Trial Outcomes & Findings for Evaluation of the Safety and Immunogenicity of a Recombinant Trivalent Nanoparticle Influenza Vaccine With Matrix M-1 Adjuvant (NanoFlu) (NCT NCT03293498)
NCT ID: NCT03293498
Last Updated: 2022-12-21
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
330 participants
Primary outcome timeframe
Day 0 - Day 21 post dosing
Results posted on
2022-12-21
Participant Flow
Participants took part in a study conducted at 3 different clinical sites from September 18, 2017 to October 29, 2018.
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
109
|
111
|
110
|
|
Overall Study
COMPLETED
|
109
|
111
|
110
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of the Safety and Immunogenicity of a Recombinant Trivalent Nanoparticle Influenza Vaccine With Matrix M-1 Adjuvant (NanoFlu)
Baseline characteristics by cohort
| Measure |
Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21
n=109 Participants
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.
|
Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21
n=111 Participants
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.
|
Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21.
n=110 Participants
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.
|
Total
n=330 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
60 to < 75 years
|
90 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
271 Participants
n=4 Participants
|
|
Age, Customized
≥ 75 years
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
175 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
155 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
108 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
327 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
91 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
288 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
History of Prior Flu Vaccinations
Receipt of 2016 - 17 Flu Vaccine
|
95 participants
n=5 Participants
|
94 participants
n=7 Participants
|
93 participants
n=5 Participants
|
282 participants
n=4 Participants
|
|
History of Prior Flu Vaccinations
Receipt of Flu Vaccine in Past 3 Years
|
102 participants
n=5 Participants
|
101 participants
n=7 Participants
|
102 participants
n=5 Participants
|
305 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 0 - Day 21 post dosingPopulation: 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.
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.
Outcome measures
| Measure |
Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21
n=109 Participants
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.
|
Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21
n=111 Participants
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.
|
Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21.
n=110 Participants
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.
|
|---|---|---|---|
|
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
|
6 participants
|
2 participants
|
|
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
|
1 participants
|
0 participants
|
|
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
|
1 participants
|
0 participants
|
|
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
|
52 participants
|
51 participants
|
PRIMARY outcome
Timeframe: Day 0 - Day 6 post-dosingPopulation: 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.
Number of participants with solicited local and systemic adverse events over the 7 days post-injection
Outcome measures
| Measure |
Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21
n=109 Participants
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.
|
Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21
n=111 Participants
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.
|
Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21.
n=110 Participants
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.
|
|---|---|---|---|
|
Number of Participants With Solicited Local and Systemic AEs
Solicited Local AE's (Day 0 to Day 6)
|
15 participants
|
26 participants
|
30 participants
|
|
Number of Participants With Solicited Local and Systemic AEs
Solicited Systemic AE's (Day 0 to Day 6)
|
23 participants
|
24 participants
|
20 participants
|
PRIMARY outcome
Timeframe: Day 0 - Day 21 post dosingPopulation: 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.
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.
Outcome measures
| Measure |
Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21
n=109 Participants
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.
|
Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21
n=111 Participants
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.
|
Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21.
n=110 Participants
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.
|
|---|---|---|---|
|
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
Interval 31.0 to 48.0
|
34 titers
Interval 27.0 to 42.0
|
31 titers
Interval 25.0 to 38.0
|
|
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
Interval 75.0 to 121.0
|
130 titers
Interval 102.0 to 166.0
|
139.1 titers
Interval 112.0 to 174.0
|
|
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
Interval 21.0 to 33.0
|
21 titers
Interval 17.0 to 27.0
|
26 titers
Interval 21.0 to 33.0
|
|
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
Interval 48.0 to 79.0
|
75 titers
Interval 59.0 to 94.0
|
94 titers
Interval 74.0 to 119.0
|
|
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
Interval 15.0 to 23.0
|
18 titers
Interval 15.0 to 22.0
|
15 titers
Interval 12.0 to 17.0
|
|
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
Interval 20.0 to 30.0
|
29 titers
Interval 24.0 to 35.0
|
37 titers
Interval 31.0 to 46.0
|
|
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
Interval 53.0 to 80.0
|
59 titers
Interval 48.0 to 73.0
|
52 titers
Interval 42.0 to 64.0
|
|
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
Interval 116.0 to 176.0
|
194 titers
Interval 156.0 to 242.0
|
206 titers
Interval 169.0 to 222.0
|
|
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
Interval 155.0 to 251.0
|
160 titers
Interval 123.0 to 207.0
|
196 titers
Interval 151.0 to 253.0
|
|
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
Interval 352.0 to 523.0
|
485 titers
Interval 397.0 to 592.0
|
470 titers
Interval 382.0 to 577.0
|
|
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
Interval 50.0 to 83.0
|
55 titers
Interval 43.0 to 71.0
|
60 titers
Interval 47.0 to 78.0
|
|
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
Interval 128.0 to 198.0
|
187 titers
Interval 150.0 to 234.0
|
151 titers
Interval 122.0 to 188.0
|
PRIMARY outcome
Timeframe: Day 0 - Day 21 post dosingThe 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.
Outcome measures
| Measure |
Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21
n=109 Participants
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.
|
Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21
n=111 Participants
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.
|
Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21.
n=110 Participants
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.
|
|---|---|---|---|
|
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
Interval 2.05 to 2.98
|
3.86 Ratio
Interval 3.07 to 4.85
|
4.55 Ratio
Interval 3.6 to 5.75
|
|
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
Interval 1.94 to 2.84
|
3.49 Ratio
Interval 2.78 to 4.37
|
3.57 Ratio
Interval 2.87 to 4.45
|
|
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
Interval 1.16 to 1.44
|
1.57 Ratio
Interval 1.39 to 1.78
|
2.56 Ratio
Interval 2.1 to 3.11
|
|
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
Interval 1.87 to 2.59
|
3.29 Ratio
Interval 2.67 to 4.05
|
3.94 Ratio
Interval 3.16 to 4.92
|
|
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
Interval 1.83 to 2.58
|
3.04 Ratio
Interval 2.48 to 3.72
|
2.40 Ratio
Interval 2.01 to 2.87
|
|
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
Interval 2.04 to 2.95
|
3.38 Ratio
Interval 2.72 to 4.21
|
2.51 Ratio
Interval 2.08 to 3.02
|
PRIMARY outcome
Timeframe: Day 0 - Day 21 post dosingPopulation: 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.
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.
Outcome measures
| Measure |
Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21
n=109 Participants
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.
|
Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21
n=111 Participants
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.
|
Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21.
n=110 Participants
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.
|
|---|---|---|---|
|
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
|
49 participants
|
54 participants
|
|
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
|
34 participants
|
43 participants
|
|
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
|
13 participants
|
29 participants
|
|
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
|
45 participants
|
53 participants
|
|
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
|
38 participants
|
29 participants
|
|
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
|
43 participants
|
30 participants
|
PRIMARY outcome
Timeframe: Day 0 - Day 21 post dosingPopulation: 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.
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.
Outcome measures
| Measure |
Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21
n=109 Participants
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.
|
Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21
n=111 Participants
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.
|
Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21.
n=110 Participants
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.
|
|---|---|---|---|
|
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
|
63 participants
|
57 participants
|
|
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
|
96 participants
|
98 participants
|
|
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
|
45 participants
|
45 participants
|
|
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
|
79 participants
|
89 participants
|
|
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
|
30 participants
|
19 participants
|
|
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
|
53 participants
|
57 participants
|
|
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
|
77 participants
|
74 participants
|
|
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
|
102 participants
|
104 participants
|
|
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
|
96 participants
|
98 participants
|
|
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
|
110 participants
|
108 participants
|
|
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
|
71 participants
|
73 participants
|
|
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
|
103 participants
|
100 participants
|
SECONDARY outcome
Timeframe: Day 0 - Day 21Population: 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.
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.
Outcome measures
| Measure |
Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21
n=109 Participants
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.
|
Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21
n=111 Participants
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.
|
Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21.
n=110 Participants
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.
|
|---|---|---|---|
|
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
Interval 61.0 to 78.0
|
66 titers
Interval 59.0 to 74.0
|
65 titers
Interval 58.0 to 74.0
|
|
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
Interval 120.0 to 178.0
|
210 titers
Interval 171.0 to 258.0
|
171 titers
Interval 141.0 to 206.0
|
|
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
Interval 53.0 to 69.0
|
58 titers
Interval 51.0 to 66.0
|
62 titers
Interval 53.0 to 74.0
|
|
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
Interval 103.0 to 157.0
|
159 titers
Interval 126.0 to 201.0
|
116 titers
Interval 91.0 to 147.0
|
SECONDARY outcome
Timeframe: Day 0 - Day 21Population: 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.
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.
Outcome measures
| Measure |
Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21
n=109 Participants
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.
|
Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21
n=111 Participants
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.
|
Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21.
n=110 Participants
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.
|
|---|---|---|---|
|
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
Interval 1.83 to 2.48
|
3.17 Ratio
Interval 2.61 to 3.85
|
2.61 Ratio
Interval 2.21 to 3.09
|
|
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
Interval 1.75 to 2.53
|
2.74 Ratio
Interval 2.22 to 3.38
|
1.85 Ratio
Interval 1.56 to 2.2
|
SECONDARY outcome
Timeframe: Day 0 - Day 21Population: 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.
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.
Outcome measures
| Measure |
Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21
n=109 Participants
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.
|
Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21
n=111 Participants
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.
|
Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21.
n=110 Participants
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.
|
|---|---|---|---|
|
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
Interval 17.0 to 34.0
|
45 participants
Interval 31.6 to 50.7
|
40 participants
Interval 27.7 to 46.5
|
|
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
Interval 18.6 to 35.9
|
38 participants
Interval 25.7 to 44.2
|
25 participants
Interval 15.4 to 32.0
|
SECONDARY outcome
Timeframe: Day 0 - Day 21Population: 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.
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.
Outcome measures
| Measure |
Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21
n=109 Participants
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.
|
Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21
n=111 Participants
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.
|
Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21.
n=110 Participants
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.
|
|---|---|---|---|
|
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
Interval 95.0 to 100.0
|
98.2 percentage of participants
Interval 93.6 to 99.8
|
97.2 percentage of participants
Interval 92.2 to 99.4
|
|
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
Interval 96.7 to 100.0
|
100 percentage of participants
Interval 96.7 to 100.0
|
99.1 percentage of participants
Interval 95.0 to 100.0
|
|
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
Interval 92.2 to 99.4
|
96.4 percentage of participants
Interval 91.0 to 99.0
|
90.8 percentage of participants
Interval 83.8 to 95.5
|
|
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
Interval 96.7 to 100.0
|
98.2 percentage of participants
Interval 93.6 to 99.8
|
94.5 percentage of participants
Interval 88.4 to 98.0
|
SECONDARY outcome
Timeframe: Day 0 - Day 21 post dosingPopulation: 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.
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.
Outcome measures
| Measure |
Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21
n=109 Participants
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.
|
Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21
n=111 Participants
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.
|
Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21.
n=110 Participants
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.
|
|---|---|---|---|
|
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
Interval 1292.0 to 2227.0
|
1258 titers
Interval 954.0 to 1658.0
|
1400 titers
Interval 1046.0 to 1873.0
|
|
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
Interval 3391.0 to 5758.0
|
5223 titers
Interval 3997.0 to 6824.0
|
3011 titers
Interval 2268.0 to 3997.0
|
|
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
Interval 2803.0 to 4778.0
|
2768 titers
Interval 2142.0 to 3577.0
|
3307 titers
Interval 2484.0 to 4402.0
|
|
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
Interval 7165.0 to 11822.0
|
10495 titers
Interval 8213.0 to 13410.0
|
8383 titers
Interval 6409.0 to 10964.0
|
|
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
Interval 461.0 to 748.0
|
437 titers
Interval 349.0 to 547.0
|
489 titers
Interval 367.0 to 651.0
|
|
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
Interval 1113.0 to 1940.0
|
1640 titers
Interval 1254.0 to 2146.0
|
1905 titers
Interval 1434.0 to 2531.0
|
|
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
Interval 327.0 to 516.0
|
342 titers
Interval 269.0 to 436.0
|
334 titers
Interval 259.0 to 432.0
|
|
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
Interval 1070.0 to 1868.0
|
2005 titers
Interval 1485.0 to 2708.0
|
1741 titers
Interval 1313.0 to 2309.0
|
|
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
Interval 957.0 to 1605.0
|
891 titers
Interval 698.0 to 1137.0
|
1081 titers
Interval 816.0 to 1433.0
|
|
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
Interval 2577.0 to 4378.0
|
3791 titers
Interval 2906.0 to 4944.0
|
4455 titers
Interval 3426.0 to 5793.0
|
|
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
Interval 129.0 to 216.0
|
174 titers
Interval 137.0 to 220.0
|
154 titers
Interval 124.0 to 193.0
|
|
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
Interval 228.0 to 361.0
|
354 titers
Interval 285.0 to 439.0
|
425 titers
Interval 341.0 to 529.0
|
SECONDARY outcome
Timeframe: Day 0 - Day 21Population: 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.
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.
Outcome measures
| Measure |
Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21
n=109 Participants
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.
|
Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21
n=111 Participants
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.
|
Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21.
n=110 Participants
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.
|
|---|---|---|---|
|
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
Interval 2.13 to 3.19
|
4.15 Ratio
Interval 3.25 to 5.31
|
2.15 Ratio
Interval 1.82 to 2.55
|
|
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
Interval 2.04 to 3.1
|
3.79 Ratio
Interval 3.05 to 4.72
|
2.53 Ratio
Interval 2.09 to 3.07
|
|
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
Interval 1.99 to 3.15
|
3.76 Ratio
Interval 2.98 to 4.74
|
3.90 Ratio
Interval 3.09 to 4.92
|
|
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
Interval 2.74 to 4.33
|
5.86 Ratio
Interval 4.45 to 7.72
|
5.21 Ratio
Interval 3.94 to 6.89
|
|
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
Interval 2.2 to 3.33
|
4.25 Ratio
Interval 3.34 to 5.42
|
4.12 Ratio
Interval 3.26 to 5.2
|
|
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
Interval 1.48 to 2.0
|
2.03 Ratio
Interval 1.7 to 2.43
|
2.75 Ratio
Interval 2.19 to 3.47
|
SECONDARY outcome
Timeframe: Day 0 - Day 21Population: 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.
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.
Outcome measures
| Measure |
Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21
n=109 Participants
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.
|
Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21
n=111 Participants
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.
|
Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21.
n=110 Participants
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.
|
|---|---|---|---|
|
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
Interval 13.1 to 29.0
|
45 participants
Interval 31.6 to 50.7
|
20 participants
Interval 11.6 to 26.9
|
|
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
Interval 16.2 to 33.0
|
47 participants
Interval 33.3 to 52.5
|
28 participants
Interval 17.8 to 34.9
|
|
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
Interval 17.0 to 34.0
|
38 participants
Interval 25.7 to 44.2
|
43 participants
Interval 30.2 to 49.3
|
|
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
Interval 21.8 to 39.8
|
53 participants
Interval 38.6 to 57.9
|
50 participants
Interval 36.3 to 55.7
|
|
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
Interval 17.8 to 34.9
|
43 participants
Interval 29.9 to 48.9
|
48 participants
Interval 34.5 to 53.9
|
|
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
Interval 6.5 to 19.5
|
18 participants
Interval 10.0 to 24.6
|
23 participants
Interval 13.9 to 30.0
|
Adverse Events
Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21
Serious events: 7 serious events
Other events: 32 other events
Deaths: 0 deaths
Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21
Serious events: 11 serious events
Other events: 27 other events
Deaths: 0 deaths
Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21.
Serious events: 8 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21
n=109 participants at risk
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.
|
Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21
n=111 participants at risk
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.
|
Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21.
n=110 participants at risk
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.
|
|---|---|---|---|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.92%
1/109 • Number of events 1 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
0.00%
0/111 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
0.91%
1/110 • Number of events 2 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
COLITIS MICROSCOPIC
|
0.00%
0/109 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
0.90%
1/111 • Number of events 1 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
0.00%
0/110 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
|
General disorders
CHEST DISCOMFORT
|
0.92%
1/109 • Number of events 1 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
0.00%
0/111 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
0.00%
0/110 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
|
General disorders
CHEST PAIN
|
0.00%
0/109 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
0.90%
1/111 • Number of events 1 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
0.00%
0/110 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
|
General disorders
PYREXIA
|
0.00%
0/109 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
0.00%
0/111 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
0.91%
1/110 • Number of events 1 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
BETA HAEMOLYTIC STREPTOCOCCAL INFECTION
|
0.00%
0/109 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
0.00%
0/111 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
0.91%
1/110 • Number of events 1 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
PELVIC ABSCESS
|
0.92%
1/109 • Number of events 1 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
0.00%
0/111 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
0.00%
0/110 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/109 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
0.90%
1/111 • Number of events 1 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
0.00%
0/110 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
0.00%
0/109 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
0.00%
0/111 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
0.91%
1/110 • Number of events 1 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
|
Injury, poisoning and procedural complications
SEROMA
|
0.92%
1/109 • Number of events 1 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
0.00%
0/111 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
0.00%
0/110 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
|
Injury, poisoning and procedural complications
UPPER LIMB FRACTURE
|
0.00%
0/109 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
0.90%
1/111 • Number of events 1 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
0.00%
0/110 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA GASTRIC
|
0.00%
0/109 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
0.90%
1/111 • Number of events 1 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
0.00%
0/110 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA OF COLON
|
0.00%
0/109 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
0.00%
0/111 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
0.91%
1/110 • Number of events 1 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA PANCREAS
|
0.00%
0/109 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
0.00%
0/111 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
0.91%
1/110 • Number of events 1 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BLADDER TRANSITIONAL CELL CARCINOMA
|
0.00%
0/109 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
0.00%
0/111 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
0.91%
1/110 • Number of events 1 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO MENINGES
|
0.00%
0/109 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
0.90%
1/111 • Number of events 1 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
0.00%
0/110 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
0.92%
1/109 • Number of events 1 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
0.00%
0/111 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
0.00%
0/110 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER METASTATIC
|
0.00%
0/109 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
0.90%
1/111 • Number of events 1 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
0.00%
0/110 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.00%
0/109 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
1.8%
2/111 • Number of events 2 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
0.00%
0/110 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
|
Nervous system disorders
CERVICAL RADICULOPATHY
|
0.00%
0/109 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
0.90%
1/111 • Number of events 1 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
0.00%
0/110 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
|
Nervous system disorders
SYNCOPE
|
0.92%
1/109 • Number of events 1 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
0.00%
0/111 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
0.00%
0/110 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.00%
0/109 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
0.00%
0/111 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
0.91%
1/110 • Number of events 1 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
|
Product Issues
DEVICE DISLOCATION
|
0.00%
0/109 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
0.90%
1/111 • Number of events 1 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
0.00%
0/110 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.92%
1/109 • Number of events 1 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
0.00%
0/111 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
0.00%
0/110 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
Other adverse events
| Measure |
Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21
n=109 participants at risk
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.
|
Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21
n=111 participants at risk
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.
|
Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21.
n=110 participants at risk
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.
|
|---|---|---|---|
|
Infections and infestations
BRONCHITIS
|
10.1%
11/109 • Number of events 11 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
8.1%
9/111 • Number of events 10 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
5.5%
6/110 • Number of events 6 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
SINUSITIS
|
3.7%
4/109 • Number of events 4 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
4.5%
5/111 • Number of events 5 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
6.4%
7/110 • Number of events 7 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
|
Investigations
BLOOD PRESSURE SYSTOLIC INCREASED
|
10.1%
11/109 • Number of events 11 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
3.6%
4/111 • Number of events 4 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
7.3%
8/110 • Number of events 8 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
|
Nervous system disorders
HEADACHE
|
1.8%
2/109 • Number of events 3 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
6.3%
7/111 • Number of events 8 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
0.91%
1/110 • Number of events 1 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
|
Vascular disorders
HYPERTENSION
|
3.7%
4/109 • Number of events 4 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
1.8%
2/111 • Number of events 2 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
5.5%
6/110 • Number of events 6 • 1 year
Serious Adverse Events Other (Not Including Serious) Adverse Events
|
Additional Information
Novavax Customer Service Center
Novavax Inc.
Phone: 1-844-Novavax (668-2829)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place