Trial Outcomes & Findings for Phase 3 Pivotal Trial of NanoFlu™ in Older Adults (NCT NCT04120194)
NCT ID: NCT04120194
Last Updated: 2023-05-06
Results Overview
Egg-Based HAI Assay responses for all 4 vaccine homologous influenza strains (ie, 2 influenza A and 2 influenza B strains) expressed as GMFR on Day 28
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2654 participants
Primary outcome timeframe
Day 28
Results posted on
2023-05-06
Participant Flow
Participant milestones
| Measure |
NanoFlu
NanoFlu will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.
NanoFlu: Investigational quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.
|
Fluzone Quadrivalent
Fluzone Quadrivalent will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.
Fluzone Quadrivalent: Licensed quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.
|
|---|---|---|
|
Overall Study
STARTED
|
1332
|
1322
|
|
Overall Study
Safety Population
|
1333
|
1319
|
|
Overall Study
COMPLETED
|
1312
|
1302
|
|
Overall Study
NOT COMPLETED
|
20
|
20
|
Reasons for withdrawal
| Measure |
NanoFlu
NanoFlu will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.
NanoFlu: Investigational quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.
|
Fluzone Quadrivalent
Fluzone Quadrivalent will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.
Fluzone Quadrivalent: Licensed quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
11
|
8
|
|
Overall Study
Adverse Event
|
4
|
5
|
|
Overall Study
Voluntary withdrawal unrelated to adverse event
|
1
|
2
|
|
Overall Study
Miscellaneous
|
4
|
5
|
Baseline Characteristics
Phase 3 Pivotal Trial of NanoFlu™ in Older Adults
Baseline characteristics by cohort
| Measure |
NanoFlu
n=1333 Participants
NanoFlu will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.
NanoFlu: Investigational quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.
|
Fluzone Quadrivalent
n=1319 Participants
Fluzone Quadrivalent will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.
Fluzone Quadrivalent: Licensed quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.
|
Total
n=2652 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.5 years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
72.5 years
STANDARD_DEVIATION 5.7 • n=7 Participants
|
72.5 years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
792 Participants
n=5 Participants
|
845 Participants
n=7 Participants
|
1637 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
541 Participants
n=5 Participants
|
474 Participants
n=7 Participants
|
1015 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
64 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1269 Participants
n=5 Participants
|
1254 Participants
n=7 Participants
|
2523 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
14 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
105 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
208 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1208 Participants
n=5 Participants
|
1200 Participants
n=7 Participants
|
2408 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Received 2018-2019 Influenza Vaccine
|
1117 Participants
n=5 Participants
|
1102 Participants
n=7 Participants
|
2219 Participants
n=5 Participants
|
|
Received any influenza vaccination within the past 3 years
|
1210 Participants
n=5 Participants
|
1200 Participants
n=7 Participants
|
2410 Participants
n=5 Participants
|
|
Reaction from vaccine within the past 3 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 28Population: Per-Protocol (PP) Population including all subjects who provided consent, were randomized and received the assigned dose of the test article according to protocol.
Egg-Based HAI Assay responses for all 4 vaccine homologous influenza strains (ie, 2 influenza A and 2 influenza B strains) expressed as GMFR on Day 28
Outcome measures
| Measure |
NanoFlu
n=1280 Participants
NanoFlu will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.
NanoFlu: Investigational quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.
|
Fluzone Quadrivalent
n=1286 Participants
Fluzone Quadrivalent will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.
Fluzone Quadrivalent: Licensed quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.
|
|---|---|---|
|
HAI Antibody Responses for Vaccine Homologous Influenza Strains Expressed as Ratio of Geometric Mean Fold Ratio (GMFR)
A/Brisbane/02/2018 (H1N1)
|
1.9 Geometric Mean Fold Ratio
Interval 1.8 to 2.0
|
1.7 Geometric Mean Fold Ratio
Interval to 1.8
|
|
HAI Antibody Responses for Vaccine Homologous Influenza Strains Expressed as Ratio of Geometric Mean Fold Ratio (GMFR)
A/Kansas/14/2017 (H3N2)
|
2.7 Geometric Mean Fold Ratio
Interval 2.6 to 2.9
|
2.3 Geometric Mean Fold Ratio
Interval 2.2 to 2.4
|
|
HAI Antibody Responses for Vaccine Homologous Influenza Strains Expressed as Ratio of Geometric Mean Fold Ratio (GMFR)
B/Maryland/15/2016 (Victoria lineage)
|
1.6 Geometric Mean Fold Ratio
Interval 1.5 to 1.6
|
1.5 Geometric Mean Fold Ratio
Interval 1.5 to 1.6
|
|
HAI Antibody Responses for Vaccine Homologous Influenza Strains Expressed as Ratio of Geometric Mean Fold Ratio (GMFR)
B/Phuket/3073/2013 (Yamagata lineage)
|
2.4 Geometric Mean Fold Ratio
Interval 2.3 to 2.5
|
2.0 Geometric Mean Fold Ratio
Interval 1.9 to 2.1
|
PRIMARY outcome
Timeframe: Day 0 - Day 28Population: Per-Protocol (PP) Population including all subjects who provided consent, were randomized and received the assigned dose of the test article according to protocol.
Egg-Based HAI Assay responses for all 4 vaccine homologous influenza strains (ie, 2 influenza A and 2 influenza B strains) summarized in terms of SCR on Day 28
Outcome measures
| Measure |
NanoFlu
n=1280 Participants
NanoFlu will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.
NanoFlu: Investigational quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.
|
Fluzone Quadrivalent
n=1286 Participants
Fluzone Quadrivalent will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.
Fluzone Quadrivalent: Licensed quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.
|
|---|---|---|
|
Mean Difference in the Seroconversion Rate (SCR) HAI Antibody Responses for Vaccine Homologous Influenza Strains Expressed as a Percentage of Participants
A/Brisbane/02/2018 (H1N1) pdm09
|
22.0 percentage of participants
Interval 19.8 to 24.4
|
17.0 percentage of participants
Interval 15.0 to 19.2
|
|
Mean Difference in the Seroconversion Rate (SCR) HAI Antibody Responses for Vaccine Homologous Influenza Strains Expressed as a Percentage of Participants
A/Kansas/14/2017 (H3N2)
|
41.8 percentage of participants
Interval 39.1 to 44.6
|
34.4 percentage of participants
Interval 31.8 to 37.1
|
|
Mean Difference in the Seroconversion Rate (SCR) HAI Antibody Responses for Vaccine Homologous Influenza Strains Expressed as a Percentage of Participants
B/Maryland/15/2016 (Victoria lineage)
|
11.2 percentage of participants
Interval 9.5 to 13.0
|
10.7 percentage of participants
Interval 9.0 to 12.5
|
|
Mean Difference in the Seroconversion Rate (SCR) HAI Antibody Responses for Vaccine Homologous Influenza Strains Expressed as a Percentage of Participants
B/Phuket/3073/2013 (Yamagata lineage)
|
31.3 percentage of participants
Interval 28.8 to 33.9
|
22.9 percentage of participants
Interval 20.6 to 25.3
|
PRIMARY outcome
Timeframe: Day 0 - Day 6Population: Safety Population, including all study subjects who provided consent, were randomized, and received a test article. The Safety Population was analyzed as actually treated (ie, based on the actual dose received).
Number of subjects with solicited local and systemic AEs over 7 days post-injection (ie, Day 0 through Day 6, inclusive).
Outcome measures
| Measure |
NanoFlu
n=1333 Participants
NanoFlu will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.
NanoFlu: Investigational quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.
|
Fluzone Quadrivalent
n=1319 Participants
Fluzone Quadrivalent will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.
Fluzone Quadrivalent: Licensed quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.
|
|---|---|---|
|
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs)
Local solicited TEAEs
|
372 participants
|
243 participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs)
Systemic Solicited TEAEs
|
369 participants
|
292 participants
|
PRIMARY outcome
Timeframe: Day 0 - Day 364Population: Safety Population, including all study subjects who provided consent, were randomized, and received a test article. The Safety Population was analyzed as actually treated (ie, based on the actual dose received).
Number of subjects with Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), Significant New Medical Conditions (SNMCs) - including AESIs - through 1-year post-injection.
Outcome measures
| Measure |
NanoFlu
n=1333 Participants
NanoFlu will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.
NanoFlu: Investigational quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.
|
Fluzone Quadrivalent
n=1319 Participants
Fluzone Quadrivalent will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.
Fluzone Quadrivalent: Licensed quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.
|
|---|---|---|
|
Number of Subjects With Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), Significant New Medical Conditions (SNMCs)
SAEs
|
81 participants
|
78 participants
|
|
Number of Subjects With Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), Significant New Medical Conditions (SNMCs)
SNMCs
|
42 participants
|
49 participants
|
|
Number of Subjects With Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), Significant New Medical Conditions (SNMCs)
MAAEs
|
353 participants
|
354 participants
|
PRIMARY outcome
Timeframe: Day 0 - Day 27Population: Safety Population, including all study subjects who provided consent, were randomized and received a test article. The Safety Population was analyzed as actually treated (ie, based on the actual dose received).
Number of subjects with MAEs, SAEs, and SNMCs - including AESIs.
Outcome measures
| Measure |
NanoFlu
n=1333 Participants
NanoFlu will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.
NanoFlu: Investigational quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.
|
Fluzone Quadrivalent
n=1319 Participants
Fluzone Quadrivalent will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.
Fluzone Quadrivalent: Licensed quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.
|
|---|---|---|
|
Number of Subjects With MAAEs, SAEs, SNMCs
SAEs
|
10 participants
|
5 participants
|
|
Number of Subjects With MAAEs, SAEs, SNMCs
SNMCs
|
4 participants
|
11 participants
|
|
Number of Subjects With MAAEs, SAEs, SNMCs
MAAEs
|
108 participants
|
108 participants
|
SECONDARY outcome
Timeframe: Day 0 - Day 28Population: Per-Protocol (PP) Population including all subjects provided consent, were randomized and 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 as determined by the sponsor prior to database lock and unblinding.
Homologous influenza strains and 1 antigenically drifted strain expressed as GMT
Outcome measures
| Measure |
NanoFlu
n=1280 Participants
NanoFlu will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.
NanoFlu: Investigational quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.
|
Fluzone Quadrivalent
n=1286 Participants
Fluzone Quadrivalent will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.
Fluzone Quadrivalent: Licensed quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.
|
|---|---|---|
|
HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain Expressed as Geometric Mean Titers (GMT)
Day 0 - A/ Brisbane (H1N1)
|
26.2 titers
Interval 25.0 to 27.4
|
26.0 titers
Interval 24.9 to 27.1
|
|
HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain Expressed as Geometric Mean Titers (GMT)
Day 28 - A / Brisbane (H1N1)
|
49.3 titers
Interval 46.7 to 51.9
|
45.0 titers
Interval 42.7 to 47.3
|
|
HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain Expressed as Geometric Mean Titers (GMT)
Day 0 - A/ Kansas (H3N2)
|
55.1 titers
Interval 53.5 to 56.8
|
54.7 titers
Interval 53.1 to 56.3
|
|
HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain Expressed as Geometric Mean Titers (GMT)
Day 28- A/ Kansas (H3N2)
|
151.5 titers
Interval 143.3 to 160.2
|
126.8 titers
Interval 120.3 to 133.6
|
|
HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain Expressed as Geometric Mean Titers (GMT)
Day 0 - B (Victoria Lineage)
|
70.7 titers
Interval 68.0 to 73.5
|
69.8 titers
Interval 67.2 to 72.5
|
|
HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain Expressed as Geometric Mean Titers (GMT)
Day 28 - B (Victoria Lineage)
|
110.7 titers
Interval 106.1 to 115.6
|
106.3 titers
Interval 102.3 to 110.6
|
|
HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain Expressed as Geometric Mean Titers (GMT)
Day 0 - B (Yamagata Lineage)
|
69.1 titers
Interval 66.0 to 72.3
|
66.5 titers
Interval 63.6 to 69.6
|
|
HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain Expressed as Geometric Mean Titers (GMT)
Day 28- B (Yamagata Lineage)
|
168.5 titers
Interval 160.2 to 177.2
|
133.9 titers
Interval 127.7 to 140.5
|
|
HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain Expressed as Geometric Mean Titers (GMT)
Day 0 - A/California (H3N2)
|
44.5 titers
Interval 42.4 to 46.7
|
44.0 titers
Interval 42.0 to 46.0
|
|
HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain Expressed as Geometric Mean Titers (GMT)
Day 28- A/California (H3N2)
|
115.0 titers
Interval 108.0 to 122.4
|
80.6 titers
Interval 75.9 to 85.6
|
SECONDARY outcome
Timeframe: Day 28 - 364Population: Per-Protocol (PP) Population including all subjects who provided consent, were randomized and received the assigned dose of the test article according to protocol.
Wild-Type HAI Assay Homologous influenza strains and 1 antigenically drifted strain expressed as GMFR.
Outcome measures
| Measure |
NanoFlu
n=1280 Participants
NanoFlu will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.
NanoFlu: Investigational quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.
|
Fluzone Quadrivalent
n=1286 Participants
Fluzone Quadrivalent will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.
Fluzone Quadrivalent: Licensed quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.
|
|---|---|---|
|
HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain Expressed as Geometric Mean Fold Ratio (GMFR)
Day 28- A/Brisbane (H1N1)
|
2.4 Geometric Mean Fold Rise
Interval 2.3 to 2.5
|
1.9 Geometric Mean Fold Rise
Interval 1.8 to 2.0
|
|
HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain Expressed as Geometric Mean Fold Ratio (GMFR)
Day 28 - A/Kansas (H3N2)
|
5.6 Geometric Mean Fold Rise
Interval 5.3 to 6.0
|
3.4 Geometric Mean Fold Rise
Interval 3.2 to 3.6
|
|
HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain Expressed as Geometric Mean Fold Ratio (GMFR)
Day 28 - B/ Maryland (Victoria Lineage)
|
2.1 Geometric Mean Fold Rise
Interval 2.0 to 2.2
|
1.6 Geometric Mean Fold Rise
Interval 1.5 to 1.7
|
|
HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain Expressed as Geometric Mean Fold Ratio (GMFR)
Day 28 - B/Phuket (Yamagata Linage)
|
2.6 Geometric Mean Fold Rise
Interval 2.5 to 2.7
|
1.8 Geometric Mean Fold Rise
Interval 1.7 to 1.8
|
|
HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain Expressed as Geometric Mean Fold Ratio (GMFR)
Day 28 - A/California (H3N2)
|
2.6 Geometric Mean Fold Rise
Interval 2.5 to 2.7
|
1.8 Geometric Mean Fold Rise
Interval 1.8 to 1.9
|
|
HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain Expressed as Geometric Mean Fold Ratio (GMFR)
Day 28 - A/Cardiff (H3N2)
|
2.4 Geometric Mean Fold Rise
Interval 2.3 to 2.5
|
1.8 Geometric Mean Fold Rise
Interval 1.7 to 1.8
|
|
HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain Expressed as Geometric Mean Fold Ratio (GMFR)
Day 364- A/Brisbane (H1N1)
|
2.0 Geometric Mean Fold Rise
Interval 1.6 to 2.5
|
2.0 Geometric Mean Fold Rise
Interval 1.6 to 2.4
|
|
HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain Expressed as Geometric Mean Fold Ratio (GMFR)
Day 364 - A/Kansas (H3N2)
|
2.9 Geometric Mean Fold Rise
Interval 2.3 to 3.6
|
2.2 Geometric Mean Fold Rise
Interval 1.9 to 2.7
|
|
HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain Expressed as Geometric Mean Fold Ratio (GMFR)
Day 364 - B/ Maryland (Victoria Lineage)
|
2.0 Geometric Mean Fold Rise
Interval 1.7 to 2.2
|
1.8 Geometric Mean Fold Rise
Interval 1.6 to 2.0
|
|
HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain Expressed as Geometric Mean Fold Ratio (GMFR)
Day 364 - B/Phuket (Yamagata Linage)
|
1.1 Geometric Mean Fold Rise
Interval 1.0 to 1.3
|
1.1 Geometric Mean Fold Rise
Interval 0.9 to 1.2
|
|
HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain Expressed as Geometric Mean Fold Ratio (GMFR)
Day 364 - A/California (H3N2)
|
79.6 Geometric Mean Fold Rise
Interval 65.8 to 96.2
|
75.7 Geometric Mean Fold Rise
Interval 65.5 to 87.3
|
|
HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain Expressed as Geometric Mean Fold Ratio (GMFR)
Day 364 - A/Cardiff (H3N2)
|
2.0 Geometric Mean Fold Rise
Interval 1.7 to 2.4
|
1.5 Geometric Mean Fold Rise
Interval 1.2 to 1.7
|
SECONDARY outcome
Timeframe: Day 28 - Day 364Population: Per-Protocol (PP) Population including all subjects who provided consent, were randomized and received the assigned dose of the test article according to protocol.
Wild-Type HAI Assay Homologous Influenza Strains and at least 1 Antigenically Drifted Strain Expressed as Seroconversion Rate (SCR).
Outcome measures
| Measure |
NanoFlu
n=1280 Participants
NanoFlu will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.
NanoFlu: Investigational quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.
|
Fluzone Quadrivalent
n=1286 Participants
Fluzone Quadrivalent will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.
Fluzone Quadrivalent: Licensed quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.
|
|---|---|---|
|
Subjects Who Seroconverted as Determined by HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain
Day 364 - A/California (H3N2)
|
19.0 percentage of participants
Interval 10.2 to 30.9
|
5.4 percentage of participants
Interval 1.1 to 14.9
|
|
Subjects Who Seroconverted as Determined by HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain
Day 28- A/Brisbane/02/2018 (H1N1) pdm09
|
32.7 percentage of participants
Interval 30.2 to 35.4
|
21.4 percentage of participants
Interval 19.2 to 23.7
|
|
Subjects Who Seroconverted as Determined by HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain
Day 28-A/Kansas/14/2017 (H3N2)
|
69.8 percentage of participants
Interval 67.2 to 72.3
|
49.5 percentage of participants
Interval 46.7 to 52.2
|
|
Subjects Who Seroconverted as Determined by HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain
Day 28- B/Maryland/15/2016 (Victoria lineage)
|
25.1 percentage of participants
Interval 22.7 to 27.5
|
13.5 percentage of participants
Interval 11.6 to 15.4
|
|
Subjects Who Seroconverted as Determined by HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain
Day 28- B/Phuket/3073/2013 (Yamagata lineage)
|
35.4 percentage of participants
Interval 32.8 to 38.1
|
17.7 percentage of participants
Interval 15.7 to 19.9
|
|
Subjects Who Seroconverted as Determined by HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain
Day 28 - A/California (H3N2)
|
37.1 percentage of participants
Interval 34.5 to 39.8
|
20.5 percentage of participants
Interval 18.4 to 22.8
|
|
Subjects Who Seroconverted as Determined by HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain
Day 28 - A/Cardiff (H3N2)
|
32.7 percentage of participants
Interval 30.2 to 35.4
|
18.6 percentage of participants
Interval 16.5 to 20.8
|
|
Subjects Who Seroconverted as Determined by HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain
Day 364 - A/Cardiff (H3N2)
|
22.2 percentage of participants
Interval 12.7 to 34.5
|
7.1 percentage of participants
Interval 2.0 to 17.3
|
|
Subjects Who Seroconverted as Determined by HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain
Day 364- A/Brisbane/02/2018 (H1N1) pdm09
|
19.0 percentage of participants
Interval 10.2 to 30.9
|
19.6 percentage of participants
Interval 10.2 to 32.4
|
|
Subjects Who Seroconverted as Determined by HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain
Day 364-A/Kansas/14/2017 (H3N2)
|
54.0 percentage of participants
Interval 40.9 to 66.6
|
28.6 percentage of participants
Interval 17.3 to 42.2
|
|
Subjects Who Seroconverted as Determined by HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain
Day 364- B/Maryland/15/2016 (Victoria lineage)
|
17.5 percentage of participants
Interval 9.1 to 29.1
|
8.9 percentage of participants
Interval 3.0 to 19.6
|
|
Subjects Who Seroconverted as Determined by HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain
Day 364- B/Phuket/3073/2013 (Yamagata lineage)
|
6.3 percentage of participants
Interval 1.8 to 15.5
|
3.6 percentage of participants
Interval 0.4 to 12.3
|
SECONDARY outcome
Timeframe: Day 28Population: Per-Protocol (PP) Population including all subjects provided consent, were randomized and 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 as determined by the sponsor prior to database lock and unblinding.
Homologous Influenza Strains and at least 1 Antigenically Drifted Strain Expressed as Seroprotection Rate (SPR).
Outcome measures
| Measure |
NanoFlu
n=1280 Participants
NanoFlu will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.
NanoFlu: Investigational quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.
|
Fluzone Quadrivalent
n=1286 Participants
Fluzone Quadrivalent will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.
Fluzone Quadrivalent: Licensed quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.
|
|---|---|---|
|
Subjects Who Seroprotected as Determined by HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain Expressed as SPR
A/Brisbane/02/2018 (H1N1) pdm09
|
69.1 percentage of participants
Interval 66.4 to 71.6
|
64.5 percentage of participants
Interval 61.9 to 67.2
|
|
Subjects Who Seroprotected as Determined by HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain Expressed as SPR
A/Kansas/14/2017 (H3N2)
|
98.8 percentage of participants
Interval 98.1 to 99.3
|
98.3 percentage of participants
Interval 97.4 to 98.9
|
|
Subjects Who Seroprotected as Determined by HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain Expressed as SPR
B/Maryland/15/2016 (Victoria lineage)
|
99.1 percentage of participants
Interval 98.5 to 99.6
|
98.7 percentage of participants
Interval 97.9 to 99.2
|
|
Subjects Who Seroprotected as Determined by HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain Expressed as SPR
B/Phuket/3073/2013 (Yamagata lineage)
|
99.0 percentage of participants
Interval 98.6 to 99.5
|
97.5 percentage of participants
Interval 96.5 to 98.3
|
Adverse Events
NanoFlu
Serious events: 136 serious events
Other events: 0 other events
Deaths: 8 deaths
Fluzone Quadrivalent
Serious events: 125 serious events
Other events: 0 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
NanoFlu
n=1333 participants at risk
NanoFlu will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.
NanoFlu: Investigational quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.
|
Fluzone Quadrivalent
n=1319 participants at risk
Fluzone Quadrivalent will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.
Fluzone Quadrivalent: Licensed quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.15%
2/1319 • Number of events 2 • 1 year
Serious Adverse Events
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.15%
2/1319 • Number of events 2 • 1 year
Serious Adverse Events
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.15%
2/1319 • Number of events 2 • 1 year
Serious Adverse Events
|
|
Cardiac disorders
Angina unstable
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Cardiac disorders
Atrial fibrillation
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.23%
3/1319 • Number of events 3 • 1 year
Serious Adverse Events
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Cardiac disorders
Cardiac failure congestive
|
0.30%
4/1333 • Number of events 4 • 1 year
Serious Adverse Events
|
0.30%
4/1319 • Number of events 4 • 1 year
Serious Adverse Events
|
|
Cardiac disorders
Coronary artery disease
|
0.23%
3/1333 • Number of events 3 • 1 year
Serious Adverse Events
|
0.15%
2/1319 • Number of events 2 • 1 year
Serious Adverse Events
|
|
Cardiac disorders
Myocardial infarction
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.15%
2/1319 • Number of events 2 • 1 year
Serious Adverse Events
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Endocrine disorders
Goitre
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.15%
2/1319 • Number of events 2 • 1 year
Serious Adverse Events
|
|
Gastrointestinal disorders
Colonic fistula
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Gastrointestinal disorders
Diverticulum
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Gastrointestinal disorders
Enterocutaneous fistula
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Gastrointestinal disorders
Gastrointestinal fistula
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.30%
4/1319 • Number of events 4 • 1 year
Serious Adverse Events
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.15%
2/1333 • Number of events 2 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Gastrointestinal disorders
Pancreatitis
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
General disorders
Asthenia
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
General disorders
Complication associated with device
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
General disorders
Death
|
0.15%
2/1333 • Number of events 2 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
General disorders
Non-cardiac chest pain
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Hepatobiliary disorders
Ischaemic hepatitis
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Infections and infestations
Appendicitis
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.23%
3/1319 • Number of events 3 • 1 year
Serious Adverse Events
|
|
Infections and infestations
Arthritis infective
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Infections and infestations
COVID-19
|
0.30%
4/1333 • Number of events 4 • 1 year
Serious Adverse Events
|
0.15%
2/1319 • Number of events 2 • 1 year
Serious Adverse Events
|
|
Infections and infestations
COVID-19 pneumonia
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Infections and infestations
Cellulitis
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.15%
2/1333 • Number of events 2 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Infections and infestations
Cholecystitis infective
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Infections and infestations
Diverticulitis
|
0.15%
2/1333 • Number of events 2 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Infections and infestations
Gastroenteritis viral
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Infections and infestations
Infected skin ulcer
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Infections and infestations
Influenza
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Infections and infestations
Localised infection
|
0.23%
3/1333 • Number of events 3 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Infections and infestations
Osteomyelitis
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Infections and infestations
Pelvic abscess
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Infections and infestations
Pneumonia
|
0.60%
8/1333 • Number of events 8 • 1 year
Serious Adverse Events
|
0.45%
6/1319 • Number of events 6 • 1 year
Serious Adverse Events
|
|
Infections and infestations
Pneumonia bacterial
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Infections and infestations
Postoperative abscess
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Infections and infestations
Renal abscess
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Infections and infestations
Sepsis
|
0.30%
4/1333 • Number of events 4 • 1 year
Serious Adverse Events
|
0.15%
2/1319 • Number of events 2 • 1 year
Serious Adverse Events
|
|
Infections and infestations
Septic shock
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 2 • 1 year
Serious Adverse Events
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Infections and infestations
Urosepsis
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Infections and infestations
Wound infection
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.15%
2/1333 • Number of events 2 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Injury, poisoning and procedural complications
Face injury
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.15%
2/1333 • Number of events 2 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Injury, poisoning and procedural complications
Injury
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.15%
2/1333 • Number of events 2 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Injury, poisoning and procedural complications
Periprosthetic fracture
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Injury, poisoning and procedural complications
Pulmonary contusion
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.15%
2/1333 • Number of events 2 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.15%
2/1319 • Number of events 2 • 1 year
Serious Adverse Events
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Injury, poisoning and procedural complications
Traumatic haemothorax
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Metabolism and nutrition disorders
Dehydration
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.08%
1/1333 • Number of events 2 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.15%
2/1333 • Number of events 2 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.15%
2/1333 • Number of events 2 • 1 year
Serious Adverse Events
|
0.38%
5/1319 • Number of events 5 • 1 year
Serious Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign ovarian tumour
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer stage I
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Follicular thyroid cancer
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hormone receptor positive breast cancer
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyosarcoma
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage IV
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma recurrent
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Nervous system disorders
Ataxia
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Nervous system disorders
Carotid artery disease
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Nervous system disorders
Cerebral infarction
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Nervous system disorders
Cerebrovascular accident
|
0.23%
3/1333 • Number of events 3 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Nervous system disorders
Encephalopathy
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Nervous system disorders
Hemiparesis
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Nervous system disorders
Ischaemic stroke
|
0.15%
2/1333 • Number of events 2 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.15%
2/1319 • Number of events 2 • 1 year
Serious Adverse Events
|
|
Nervous system disorders
Transient aphasia
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Nervous system disorders
Transient global amnesia
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Nervous system disorders
Transient ischaemic attack
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Psychiatric disorders
Hallucination, visual
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Renal and urinary disorders
Acute kidney injury
|
0.23%
3/1333 • Number of events 3 • 1 year
Serious Adverse Events
|
0.15%
2/1319 • Number of events 2 • 1 year
Serious Adverse Events
|
|
Renal and urinary disorders
Anuria
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.15%
2/1319 • Number of events 2 • 1 year
Serious Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.15%
2/1333 • Number of events 2 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.23%
3/1319 • Number of events 3 • 1 year
Serious Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.30%
4/1333 • Number of events 4 • 1 year
Serious Adverse Events
|
0.15%
2/1319 • Number of events 2 • 1 year
Serious Adverse Events
|
|
Vascular disorders
Accelerated hypertension
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Vascular disorders
Aortic aneurysm
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Vascular disorders
Aortic stenosis
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Vascular disorders
Arterial spasm
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Vascular disorders
Deep vein thrombosis
|
0.15%
2/1333 • Number of events 2 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Vascular disorders
Hypertension
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Vascular disorders
Hypertensive urgency
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
|
Vascular disorders
Hypotension
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/1333 • 1 year
Serious Adverse Events
|
0.08%
1/1319 • Number of events 1 • 1 year
Serious Adverse Events
|
|
Vascular disorders
Thrombosis
|
0.08%
1/1333 • Number of events 1 • 1 year
Serious Adverse Events
|
0.00%
0/1319 • 1 year
Serious Adverse Events
|
Other adverse events
Adverse event data not reported
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