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Comparison of Three Licensed Influenza Vaccines

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ClinicalTrials.gov Identifier: NCT03068949
Recruitment Status : Completed
First Posted : March 3, 2017
Results First Posted : November 30, 2021
Last Update Posted : November 30, 2021
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Angela Branche, University of Rochester

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Basic Science
Condition Influenza
Interventions Biological: FluBlok
Biological: Fluzone
Biological: FluCelVax
Biological: Fluzone HD
Enrollment 413
Recruitment Details  
Pre-assignment Details  
Arm/Group Title FluBlok Fluzone FluCelVax Fluzone HD
Hide Arm/Group Description

FluBlok 0.5 mL given IM X1

FluBlok: FluBlok trivalent Influenza Vaccine .5 mL given Intramuscularly

Fluzone 0.5 mL given IM X1

Fluzone: Fluzone Quadrivalent Influenza Vaccine .5 mL given intramuscularly

FluCelVax 0.5 mL given IM X 1

FluCelVax: FluCelVax Quadrivalent Influenza Vaccine .5 mL given intramuscularly

Fluzone HD 0.5 mL given IM X1

Fluzone HD: Fluzone HD Trivalent High Dose Influenza Vaccine .5 mL given intramuscularly

Period Title: Overall Study
Started 113 102 122 76
Completed 105 90 113 63
Not Completed 8 12 9 13
Arm/Group Title FluBlok Fluzone FluCelVax Fluzone HD Total
Hide Arm/Group Description

FluBlok 0.5 mL given IM X1

FluBlok: FluBlok trivalent Influenza Vaccine .5 mL given Intramuscularly

Fluzone 0.5 mL given IM X1

Fluzone: Fluzone Quadrivalent Influenza Vaccine .5 mL given intramuscularly

FluCelVax 0.5 mL given IM X 1

FluCelVax: FluCelVax Quadrivalent Influenza Vaccine .5 mL given intramuscularly

Fluzone HD 0.5 mL given IM X1

Fluzone HD: Fluzone HD Trivalent High Dose Influenza Vaccine .5 mL given intramuscularly

Total of all reporting groups
Overall Number of Baseline Participants 113 102 122 76 413
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 113 participants 102 participants 122 participants 76 participants 413 participants
34.2  (16.7) 29.0  (10.2) 33.4  (15.6) 35.9  (18.0) 33.0  (15.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 113 participants 102 participants 122 participants 76 participants 413 participants
Female
72
  63.7%
52
  51.0%
67
  54.9%
39
  51.3%
230
  55.7%
Male
41
  36.3%
50
  49.0%
55
  45.1%
37
  48.7%
183
  44.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 113 participants 102 participants 122 participants 76 participants 413 participants
Hispanic or Latino
1
   0.9%
5
   4.9%
11
   9.0%
5
   6.6%
22
   5.3%
Not Hispanic or Latino
112
  99.1%
97
  95.1%
111
  91.0%
71
  93.4%
391
  94.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Mean Change of HAI Serum Antibody Titers to A/California/07/09 (H1N1)
Hide Description Mean change of HAI serum antibody titers to A/California/07/09 (H1N1) using serum hemagglutination-inhibition (HAI) assay.
Time Frame Day 0 to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title FluBlok Fluzone FluCelVax
Hide Arm/Group Description:

FluBlok 0.5 mL given IM X1

FluBlok: FluBlok trivalent Influenza Vaccine .5 mL given Intramuscularly

Fluzone 0.5 mL given IM X1

Fluzone: Fluzone Quadrivalent Influenza Vaccine .5 mL given intramuscularly

FluCelVax 0.5 mL given IM X 1

FluCelVax: FluCelVax Quadrivalent Influenza Vaccine .5 mL given intramuscularly

Overall Number of Participants Analyzed 32 31 38
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
1937
(636 to 3238)
383
(176 to 590)
607
(370 to 845)
2.Primary Outcome
Title Mean Change of HAI Serum Antibody Titers to A/Michigan/45/2015 (H1N1)
Hide Description Mean Change of HAI Serum Antibody Titers to A/Michigan/45/2015 (H1N1) using serum hemagglutination-inhibition (HAI) assay.
Time Frame Day 0 to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FluBlok Fluzone FluCelVax Fluzone HD
Hide Arm/Group Description:

FluBlok 0.5 mL given IM X1

FluBlok: FluBlok trivalent Influenza Vaccine .5 mL given Intramuscularly

Fluzone 0.5 mL given IM X1

Fluzone: Fluzone Quadrivalent Influenza Vaccine .5 mL given intramuscularly

FluCelVax 0.5 mL given IM X 1

FluCelVax: FluCelVax Quadrivalent Influenza Vaccine .5 mL given intramuscularly

Fluzone HD 0.5 mL given IM X1

Fluzone HD: Fluzone HD Trivalent High Dose Influenza Vaccine .5 mL given intramuscularly

Overall Number of Participants Analyzed 23 25 30 22
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
564
(68 to 1059)
420
(137 to 703)
354
(143 to 564)
898
(238 to 1557)
3.Primary Outcome
Title Mean Change of HAI Serum Antibody Titers to A/Switzerland/9715293/13 (H3N2)
Hide Description Mean Change of HAI Serum Antibody Titers to A/Switzerland/9715293/13 (H3N2)
Time Frame Day 0 to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title FluBlok Fluzone FluCelVax
Hide Arm/Group Description:

FluBlok 0.5 mL given IM X1

FluBlok: FluBlok trivalent Influenza Vaccine .5 mL given Intramuscularly

Fluzone 0.5 mL given IM X1

Fluzone: Fluzone Quadrivalent Influenza Vaccine .5 mL given intramuscularly

FluCelVax 0.5 mL given IM X 1

FluCelVax: FluCelVax Quadrivalent Influenza Vaccine .5 mL given intramuscularly

Overall Number of Participants Analyzed 32 31 38
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
1733
(655 to 2811)
1711
(450 to 2971)
799
(221 to 1377)
4.Primary Outcome
Title Mean Change of MN Serum Antibody Titers to A/California/07/09 (H1N1)
Hide Description Mean Change of MN Serum Antibody Titers to A/California/07/09 (H1N1) using Microneutralization (MN) assay.
Time Frame Day 0 to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title FluBlok Fluzone FluCelVax
Hide Arm/Group Description:

FluBlok 0.5 mL given IM X1

FluBlok: FluBlok trivalent Influenza Vaccine .5 mL given Intramuscularly

Fluzone 0.5 mL given IM X1

Fluzone: Fluzone Quadrivalent Influenza Vaccine .5 mL given intramuscularly

FluCelVax 0.5 mL given IM X 1

FluCelVax: FluCelVax Quadrivalent Influenza Vaccine .5 mL given intramuscularly

Overall Number of Participants Analyzed 32 31 38
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
2786
(1390 to 4182)
373
(131 to 615)
881
(477 to 1286)
5.Primary Outcome
Title Mean Change of MN Serum Antibody Titers to A/Michigan/45/2015 (H1N1)
Hide Description Mean Change of MN Serum Antibody Titers to A/Michigan/45/2015 (H1N1) using Microneutralization (MN) assay.
Time Frame Day 0 to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FluBlok Fluzone FluCelVax Fluzone HD
Hide Arm/Group Description:

FluBlok 0.5 mL given IM X1

FluBlok: FluBlok trivalent Influenza Vaccine .5 mL given Intramuscularly

Fluzone 0.5 mL given IM X1

Fluzone: Fluzone Quadrivalent Influenza Vaccine .5 mL given intramuscularly

FluCelVax 0.5 mL given IM X 1

FluCelVax: FluCelVax Quadrivalent Influenza Vaccine .5 mL given intramuscularly

Fluzone HD 0.5 mL given IM X1

Fluzone HD: Fluzone HD Trivalent High Dose Influenza Vaccine .5 mL given intramuscularly

Overall Number of Participants Analyzed 23 25 30 22
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
1007
(246 to 1769)
554
(104 to 1003)
308
(94 to 710)
1477
(660 to 2293)
6.Primary Outcome
Title Mean Change in CD4 T Cells Reactivity to Pools of Total pHA Peptides Derived From pH1N1 HA
Hide Description Mean change in CD4 T cells reactivity to pools of total pHA peptides derived from pH1N1 HA using cytokine Elispot
Time Frame Day 0 to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FluBlok Fluzone FluCelVax Fluzone HD
Hide Arm/Group Description:

FluBlok 0.5 mL given IM X1

FluBlok: FluBlok trivalent Influenza Vaccine .5 mL given Intramuscularly

Fluzone 0.5 mL given IM X1

Fluzone: Fluzone Quadrivalent Influenza Vaccine .5 mL given intramuscularly

FluCelVax 0.5 mL given IM X 1

FluCelVax: FluCelVax Quadrivalent Influenza Vaccine .5 mL given intramuscularly

Fluzone HD 0.5 mL given IM X1

Fluzone HD: Fluzone HD Trivalent High Dose Influenza Vaccine .5 mL given intramuscularly

Overall Number of Participants Analyzed 50 49 51 21
Mean (Standard Error)
Unit of Measure: cells per million CD8- and CD56- PBMC
71.2  (97.4) 21.4  (57.3) 29.5  (92.8) 39.8  (84.7)
7.Primary Outcome
Title Mean Change in CD4 T Cells Reactivity to Pools of Total pHA Peptides Derived From H3 HA
Hide Description Mean change in CD4 T cells reactivity to pools of total pHA peptides derived from H3 HA using cytokine Elispot
Time Frame Day 0 to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FluBlok Fluzone FluCelVax Fluzone HD
Hide Arm/Group Description:

FluBlok 0.5 mL given IM X1

FluBlok: FluBlok trivalent Influenza Vaccine .5 mL given Intramuscularly

Fluzone 0.5 mL given IM X1

Fluzone: Fluzone Quadrivalent Influenza Vaccine .5 mL given intramuscularly

FluCelVax 0.5 mL given IM X 1

FluCelVax: FluCelVax Quadrivalent Influenza Vaccine .5 mL given intramuscularly

Fluzone HD 0.5 mL given IM X1

Fluzone HD: Fluzone HD Trivalent High Dose Influenza Vaccine .5 mL given intramuscularly

Overall Number of Participants Analyzed 50 49 51 21
Mean (Standard Error)
Unit of Measure: cells per million CD8- and CD56- PBMC
93.2  (128.0) 14.0  (69.8) 21.5  (157.3) 58.6  (162.7)
8.Primary Outcome
Title Mean Change in CD4 T Cells Reactivity to Pools of Total pHA Peptides Derived From Influenza B HA
Hide Description Mean change in CD4 T cells reactivity to pools of total pHA peptides derived from influenza B HA using cytokine Elispot.
Time Frame Day 0 to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FluBlok Fluzone FluCelVax Fluzone HD
Hide Arm/Group Description:

FluBlok 0.5 mL given IM X1

FluBlok: FluBlok trivalent Influenza Vaccine .5 mL given Intramuscularly

Fluzone 0.5 mL given IM X1

Fluzone: Fluzone Quadrivalent Influenza Vaccine .5 mL given intramuscularly

FluCelVax 0.5 mL given IM X 1

FluCelVax: FluCelVax Quadrivalent Influenza Vaccine .5 mL given intramuscularly

Fluzone HD 0.5 mL given IM X1

Fluzone HD: Fluzone HD Trivalent High Dose Influenza Vaccine .5 mL given intramuscularly

Overall Number of Participants Analyzed 50 49 51 21
Mean (Standard Error)
Unit of Measure: cells per million CD8- and CD56- PBMC
178.0  (218.8) 89.2  (162.1) 79.0  (203.5) 42.1  (171.6)
9.Primary Outcome
Title Mean Change in CD4 T Cells Reactivity to Pools of Total pHA Peptides Derived From NP
Hide Description Mean change in CD4 T cells reactivity to pools of total pHA peptides derived from NP using cytokine Elispot.
Time Frame Day 0 to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FluBlok Fluzone FluCelVax Fluzone HD
Hide Arm/Group Description:

FluBlok 0.5 mL given IM X1

FluBlok: FluBlok trivalent Influenza Vaccine .5 mL given Intramuscularly

Fluzone 0.5 mL given IM X1

Fluzone: Fluzone Quadrivalent Influenza Vaccine .5 mL given intramuscularly

FluCelVax 0.5 mL given IM X 1

FluCelVax: FluCelVax Quadrivalent Influenza Vaccine .5 mL given intramuscularly

Fluzone HD 0.5 mL given IM X1

Fluzone HD: Fluzone HD Trivalent High Dose Influenza Vaccine .5 mL given intramuscularly

Overall Number of Participants Analyzed 49 49 51 20
Mean (Standard Error)
Unit of Measure: cells per million CD8- and CD56- PBMC
-23.9  (81.3) -9.7  (95.5) -16.9  (128.1) 19.6  (165.2)
10.Primary Outcome
Title Mean Change in CD4 T Cells Reactivity to Pools of Total pHA Peptides Derived From M1
Hide Description Mean change in CD4 T cells reactivity to pools of total pHA peptides derived from M1 using cytokine Elispot.
Time Frame Day 0 to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FluBlok Fluzone FluCelVax Fluzone HD
Hide Arm/Group Description:

FluBlok 0.5 mL given IM X1

FluBlok: FluBlok trivalent Influenza Vaccine .5 mL given Intramuscularly

Fluzone 0.5 mL given IM X1

Fluzone: Fluzone Quadrivalent Influenza Vaccine .5 mL given intramuscularly

FluCelVax 0.5 mL given IM X 1

FluCelVax: FluCelVax Quadrivalent Influenza Vaccine .5 mL given intramuscularly

Fluzone HD 0.5 mL given IM X1

Fluzone HD: Fluzone HD Trivalent High Dose Influenza Vaccine .5 mL given intramuscularly

Overall Number of Participants Analyzed 50 49 51 21
Mean (Standard Error)
Unit of Measure: cells per million CD8- and CD56- PBMC
-18.9  (99.7) -18.7  (118.0) 20.9  (143.8) -36.3  (212.3)
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title FluBlok Fluzone FluCelVax Fluzone HD
Hide Arm/Group Description

FluBlok 0.5 mL given IM X1

FluBlok: FluBlok trivalent Influenza Vaccine .5 mL given Intramuscularly

Fluzone 0.5 mL given IM X1

Fluzone: Fluzone Quadrivalent Influenza Vaccine .5 mL given intramuscularly

FluCelVax 0.5 mL given IM X 1

FluCelVax: FluCelVax Quadrivalent Influenza Vaccine .5 mL given intramuscularly

Fluzone HD 0.5 mL given IM X1

Fluzone HD: Fluzone HD Trivalent High Dose Influenza Vaccine .5 mL given intramuscularly

All-Cause Mortality
FluBlok Fluzone FluCelVax Fluzone HD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/113 (0.00%)      0/102 (0.00%)      0/122 (0.00%)      0/76 (0.00%)    
Hide Serious Adverse Events
FluBlok Fluzone FluCelVax Fluzone HD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/113 (0.00%)      0/102 (0.00%)      0/122 (0.00%)      0/76 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
FluBlok Fluzone FluCelVax Fluzone HD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   36/113 (31.86%)      30/102 (29.41%)      45/122 (36.89%)      28/76 (36.84%)    
Cardiac disorders         
chest pain *  0/113 (0.00%)  0 0/102 (0.00%)  0 1/122 (0.82%)  1 0/76 (0.00%)  0
heart palpitations *  1/113 (0.88%)  1 0/102 (0.00%)  0 0/122 (0.00%)  0 0/76 (0.00%)  0
pericarditis *  0/113 (0.00%)  0 0/102 (0.00%)  0 1/122 (0.82%)  1 0/76 (0.00%)  0
tachycardia *  0/113 (0.00%)  0 0/102 (0.00%)  0 0/122 (0.00%)  0 1/76 (1.32%)  1
Ear and labyrinth disorders         
middle ear effusion *  0/113 (0.00%)  0 0/102 (0.00%)  0 0/122 (0.00%)  0 1/76 (1.32%)  2
right ear pain *  0/113 (0.00%)  0 0/102 (0.00%)  0 1/122 (0.82%)  1 0/76 (0.00%)  0
Endocrine disorders         
thyroid nodules *  0/113 (0.00%)  0 1/102 (0.98%)  1 0/122 (0.00%)  0 0/76 (0.00%)  0
Eye disorders         
bilateral conjunctivities *  0/113 (0.00%)  0 1/102 (0.98%)  1 0/122 (0.00%)  0 0/76 (0.00%)  0
dry eye *  0/113 (0.00%)  0 1/102 (0.98%)  1 0/122 (0.00%)  0 0/76 (0.00%)  0
eyelid swelling *  0/113 (0.00%)  0 0/102 (0.00%)  0 1/122 (0.82%)  1 0/76 (0.00%)  0
Gastrointestinal disorders         
abdomina l pain *  1/113 (0.88%)  1 0/102 (0.00%)  0 0/122 (0.00%)  0 1/76 (1.32%)  1
diarrhea *  0/113 (0.00%)  0 1/102 (0.98%)  1 0/122 (0.00%)  0 0/76 (0.00%)  0
gastrointestional illness *  0/113 (0.00%)  0 0/102 (0.00%)  0 2/122 (1.64%)  2 0/76 (0.00%)  0
nausea *  0/113 (0.00%)  0 0/102 (0.00%)  0 0/122 (0.00%)  0 1/76 (1.32%)  1
nausea and vomiting *  0/113 (0.00%)  0 0/102 (0.00%)  0 1/122 (0.82%)  1 0/76 (0.00%)  0
vomiting *  0/113 (0.00%)  0 0/102 (0.00%)  0 0/122 (0.00%)  0 1/76 (1.32%)  1
stomach ache *  1/113 (0.88%)  1 0/102 (0.00%)  0 0/122 (0.00%)  0 1/76 (1.32%)  1
General disorders         
chills *  1/113 (0.88%)  1 0/102 (0.00%)  0 0/122 (0.00%)  0 0/76 (0.00%)  0
chipped tooth/dentral extraction *  0/113 (0.00%)  0 0/102 (0.00%)  0 1/122 (0.82%)  1 0/76 (0.00%)  0
sore throat *  1/113 (0.88%)  1 3/102 (2.94%)  3 4/122 (3.28%)  4 3/76 (3.95%)  3
tooth ache *  0/113 (0.00%)  0 1/102 (0.98%)  1 0/122 (0.00%)  0 0/76 (0.00%)  0
feverish *  2/113 (1.77%)  2 0/102 (0.00%)  0 1/122 (0.82%)  1 0/76 (0.00%)  0
fatigue *  0/113 (0.00%)  0 0/102 (0.00%)  0 0/122 (0.00%)  0 2/76 (2.63%)  2
headache *  1/113 (0.88%)  1 0/102 (0.00%)  0 0/122 (0.00%)  0 3/76 (3.95%)  3
myalgia *  1/113 (0.88%)  1 0/102 (0.00%)  0 1/122 (0.82%)  1 1/76 (1.32%)  1
dizziness *  0/113 (0.00%)  0 0/102 (0.00%)  0 0/122 (0.00%)  0 1/76 (1.32%)  1
fatigue *  0/113 (0.00%)  0 0/102 (0.00%)  0 0/122 (0.00%)  0 1/76 (1.32%)  1
lethargy *  1/113 (0.88%)  1 0/102 (0.00%)  0 0/122 (0.00%)  0 0/76 (0.00%)  0
lightheadedness *  0/113 (0.00%)  0 0/102 (0.00%)  0 1/122 (0.82%)  1 0/76 (0.00%)  0
malaise *  1/113 (0.88%)  1 0/102 (0.00%)  0 0/122 (0.00%)  0 0/76 (0.00%)  0
sneezing *  0/113 (0.00%)  0 0/102 (0.00%)  0 1/122 (0.82%)  1 0/76 (0.00%)  0
rhinitis *  1/113 (0.88%)  1 0/102 (0.00%)  0 1/122 (0.82%)  1 0/76 (0.00%)  0
vaginal spotting *  1/113 (0.88%)  1 0/102 (0.00%)  0 0/122 (0.00%)  0 0/76 (0.00%)  0
right labral pain *  0/113 (0.00%)  0 0/102 (0.00%)  0 1/122 (0.82%)  1 0/76 (0.00%)  0
Infections and infestations         
sinusitis *  0/113 (0.00%)  0 1/102 (0.98%)  1 3/122 (2.46%)  3 1/76 (1.32%)  1
strep throat *  0/113 (0.00%)  0 1/102 (0.98%)  3 0/122 (0.00%)  0 0/76 (0.00%)  0
urinary tract infection *  2/113 (1.77%)  4 0/102 (0.00%)  0 0/122 (0.00%)  0 0/76 (0.00%)  0
yeast infection *  1/113 (0.88%)  1 0/102 (0.00%)  0 0/122 (0.00%)  0 0/76 (0.00%)  0
tooth infection *  1/113 (0.88%)  1 0/102 (0.00%)  0 1/122 (0.82%)  1 0/76 (0.00%)  0
otitis media *  1/113 (0.88%)  1 0/102 (0.00%)  0 1/122 (0.82%)  1 0/76 (0.00%)  0
serous otitis *  0/113 (0.00%)  0 1/102 (0.98%)  1 0/122 (0.00%)  0 0/76 (0.00%)  0
influenza like illness *  0/113 (0.00%)  0 2/102 (1.96%)  2 0/122 (0.00%)  0 1/76 (1.32%)  1
influenza *  2/113 (1.77%)  2 0/102 (0.00%)  0 2/122 (1.64%)  2 0/76 (0.00%)  0
Musculoskeletal and connective tissue disorders         
back pain *  2/113 (1.77%)  2 0/102 (0.00%)  0 0/122 (0.00%)  0 1/76 (1.32%)  1
body aches *  1/113 (0.88%)  1 0/102 (0.00%)  0 0/122 (0.00%)  0 0/76 (0.00%)  0
foot pain due to bone chip *  1/113 (0.88%)  1 0/102 (0.00%)  0 0/122 (0.00%)  0 0/76 (0.00%)  0
fractured right thumb *  0/113 (0.00%)  0 1/102 (0.98%)  1 0/122 (0.00%)  0 0/76 (0.00%)  0
knee replacement surgery *  1/113 (0.88%)  1 0/102 (0.00%)  0 0/122 (0.00%)  0 1/76 (1.32%)  1
left wrist pain secondary to electric shock *  0/113 (0.00%)  0 0/102 (0.00%)  0 0/122 (0.00%)  0 1/76 (1.32%)  1
left arm pain *  0/113 (0.00%)  0 0/102 (0.00%)  0 0/122 (0.00%)  0 1/76 (1.32%)  1
left arm laceration *  0/113 (0.00%)  0 0/102 (0.00%)  0 1/122 (0.82%)  1 0/76 (0.00%)  0
right ankle sprain *  0/113 (0.00%)  0 0/102 (0.00%)  0 1/122 (0.82%)  1 0/76 (0.00%)  0
right elbow pain *  1/113 (0.88%)  1 0/102 (0.00%)  0 0/122 (0.00%)  0 0/76 (0.00%)  0
sensation of heaviness and heat of legs *  0/113 (0.00%)  0 0/102 (0.00%)  0 1/122 (0.82%)  1 0/76 (0.00%)  0
tendon sheath inflammation *  0/113 (0.00%)  0 0/102 (0.00%)  0 1/122 (0.82%)  1 0/76 (0.00%)  0
rigth breast lump *  0/113 (0.00%)  0 0/102 (0.00%)  0 1/122 (0.82%)  1 0/76 (0.00%)  0
Nervous system disorders         
concussion *  0/113 (0.00%)  0 2/102 (1.96%)  2 0/122 (0.00%)  0 0/76 (0.00%)  0
trembling in hands *  0/113 (0.00%)  0 0/102 (0.00%)  0 1/122 (0.82%)  1 0/76 (0.00%)  0
migraine headache *  0/113 (0.00%)  0 0/102 (0.00%)  0 1/122 (0.82%)  1 0/76 (0.00%)  0
tingling in both hands *  1/113 (0.88%)  1 0/102 (0.00%)  0 0/122 (0.00%)  0 0/76 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
bronchitis *  1/113 (0.88%)  1 1/102 (0.98%)  1 1/122 (0.82%)  1 0/76 (0.00%)  0
congestion *  3/113 (2.65%)  3 2/102 (1.96%)  2 4/122 (3.28%)  4 0/76 (0.00%)  0
Uri *  18/113 (15.93%)  21 21/102 (20.59%)  21 24/122 (19.67%)  26 14/76 (18.42%)  17
Skin and subcutaneous tissue disorders         
alopecia *  0/113 (0.00%)  0 0/102 (0.00%)  0 1/122 (0.82%)  1 0/76 (0.00%)  0
injection site bruise *  1/113 (0.88%)  1 0/102 (0.00%)  0 1/122 (0.82%)  1 0/76 (0.00%)  0
injection site erythema *  0/113 (0.00%)  0 1/102 (0.98%)  1 0/122 (0.00%)  0 0/76 (0.00%)  0
injection site hematoma *  0/113 (0.00%)  0 0/102 (0.00%)  0 1/122 (0.82%)  1 0/76 (0.00%)  0
injection site pain *  0/113 (0.00%)  0 1/102 (0.98%)  1 0/122 (0.00%)  0 1/76 (1.32%)  1
injection site swelling *  0/113 (0.00%)  0 1/102 (0.98%)  1 0/122 (0.00%)  0 0/76 (0.00%)  0
contact dermatitis *  1/113 (0.88%)  1 0/102 (0.00%)  0 0/122 (0.00%)  0 0/76 (0.00%)  0
psoriasis *  1/113 (0.88%)  1 0/102 (0.00%)  0 0/122 (0.00%)  0 0/76 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Angela Branche
Organization: University of Rochester
Phone: 5852750526
EMail: angela_branche@urmc.rochester.edu
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Responsible Party: Angela Branche, University of Rochester
ClinicalTrials.gov Identifier: NCT03068949    
Other Study ID Numbers: 59331
272201400005C-P00019-9999-4 ( U.S. NIH Grant/Contract )
First Submitted: February 23, 2017
First Posted: March 3, 2017
Results First Submitted: June 29, 2021
Results First Posted: November 30, 2021
Last Update Posted: November 30, 2021