 21 post dosing
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (A/Switzerland/9715293/2013 (H3N2)) | 28 participants |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (A/Texas/50/2012 (H3N2) ) | 21 participants |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (A/California/07/2009 (H1N1) ) | 24 participants |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (B/Brisbane/60/2008 (Victoria Lineage)) | 5 participants |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (A/Michigan/45/2015 (H1N1)) | 34 participants |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (A/HongKong/4801/2014 (H3N2) ) | 24 participants |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (A/Switzerland/9715293/2013 (H3N2)) | 43 participants |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (A/Michigan/45/2015 (H1N1)) | 49 participants |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (A/HongKong/4801/2014 (H3N2) ) | 34 participants |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (A/California/07/2009 (H1N1) ) | 45 participants |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (B/Brisbane/60/2008 (Victoria Lineage)) | 13 participants |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (A/Texas/50/2012 (H3N2) ) | 38 participants |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | 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. | Day 21 (B/Brisbane/60/2008 (Victoria Lineage)) | 29 participants |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | 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. | Day 21 (A/Switzerland/9715293/2013 (H3N2)) | 30 participants |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | 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. | Day 21 (A/Michigan/45/2015 (H1N1)) | 54 participants |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | 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. | Day 21 (A/Texas/50/2012 (H3N2) ) | 29 participants |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | 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. | Day 21 (A/HongKong/4801/2014 (H3N2) ) | 43 participants |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | 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. | Day 21 (A/California/07/2009 (H1N1) ) | 53 participants |
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.
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.
Time frame: Day 0 - Day 21
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 2.50 Ratio |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21: A/Michigan/45/2015 (H1N1) | 3.44 Ratio |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21: A/HongKong/4801/2014 (H3N2) | 2.71 Ratio |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21: B/Brisbane/60/2008 (Victoria Lineage) | 1.72 Ratio |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (A/Switzerland/9715293/2013 (H3N2)) | 2.61 Ratio |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (A/Texas/50/2012 (H3N2)) | 2.51 Ratio |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (A/Switzerland/9715293/2013 (H3N2)) | 4.15 Ratio |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 3.76 Ratio |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21 (A/Texas/50/2012 (H3N2)) | 3.79 Ratio |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21: A/Michigan/45/2015 (H1N1) | 5.86 Ratio |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21: B/Brisbane/60/2008 (Victoria Lineage) | 2.03 Ratio |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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. | Day 21: A/HongKong/4801/2014 (H3N2) | 4.25 Ratio |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | 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. | Day 21 (A/Texas/50/2012 (H3N2)) | 2.53 Ratio |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | 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. | Day 21: A/HongKong/4801/2014 (H3N2) | 4.12 Ratio |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | 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. | Day 21 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 3.90 Ratio |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | 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. | Day 21 (A/Switzerland/9715293/2013 (H3N2)) | 2.15 Ratio |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | 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. | Day 21: B/Brisbane/60/2008 (Victoria Lineage) | 2.75 Ratio |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | 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. | Day 21: A/Michigan/45/2015 (H1N1) | 5.21 Ratio |
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
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.
Time frame: Day 0 - Day 21
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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 | A/Michigan/45/2015 (H1N1) : Day 21 | 2.13 Ratio |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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 | A/HongKong/4801/2014 (H3N2) : Day 21 | 2.10 Ratio |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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 | A/HongKong/4801/2014 (H3N2) : Day 21 | 2.74 Ratio |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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 | A/Michigan/45/2015 (H1N1) : Day 21 | 3.17 Ratio |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at 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 | A/HongKong/4801/2014 (H3N2) : Day 21 | 1.85 Ratio |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at 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 | A/Michigan/45/2015 (H1N1) : Day 21 | 2.61 Ratio |
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.
Time frame: Day 0 - Day 21 post dosing
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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. | Day 21 (A/Texas/50/2012 (H3N2)) | 9204 titers |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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. | Day 21 (A/Switzerland/9715293/2013 (H3N2)) | 4419 titers |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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. | Day 0 (A/HongKong/4801/2014 (H3N2) ) | 1239 titers |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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. | Day 21 (A/Singapore/INFIMH-16-0019/2016 (H3N2) | 1469 titers |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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. | Day 21 (A/HongKong/4801/2014 (H3N2) ) | 3359 titers |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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. | Day 21 (B/Brisbane/60/2008 (Victoria Lineage)) | 287 titers |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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. | Day 0 (A/Michigan/45/2015 (H1N1)) | 411 titers |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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. | Day 21 (A/Michigan/45/2015 (H1N1)) | 1414 titers |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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. | Day 0 (B/Brisbane/60/2008 (Victoria Lineage)) | 167 titers |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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. | Day 0 (A/Switzerland/9715293/2013 (H3N2)) | 1696 titers |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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. | Day 0 (A/Texas/50/2012 (H3N2)) | 3660 titers |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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. | Day 0 (A/Singapore/INFIMH-16-0019/2016 (H3N2) | 587 titers |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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. | Day 0 (A/Texas/50/2012 (H3N2)) | 2768 titers |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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. | Day 0 (A/Singapore/INFIMH-16-0019/2016 (H3N2) | 437 titers |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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. | Day 21 (A/Michigan/45/2015 (H1N1)) | 2005 titers |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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. | Day 0 (A/Switzerland/9715293/2013 (H3N2)) | 1258 titers |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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. | Day 0 (A/Michigan/45/2015 (H1N1)) | 342 titers |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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. | Day 0 (A/HongKong/4801/2014 (H3N2) ) | 891 titers |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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. | Day 0 (B/Brisbane/60/2008 (Victoria Lineage)) | 174 titers |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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. | Day 21 (A/Switzerland/9715293/2013 (H3N2)) | 5223 titers |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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. | Day 21 (A/HongKong/4801/2014 (H3N2) ) | 3791 titers |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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. | Day 21 (A/Singapore/INFIMH-16-0019/2016 (H3N2) | 1640 titers |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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. | Day 21 (B/Brisbane/60/2008 (Victoria Lineage)) | 354 titers |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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. | Day 21 (A/Texas/50/2012 (H3N2)) | 10495 titers |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at 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. | Day 21 (B/Brisbane/60/2008 (Victoria Lineage)) | 425 titers |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at 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. | Day 21 (A/Switzerland/9715293/2013 (H3N2)) | 3011 titers |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at 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. | Day 21 (A/Texas/50/2012 (H3N2)) | 8383 titers |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at 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. | Day 0 (A/Singapore/INFIMH-16-0019/2016 (H3N2) | 489 titers |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at 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. | Day 21 (A/Singapore/INFIMH-16-0019/2016 (H3N2) | 1905 titers |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at 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. | Day 0 (B/Brisbane/60/2008 (Victoria Lineage)) | 154 titers |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at 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. | Day 0 (A/Texas/50/2012 (H3N2)) | 3307 titers |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at 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. | Day 0 (A/Michigan/45/2015 (H1N1)) | 334 titers |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at 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. | Day 21 (A/Michigan/45/2015 (H1N1)) | 1741 titers |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at 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. | Day 0 (A/HongKong/4801/2014 (H3N2) ) | 1081 titers |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at 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. | Day 21 (A/HongKong/4801/2014 (H3N2) ) | 4455 titers |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at 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. | Day 0 (A/Switzerland/9715293/2013 (H3N2)) | 1400 titers |
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.
Time frame: Day 0 - Day 21
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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 | A/Michigan/45/2015 (H1N1) : Day 0 | 69 titers |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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 | A/Michigan/45/2015 (H1N1): Day 21 | 146 titers |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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 | A/HongKong/4801/2014 (H3N2) : Day 0 | 60 titers |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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 | A/HongKong/4801/2014 (H3N2) : Day 21 | 127 titers |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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 | A/HongKong/4801/2014 (H3N2) : Day 21 | 159 titers |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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 | A/HongKong/4801/2014 (H3N2) : Day 0 | 58 titers |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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 | A/Michigan/45/2015 (H1N1) : Day 0 | 66 titers |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21 | 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 | A/Michigan/45/2015 (H1N1): Day 21 | 210 titers |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | 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 | A/Michigan/45/2015 (H1N1) : Day 0 | 65 titers |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | 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 | A/Michigan/45/2015 (H1N1): Day 21 | 171 titers |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | 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 | A/HongKong/4801/2014 (H3N2) : Day 0 | 62 titers |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21. | 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 | A/HongKong/4801/2014 (H3N2) : Day 21 | 116 titers |
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
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.
Time frame: Day 0 - Day 21
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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 | A/Michigan/45/2015 (H1N1) : Day 21 | 100.0 percentage of participants |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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 | A/HongKong/4801/2014 (H3N2) : Day 21 | 100.0 percentage of participants |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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 | A/HongKong/4801/2014 (H3N2) : Day 0 | 97.2 percentage of participants |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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 | A/Michigan/45/2015 (H1N1) : Day 0 | 99.1 percentage of participants |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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 | A/Michigan/45/2015 (H1N1) : Day 0 | 98.2 percentage of participants |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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 | A/Michigan/45/2015 (H1N1) : Day 21 | 100 percentage of participants |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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 | A/HongKong/4801/2014 (H3N2) : Day 0 | 96.4 percentage of participants |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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 | A/HongKong/4801/2014 (H3N2) : Day 21 | 98.2 percentage of participants |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at 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 | A/Michigan/45/2015 (H1N1) : Day 0 | 97.2 percentage of participants |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at 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 | A/HongKong/4801/2014 (H3N2) : Day 0 | 90.8 percentage of participants |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at 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 | A/Michigan/45/2015 (H1N1) : Day 21 | 99.1 percentage of participants |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at 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 | A/HongKong/4801/2014 (H3N2) : Day 21 | 94.5 percentage of participants |
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.
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.
Time frame: Day 0 - Day 21
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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. | Day 21: A/HongKong/4801/2014 (H3N2) | 28 participants |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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. | Day 21 (A/Texas/50/2012 (H3N2)) | 26 participants |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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. | Day 21: A/Michigan/45/2015 (H1N1) | 33 participants |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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. | Day 21: B/Brisbane/60/2008 (Victoria Lineage) | 13 participants |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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. | Day 21 (A/Switzerland/9715293/2013 (H3N2)) | 22 participants |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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. | Day 21 (A/Singapore/INFIMH-16-0019/2016 (H3N2) | 27 participants |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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. | Day 21 (A/Texas/50/2012 (H3N2)) | 47 participants |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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. | Day 21 (A/Singapore/INFIMH-16-0019/2016 (H3N2) | 38 participants |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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. | Day 21 (A/Switzerland/9715293/2013 (H3N2)) | 45 participants |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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. | Day 21: A/Michigan/45/2015 (H1N1) | 53 participants |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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. | Day 21: A/HongKong/4801/2014 (H3N2) | 43 participants |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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. | Day 21: B/Brisbane/60/2008 (Victoria Lineage) | 18 participants |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at 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. | Day 21 (A/Switzerland/9715293/2013 (H3N2)) | 20 participants |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at 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. | Day 21: B/Brisbane/60/2008 (Victoria Lineage) | 23 participants |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at 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. | Day 21: A/HongKong/4801/2014 (H3N2) | 48 participants |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at 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. | Day 21 (A/Singapore/INFIMH-16-0019/2016 (H3N2) | 43 participants |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at 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. | Day 21 (A/Texas/50/2012 (H3N2)) | 28 participants |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at 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. | Day 21: A/Michigan/45/2015 (H1N1) | 50 participants |
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
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.
Time frame: Day 0 - Day 21
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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 | A/Michigan/45/2015 (H1N1): Day 21 | 27 participants |
| Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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 | A/Michigan/45/2015 (H1N1) : Day 21 | 29 participants |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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 | A/Michigan/45/2015 (H1N1): Day 21 | 45 participants |
| Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at 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 | A/Michigan/45/2015 (H1N1) : Day 21 | 38 participants |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at 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 | A/Michigan/45/2015 (H1N1): Day 21 | 40 participants |
| Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at 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 | A/Michigan/45/2015 (H1N1) : Day 21 | 25 participants |