Trial Outcomes & Findings for Phase 2 Dose and Formulation Confirmation of Quad-NIV in Older Adults (NCT NCT03658629)
NCT ID: NCT03658629
Last Updated: 2022-11-04
Results Overview
Adverse Events over the 7 days post-injection; all adverse events (including adverse changes in clinical laboratory parameters) through 21 days post-injection; and Medically Attended Adverse Events (MAEs), Serious Adverse Events (SAEs), and Significant New Medical Conditions (SNMCs) through 6 months post-injection.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
1375 participants
Primary outcome timeframe
Day 0 - Day 182
Results posted on
2022-11-04
Participant Flow
Participant milestones
| Measure |
Group A
Alternating deltoid injections of Quad-NIV (60 µg HA per A strain and B strain; in-clinic mix with 50 µg of Matrix-M1) on Day 0 and Placebo on Day 28.
|
Group B
Alternating deltoid injections of Quad-NIV (60 µg HA per A strain and B strain; co-formulated with 50 µg of Matrix-M1) on Day 0 and Placebo on Day 28.
|
Group C
Alternating deltoid injections of Quad-NIV (60 µg HA per A strain and B strain; co-formulated with 75 µg of Matrix-M1) on Day 0 and Placebo on Day 28.
|
Group D
Alternating deltoid injections of Quad-NIV (60 µg HA per A strain and 90 µg HA per B strain; co-formulated with 50 µg of Matrix-M1) on Day 0 and Placebo on Day 28.
|
Group E
Alternating deltoid injections of Quad-NIV (60 µg HA per A and B strain without adjuvant) on Day 0 and Licensed 2018-2019 Influenza vaccine on Day 28.
|
Group F
Alternating deltoid injections of 2018-2019 High-Dose Trivalent Vaccine on Day 0 and Placebo on Day 28.
|
Group G
Alternating deltoid injections of 2018-2019 Quadrivalent Vaccine on Day 0 and Placebo on Day 28.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
158
|
309
|
155
|
133
|
313
|
154
|
153
|
|
Overall Study
Participants in Safety Population
|
157
|
305
|
156
|
132
|
311
|
153
|
151
|
|
Overall Study
COMPLETED
|
151
|
296
|
149
|
125
|
303
|
151
|
148
|
|
Overall Study
NOT COMPLETED
|
7
|
13
|
6
|
8
|
10
|
3
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Population analyzed is the number of participants that completed the study. Safety Population
Baseline characteristics by cohort
| Measure |
Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A
n=157 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-1 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Preformulated With Adjuvant Dose A
n=305 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-2 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Preformulated With Adjuvant Dose B
n=156 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-3 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Preformulated With Increased B HA Adjuvant Dose A
n=132 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-4 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Without Adjuvant
n=311 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-5 (Day 0) and Licensed 2018-2019 Influenza vaccine (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Fluzone HD: 2018-2019 Licensed Trivalent Seasonal Influenza Vaccine
Flublok Quadrivalent: 2018-2019 Licensed Quadrivalent Seasonal Influenza Vaccine
|
Licensed High-Dose Trivalent Influenza Vaccine
n=153 Participants
Alternating deltoid injections of 2018-2019 High-Dose Trivalent Vaccine (Day 0) and Placebo (Day 28)
Placebo: Placebo
Fluzone HD: 2018-2019 Licensed Trivalent Seasonal Influenza Vaccine
|
Licensed Quadrivalent Influenza Vaccine
n=151 Participants
Alternating deltoid injections of 2018-2019 Quadrivalent Vaccine (Day 0) and Placebo (Day 28)
Placebo: Placebo
Flublok Quadrivalent: 2018-2019 Licensed Quadrivalent Seasonal Influenza Vaccine
|
Total
n=1365 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
72.7 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
72.0 years
STANDARD_DEVIATION 5.5 • n=7 Participants
|
71.8 years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
72.6 years
STANDARD_DEVIATION 6.1 • n=4 Participants
|
72.6 years
STANDARD_DEVIATION 6.3 • n=21 Participants
|
72.5 years
STANDARD_DEVIATION 5.5 • n=8 Participants
|
72.9 years
STANDARD_DEVIATION 5.6 • n=8 Participants
|
72.7 years
STANDARD_DEVIATION 6.3 • n=24 Participants
|
|
Sex: Female, Male
Female
|
90 Participants
n=5 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
179 Participants
n=7 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
77 Participants
n=5 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
81 Participants
n=4 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
185 Participants
n=21 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
99 Participants
n=8 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
87 Participants
n=8 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
798 Participants
n=24 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
|
Sex: Female, Male
Male
|
67 Participants
n=5 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
126 Participants
n=7 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
79 Participants
n=5 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
51 Participants
n=4 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
126 Participants
n=21 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
54 Participants
n=8 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
64 Participants
n=8 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
567 Participants
n=24 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
40 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
151 Participants
n=5 Participants
|
299 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
128 Participants
n=4 Participants
|
304 Participants
n=21 Participants
|
147 Participants
n=8 Participants
|
147 Participants
n=8 Participants
|
1325 Participants
n=24 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
0 Participants
n=7 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
0 Participants
n=5 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
0 Participants
n=4 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
3 Participants
n=21 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
0 Participants
n=8 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
1 Participants
n=8 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
5 Participants
n=24 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
1 Participants
n=7 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
0 Participants
n=5 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
0 Participants
n=4 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
1 Participants
n=21 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
1 Participants
n=8 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
1 Participants
n=8 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
6 Participants
n=24 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
1 Participants
n=7 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
0 Participants
n=5 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
0 Participants
n=4 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
0 Participants
n=21 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
0 Participants
n=8 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
0 Participants
n=8 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
1 Participants
n=24 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
41 Participants
n=7 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
15 Participants
n=5 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
12 Participants
n=4 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
29 Participants
n=21 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
17 Participants
n=8 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
14 Participants
n=8 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
141 Participants
n=24 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
|
Race (NIH/OMB)
White
|
138 Participants
n=5 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
261 Participants
n=7 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
140 Participants
n=5 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
120 Participants
n=4 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
277 Participants
n=21 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
133 Participants
n=8 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
135 Participants
n=8 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
1204 Participants
n=24 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
1 Participants
n=7 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
1 Participants
n=5 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
0 Participants
n=4 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
1 Participants
n=21 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
2 Participants
n=8 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
0 Participants
n=8 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
8 Participants
n=24 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
0 Participants
n=7 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
0 Participants
n=5 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
0 Participants
n=4 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
0 Participants
n=21 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
0 Participants
n=8 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
0 Participants
n=8 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
0 Participants
n=24 Participants • Population analyzed is the number of participants that completed the study. Safety Population
|
PRIMARY outcome
Timeframe: Day 0 - Day 182Population: Safety Population
Adverse Events over the 7 days post-injection; all adverse events (including adverse changes in clinical laboratory parameters) through 21 days post-injection; and Medically Attended Adverse Events (MAEs), Serious Adverse Events (SAEs), and Significant New Medical Conditions (SNMCs) through 6 months post-injection.
Outcome measures
| Measure |
Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A
n=157 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-1 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Preformulated With Adjuvant Dose A
n=305 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-2 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Preformulated With Adjuvant Dose B
n=156 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-3 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Preformulated With Increased B HA Adjuvant Dose A
n=132 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-4 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Without Adjuvant
n=311 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-5 (Day 0) and Licensed 2018-2019 Influenza vaccine (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Fluzone HD: 2018-2019 Licensed Trivalent Seasonal Influenza Vaccine
Flublok Quadrivalent: 2018-2019 Licensed Quadrivalent Seasonal Influenza Vaccine
|
Licensed High-Dose Trivalent Influenza Vaccine
n=153 Participants
Alternating deltoid injections of 2018-2019 High-Dose Trivalent Vaccine (Day 0) and Placebo (Day 28)
Placebo: Placebo
Fluzone HD: 2018-2019 Licensed Trivalent Seasonal Influenza Vaccine
|
Licensed Quadrivalent Influenza Vaccine
n=151 Participants
Alternating deltoid injections of 2018-2019 Quadrivalent Vaccine (Day 0) and Placebo (Day 28)
Placebo: Placebo
Flublok Quadrivalent: 2018-2019 Licensed Quadrivalent Seasonal Influenza Vaccine
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects With Adverse Events (AEs)
SAE's
|
8 participants
|
16 participants
|
8 participants
|
12 participants
|
6 participants
|
6 participants
|
3 participants
|
|
Number of Subjects With Adverse Events (AEs)
MAE's
|
51 participants
|
87 participants
|
29 participants
|
38 participants
|
74 participants
|
34 participants
|
40 participants
|
|
Number of Subjects With Adverse Events (AEs)
All AE's
|
100 participants
|
189 participants
|
92 participants
|
71 participants
|
165 participants
|
93 participants
|
87 participants
|
|
Number of Subjects With Adverse Events (AEs)
SNMC's
|
5 participants
|
18 participants
|
10 participants
|
10 participants
|
15 participants
|
6 participants
|
9 participants
|
PRIMARY outcome
Timeframe: Day 0 - Day 28Population: Per-Protocol Population for immunogenicity was used for the primary outcome measure and included all randomized subjects that received the assigned dose of the test article according to protocol, had HAI serology results for Day 0 and Day 28, and had no major protocol deviations affecting the primary immunogenicity outcomes.
HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B strain(s) at Days 0 and Day 28 post-vaccination expressed as geometric man titer (GMT).
Outcome measures
| Measure |
Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A
n=149 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-1 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Preformulated With Adjuvant Dose A
n=295 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-2 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Preformulated With Adjuvant Dose B
n=147 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-3 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Preformulated With Increased B HA Adjuvant Dose A
n=121 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-4 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Without Adjuvant
n=290 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-5 (Day 0) and Licensed 2018-2019 Influenza vaccine (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Fluzone HD: 2018-2019 Licensed Trivalent Seasonal Influenza Vaccine
Flublok Quadrivalent: 2018-2019 Licensed Quadrivalent Seasonal Influenza Vaccine
|
Licensed High-Dose Trivalent Influenza Vaccine
n=143 Participants
Alternating deltoid injections of 2018-2019 High-Dose Trivalent Vaccine (Day 0) and Placebo (Day 28)
Placebo: Placebo
Fluzone HD: 2018-2019 Licensed Trivalent Seasonal Influenza Vaccine
|
Licensed Quadrivalent Influenza Vaccine
n=144 Participants
Alternating deltoid injections of 2018-2019 Quadrivalent Vaccine (Day 0) and Placebo (Day 28)
Placebo: Placebo
Flublok Quadrivalent: 2018-2019 Licensed Quadrivalent Seasonal Influenza Vaccine
|
|---|---|---|---|---|---|---|---|
|
Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT)
Day 0 (A/Michigan/45/2015 (H1N1))
|
50.1 titers
Interval 44.6 to 56.4
|
47.9 titers
Interval 44.2 to 51.9
|
55.3 titers
Interval 49.0 to 62.3
|
48.7 titers
Interval 42.6 to 55.8
|
48.7 titers
Interval 44.8 to 52.8
|
50.5 titers
Interval 45.2 to 56.4
|
44.0 titers
Interval 39.5 to 49.1
|
|
Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT)
Day 28 (A/Michigan/45/2015 (H1N1))
|
98.9 titers
Interval 86.4 to 113.1
|
91.3 titers
Interval 82.5 to 101.0
|
99.1 titers
Interval 86.2 to 114.0
|
79.5 titers
Interval 68.6 to 92.2
|
90.3 titers
Interval 81.0 to 100.5
|
96.9 titers
Interval 84.5 to 111.1
|
82.1 titers
Interval 71.6 to 94.2
|
|
Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT)
Day 0 (B/Colorado/06/2017 (Victoria Lineage))
|
47.6 titers
Interval 43.1 to 52.6
|
46.4 titers
Interval 42.8 to 50.2
|
48.5 titers
Interval 44.0 to 53.6
|
52.7 titers
Interval 46.7 to 59.4
|
47.5 titers
Interval 43.9 to 51.3
|
52.0 titers
Interval 46.1 to 58.5
|
42.9 titers
Interval 38.5 to 47.7
|
|
Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT)
Day 28 (B/Colorado/06/2017 (Victoria Lineage))
|
86.8 titers
Interval 77.1 to 97.7
|
83.2 titers
Interval 76.0 to 91.0
|
89.6 titers
Interval 79.3 to 101.2
|
95.5 titers
Interval 82.2 to 110.3
|
73.2 titers
Interval 67.6 to 79.3
|
93.2 titers
Interval 81.6 to 106.5
|
83.3 titers
Interval 73.2 to 94.9
|
|
Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT)
Day 0 (B/Phuket/3073/2013 (Yamagata Lineage))
|
50.4 titers
Interval 44.7 to 56.7
|
47.7 titers
Interval 44.4 to 51.3
|
47.6 titers
Interval 42.9 to 52.9
|
53.6 titers
Interval 46.9 to 61.2
|
48.8 titers
Interval 45.2 to 52.7
|
52.9 titers
Interval 47.3 to 59.1
|
46.9 titers
Interval 42.1 to 52.2
|
|
Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT)
Day 28 (B/Phuket/3073/2013 (Yamagata Lineage))
|
108.5 titers
Interval 96.2 to 122.4
|
101.7 titers
Interval 93.3 to 110.3
|
104.9 titers
Interval 92.4 to 119.2
|
113.8 titers
Interval 97.6 to 132.6
|
87.5 titers
Interval 79.5 to 96.4
|
64.5 titers
Interval 57.3 to 72.6
|
102.0 titers
Interval 88.6 to 117.4
|
|
Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT)
Day 0 (A/Singapore/INFIMH-16-0019/2016 (H3N2))
|
21.4 titers
Interval 18.9 to 24.3
|
22.0 titers
Interval 20.0 to 24.1
|
22.8 titers
Interval 19.7 to 26.3
|
23.4 titers
Interval 20.2 to 27.1
|
21.3 titers
Interval 19.3 to 23.5
|
23.2 titers
Interval 20.4 to 26.4
|
19.5 titers
Interval 17.1 to 22.2
|
|
Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT)
Day 28 (A/Singapore/INFIMH-16-0019/2016 (H3N2))
|
65.8 titers
Interval 55.2 to 78.4
|
65.4 titers
Interval 58.3 to 73.5
|
64.2 titers
Interval 54.2 to 76.2
|
59.4 titers
Interval 50.0 to 70.5
|
50.8 titers
Interval 45.0 to 57.4
|
46.5 titers
Interval 38.6 to 55.9
|
66.6 titers
Interval 54.9 to 80.9
|
PRIMARY outcome
Timeframe: Day 0 - Day 28Population: Per-Protocol Population for immunogenicity was used for the primary outcome measure and included all randomized subjects that received the assigned dose of the test article according to protocol, had HAI serology results for Day 0 and Day 28, and had no major protocol deviations affecting the primary immunogenicity outcomes.
HAI antibody titers specific for at least 2 antigenically-drifted influenza strains, at Days 0 and 28 post-vaccination expressed as geometric man titer (GMT).
Outcome measures
| Measure |
Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A
n=149 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-1 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Preformulated With Adjuvant Dose A
n=295 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-2 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Preformulated With Adjuvant Dose B
n=147 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-3 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Preformulated With Increased B HA Adjuvant Dose A
n=121 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-4 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Without Adjuvant
n=290 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-5 (Day 0) and Licensed 2018-2019 Influenza vaccine (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Fluzone HD: 2018-2019 Licensed Trivalent Seasonal Influenza Vaccine
Flublok Quadrivalent: 2018-2019 Licensed Quadrivalent Seasonal Influenza Vaccine
|
Licensed High-Dose Trivalent Influenza Vaccine
n=143 Participants
Alternating deltoid injections of 2018-2019 High-Dose Trivalent Vaccine (Day 0) and Placebo (Day 28)
Placebo: Placebo
Fluzone HD: 2018-2019 Licensed Trivalent Seasonal Influenza Vaccine
|
Licensed Quadrivalent Influenza Vaccine
n=144 Participants
Alternating deltoid injections of 2018-2019 Quadrivalent Vaccine (Day 0) and Placebo (Day 28)
Placebo: Placebo
Flublok Quadrivalent: 2018-2019 Licensed Quadrivalent Seasonal Influenza Vaccine
|
|---|---|---|---|---|---|---|---|
|
HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT
Day 0 (A/Switzerland/9715293/2013 (H3N2)))
|
54.6 titers
Interval 47.8 to 62.4
|
60.0 titers
Interval 54.3 to 66.2
|
60.9 titers
Interval 52.7 to 70.3
|
60.6 titers
Interval 52.1 to 70.5
|
58.6 titers
Interval 52.8 to 65.1
|
62.3 titers
Interval 54.3 to 71.6
|
54.8 titers
Interval 47.8 to 62.9
|
|
HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT
Day 28 (A/Switzerland/9715293/2013 (H3N2))
|
146.8 titers
Interval 124.0 to 173.9
|
160.4 titers
Interval 143.9 to 178.7
|
154.8 titers
Interval 132.7 to 180.7
|
137.9 titers
Interval 117.2 to 162.2
|
122.4 titers
Interval 109.1 to 137.3
|
133.4 titers
Interval 111.2 to 160.0
|
158.8 titers
Interval 132.2 to 190.9
|
|
HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT
Day 0 (A/Wisconsin/19/2017 (H3N2))
|
21.7 titers
Interval 19.2 to 24.6
|
23.1 titers
Interval 21.1 to 25.3
|
24.0 titers
Interval 20.7 to 27.7
|
23.9 titers
Interval 20.9 to 27.3
|
22.1 titers
Interval 20.1 to 24.4
|
24.5 titers
Interval 21.6 to 27.7
|
20.7 titers
Interval 18.1 to 23.6
|
|
HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT
Day 28 (A/Wisconsin/19/2017 (H3N2))
|
61.1 titers
Interval 51.8 to 72.0
|
63.2 titers
Interval 56.3 to 70.9
|
63.0 titers
Interval 53.5 to 74.2
|
58.2 titers
Interval 48.9 to 69.2
|
50.1 titers
Interval 44.4 to 56.5
|
46.1 titers
Interval 38.7 to 55.1
|
64.3 titers
Interval 53.5 to 77.2
|
SECONDARY outcome
Timeframe: Day 0 - Day 182Population: Per-Protocol Population for immunogenicity was used for this display of secondary outcome measures and included all randomized subjects that received the assigned dose of the test article according to protocol, had HAI serology results for Day 0 and Day 28, and had no major protocol deviations affecting the primary immunogenicity outcomes
HAI antibody titers specific for the HA receptor binding domains of vaccine-homologous A and B strain(s) expressed as GMT on Day 0,28,56 and 182.
Outcome measures
| Measure |
Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A
n=149 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-1 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Preformulated With Adjuvant Dose A
n=295 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-2 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Preformulated With Adjuvant Dose B
n=147 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-3 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Preformulated With Increased B HA Adjuvant Dose A
n=121 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-4 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Without Adjuvant
n=290 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-5 (Day 0) and Licensed 2018-2019 Influenza vaccine (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Fluzone HD: 2018-2019 Licensed Trivalent Seasonal Influenza Vaccine
Flublok Quadrivalent: 2018-2019 Licensed Quadrivalent Seasonal Influenza Vaccine
|
Licensed High-Dose Trivalent Influenza Vaccine
n=143 Participants
Alternating deltoid injections of 2018-2019 High-Dose Trivalent Vaccine (Day 0) and Placebo (Day 28)
Placebo: Placebo
Fluzone HD: 2018-2019 Licensed Trivalent Seasonal Influenza Vaccine
|
Licensed Quadrivalent Influenza Vaccine
n=144 Participants
Alternating deltoid injections of 2018-2019 Quadrivalent Vaccine (Day 0) and Placebo (Day 28)
Placebo: Placebo
Flublok Quadrivalent: 2018-2019 Licensed Quadrivalent Seasonal Influenza Vaccine
|
|---|---|---|---|---|---|---|---|
|
HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT
Day 56 (A/Michigan/45/2015 (H1N1))
|
71.0 titers
Interval 61.2 to 82.5
|
62.8 titers
Interval 56.7 to 69.7
|
68.2 titers
Interval 58.5 to 79.7
|
52.7 titers
Interval 45.5 to 61.2
|
81.4 titers
Interval 73.0 to 90.8
|
72.4 titers
Interval 63.0 to 83.2
|
57.1 titers
Interval 49.8 to 65.5
|
|
HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT
Day 28 (B/Colorado/06/2017 (Victoria Lineage))
|
159.3 titers
Interval 138.9 to 182.6
|
142.1 titers
Interval 128.0 to 157.8
|
154.8 titers
Interval 133.9 to 179.0
|
173.9 titers
Interval 149.0 to 202.9
|
135.8 titers
Interval 124.1 to 148.7
|
184.1 titers
Interval 159.7 to 212.3
|
141.9 titers
Interval 123.7 to 162.7
|
|
HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT
Day 0 (B/Phuket/3073/2013 (Yamagata Lineage))
|
104.0 titers
Interval 92.0 to 117.7
|
97.1 titers
Interval 89.4 to 105.5
|
94.1 titers
Interval 84.1 to 105.3
|
105.0 titers
Interval 90.5 to 121.9
|
99.7 titers
Interval 91.9 to 108.1
|
100.0 titers
Interval 88.6 to 112.8
|
85.4 titers
Interval 77.0 to 94.6
|
|
HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT
Day 28 (B/Phuket/3073/2013 (Yamagata Lineage))
|
202.4 titers
Interval 175.8 to 233.0
|
195.6 titers
Interval 177.1 to 216.0
|
205.9 titers
Interval 180.1 to 235.4
|
211.2 titers
Interval 178.0 to 250.7
|
179.5 titers
Interval 162.3 to 198.4
|
137.0 titers
Interval 120.6 to 155.6
|
174.9 titers
Interval 150.7 to 203.0
|
|
HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT
Day 0 (A/Michigan/45/2015 (H1N1))
|
45.7 titers
Interval 40.2 to 51.9
|
45.6 titers
Interval 41.8 to 49.8
|
48.3 titers
Interval 42.3 to 55.2
|
43.1 titers
Interval 37.6 to 49.4
|
46.3 titers
Interval 42.4 to 50.5
|
48.3 titers
Interval 42.4 to 55.1
|
40.8 titers
Interval 36.7 to 45.3
|
|
HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT
Day 28 (A/Michigan/45/2015 (H1N1))
|
86.4 titers
Interval 74.4 to 100.3
|
78.9 titers
Interval 70.8 to 87.9
|
84.5 titers
Interval 72.3 to 98.7
|
66.2 titers
Interval 56.6 to 77.5
|
80.3 titers
Interval 72.0 to 89.6
|
92.7 titers
Interval 79.6 to 108.1
|
74.2 titers
Interval 64.2 to 85.9
|
|
HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT
Day 182 (A/Michigan/45/2015 (H1N1))
|
62.0 titers
Interval 53.4 to 72.0
|
55.5 titers
Interval 50.3 to 61.3
|
63.1 titers
Interval 54.2 to 73.6
|
50.4 titers
Interval 43.7 to 58.1
|
66.8 titers
Interval 60.4 to 73.8
|
67.0 titers
Interval 58.9 to 76.2
|
50.6 titers
Interval 44.2 to 58.0
|
|
HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT
Day 0 (B/Colorado/06/2017 (Victoria Lineage))
|
99.8 titers
Interval 88.5 to 112.5
|
90.4 titers
Interval 82.7 to 98.9
|
95.0 titers
Interval 83.8 to 107.8
|
108.1 titers
Interval 93.3 to 125.1
|
100.2 titers
Interval 91.9 to 109.1
|
99.5 titers
Interval 87.9 to 112.6
|
88.7 titers
Interval 79.2 to 99.3
|
|
HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT
Day 56 (B/Colorado/06/2017 (Victoria Lineage))
|
132.6 titers
Interval 115.7 to 152.0
|
122.5 titers
Interval 110.4 to 135.9
|
134.0 titers
Interval 116.4 to 154.3
|
147.3 titers
Interval 124.8 to 173.9
|
156.0 titers
Interval 143.0 to 170.1
|
156.4 titers
Interval 134.2 to 182.2
|
113.4 titers
Interval 98.7 to 130.3
|
|
HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT
Day 128 (B/Colorado/06/2017 (Victoria Lineage))
|
119.6 titers
Interval 103.8 to 137.8
|
107.2 titers
Interval 96.2 to 119.2
|
122.1 titers
Interval 105.3 to 141.6
|
131.8 titers
Interval 112.5 to 154.3
|
141.4 titers
Interval 128.4 to 155.7
|
141.9 titers
Interval 123.6 to 162.9
|
108.5 titers
Interval 93.8 to 125.5
|
|
HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT
Day 56 (B/Phuket/3073/2013 (Yamagata Lineage))
|
192.7 titers
Interval 167.1 to 222.1
|
190.5 titers
Interval 171.3 to 211.8
|
199.2 titers
Interval 172.6 to 229.8
|
200.9 titers
Interval 168.2 to 239.9
|
199.3 titers
Interval 180.0 to 220.7
|
137.1 titers
Interval 118.3 to 158.8
|
168.9 titers
Interval 144.1 to 197.8
|
|
HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT
Day 182 (B/Phuket/3073/2013 (Yamagata Lineage))
|
132.2 titers
Interval 115.3 to 151.6
|
126.8 titers
Interval 115.1 to 139.6
|
127.2 titers
Interval 111.6 to 144.8
|
143.4 titers
Interval 121.8 to 168.8
|
131.4 titers
Interval 119.3 to 144.7
|
111.2 titers
Interval 98.4 to 125.8
|
125.3 titers
Interval 107.8 to 141.1
|
|
HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT
Day 0 (A/Singapore/INFIMH-16-0019/2016 (H3N2))
|
69.9 titers
Interval 62.9 to 77.7
|
75.8 titers
Interval 70.0 to 82.1
|
70.3 titers
Interval 62.6 to 78.8
|
77.7 titers
Interval 69.4 to 87.1
|
71.8 titers
Interval 66.5 to 77.6
|
73.0 titers
Interval 65.6 to 81.2
|
71.3 titers
Interval 64.3 to 79.0
|
|
HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT
Day 28 (A/Singapore/INFIMH-16-0019/2016 (H3N2))
|
140.1 titers
Interval 120.8 to 162.6
|
147.9 titers
Interval 133.9 to 163.3
|
128.8 titers
Interval 112.2 to 147.9
|
140.7 titers
Interval 121.3 to 163.0
|
122.1 titers
Interval 110.4 to 135.1
|
141.7 titers
Interval 122.0 to 164.7
|
149.2 titers
Interval 127.8 to 174.2
|
|
HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT
Day 56 (A/Singapore/INFIMH-16-0019/2016 (H3N2))
|
132.0 titers
Interval 113.0 to 154.1
|
132.2 titers
Interval 119.1 to 146.8
|
126.4 titers
Interval 107.8 to 140.8
|
120.5 titers
Interval 103.1 to 140.8
|
150.4 titers
Interval 134.5 to 168.2
|
125.4 titers
Interval 107.5 to 146.3
|
119.3 titers
Interval 101.0 to 141.0
|
|
HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT
Day 182 (A/Singapore/INFIMH-16-0019/2016 (H3N2))
|
87.1 titers
Interval 73.9 to 102.6
|
90.2 titers
Interval 81.0 to 100.4
|
91.4 titers
Interval 77.2 to 108.3
|
85.1 titers
Interval 71.8 to 101.0
|
97.8 titers
Interval 87.4 to 109.5
|
86.1 titers
Interval 74.2 to 100.0
|
84.0 titers
Interval 71.2 to 99.1
|
SECONDARY outcome
Timeframe: Day 28 - Day 182Population: Per-Protocol Population for immunogenicity was used for this display of secondary outcome measures and included all randomized subjects that received the assigned dose of the test article according to protocol, had HAI serology results for Day 0 and Day 28, and had no major protocol deviations affecting the primary immunogenicity outcomes
HAI antibody titers specific for the HA receptor binding domains of vaccine-homologous A and B strain(s) expressed as GMFR on Day 28,56 and 182.
Outcome measures
| Measure |
Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A
n=149 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-1 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Preformulated With Adjuvant Dose A
n=295 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-2 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Preformulated With Adjuvant Dose B
n=147 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-3 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Preformulated With Increased B HA Adjuvant Dose A
n=121 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-4 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Without Adjuvant
n=290 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-5 (Day 0) and Licensed 2018-2019 Influenza vaccine (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Fluzone HD: 2018-2019 Licensed Trivalent Seasonal Influenza Vaccine
Flublok Quadrivalent: 2018-2019 Licensed Quadrivalent Seasonal Influenza Vaccine
|
Licensed High-Dose Trivalent Influenza Vaccine
n=143 Participants
Alternating deltoid injections of 2018-2019 High-Dose Trivalent Vaccine (Day 0) and Placebo (Day 28)
Placebo: Placebo
Fluzone HD: 2018-2019 Licensed Trivalent Seasonal Influenza Vaccine
|
Licensed Quadrivalent Influenza Vaccine
n=144 Participants
Alternating deltoid injections of 2018-2019 Quadrivalent Vaccine (Day 0) and Placebo (Day 28)
Placebo: Placebo
Flublok Quadrivalent: 2018-2019 Licensed Quadrivalent Seasonal Influenza Vaccine
|
|---|---|---|---|---|---|---|---|
|
HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR)
Day 56 (A/Singapore/INFIMH-16-0019/2016 (H3N2))
|
1.9 Fold Ratio
Interval 1.6 to 2.2
|
1.7 Fold Ratio
Interval 1.6 to 1.9
|
1.8 Fold Ratio
Interval 1.6 to 2.1
|
1.6 Fold Ratio
Interval 1.4 to 1.8
|
2.1 Fold Ratio
Interval 1.9 to 2.3
|
1.7 Fold Ratio
Interval 1.5 to 2.0
|
1.7 Fold Ratio
Interval 1.4 to 2.0
|
|
HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR)
Day 182 (A/Singapore/INFIMH-16-0019/2016 (H3N2))
|
1.2 Fold Ratio
Interval 1.1 to 1.4
|
1.2 Fold Ratio
Interval 1.1 to 1.3
|
1.3 Fold Ratio
Interval 1.1 to 1.5
|
1.1 Fold Ratio
Interval 1.0 to 1.3
|
1.4 Fold Ratio
Interval 1.3 to 1.5
|
1.2 Fold Ratio
Interval 1.0 to 1.3
|
1.2 Fold Ratio
Interval 1.0 to 1.4
|
|
HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR)
Day 28 (A/Michigan/45/2015 (H1N1))
|
1.9 Fold Ratio
Interval 1.7 to 2.1
|
1.7 Fold Ratio
Interval 1.6 to 1.9
|
1.7 Fold Ratio
Interval 1.6 to 2.0
|
1.5 Fold Ratio
Interval 1.4 to 1.7
|
1.7 Fold Ratio
Interval 1.6 to 1.9
|
1.9 Fold Ratio
Interval 1.7 to 2.2
|
1.8 Fold Ratio
Interval 1.6 to 2.1
|
|
HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR)
Day 56 (A/Michigan/45/2015 (H1N1))
|
1.6 Fold Ratio
Interval 1.4 to 1.8
|
1.4 Fold Ratio
Interval 1.3 to 1.5
|
1.4 Fold Ratio
Interval 1.3 to 1.6
|
1.2 Fold Ratio
Interval 1.1 to 1.4
|
1.8 Fold Ratio
Interval 1.6 to 1.9
|
1.5 Fold Ratio
Interval 1.3 to 1.7
|
1.4 Fold Ratio
Interval 1.2 to 1.6
|
|
HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR)
Day 182 (A/Michigan/45/2015 (H1N1))
|
1.3 Fold Ratio
Interval 1.2 to 1.5
|
1.2 Fold Ratio
Interval 1.1 to 1.3
|
1.3 Fold Ratio
Interval 1.2 to 1.5
|
1.1 Fold Ratio
Interval 1.0 to 1.3
|
1.4 Fold Ratio
Interval 1.3 to 1.6
|
1.4 Fold Ratio
Interval 1.3 to 1.5
|
1.3 Fold Ratio
Interval 1.1 to 1.4
|
|
HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR)
Day 28 (B/Colorado/06/2017 (Victoria Lineage))
|
1.6 Fold Ratio
Interval 1.4 to 1.8
|
1.6 Fold Ratio
Interval 1.5 to 1.7
|
1.6 Fold Ratio
Interval 1.5 to 1.8
|
1.6 Fold Ratio
Interval 1.4 to 1.8
|
1.4 Fold Ratio
Interval 1.3 to 1.4
|
1.9 Fold Ratio
Interval 1.6 to 2.1
|
1.6 Fold Ratio
Interval 1.4 to 1.8
|
|
HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR)
Day 56 (B/Colorado/06/2017 (Victoria Lineage))
|
1.3 Fold Ratio
Interval 1.2 to 1.5
|
1.4 Fold Ratio
Interval 1.3 to 1.5
|
1.4 Fold Ratio
Interval 1.2 to 1.6
|
1.4 Fold Ratio
Interval 1.2 to 1.6
|
1.6 Fold Ratio
Interval 1.5 to 1.7
|
1.6 Fold Ratio
Interval 1.4 to 1.8
|
1.3 Fold Ratio
Interval 1.2 to 1.4
|
|
HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR)
Day 182 (B/Colorado/06/2017 (Victoria Lineage))
|
1.2 Fold Ratio
Interval 1.1 to 1.3
|
1.2 Fold Ratio
Interval 1.1 to 1.3
|
1.3 Fold Ratio
Interval 1.2 to 1.4
|
1.2 Fold Ratio
Interval 1.1 to 1.4
|
1.4 Fold Ratio
Interval 1.3 to 1.5
|
1.4 Fold Ratio
Interval 1.3 to 1.6
|
1.2 Fold Ratio
Interval 1.1 to 1.3
|
|
HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR)
Day 28 (B/Phuket/3073/2013 (Yamagata Lineage))
|
1.9 Fold Ratio
Interval 1.7 to 2.2
|
2.0 Fold Ratio
Interval 1.9 to 2.2
|
2.2 Fold Ratio
Interval 1.9 to 2.5
|
2.0 Fold Ratio
Interval 1.7 to 2.4
|
1.8 Fold Ratio
Interval 1.7 to 2.0
|
1.4 Fold Ratio
Interval 1.3 to 1.5
|
2.0 Fold Ratio
Interval 1.8 to 2.3
|
|
HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR)
Day 56 (B/Phuket/3073/2013 (Yamagata Lineage))
|
1.9 Fold Ratio
Interval 1.7 to 2.1
|
2.0 Fold Ratio
Interval 1.8 to 2.1
|
2.1 Fold Ratio
Interval 1.8 to 2.4
|
1.9 Fold Ratio
Interval 1.7 to 2.3
|
2.0 Fold Ratio
Interval 1.8 to 2.2
|
1.4 Fold Ratio
Interval 1.3 to 1.5
|
2.0 Fold Ratio
Interval 1.7 to 2.3
|
|
HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR)
Day 182 (B/Phuket/3073/2013 (Yamagata Lineage))
|
1.3 Fold Ratio
Interval 1.2 to 1.4
|
1.3 Fold Ratio
Interval 1.2 to 1.4
|
1.4 Fold Ratio
Interval 1.2 to 1.5
|
1.4 Fold Ratio
Interval 1.2 to 1.6
|
1.3 Fold Ratio
Interval 1.2 to 1.4
|
1.1 Fold Ratio
Interval 1.0 to 1.2
|
1.4 Fold Ratio
Interval 1.3 to 1.6
|
|
HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR)
Day 28 (A/Singapore/INFIMH-16-0019/2016 (H3N2))
|
2.0 Fold Ratio
Interval 1.8 to 2.3
|
2.0 Fold Ratio
Interval 1.8 to 2.1
|
1.8 Fold Ratio
Interval 1.6 to 2.0
|
1.8 Fold Ratio
Interval 1.6 to 2.1
|
1.7 Fold Ratio
Interval 1.6 to 1.8
|
1.9 Fold Ratio
Interval 1.7 to 2.2
|
2.1 Fold Ratio
Interval 1.8 to 2.4
|
SECONDARY outcome
Timeframe: Day 28 - Day 182Population: Per-Protocol Population for immunogenicity was used for this display of secondary outcome measures and included all randomized subjects that received the assigned dose of the test article according to protocol, had HAI serology results for Day 0 and Day 28, and had no major protocol deviations affecting the primary immunogenicity outcomes
HAI antibody titers specific for the HA receptor binding domains of vaccine-homologous A and B strain(s) expressed as SCR on Day 28,56 and 182.
Outcome measures
| Measure |
Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A
n=149 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-1 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Preformulated With Adjuvant Dose A
n=295 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-2 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Preformulated With Adjuvant Dose B
n=147 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-3 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Preformulated With Increased B HA Adjuvant Dose A
n=121 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-4 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Without Adjuvant
n=290 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-5 (Day 0) and Licensed 2018-2019 Influenza vaccine (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Fluzone HD: 2018-2019 Licensed Trivalent Seasonal Influenza Vaccine
Flublok Quadrivalent: 2018-2019 Licensed Quadrivalent Seasonal Influenza Vaccine
|
Licensed High-Dose Trivalent Influenza Vaccine
n=143 Participants
Alternating deltoid injections of 2018-2019 High-Dose Trivalent Vaccine (Day 0) and Placebo (Day 28)
Placebo: Placebo
Fluzone HD: 2018-2019 Licensed Trivalent Seasonal Influenza Vaccine
|
Licensed Quadrivalent Influenza Vaccine
n=144 Participants
Alternating deltoid injections of 2018-2019 Quadrivalent Vaccine (Day 0) and Placebo (Day 28)
Placebo: Placebo
Flublok Quadrivalent: 2018-2019 Licensed Quadrivalent Seasonal Influenza Vaccine
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains
Day 28 (A/Michigan/45/2015 (H1N1))
|
31 Participants
|
41 Participants
|
22 Participants
|
13 Participants
|
52 Participants
|
32 Participants
|
26 Participants
|
|
Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains
Day 56 (A/Michigan/45/2015 (H1N1))
|
15 Participants
|
23 Participants
|
10 Participants
|
4 Participants
|
39 Participants
|
10 Participants
|
13 Participants
|
|
Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains
Day 182 (A/Michigan/45/2015 (H1N1))
|
8 Participants
|
14 Participants
|
7 Participants
|
5 Participants
|
23 Participants
|
8 Participants
|
6 Participants
|
|
Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains
Day 28 (B/Colorado/06/2017 (Victoria Lineage))
|
25 Participants
|
32 Participants
|
20 Participants
|
20 Participants
|
23 Participants
|
32 Participants
|
18 Participants
|
|
Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains
Day 56 (B/Colorado/06/2017 (Victoria Lineage))
|
6 Participants
|
21 Participants
|
7 Participants
|
8 Participants
|
21 Participants
|
12 Participants
|
8 Participants
|
|
Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains
Day 182 (B/Colorado/06/2017 (Victoria Lineage))
|
7 Participants
|
11 Participants
|
7 Participants
|
7 Participants
|
12 Participants
|
9 Participants
|
6 Participants
|
|
Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains
Day 28 (B/Phuket/3073/2013 (Yamagata Lineage))
|
32 Participants
|
70 Participants
|
43 Participants
|
35 Participants
|
57 Participants
|
10 Participants
|
37 Participants
|
|
Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains
Day 56 (B/Phuket/3073/2013 (Yamagata Lineage))
|
24 Participants
|
46 Participants
|
33 Participants
|
27 Participants
|
52 Participants
|
7 Participants
|
34 Participants
|
|
Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains
Day 182 (B/Phuket/3073/2013 (Yamagata Lineage))
|
6 Participants
|
11 Participants
|
7 Participants
|
10 Participants
|
10 Participants
|
0 Participants
|
5 Participants
|
|
Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains
Day 28 (A/Singapore/INFIMH-16-0019/2016 (H3N2))
|
40 Participants
|
68 Participants
|
29 Participants
|
23 Participants
|
54 Participants
|
31 Participants
|
37 Participants
|
|
Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains
Day 56 (A/Singapore/INFIMH-16-0019/2016 (H3N2))
|
29 Participants
|
41 Participants
|
16 Participants
|
11 Participants
|
52 Participants
|
21 Participants
|
20 Participants
|
|
Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains
Day 182 (A/Singapore/INFIMH-16-0019/2016 (H3N2))
|
16 Participants
|
10 Participants
|
10 Participants
|
5 Participants
|
17 Participants
|
6 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Day 28 - Day 182Population: Per-Protocol Population for immunogenicity was used for this display of secondary outcome measures and included all randomized subjects that received the assigned dose of the test article according to protocol, had HAI serology results for Day 0 and Day 28, and had no major protocol deviations affecting the primary immunogenicity outcomes
HAI antibody titers specific for the HA receptor binding domains of vaccine-homologous A and B strain(s) expressed as SPR on Day 28,56 and 182.
Outcome measures
| Measure |
Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A
n=149 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-1 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Preformulated With Adjuvant Dose A
n=295 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-2 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Preformulated With Adjuvant Dose B
n=147 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-3 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Preformulated With Increased B HA Adjuvant Dose A
n=121 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-4 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Without Adjuvant
n=290 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-5 (Day 0) and Licensed 2018-2019 Influenza vaccine (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Fluzone HD: 2018-2019 Licensed Trivalent Seasonal Influenza Vaccine
Flublok Quadrivalent: 2018-2019 Licensed Quadrivalent Seasonal Influenza Vaccine
|
Licensed High-Dose Trivalent Influenza Vaccine
n=143 Participants
Alternating deltoid injections of 2018-2019 High-Dose Trivalent Vaccine (Day 0) and Placebo (Day 28)
Placebo: Placebo
Fluzone HD: 2018-2019 Licensed Trivalent Seasonal Influenza Vaccine
|
Licensed Quadrivalent Influenza Vaccine
n=144 Participants
Alternating deltoid injections of 2018-2019 Quadrivalent Vaccine (Day 0) and Placebo (Day 28)
Placebo: Placebo
Flublok Quadrivalent: 2018-2019 Licensed Quadrivalent Seasonal Influenza Vaccine
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains
Day 28 (A/Michigan/45/2015 (H1N1))
|
133 participants
|
260 participants
|
131 participants
|
105 participants
|
257 participants
|
133 participants
|
126 participants
|
|
Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains
Day 56 (A/Michigan/45/2015 (H1N1))
|
94 participants
|
174 participants
|
92 participants
|
58 participants
|
203 participants
|
95 participants
|
76 participants
|
|
Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains
Day 182 (A/Michigan/45/2015 (H1N1))
|
106 participants
|
188 participants
|
99 participants
|
73 participants
|
212 participants
|
110 participants
|
88 participants
|
|
Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains
Day 28 (B/Colorado/06/2017 (Victoria Lineage))
|
149 participants
|
295 participants
|
147 participants
|
120 participants
|
290 participants
|
142 participants
|
144 participants
|
|
Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains
Day 56 (B/Colorado/06/2017 (Victoria Lineage))
|
141 participants
|
282 participants
|
139 participants
|
114 participants
|
282 participants
|
134 participants
|
129 participants
|
|
Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains
Day 182 (B/Colorado/06/2017 (Victoria Lineage))
|
141 participants
|
277 participants
|
136 participants
|
115 participants
|
280 participants
|
140 participants
|
134 participants
|
|
Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains
Day 28 (B/Phuket/3073/2013 (Yamagata Lineage))
|
149 participants
|
295 participants
|
147 participants
|
120 participants
|
290 participants
|
143 participants
|
143 participants
|
|
Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains
Day 56 (B/Phuket/3073/2013 (Yamagata Lineage))
|
146 participants
|
292 participants
|
141 participants
|
118 participants
|
286 participants
|
137 participants
|
135 participants
|
|
Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains
Day 182 (B/Phuket/3073/2013 (Yamagata Lineage))
|
137 participants
|
279 participants
|
133 participants
|
114 participants
|
274 participants
|
134 participants
|
130 participants
|
|
Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains
Day 28 (A/Singapore/INFIMH-16-0019/2016 (H3N2))
|
147 participants
|
293 participants
|
145 participants
|
120 participants
|
285 participants
|
142 participants
|
143 participants
|
|
Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains
Day 56 (A/Singapore/INFIMH-16-0019/2016 (H3N2))
|
130 participants
|
272 participants
|
126 participants
|
105 participants
|
265 participants
|
124 participants
|
120 participants
|
|
Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains
Day 182 (A/Singapore/INFIMH-16-0019/2016 (H3N2))
|
109 participants
|
233 participants
|
108 participants
|
88 participants
|
224 participants
|
113 participants
|
104 participants
|
SECONDARY outcome
Timeframe: Day 0 - Day 182Population: Per-Protocol Population for immunogenicity was used for this display of secondary outcome measures and included all randomized subjects that received the assigned dose of the test article according to protocol, had HAI serology results for Day 0 and Day 28, and had no major protocol deviations affecting the primary immunogenicity outcomes
HAI antibody titers specific for antigenically-drifted influenza strains, at Days 0,28, 56 and 182 expressed as geometric man titer (GMT).
Outcome measures
| Measure |
Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A
n=149 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-1 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Preformulated With Adjuvant Dose A
n=295 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-2 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Preformulated With Adjuvant Dose B
n=147 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-3 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Preformulated With Increased B HA Adjuvant Dose A
n=121 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-4 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Without Adjuvant
n=290 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-5 (Day 0) and Licensed 2018-2019 Influenza vaccine (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Fluzone HD: 2018-2019 Licensed Trivalent Seasonal Influenza Vaccine
Flublok Quadrivalent: 2018-2019 Licensed Quadrivalent Seasonal Influenza Vaccine
|
Licensed High-Dose Trivalent Influenza Vaccine
n=143 Participants
Alternating deltoid injections of 2018-2019 High-Dose Trivalent Vaccine (Day 0) and Placebo (Day 28)
Placebo: Placebo
Fluzone HD: 2018-2019 Licensed Trivalent Seasonal Influenza Vaccine
|
Licensed Quadrivalent Influenza Vaccine
n=144 Participants
Alternating deltoid injections of 2018-2019 Quadrivalent Vaccine (Day 0) and Placebo (Day 28)
Placebo: Placebo
Flublok Quadrivalent: 2018-2019 Licensed Quadrivalent Seasonal Influenza Vaccine
|
|---|---|---|---|---|---|---|---|
|
HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT
Day 0 (A/Switzerland/9715293/2013 (H3N2))
|
51.7 titers
Interval 46.0 to 58.1
|
53.8 titers
Interval 49.1 to 58.9
|
57.1 titers
Interval 50.1 to 65.1
|
55.3 titers
Interval 48.3 to 63.3
|
55.7 titers
Interval 51.1 to 60.7
|
60.5 titers
Interval 53.4 to 68.6
|
54.3 titers
Interval 47.6 to 61.9
|
|
HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT
Day 28 (A/Switzerland/9715293/2013 (H3N2))
|
118.5 titers
Interval 101.0 to 139.1
|
124.7 titers
Interval 112.7 to 138.1
|
120.0 titers
Interval 103.4 to 139.2
|
115.1 titers
Interval 97.3 to 136.1
|
105.4 titers
Interval 95.1 to 116.9
|
102.7 titers
Interval 86.7 to 121.6
|
138.2 titers
Interval 115.7 to 165.0
|
|
HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT
Day 56 (A/Switzerland/9715293/2013 (H3N2))
|
93.9 titers
Interval 81.0 to 108.0
|
91.4 titers
Interval 83.1 to 100.5
|
92.2 titers
Interval 80.4 to 105.7
|
88.3 titers
Interval 75.3 to 103.6
|
97.3 titers
Interval 87.7 to 108.0
|
77.2 titers
Interval 66.2 to 89.9
|
96.3 titers
Interval 81.3 to 114.0
|
|
HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT
Day 182 (A/Switzerland/9715293/2013 (H3N2))
|
73.4 titers
Interval 63.8 to 84.5
|
72.4 titers
Interval 66.1 to 79.2
|
73.4 titers
Interval 64.1 to 84.0
|
72.0 titers
Interval 62.3 to 83.0
|
77.2 titers
Interval 69.8 to 85.4
|
66.1 titers
Interval 57.3 to 76.4
|
77.2 titers
Interval 66.6 to 86.6
|
SECONDARY outcome
Timeframe: Day 28 - Day 182Population: Per-Protocol Population for immunogenicity was used for this display of secondary outcome measures and included all randomized subjects that received the assigned dose of the test article according to protocol, had HAI serology results for Day 0 and Day 28, and had no major protocol deviations affecting the primary immunogenicity outcomes
HAI antibody titer responses specific for antigenically-drifted influenza strains, at Days 28, 56, and 182 expressed as Geometric Fold Ratio.
Outcome measures
| Measure |
Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A
n=149 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-1 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Preformulated With Adjuvant Dose A
n=295 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-2 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Preformulated With Adjuvant Dose B
n=147 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-3 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Preformulated With Increased B HA Adjuvant Dose A
n=121 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-4 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Without Adjuvant
n=290 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-5 (Day 0) and Licensed 2018-2019 Influenza vaccine (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Fluzone HD: 2018-2019 Licensed Trivalent Seasonal Influenza Vaccine
Flublok Quadrivalent: 2018-2019 Licensed Quadrivalent Seasonal Influenza Vaccine
|
Licensed High-Dose Trivalent Influenza Vaccine
n=143 Participants
Alternating deltoid injections of 2018-2019 High-Dose Trivalent Vaccine (Day 0) and Placebo (Day 28)
Placebo: Placebo
Fluzone HD: 2018-2019 Licensed Trivalent Seasonal Influenza Vaccine
|
Licensed Quadrivalent Influenza Vaccine
n=144 Participants
Alternating deltoid injections of 2018-2019 Quadrivalent Vaccine (Day 0) and Placebo (Day 28)
Placebo: Placebo
Flublok Quadrivalent: 2018-2019 Licensed Quadrivalent Seasonal Influenza Vaccine
|
|---|---|---|---|---|---|---|---|
|
HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR
Day 28 (A/Switzerland/9715293/2013 (H3N2))
|
2.3 Fold Ratio
Interval 2.0 to 2.6
|
2.3 Fold Ratio
Interval 2.1 to 2.5
|
2.1 Fold Ratio
Interval 1.9 to 2.4
|
2.1 Fold Ratio
Interval 1.8 to 2.4
|
1.9 Fold Ratio
Interval 1.7 to 2.1
|
1.7 Fold Ratio
Interval 1.5 to 1.9
|
2.5 Fold Ratio
Interval 2.2 to 3.0
|
|
HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR
Day 56 (A/Switzerland/9715293/2013 (H3N2))
|
1.8 Fold Ratio
Interval 1.6 to 2.1
|
1.7 Fold Ratio
Interval 1.5 to 1.9
|
1.6 Fold Ratio
Interval 1.4 to 1.8
|
1.6 Fold Ratio
Interval 1.4 to 1.8
|
1.7 Fold Ratio
Interval 1.6 to 1.9
|
1.3 Fold Ratio
Interval 1.1 to 1.4
|
1.8 Fold Ratio
Interval 1.5 to 2.1
|
|
HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR
Day 182 (A/Switzerland/9715293/2013 (H3N2))
|
1.4 Fold Ratio
Interval 1.3 to 1.6
|
1.3 Fold Ratio
Interval 1.2 to 1.4
|
1.3 Fold Ratio
Interval 1.2 to 1.4
|
1.3 Fold Ratio
Interval 1.2 to 1.5
|
1.4 Fold Ratio
Interval 1.3 to 1.5
|
1.1 Fold Ratio
Interval 1.0 to 1.2
|
1.4 Fold Ratio
Interval 1.3 to 1.6
|
|
HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR
Day 28 (A/Wisconsin/19/2017 (H3N2))
|
2.4 Fold Ratio
Interval 2.0 to 2.8
|
2.5 Fold Ratio
Interval 2.3 to 2.8
|
2.3 Fold Ratio
Interval 2.0 to 2.6
|
2.1 Fold Ratio
Interval 1.8 to 2.5
|
1.9 Fold Ratio
Interval 1.8 to 2.2
|
2.4 Fold Ratio
Interval 2.1 to 2.8
|
2.7 Fold Ratio
Interval 2.2 to 3.2
|
|
HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR
Day 56 (A/Wisconsin/19/2017 (H3N2))
|
2.0 Fold Ratio
Interval 1.7 to 2.3
|
1.9 Fold Ratio
Interval 1.7 to 2.1
|
1.9 Fold Ratio
Interval 1.7 to 2.2
|
1.7 Fold Ratio
Interval 1.4 to 2.0
|
2.4 Fold Ratio
Interval 2.2 to 2.7
|
1.8 Fold Ratio
Interval 1.6 to 2.1
|
1.9 Fold Ratio
Interval 1.6 to 2.2
|
|
HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR
Day 182 (A/Wisconsin/19/2017 (H3N2))
|
1.4 Fold Ratio
Interval 1.2 to 1.6
|
1.3 Fold Ratio
Interval 1.2 to 1.4
|
1.4 Fold Ratio
Interval 1.3 to 1.6
|
1.3 Fold Ratio
Interval 1.1 to 1.5
|
1.5 Fold Ratio
Interval 1.4 to 1.6
|
1.3 Fold Ratio
Interval 1.1 to 1.4
|
1.3 Fold Ratio
Interval 1.1 to 1.4
|
SECONDARY outcome
Timeframe: Day 28 - Day 182Population: Per-Protocol Population for immunogenicity was used for this display of secondary outcome measures and included all randomized subjects that received the assigned dose of the test article according to protocol, had HAI serology results for Day 0 and Day 28, and had no major protocol deviations affecting the primary immunogenicity outcomes
HAI antibody titers specific for antigenically-drifted influenza strains, at Days 28, 56 and 182 expressed as SCR.
Outcome measures
| Measure |
Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A
n=149 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-1 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Preformulated With Adjuvant Dose A
n=295 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-2 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Preformulated With Adjuvant Dose B
n=147 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-3 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Preformulated With Increased B HA Adjuvant Dose A
n=121 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-4 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Without Adjuvant
n=290 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-5 (Day 0) and Licensed 2018-2019 Influenza vaccine (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Fluzone HD: 2018-2019 Licensed Trivalent Seasonal Influenza Vaccine
Flublok Quadrivalent: 2018-2019 Licensed Quadrivalent Seasonal Influenza Vaccine
|
Licensed High-Dose Trivalent Influenza Vaccine
n=143 Participants
Alternating deltoid injections of 2018-2019 High-Dose Trivalent Vaccine (Day 0) and Placebo (Day 28)
Placebo: Placebo
Fluzone HD: 2018-2019 Licensed Trivalent Seasonal Influenza Vaccine
|
Licensed Quadrivalent Influenza Vaccine
n=144 Participants
Alternating deltoid injections of 2018-2019 Quadrivalent Vaccine (Day 0) and Placebo (Day 28)
Placebo: Placebo
Flublok Quadrivalent: 2018-2019 Licensed Quadrivalent Seasonal Influenza Vaccine
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains
Day 56 (A/Wisconsin/19/2017 (H3N2))
|
28 participants
|
49 participants
|
23 participants
|
16 participants
|
63 participants
|
18 participants
|
26 participants
|
|
Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains
Day 182 (A/Wisconsin/19/2017 (H3N2))
|
8 participants
|
17 participants
|
8 participants
|
8 participants
|
21 participants
|
6 participants
|
8 participants
|
|
Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains
Day 28 (A/Switzerland/9715293/2013 (H3N2))
|
45 participants
|
89 participants
|
38 participants
|
28 participants
|
63 participants
|
20 participants
|
47 participants
|
|
Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains
Day 56 (A/Switzerland/9715293/2013 (H3N2))
|
15 participants
|
27 participants
|
9 participants
|
8 participants
|
26 participants
|
5 participants
|
18 participants
|
|
Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains
Day 182 (A/Switzerland/9715293/2013 (H3N2))
|
15 participants
|
22 participants
|
6 participants
|
9 participants
|
21 participants
|
4 participants
|
14 participants
|
|
Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains
Day 28 (A/Wisconsin/19/2017 (H3N2))
|
50 participants
|
94 participants
|
41 participants
|
30 participants
|
69 participants
|
44 participants
|
50 participants
|
SECONDARY outcome
Timeframe: Day 28 - Day 182Population: Per-Protocol Population for immunogenicity was used for this display of secondary outcome measures and included all randomized subjects that received the assigned dose of the test article according to protocol, had HAI serology results for Day 0 and Day 28, and had no major protocol deviations affecting the primary immunogenicity outcomes
HAI antibody titers specific for antigenically-drifted influenza strains, at Days 28, 56 and 182 expressed as SPR.
Outcome measures
| Measure |
Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A
n=149 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-1 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Preformulated With Adjuvant Dose A
n=295 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-2 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Preformulated With Adjuvant Dose B
n=147 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-3 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Preformulated With Increased B HA Adjuvant Dose A
n=121 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-4 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Without Adjuvant
n=290 Participants
Alternating deltoid injections of 2018-2019 Quad-NIV-5 (Day 0) and Licensed 2018-2019 Influenza vaccine (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Fluzone HD: 2018-2019 Licensed Trivalent Seasonal Influenza Vaccine
Flublok Quadrivalent: 2018-2019 Licensed Quadrivalent Seasonal Influenza Vaccine
|
Licensed High-Dose Trivalent Influenza Vaccine
n=143 Participants
Alternating deltoid injections of 2018-2019 High-Dose Trivalent Vaccine (Day 0) and Placebo (Day 28)
Placebo: Placebo
Fluzone HD: 2018-2019 Licensed Trivalent Seasonal Influenza Vaccine
|
Licensed Quadrivalent Influenza Vaccine
n=144 Participants
Alternating deltoid injections of 2018-2019 Quadrivalent Vaccine (Day 0) and Placebo (Day 28)
Placebo: Placebo
Flublok Quadrivalent: 2018-2019 Licensed Quadrivalent Seasonal Influenza Vaccine
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains
Day 28 (A/Switzerland/9715293/2013 (H3N2))
|
139 participants
|
288 participants
|
138 participants
|
112 participants
|
276 participants
|
129 participants
|
135 participants
|
|
Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains
Day 56 (A/Switzerland/9715293/2013 (H3N2))
|
107 participants
|
215 participants
|
108 participants
|
85 participants
|
212 participants
|
87 participants
|
101 participants
|
|
Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains
Day 182 (A/Switzerland/9715293/2013 (H3N2))
|
113 participants
|
234 participants
|
112 participants
|
90 participants
|
224 participants
|
101 participants
|
112 participants
|
|
Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains
Day 28 (A/Wisconsin/19/2017 (H3N2))
|
130 participants
|
276 participants
|
134 participants
|
108 participants
|
246 participants
|
129 participants
|
130 participants
|
|
Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains
Day 56 (A/Wisconsin/19/2017 (H3N2))
|
110 participants
|
233 participants
|
111 participants
|
87 participants
|
245 participants
|
109 participants
|
103 participants
|
|
Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains
Day 182 (A/Wisconsin/19/2017 (H3N2))
|
104 participants
|
215 participants
|
103 participants
|
91 participants
|
213 participants
|
105 participants
|
105 participants
|
Adverse Events
Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A
Serious events: 12 serious events
Other events: 4 other events
Deaths: 1 deaths
Quad-NIV Preformulated With Adjuvant Dose A
Serious events: 21 serious events
Other events: 14 other events
Deaths: 3 deaths
Quad-NIV Preformulated With Adjuvant Dose B
Serious events: 16 serious events
Other events: 7 other events
Deaths: 0 deaths
Quad-NIV Preformulated With Increased B HA Adjuvant Dose A
Serious events: 22 serious events
Other events: 2 other events
Deaths: 2 deaths
Quad-NIV Without Adjuvant
Serious events: 7 serious events
Other events: 16 other events
Deaths: 0 deaths
Licensed High-Dose Trivalent Influenza Vaccine
Serious events: 8 serious events
Other events: 10 other events
Deaths: 0 deaths
Licensed Quadrivalent Influenza Vaccine
Serious events: 6 serious events
Other events: 2 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A
n=157 participants at risk
Alternating deltoid injections of 2018-2019 Quad-NIV-1 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Preformulated With Adjuvant Dose A
n=305 participants at risk
Alternating deltoid injections of 2018-2019 Quad-NIV-2 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Preformulated With Adjuvant Dose B
n=156 participants at risk
Alternating deltoid injections of 2018-2019 Quad-NIV-3 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Preformulated With Increased B HA Adjuvant Dose A
n=132 participants at risk
Alternating deltoid injections of 2018-2019 Quad-NIV-4 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Without Adjuvant
n=311 participants at risk
Alternating deltoid injections of 2018-2019 Quad-NIV-5 (Day 0) and Licensed 2018-2019 Influenza vaccine (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Fluzone HD: 2018-2019 Licensed Trivalent Seasonal Influenza Vaccine
Flublok Quadrivalent: 2018-2019 Licensed Quadrivalent Seasonal Influenza Vaccine
|
Licensed High-Dose Trivalent Influenza Vaccine
n=153 participants at risk
Alternating deltoid injections of 2018-2019 High-Dose Trivalent Vaccine (Day 0) and Placebo (Day 28)
Placebo: Placebo
Fluzone HD: 2018-2019 Licensed Trivalent Seasonal Influenza Vaccine
|
Licensed Quadrivalent Influenza Vaccine
n=151 participants at risk
Alternating deltoid injections of 2018-2019 Quadrivalent Vaccine (Day 0) and Placebo (Day 28)
Placebo: Placebo
Flublok Quadrivalent: 2018-2019 Licensed Quadrivalent Seasonal Influenza Vaccine
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.76%
1/132 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Cardiac disorders
Acute myocardial infarction
|
0.64%
1/157 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.65%
1/153 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Cardiac disorders
Angina unstable
|
0.64%
1/157 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.33%
1/305 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.76%
1/132 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.32%
1/311 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.33%
1/305 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.64%
1/156 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.76%
1/132 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.64%
1/156 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
1.5%
2/132 • Number of events 2 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.33%
1/305 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Gastroptosis
|
0.64%
1/157 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.64%
1/157 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.64%
1/157 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.64%
1/157 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.32%
1/311 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.76%
1/132 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
General disorders
Chest discomfort
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.33%
1/305 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
General disorders
Chest pain
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.33%
1/305 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
General disorders
Death
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.33%
1/305 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.76%
1/132 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.76%
1/132 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Appendicitis
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.33%
1/305 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Bronchitis
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.65%
1/153 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.64%
1/156 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Cellulitis
|
0.64%
1/157 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.32%
1/311 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Clostridium difficile infection
|
0.64%
1/157 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Diverticulitis
|
0.64%
1/157 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
1.5%
2/132 • Number of events 2 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Influenza
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.76%
1/132 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Pneumonia
|
0.64%
1/157 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
1.3%
2/156 • Number of events 2 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.65%
1/153 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.66%
1/151 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Sepsis
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.64%
1/156 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.32%
1/311 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.66%
1/151 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.64%
1/156 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.65%
1/153 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.33%
1/305 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.66%
1/151 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.66%
1/151 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.33%
1/305 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.65%
1/153 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.66%
1/151 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.64%
1/156 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.66%
1/151 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.64%
1/156 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Injury, poisoning and procedural complications
Spinal column injury
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.64%
1/156 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.64%
1/156 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.32%
1/311 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.33%
1/305 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.76%
1/132 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.65%
1/153 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.64%
1/157 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.76%
1/132 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.76%
1/132 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.65%
1/153 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.76%
1/132 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.32%
1/311 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.33%
1/305 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.33%
1/305 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.76%
1/132 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.64%
1/156 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.33%
1/305 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the tongue
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.32%
1/311 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Nervous system disorders
Cerebral arteriosclerosis
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.33%
1/305 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.64%
1/156 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.76%
1/132 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.33%
1/305 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.33%
1/305 • Number of events 2 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.64%
1/156 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.33%
1/305 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Nervous system disorders
Seizure
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.33%
1/305 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.76%
1/132 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Nervous system disorders
Syncope
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.76%
1/132 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.64%
1/156 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.33%
1/305 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.76%
1/132 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.64%
1/156 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.65%
1/153 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.76%
1/132 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.64%
1/157 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/305 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.76%
1/132 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.33%
1/305 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.00%
0/157 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.33%
1/305 • Number of events 1 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/156 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/132 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/311 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/153 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
0.00%
0/151 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
Other adverse events
| Measure |
Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A
n=157 participants at risk
Alternating deltoid injections of 2018-2019 Quad-NIV-1 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Preformulated With Adjuvant Dose A
n=305 participants at risk
Alternating deltoid injections of 2018-2019 Quad-NIV-2 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Preformulated With Adjuvant Dose B
n=156 participants at risk
Alternating deltoid injections of 2018-2019 Quad-NIV-3 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Preformulated With Increased B HA Adjuvant Dose A
n=132 participants at risk
Alternating deltoid injections of 2018-2019 Quad-NIV-4 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo
|
Quad-NIV Without Adjuvant
n=311 participants at risk
Alternating deltoid injections of 2018-2019 Quad-NIV-5 (Day 0) and Licensed 2018-2019 Influenza vaccine (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Fluzone HD: 2018-2019 Licensed Trivalent Seasonal Influenza Vaccine
Flublok Quadrivalent: 2018-2019 Licensed Quadrivalent Seasonal Influenza Vaccine
|
Licensed High-Dose Trivalent Influenza Vaccine
n=153 participants at risk
Alternating deltoid injections of 2018-2019 High-Dose Trivalent Vaccine (Day 0) and Placebo (Day 28)
Placebo: Placebo
Fluzone HD: 2018-2019 Licensed Trivalent Seasonal Influenza Vaccine
|
Licensed Quadrivalent Influenza Vaccine
n=151 participants at risk
Alternating deltoid injections of 2018-2019 Quadrivalent Vaccine (Day 0) and Placebo (Day 28)
Placebo: Placebo
Flublok Quadrivalent: 2018-2019 Licensed Quadrivalent Seasonal Influenza Vaccine
|
|---|---|---|---|---|---|---|---|
|
Investigations
Blood urea increased
|
2.5%
4/157 • Number of events 4 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
4.6%
14/305 • Number of events 14 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
4.5%
7/156 • Number of events 7 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
1.5%
2/132 • Number of events 2 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
5.1%
16/311 • Number of events 16 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
6.5%
10/153 • Number of events 10 • 6 Months
Serious Adverse Events, Other (Not Including Serious) Adverse Events
|
1.3%
2/151 • Number of events 2 • 6 Months
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