Trial Outcomes & Findings for Comparison of Three Licensed Influenza Vaccines (NCT NCT03068949)
NCT ID: NCT03068949
Last Updated: 2021-11-30
Results Overview
Mean change of HAI serum antibody titers to A/California/07/09 (H1N1) using serum hemagglutination-inhibition (HAI) assay.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
413 participants
Primary outcome timeframe
Day 0 to Day 28
Results posted on
2021-11-30
Participant Flow
Participant milestones
| Measure |
FluBlok
FluBlok 0.5 mL given IM X1
FluBlok: FluBlok trivalent Influenza Vaccine .5 mL given Intramuscularly
|
Fluzone
Fluzone 0.5 mL given IM X1
Fluzone: Fluzone Quadrivalent Influenza Vaccine .5 mL given intramuscularly
|
FluCelVax
FluCelVax 0.5 mL given IM X 1
FluCelVax: FluCelVax Quadrivalent Influenza Vaccine .5 mL given intramuscularly
|
Fluzone HD
Fluzone HD 0.5 mL given IM X1
Fluzone HD: Fluzone HD Trivalent High Dose Influenza Vaccine .5 mL given intramuscularly
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
113
|
102
|
122
|
76
|
|
Overall Study
COMPLETED
|
105
|
90
|
113
|
63
|
|
Overall Study
NOT COMPLETED
|
8
|
12
|
9
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Three Licensed Influenza Vaccines
Baseline characteristics by cohort
| Measure |
FluBlok
n=113 Participants
FluBlok 0.5 mL given IM X1
FluBlok: FluBlok trivalent Influenza Vaccine .5 mL given Intramuscularly
|
Fluzone
n=102 Participants
Fluzone 0.5 mL given IM X1
Fluzone: Fluzone Quadrivalent Influenza Vaccine .5 mL given intramuscularly
|
FluCelVax
n=122 Participants
FluCelVax 0.5 mL given IM X 1
FluCelVax: FluCelVax Quadrivalent Influenza Vaccine .5 mL given intramuscularly
|
Fluzone HD
n=76 Participants
Fluzone HD 0.5 mL given IM X1
Fluzone HD: Fluzone HD Trivalent High Dose Influenza Vaccine .5 mL given intramuscularly
|
Total
n=413 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
34.2 years
STANDARD_DEVIATION 16.7 • n=5 Participants
|
29.0 years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
33.4 years
STANDARD_DEVIATION 15.6 • n=5 Participants
|
35.9 years
STANDARD_DEVIATION 18.0 • n=4 Participants
|
33.0 years
STANDARD_DEVIATION 15.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
230 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
183 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
112 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
391 Participants
n=21 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
|
PRIMARY outcome
Timeframe: Day 0 to Day 28Population: HAI serum antibody titers to A/California/07/09 (H1N1) for Fluzone HD arm are unavailable. Fluzone HD group was only enrolled in flu seasons Fall 2017 - Fall 2019. HAI serum antibody titers to A/California/07/09 (H1N1) was only tested on subjects enrolled in Fall 2015 and Fall 2016.
Mean change of HAI serum antibody titers to A/California/07/09 (H1N1) using serum hemagglutination-inhibition (HAI) assay.
Outcome measures
| Measure |
FluBlok
n=32 Participants
FluBlok 0.5 mL given IM X1
FluBlok: FluBlok trivalent Influenza Vaccine .5 mL given Intramuscularly
|
Fluzone
n=31 Participants
Fluzone 0.5 mL given IM X1
Fluzone: Fluzone Quadrivalent Influenza Vaccine .5 mL given intramuscularly
|
FluCelVax
n=38 Participants
FluCelVax 0.5 mL given IM X 1
FluCelVax: FluCelVax Quadrivalent Influenza Vaccine .5 mL given intramuscularly
|
Fluzone HD
Fluzone HD 0.5 mL given IM X1
Fluzone HD: Fluzone HD Trivalent High Dose Influenza Vaccine .5 mL given intramuscularly
|
|---|---|---|---|---|
|
Mean Change of HAI Serum Antibody Titers to A/California/07/09 (H1N1)
|
1937 titer
Interval 636.0 to 3238.0
|
383 titer
Interval 176.0 to 590.0
|
607 titer
Interval 370.0 to 845.0
|
—
|
PRIMARY outcome
Timeframe: Day 0 to Day 28Mean Change of HAI Serum Antibody Titers to A/Michigan/45/2015 (H1N1) using serum hemagglutination-inhibition (HAI) assay.
Outcome measures
| Measure |
FluBlok
n=23 Participants
FluBlok 0.5 mL given IM X1
FluBlok: FluBlok trivalent Influenza Vaccine .5 mL given Intramuscularly
|
Fluzone
n=25 Participants
Fluzone 0.5 mL given IM X1
Fluzone: Fluzone Quadrivalent Influenza Vaccine .5 mL given intramuscularly
|
FluCelVax
n=30 Participants
FluCelVax 0.5 mL given IM X 1
FluCelVax: FluCelVax Quadrivalent Influenza Vaccine .5 mL given intramuscularly
|
Fluzone HD
n=22 Participants
Fluzone HD 0.5 mL given IM X1
Fluzone HD: Fluzone HD Trivalent High Dose Influenza Vaccine .5 mL given intramuscularly
|
|---|---|---|---|---|
|
Mean Change of HAI Serum Antibody Titers to A/Michigan/45/2015 (H1N1)
|
564 titer
Interval 68.0 to 1059.0
|
420 titer
Interval 137.0 to 703.0
|
354 titer
Interval 143.0 to 564.0
|
898 titer
Interval 238.0 to 1557.0
|
PRIMARY outcome
Timeframe: Day 0 to Day 28Population: HAI serum antibody titers to A/Switzerland/9715293/13 (H3N2) for Fluzone HD arm are unavailable. Fluzone HD group was only enrolled in flu seasons Fall 2017 - Fall 2019. HAI serum antibody titers to A/Switzerland/9715293/13 (H3N2) was only tested on subjects enrolled in Fall 2015 and Fall 2016.
Mean Change of HAI Serum Antibody Titers to A/Switzerland/9715293/13 (H3N2)
Outcome measures
| Measure |
FluBlok
n=32 Participants
FluBlok 0.5 mL given IM X1
FluBlok: FluBlok trivalent Influenza Vaccine .5 mL given Intramuscularly
|
Fluzone
n=31 Participants
Fluzone 0.5 mL given IM X1
Fluzone: Fluzone Quadrivalent Influenza Vaccine .5 mL given intramuscularly
|
FluCelVax
n=38 Participants
FluCelVax 0.5 mL given IM X 1
FluCelVax: FluCelVax Quadrivalent Influenza Vaccine .5 mL given intramuscularly
|
Fluzone HD
Fluzone HD 0.5 mL given IM X1
Fluzone HD: Fluzone HD Trivalent High Dose Influenza Vaccine .5 mL given intramuscularly
|
|---|---|---|---|---|
|
Mean Change of HAI Serum Antibody Titers to A/Switzerland/9715293/13 (H3N2)
|
1733 titer
Interval 655.0 to 2811.0
|
1711 titer
Interval 450.0 to 2971.0
|
799 titer
Interval 221.0 to 1377.0
|
—
|
PRIMARY outcome
Timeframe: Day 0 to Day 28Population: MN serum antibody titers to A/California/07/09 (H1N1) for Fluzone HD arm are unavailable. Fluzone HD group was only enrolled in flu seasons Fall 2017 - Fall 2019. MN serum antibody titers to A/California/07/09 (H1N1) was only tested on subjects enrolled in Fall 2015 and Fall 2016.
Mean Change of MN Serum Antibody Titers to A/California/07/09 (H1N1) using Microneutralization (MN) assay.
Outcome measures
| Measure |
FluBlok
n=32 Participants
FluBlok 0.5 mL given IM X1
FluBlok: FluBlok trivalent Influenza Vaccine .5 mL given Intramuscularly
|
Fluzone
n=31 Participants
Fluzone 0.5 mL given IM X1
Fluzone: Fluzone Quadrivalent Influenza Vaccine .5 mL given intramuscularly
|
FluCelVax
n=38 Participants
FluCelVax 0.5 mL given IM X 1
FluCelVax: FluCelVax Quadrivalent Influenza Vaccine .5 mL given intramuscularly
|
Fluzone HD
Fluzone HD 0.5 mL given IM X1
Fluzone HD: Fluzone HD Trivalent High Dose Influenza Vaccine .5 mL given intramuscularly
|
|---|---|---|---|---|
|
Mean Change of MN Serum Antibody Titers to A/California/07/09 (H1N1)
|
2786 titer
Interval 1390.0 to 4182.0
|
373 titer
Interval 131.0 to 615.0
|
881 titer
Interval 477.0 to 1286.0
|
—
|
PRIMARY outcome
Timeframe: Day 0 to Day 28Mean Change of MN Serum Antibody Titers to A/Michigan/45/2015 (H1N1) using Microneutralization (MN) assay.
Outcome measures
| Measure |
FluBlok
n=23 Participants
FluBlok 0.5 mL given IM X1
FluBlok: FluBlok trivalent Influenza Vaccine .5 mL given Intramuscularly
|
Fluzone
n=25 Participants
Fluzone 0.5 mL given IM X1
Fluzone: Fluzone Quadrivalent Influenza Vaccine .5 mL given intramuscularly
|
FluCelVax
n=30 Participants
FluCelVax 0.5 mL given IM X 1
FluCelVax: FluCelVax Quadrivalent Influenza Vaccine .5 mL given intramuscularly
|
Fluzone HD
n=22 Participants
Fluzone HD 0.5 mL given IM X1
Fluzone HD: Fluzone HD Trivalent High Dose Influenza Vaccine .5 mL given intramuscularly
|
|---|---|---|---|---|
|
Mean Change of MN Serum Antibody Titers to A/Michigan/45/2015 (H1N1)
|
1007 titer
Interval 246.0 to 1769.0
|
554 titer
Interval 104.0 to 1003.0
|
308 titer
Interval 94.0 to 710.0
|
1477 titer
Interval 660.0 to 2293.0
|
PRIMARY outcome
Timeframe: Day 0 to Day 14Mean change in CD4 T cells reactivity to pools of total pHA peptides derived from pH1N1 HA using cytokine Elispot
Outcome measures
| Measure |
FluBlok
n=50 Participants
FluBlok 0.5 mL given IM X1
FluBlok: FluBlok trivalent Influenza Vaccine .5 mL given Intramuscularly
|
Fluzone
n=49 Participants
Fluzone 0.5 mL given IM X1
Fluzone: Fluzone Quadrivalent Influenza Vaccine .5 mL given intramuscularly
|
FluCelVax
n=51 Participants
FluCelVax 0.5 mL given IM X 1
FluCelVax: FluCelVax Quadrivalent Influenza Vaccine .5 mL given intramuscularly
|
Fluzone HD
n=21 Participants
Fluzone HD 0.5 mL given IM X1
Fluzone HD: Fluzone HD Trivalent High Dose Influenza Vaccine .5 mL given intramuscularly
|
|---|---|---|---|---|
|
Mean Change in CD4 T Cells Reactivity to Pools of Total pHA Peptides Derived From pH1N1 HA
|
71.2 cells per million CD8- and CD56- PBMC
Standard Error 97.4
|
21.4 cells per million CD8- and CD56- PBMC
Standard Error 57.3
|
29.5 cells per million CD8- and CD56- PBMC
Standard Error 92.8
|
39.8 cells per million CD8- and CD56- PBMC
Standard Error 84.7
|
PRIMARY outcome
Timeframe: Day 0 to Day 14Mean change in CD4 T cells reactivity to pools of total pHA peptides derived from H3 HA using cytokine Elispot
Outcome measures
| Measure |
FluBlok
n=50 Participants
FluBlok 0.5 mL given IM X1
FluBlok: FluBlok trivalent Influenza Vaccine .5 mL given Intramuscularly
|
Fluzone
n=49 Participants
Fluzone 0.5 mL given IM X1
Fluzone: Fluzone Quadrivalent Influenza Vaccine .5 mL given intramuscularly
|
FluCelVax
n=51 Participants
FluCelVax 0.5 mL given IM X 1
FluCelVax: FluCelVax Quadrivalent Influenza Vaccine .5 mL given intramuscularly
|
Fluzone HD
n=21 Participants
Fluzone HD 0.5 mL given IM X1
Fluzone HD: Fluzone HD Trivalent High Dose Influenza Vaccine .5 mL given intramuscularly
|
|---|---|---|---|---|
|
Mean Change in CD4 T Cells Reactivity to Pools of Total pHA Peptides Derived From H3 HA
|
93.2 cells per million CD8- and CD56- PBMC
Standard Error 128.0
|
14.0 cells per million CD8- and CD56- PBMC
Standard Error 69.8
|
21.5 cells per million CD8- and CD56- PBMC
Standard Error 157.3
|
58.6 cells per million CD8- and CD56- PBMC
Standard Error 162.7
|
PRIMARY outcome
Timeframe: Day 0 to Day 14Mean change in CD4 T cells reactivity to pools of total pHA peptides derived from influenza B HA using cytokine Elispot.
Outcome measures
| Measure |
FluBlok
n=50 Participants
FluBlok 0.5 mL given IM X1
FluBlok: FluBlok trivalent Influenza Vaccine .5 mL given Intramuscularly
|
Fluzone
n=49 Participants
Fluzone 0.5 mL given IM X1
Fluzone: Fluzone Quadrivalent Influenza Vaccine .5 mL given intramuscularly
|
FluCelVax
n=51 Participants
FluCelVax 0.5 mL given IM X 1
FluCelVax: FluCelVax Quadrivalent Influenza Vaccine .5 mL given intramuscularly
|
Fluzone HD
n=21 Participants
Fluzone HD 0.5 mL given IM X1
Fluzone HD: Fluzone HD Trivalent High Dose Influenza Vaccine .5 mL given intramuscularly
|
|---|---|---|---|---|
|
Mean Change in CD4 T Cells Reactivity to Pools of Total pHA Peptides Derived From Influenza B HA
|
178.0 cells per million CD8- and CD56- PBMC
Standard Error 218.8
|
89.2 cells per million CD8- and CD56- PBMC
Standard Error 162.1
|
79.0 cells per million CD8- and CD56- PBMC
Standard Error 203.5
|
42.1 cells per million CD8- and CD56- PBMC
Standard Error 171.6
|
PRIMARY outcome
Timeframe: Day 0 to Day 14Mean change in CD4 T cells reactivity to pools of total pHA peptides derived from NP using cytokine Elispot.
Outcome measures
| Measure |
FluBlok
n=49 Participants
FluBlok 0.5 mL given IM X1
FluBlok: FluBlok trivalent Influenza Vaccine .5 mL given Intramuscularly
|
Fluzone
n=49 Participants
Fluzone 0.5 mL given IM X1
Fluzone: Fluzone Quadrivalent Influenza Vaccine .5 mL given intramuscularly
|
FluCelVax
n=51 Participants
FluCelVax 0.5 mL given IM X 1
FluCelVax: FluCelVax Quadrivalent Influenza Vaccine .5 mL given intramuscularly
|
Fluzone HD
n=20 Participants
Fluzone HD 0.5 mL given IM X1
Fluzone HD: Fluzone HD Trivalent High Dose Influenza Vaccine .5 mL given intramuscularly
|
|---|---|---|---|---|
|
Mean Change in CD4 T Cells Reactivity to Pools of Total pHA Peptides Derived From NP
|
-23.9 cells per million CD8- and CD56- PBMC
Standard Error 81.3
|
-9.7 cells per million CD8- and CD56- PBMC
Standard Error 95.5
|
-16.9 cells per million CD8- and CD56- PBMC
Standard Error 128.1
|
19.6 cells per million CD8- and CD56- PBMC
Standard Error 165.2
|
PRIMARY outcome
Timeframe: Day 0 to Day 14Mean change in CD4 T cells reactivity to pools of total pHA peptides derived from M1 using cytokine Elispot.
Outcome measures
| Measure |
FluBlok
n=50 Participants
FluBlok 0.5 mL given IM X1
FluBlok: FluBlok trivalent Influenza Vaccine .5 mL given Intramuscularly
|
Fluzone
n=49 Participants
Fluzone 0.5 mL given IM X1
Fluzone: Fluzone Quadrivalent Influenza Vaccine .5 mL given intramuscularly
|
FluCelVax
n=51 Participants
FluCelVax 0.5 mL given IM X 1
FluCelVax: FluCelVax Quadrivalent Influenza Vaccine .5 mL given intramuscularly
|
Fluzone HD
n=21 Participants
Fluzone HD 0.5 mL given IM X1
Fluzone HD: Fluzone HD Trivalent High Dose Influenza Vaccine .5 mL given intramuscularly
|
|---|---|---|---|---|
|
Mean Change in CD4 T Cells Reactivity to Pools of Total pHA Peptides Derived From M1
|
-18.9 cells per million CD8- and CD56- PBMC
Standard Error 99.7
|
-18.7 cells per million CD8- and CD56- PBMC
Standard Error 118.0
|
20.9 cells per million CD8- and CD56- PBMC
Standard Error 143.8
|
-36.3 cells per million CD8- and CD56- PBMC
Standard Error 212.3
|
Adverse Events
FluBlok
Serious events: 0 serious events
Other events: 36 other events
Deaths: 0 deaths
Fluzone
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
FluCelVax
Serious events: 0 serious events
Other events: 45 other events
Deaths: 0 deaths
Fluzone HD
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
FluBlok
n=113 participants at risk
FluBlok 0.5 mL given IM X1
FluBlok: FluBlok trivalent Influenza Vaccine .5 mL given Intramuscularly
|
Fluzone
n=102 participants at risk
Fluzone 0.5 mL given IM X1
Fluzone: Fluzone Quadrivalent Influenza Vaccine .5 mL given intramuscularly
|
FluCelVax
n=122 participants at risk
FluCelVax 0.5 mL given IM X 1
FluCelVax: FluCelVax Quadrivalent Influenza Vaccine .5 mL given intramuscularly
|
Fluzone HD
n=76 participants at risk
Fluzone HD 0.5 mL given IM X1
Fluzone HD: Fluzone HD Trivalent High Dose Influenza Vaccine .5 mL given intramuscularly
|
|---|---|---|---|---|
|
Gastrointestinal disorders
abdomina l pain
|
0.88%
1/113 • Number of events 1 • 6 months
|
0.00%
0/102 • 6 months
|
0.00%
0/122 • 6 months
|
1.3%
1/76 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
alopecia
|
0.00%
0/113 • 6 months
|
0.00%
0/102 • 6 months
|
0.82%
1/122 • Number of events 1 • 6 months
|
0.00%
0/76 • 6 months
|
|
Musculoskeletal and connective tissue disorders
back pain
|
1.8%
2/113 • Number of events 2 • 6 months
|
0.00%
0/102 • 6 months
|
0.00%
0/122 • 6 months
|
1.3%
1/76 • Number of events 1 • 6 months
|
|
Eye disorders
bilateral conjunctivities
|
0.00%
0/113 • 6 months
|
0.98%
1/102 • Number of events 1 • 6 months
|
0.00%
0/122 • 6 months
|
0.00%
0/76 • 6 months
|
|
Musculoskeletal and connective tissue disorders
body aches
|
0.88%
1/113 • Number of events 1 • 6 months
|
0.00%
0/102 • 6 months
|
0.00%
0/122 • 6 months
|
0.00%
0/76 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
bronchitis
|
0.88%
1/113 • Number of events 1 • 6 months
|
0.98%
1/102 • Number of events 1 • 6 months
|
0.82%
1/122 • Number of events 1 • 6 months
|
0.00%
0/76 • 6 months
|
|
Cardiac disorders
chest pain
|
0.00%
0/113 • 6 months
|
0.00%
0/102 • 6 months
|
0.82%
1/122 • Number of events 1 • 6 months
|
0.00%
0/76 • 6 months
|
|
General disorders
chills
|
0.88%
1/113 • Number of events 1 • 6 months
|
0.00%
0/102 • 6 months
|
0.00%
0/122 • 6 months
|
0.00%
0/76 • 6 months
|
|
General disorders
chipped tooth/dentral extraction
|
0.00%
0/113 • 6 months
|
0.00%
0/102 • 6 months
|
0.82%
1/122 • Number of events 1 • 6 months
|
0.00%
0/76 • 6 months
|
|
Nervous system disorders
concussion
|
0.00%
0/113 • 6 months
|
2.0%
2/102 • Number of events 2 • 6 months
|
0.00%
0/122 • 6 months
|
0.00%
0/76 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
congestion
|
2.7%
3/113 • Number of events 3 • 6 months
|
2.0%
2/102 • Number of events 2 • 6 months
|
3.3%
4/122 • Number of events 4 • 6 months
|
0.00%
0/76 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Uri
|
15.9%
18/113 • Number of events 21 • 6 months
|
20.6%
21/102 • Number of events 21 • 6 months
|
19.7%
24/122 • Number of events 26 • 6 months
|
18.4%
14/76 • Number of events 17 • 6 months
|
|
General disorders
sore throat
|
0.88%
1/113 • Number of events 1 • 6 months
|
2.9%
3/102 • Number of events 3 • 6 months
|
3.3%
4/122 • Number of events 4 • 6 months
|
3.9%
3/76 • Number of events 3 • 6 months
|
|
Infections and infestations
sinusitis
|
0.00%
0/113 • 6 months
|
0.98%
1/102 • Number of events 1 • 6 months
|
2.5%
3/122 • Number of events 3 • 6 months
|
1.3%
1/76 • Number of events 1 • 6 months
|
|
Infections and infestations
strep throat
|
0.00%
0/113 • 6 months
|
0.98%
1/102 • Number of events 3 • 6 months
|
0.00%
0/122 • 6 months
|
0.00%
0/76 • 6 months
|
|
Infections and infestations
urinary tract infection
|
1.8%
2/113 • Number of events 4 • 6 months
|
0.00%
0/102 • 6 months
|
0.00%
0/122 • 6 months
|
0.00%
0/76 • 6 months
|
|
Infections and infestations
yeast infection
|
0.88%
1/113 • Number of events 1 • 6 months
|
0.00%
0/102 • 6 months
|
0.00%
0/122 • 6 months
|
0.00%
0/76 • 6 months
|
|
Infections and infestations
tooth infection
|
0.88%
1/113 • Number of events 1 • 6 months
|
0.00%
0/102 • 6 months
|
0.82%
1/122 • Number of events 1 • 6 months
|
0.00%
0/76 • 6 months
|
|
General disorders
tooth ache
|
0.00%
0/113 • 6 months
|
0.98%
1/102 • Number of events 1 • 6 months
|
0.00%
0/122 • 6 months
|
0.00%
0/76 • 6 months
|
|
Infections and infestations
otitis media
|
0.88%
1/113 • Number of events 1 • 6 months
|
0.00%
0/102 • 6 months
|
0.82%
1/122 • Number of events 1 • 6 months
|
0.00%
0/76 • 6 months
|
|
Infections and infestations
serous otitis
|
0.00%
0/113 • 6 months
|
0.98%
1/102 • Number of events 1 • 6 months
|
0.00%
0/122 • 6 months
|
0.00%
0/76 • 6 months
|
|
Infections and infestations
influenza like illness
|
0.00%
0/113 • 6 months
|
2.0%
2/102 • Number of events 2 • 6 months
|
0.00%
0/122 • 6 months
|
1.3%
1/76 • Number of events 1 • 6 months
|
|
Infections and infestations
influenza
|
1.8%
2/113 • Number of events 2 • 6 months
|
0.00%
0/102 • 6 months
|
1.6%
2/122 • Number of events 2 • 6 months
|
0.00%
0/76 • 6 months
|
|
General disorders
feverish
|
1.8%
2/113 • Number of events 2 • 6 months
|
0.00%
0/102 • 6 months
|
0.82%
1/122 • Number of events 1 • 6 months
|
0.00%
0/76 • 6 months
|
|
General disorders
fatigue
|
0.00%
0/113 • 6 months
|
0.00%
0/102 • 6 months
|
0.00%
0/122 • 6 months
|
1.3%
1/76 • Number of events 1 • 6 months
|
|
General disorders
headache
|
0.88%
1/113 • Number of events 1 • 6 months
|
0.00%
0/102 • 6 months
|
0.00%
0/122 • 6 months
|
3.9%
3/76 • Number of events 3 • 6 months
|
|
General disorders
myalgia
|
0.88%
1/113 • Number of events 1 • 6 months
|
0.00%
0/102 • 6 months
|
0.82%
1/122 • Number of events 1 • 6 months
|
1.3%
1/76 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
injection site bruise
|
0.88%
1/113 • Number of events 1 • 6 months
|
0.00%
0/102 • 6 months
|
0.82%
1/122 • Number of events 1 • 6 months
|
0.00%
0/76 • 6 months
|
|
Skin and subcutaneous tissue disorders
injection site erythema
|
0.00%
0/113 • 6 months
|
0.98%
1/102 • Number of events 1 • 6 months
|
0.00%
0/122 • 6 months
|
0.00%
0/76 • 6 months
|
|
Skin and subcutaneous tissue disorders
injection site hematoma
|
0.00%
0/113 • 6 months
|
0.00%
0/102 • 6 months
|
0.82%
1/122 • Number of events 1 • 6 months
|
0.00%
0/76 • 6 months
|
|
Skin and subcutaneous tissue disorders
injection site pain
|
0.00%
0/113 • 6 months
|
0.98%
1/102 • Number of events 1 • 6 months
|
0.00%
0/122 • 6 months
|
1.3%
1/76 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
injection site swelling
|
0.00%
0/113 • 6 months
|
0.98%
1/102 • Number of events 1 • 6 months
|
0.00%
0/122 • 6 months
|
0.00%
0/76 • 6 months
|
|
Musculoskeletal and connective tissue disorders
foot pain due to bone chip
|
0.88%
1/113 • Number of events 1 • 6 months
|
0.00%
0/102 • 6 months
|
0.00%
0/122 • 6 months
|
0.00%
0/76 • 6 months
|
|
Musculoskeletal and connective tissue disorders
fractured right thumb
|
0.00%
0/113 • 6 months
|
0.98%
1/102 • Number of events 1 • 6 months
|
0.00%
0/122 • 6 months
|
0.00%
0/76 • 6 months
|
|
Musculoskeletal and connective tissue disorders
knee replacement surgery
|
0.88%
1/113 • Number of events 1 • 6 months
|
0.00%
0/102 • 6 months
|
0.00%
0/122 • 6 months
|
1.3%
1/76 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
left wrist pain secondary to electric shock
|
0.00%
0/113 • 6 months
|
0.00%
0/102 • 6 months
|
0.00%
0/122 • 6 months
|
1.3%
1/76 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
left arm pain
|
0.00%
0/113 • 6 months
|
0.00%
0/102 • 6 months
|
0.00%
0/122 • 6 months
|
1.3%
1/76 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
left arm laceration
|
0.00%
0/113 • 6 months
|
0.00%
0/102 • 6 months
|
0.82%
1/122 • Number of events 1 • 6 months
|
0.00%
0/76 • 6 months
|
|
Musculoskeletal and connective tissue disorders
right ankle sprain
|
0.00%
0/113 • 6 months
|
0.00%
0/102 • 6 months
|
0.82%
1/122 • Number of events 1 • 6 months
|
0.00%
0/76 • 6 months
|
|
Musculoskeletal and connective tissue disorders
right elbow pain
|
0.88%
1/113 • Number of events 1 • 6 months
|
0.00%
0/102 • 6 months
|
0.00%
0/122 • 6 months
|
0.00%
0/76 • 6 months
|
|
Musculoskeletal and connective tissue disorders
sensation of heaviness and heat of legs
|
0.00%
0/113 • 6 months
|
0.00%
0/102 • 6 months
|
0.82%
1/122 • Number of events 1 • 6 months
|
0.00%
0/76 • 6 months
|
|
Musculoskeletal and connective tissue disorders
tendon sheath inflammation
|
0.00%
0/113 • 6 months
|
0.00%
0/102 • 6 months
|
0.82%
1/122 • Number of events 1 • 6 months
|
0.00%
0/76 • 6 months
|
|
General disorders
dizziness
|
0.00%
0/113 • 6 months
|
0.00%
0/102 • 6 months
|
0.00%
0/122 • 6 months
|
1.3%
1/76 • Number of events 1 • 6 months
|
|
Nervous system disorders
trembling in hands
|
0.00%
0/113 • 6 months
|
0.00%
0/102 • 6 months
|
0.82%
1/122 • Number of events 1 • 6 months
|
0.00%
0/76 • 6 months
|
|
Nervous system disorders
migraine headache
|
0.00%
0/113 • 6 months
|
0.00%
0/102 • 6 months
|
0.82%
1/122 • Number of events 1 • 6 months
|
0.00%
0/76 • 6 months
|
|
Nervous system disorders
tingling in both hands
|
0.88%
1/113 • Number of events 1 • 6 months
|
0.00%
0/102 • 6 months
|
0.00%
0/122 • 6 months
|
0.00%
0/76 • 6 months
|
|
General disorders
lethargy
|
0.88%
1/113 • Number of events 1 • 6 months
|
0.00%
0/102 • 6 months
|
0.00%
0/122 • 6 months
|
0.00%
0/76 • 6 months
|
|
General disorders
lightheadedness
|
0.00%
0/113 • 6 months
|
0.00%
0/102 • 6 months
|
0.82%
1/122 • Number of events 1 • 6 months
|
0.00%
0/76 • 6 months
|
|
General disorders
malaise
|
0.88%
1/113 • Number of events 1 • 6 months
|
0.00%
0/102 • 6 months
|
0.00%
0/122 • 6 months
|
0.00%
0/76 • 6 months
|
|
General disorders
sneezing
|
0.00%
0/113 • 6 months
|
0.00%
0/102 • 6 months
|
0.82%
1/122 • Number of events 1 • 6 months
|
0.00%
0/76 • 6 months
|
|
General disorders
rhinitis
|
0.88%
1/113 • Number of events 1 • 6 months
|
0.00%
0/102 • 6 months
|
0.82%
1/122 • Number of events 1 • 6 months
|
0.00%
0/76 • 6 months
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/113 • 6 months
|
0.98%
1/102 • Number of events 1 • 6 months
|
0.00%
0/122 • 6 months
|
0.00%
0/76 • 6 months
|
|
Gastrointestinal disorders
gastrointestional illness
|
0.00%
0/113 • 6 months
|
0.00%
0/102 • 6 months
|
1.6%
2/122 • Number of events 2 • 6 months
|
0.00%
0/76 • 6 months
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/113 • 6 months
|
0.00%
0/102 • 6 months
|
0.00%
0/122 • 6 months
|
1.3%
1/76 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
nausea and vomiting
|
0.00%
0/113 • 6 months
|
0.00%
0/102 • 6 months
|
0.82%
1/122 • Number of events 1 • 6 months
|
0.00%
0/76 • 6 months
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/113 • 6 months
|
0.00%
0/102 • 6 months
|
0.00%
0/122 • 6 months
|
1.3%
1/76 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
stomach ache
|
0.88%
1/113 • Number of events 1 • 6 months
|
0.00%
0/102 • 6 months
|
0.00%
0/122 • 6 months
|
1.3%
1/76 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
rigth breast lump
|
0.00%
0/113 • 6 months
|
0.00%
0/102 • 6 months
|
0.82%
1/122 • Number of events 1 • 6 months
|
0.00%
0/76 • 6 months
|
|
Ear and labyrinth disorders
middle ear effusion
|
0.00%
0/113 • 6 months
|
0.00%
0/102 • 6 months
|
0.00%
0/122 • 6 months
|
1.3%
1/76 • Number of events 2 • 6 months
|
|
Ear and labyrinth disorders
right ear pain
|
0.00%
0/113 • 6 months
|
0.00%
0/102 • 6 months
|
0.82%
1/122 • Number of events 1 • 6 months
|
0.00%
0/76 • 6 months
|
|
Skin and subcutaneous tissue disorders
contact dermatitis
|
0.88%
1/113 • Number of events 1 • 6 months
|
0.00%
0/102 • 6 months
|
0.00%
0/122 • 6 months
|
0.00%
0/76 • 6 months
|
|
Eye disorders
dry eye
|
0.00%
0/113 • 6 months
|
0.98%
1/102 • Number of events 1 • 6 months
|
0.00%
0/122 • 6 months
|
0.00%
0/76 • 6 months
|
|
Eye disorders
eyelid swelling
|
0.00%
0/113 • 6 months
|
0.00%
0/102 • 6 months
|
0.82%
1/122 • Number of events 1 • 6 months
|
0.00%
0/76 • 6 months
|
|
Cardiac disorders
heart palpitations
|
0.88%
1/113 • Number of events 1 • 6 months
|
0.00%
0/102 • 6 months
|
0.00%
0/122 • 6 months
|
0.00%
0/76 • 6 months
|
|
Cardiac disorders
pericarditis
|
0.00%
0/113 • 6 months
|
0.00%
0/102 • 6 months
|
0.82%
1/122 • Number of events 1 • 6 months
|
0.00%
0/76 • 6 months
|
|
Skin and subcutaneous tissue disorders
psoriasis
|
0.88%
1/113 • Number of events 1 • 6 months
|
0.00%
0/102 • 6 months
|
0.00%
0/122 • 6 months
|
0.00%
0/76 • 6 months
|
|
Cardiac disorders
tachycardia
|
0.00%
0/113 • 6 months
|
0.00%
0/102 • 6 months
|
0.00%
0/122 • 6 months
|
1.3%
1/76 • Number of events 1 • 6 months
|
|
Endocrine disorders
thyroid nodules
|
0.00%
0/113 • 6 months
|
0.98%
1/102 • Number of events 1 • 6 months
|
0.00%
0/122 • 6 months
|
0.00%
0/76 • 6 months
|
|
General disorders
vaginal spotting
|
0.88%
1/113 • Number of events 1 • 6 months
|
0.00%
0/102 • 6 months
|
0.00%
0/122 • 6 months
|
0.00%
0/76 • 6 months
|
|
General disorders
right labral pain
|
0.00%
0/113 • 6 months
|
0.00%
0/102 • 6 months
|
0.82%
1/122 • Number of events 1 • 6 months
|
0.00%
0/76 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place