Trial Outcomes & Findings for Entolimod on Immunosenescence in Healthy Geriatric Subjects Receiving Influenza Vaccination (NCT NCT04176133)
NCT ID: NCT04176133
Last Updated: 2023-06-22
Results Overview
Change of the anti- A/H1N1 influenza virus strains serum circulating antibodies (as assessed using hemagglutination inhibition (HAI) assay) levels from baseline to 1 month.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
61 participants
Primary outcome timeframe
Baseline, 1 month
Results posted on
2023-06-22
Participant Flow
Participant milestones
| Measure |
Entolimod 1 mcg
Subjects received entolimod as a single dose administered intramuscularly (1mcg)
Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
Entolimod 3 mcg
Subjects received entolimod as a single dose administered intramuscularly (3mcg)
Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
Entolimod 10 mcg
Subjects received entolimod as a single dose administered intramuscularly (10mcg)
Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
Placebo
Subjects received a placebo as a single dose administered intramuscularly (no study drug); placebo that looks exactly like the study drug, but contains no active ingredient.
Placebo: Intramuscular (IM) single dose administration, no active ingredient. A matching placebo was provided as a sterile, clear, colorless to slightly yellow liquid for IM injection in prefilled vials that are identical in appearance to the vials containing active drug.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
19
|
6
|
16
|
|
Overall Study
COMPLETED
|
20
|
19
|
6
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Entolimod on Immunosenescence in Healthy Geriatric Subjects Receiving Influenza Vaccination
Baseline characteristics by cohort
| Measure |
Entolimod 1 mcg
n=20 Participants
Subjects received entolimod as a single dose administered intramuscularly (1mcg)
Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
Entolimod 3 mcg
n=19 Participants
Subjects received entolimod as a single dose administered intramuscularly (3mcg)
Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
Entolimod 10 mcg
n=6 Participants
Subjects received entolimod as a single dose administered intramuscularly (10mcg)
Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
Placebo
n=16 Participants
Subjects received a placebo as a single dose administered intramuscularly (no study drug); placebo that looks exactly like the study drug, but contains no active ingredient.
Placebo: Intramuscular (IM) single dose administration, no active ingredient. A matching placebo was provided as a sterile, clear, colorless to slightly yellow liquid for IM injection in prefilled vials that are identical in appearance to the vials containing active drug.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
73.0 years
STANDARD_DEVIATION 6.30 • n=5 Participants
|
70.7 years
STANDARD_DEVIATION 5.35 • n=7 Participants
|
76.0 years
STANDARD_DEVIATION 6.78 • n=5 Participants
|
73.1 years
STANDARD_DEVIATION 5.89 • n=4 Participants
|
72.6 years
STANDARD_DEVIATION 6.01 • n=21 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
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
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
61 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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
|
Race (NIH/OMB)
Asian
|
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
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
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
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
61 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
19 participants
n=7 Participants
|
6 participants
n=5 Participants
|
16 participants
n=4 Participants
|
61 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1 monthChange of the anti- A/H1N1 influenza virus strains serum circulating antibodies (as assessed using hemagglutination inhibition (HAI) assay) levels from baseline to 1 month.
Outcome measures
| Measure |
Entolimod 1 mcg
n=20 Participants
Subjects received entolimod as a single dose administered intramuscularly (1mcg)
Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
Entolimod 3 mcg
n=19 Participants
Subjects received entolimod as a single dose administered intramuscularly (3mcg)
Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
Entolimod 10 mcg
n=6 Participants
Subjects received entolimod as a single dose administered intramuscularly (10mcg)
Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
Placebo
n=16 Participants
Subjects received a placebo as a single dose administered intramuscularly (no study drug); placebo that looks exactly like the study drug, but contains no active ingredient.
Placebo: Intramuscular (IM) single dose administration, no active ingredient. A matching placebo was provided as a sterile, clear, colorless to slightly yellow liquid for IM injection in prefilled vials that are identical in appearance to the vials containing active drug.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
|---|---|---|---|---|
|
Change in Anti- A/H1N1 Antibody Titer
|
65.0 titer
Standard Deviation 137.23
|
73.2 titer
Standard Deviation 111.43
|
88.4 titer
Standard Deviation 123.74
|
20.3 titer
Standard Deviation 48.56
|
PRIMARY outcome
Timeframe: Baseline, 1 monthChange of the anti-A/H3N2 influenza virus strains serum circulating antibodies (as assessed using hemagglutination inhibition (HAI) assay) levels from baseline to 1 month.
Outcome measures
| Measure |
Entolimod 1 mcg
n=20 Participants
Subjects received entolimod as a single dose administered intramuscularly (1mcg)
Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
Entolimod 3 mcg
n=19 Participants
Subjects received entolimod as a single dose administered intramuscularly (3mcg)
Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
Entolimod 10 mcg
n=6 Participants
Subjects received entolimod as a single dose administered intramuscularly (10mcg)
Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
Placebo
n=16 Participants
Subjects received a placebo as a single dose administered intramuscularly (no study drug); placebo that looks exactly like the study drug, but contains no active ingredient.
Placebo: Intramuscular (IM) single dose administration, no active ingredient. A matching placebo was provided as a sterile, clear, colorless to slightly yellow liquid for IM injection in prefilled vials that are identical in appearance to the vials containing active drug.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
|---|---|---|---|---|
|
Change in Anti-A/H3N2 Antibody Titer
|
58.4 titer
Standard Deviation 90.57
|
81.6 titer
Standard Deviation 138.59
|
28.0 titer
Standard Deviation 30.98
|
39.1 titer
Standard Deviation 79.84
|
PRIMARY outcome
Timeframe: Baseline, 1 monthChange of the anti-B influenza virus strains serum circulating antibodies (as assessed using hemagglutination inhibition (HAI) assay) levels from baseline to 1 month..
Outcome measures
| Measure |
Entolimod 1 mcg
n=20 Participants
Subjects received entolimod as a single dose administered intramuscularly (1mcg)
Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
Entolimod 3 mcg
n=19 Participants
Subjects received entolimod as a single dose administered intramuscularly (3mcg)
Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
Entolimod 10 mcg
n=6 Participants
Subjects received entolimod as a single dose administered intramuscularly (10mcg)
Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
Placebo
n=16 Participants
Subjects received a placebo as a single dose administered intramuscularly (no study drug); placebo that looks exactly like the study drug, but contains no active ingredient.
Placebo: Intramuscular (IM) single dose administration, no active ingredient. A matching placebo was provided as a sterile, clear, colorless to slightly yellow liquid for IM injection in prefilled vials that are identical in appearance to the vials containing active drug.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
|---|---|---|---|---|
|
Change in Anti-B Antibody Titer
|
11.6 titer
Standard Deviation 18.93
|
28.3 titer
Standard Deviation 67.06
|
45.0 titer
Standard Deviation 56.48
|
10.0 titer
Standard Deviation 18.26
|
PRIMARY outcome
Timeframe: 1 yearThe number of adverse events (AEs) related to dose limiting toxicities (DLTs); laboratory abnormalities; oxygen saturation and vital sign changes, and adverse electrocardiogram (ECG) findings for 1 year
Outcome measures
| Measure |
Entolimod 1 mcg
n=20 Participants
Subjects received entolimod as a single dose administered intramuscularly (1mcg)
Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
Entolimod 3 mcg
n=19 Participants
Subjects received entolimod as a single dose administered intramuscularly (3mcg)
Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
Entolimod 10 mcg
n=6 Participants
Subjects received entolimod as a single dose administered intramuscularly (10mcg)
Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
Placebo
n=16 Participants
Subjects received a placebo as a single dose administered intramuscularly (no study drug); placebo that looks exactly like the study drug, but contains no active ingredient.
Placebo: Intramuscular (IM) single dose administration, no active ingredient. A matching placebo was provided as a sterile, clear, colorless to slightly yellow liquid for IM injection in prefilled vials that are identical in appearance to the vials containing active drug.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
|---|---|---|---|---|
|
Adverse Events
|
39 adverse event
|
27 adverse event
|
23 adverse event
|
26 adverse event
|
SECONDARY outcome
Timeframe: 1 yearPopulation: The number of subjects to develop upper-respiratory infections were analyzed for each arm
Subject self-reporting of the number of days to develop an upper-respiratory infection
Outcome measures
| Measure |
Entolimod 1 mcg
n=10 Participants
Subjects received entolimod as a single dose administered intramuscularly (1mcg)
Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
Entolimod 3 mcg
n=9 Participants
Subjects received entolimod as a single dose administered intramuscularly (3mcg)
Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
Entolimod 10 mcg
n=2 Participants
Subjects received entolimod as a single dose administered intramuscularly (10mcg)
Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
Placebo
n=3 Participants
Subjects received a placebo as a single dose administered intramuscularly (no study drug); placebo that looks exactly like the study drug, but contains no active ingredient.
Placebo: Intramuscular (IM) single dose administration, no active ingredient. A matching placebo was provided as a sterile, clear, colorless to slightly yellow liquid for IM injection in prefilled vials that are identical in appearance to the vials containing active drug.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
|---|---|---|---|---|
|
Time of Onset for Upper-respiratory Infections
|
152.5 days
Standard Deviation 127.4
|
302.3 days
Standard Deviation 112.4
|
339.0 days
Standard Deviation 0
|
157.0 days
Standard Deviation 114.3
|
SECONDARY outcome
Timeframe: 1 yearThe total number of subjects to self-report an upper-respiratory infection
Outcome measures
| Measure |
Entolimod 1 mcg
n=20 Participants
Subjects received entolimod as a single dose administered intramuscularly (1mcg)
Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
Entolimod 3 mcg
n=19 Participants
Subjects received entolimod as a single dose administered intramuscularly (3mcg)
Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
Entolimod 10 mcg
n=6 Participants
Subjects received entolimod as a single dose administered intramuscularly (10mcg)
Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
Placebo
n=16 Participants
Subjects received a placebo as a single dose administered intramuscularly (no study drug); placebo that looks exactly like the study drug, but contains no active ingredient.
Placebo: Intramuscular (IM) single dose administration, no active ingredient. A matching placebo was provided as a sterile, clear, colorless to slightly yellow liquid for IM injection in prefilled vials that are identical in appearance to the vials containing active drug.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
|---|---|---|---|---|
|
Upper Respiratory Infections
|
10 Participants
|
9 Participants
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: baseline, 2 monthsChange in self-reported 5 items frail scale. Frail scale scores range from 0-5, 1 point for each component, 0 = best 5 = worst (robust=0 points; pre-frail=0-1 points; frail 3-5 points)
Outcome measures
| Measure |
Entolimod 1 mcg
n=20 Participants
Subjects received entolimod as a single dose administered intramuscularly (1mcg)
Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
Entolimod 3 mcg
n=19 Participants
Subjects received entolimod as a single dose administered intramuscularly (3mcg)
Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
Entolimod 10 mcg
n=6 Participants
Subjects received entolimod as a single dose administered intramuscularly (10mcg)
Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
Placebo
n=16 Participants
Subjects received a placebo as a single dose administered intramuscularly (no study drug); placebo that looks exactly like the study drug, but contains no active ingredient.
Placebo: Intramuscular (IM) single dose administration, no active ingredient. A matching placebo was provided as a sterile, clear, colorless to slightly yellow liquid for IM injection in prefilled vials that are identical in appearance to the vials containing active drug.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
|---|---|---|---|---|
|
Change in Frailty
|
-0.1 score on a scale
Standard Deviation 0.4
|
-0.2 score on a scale
Standard Deviation 0.6
|
-0.2 score on a scale
Standard Deviation 0.6
|
0.1 score on a scale
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: baseline, 2 monthsDistance a subject is able to walk over 6 minutes over a hard flat surface
Outcome measures
| Measure |
Entolimod 1 mcg
n=20 Participants
Subjects received entolimod as a single dose administered intramuscularly (1mcg)
Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
Entolimod 3 mcg
n=19 Participants
Subjects received entolimod as a single dose administered intramuscularly (3mcg)
Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
Entolimod 10 mcg
n=6 Participants
Subjects received entolimod as a single dose administered intramuscularly (10mcg)
Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
Placebo
n=16 Participants
Subjects received a placebo as a single dose administered intramuscularly (no study drug); placebo that looks exactly like the study drug, but contains no active ingredient.
Placebo: Intramuscular (IM) single dose administration, no active ingredient. A matching placebo was provided as a sterile, clear, colorless to slightly yellow liquid for IM injection in prefilled vials that are identical in appearance to the vials containing active drug.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
|---|---|---|---|---|
|
Change in 6-minute Walk Test
|
5.1 meters
Standard Deviation 25.64
|
11.0 meters
Standard Deviation 36.39
|
4.5 meters
Standard Deviation 9.83
|
-15.8 meters
Standard Deviation 66.73
|
SECONDARY outcome
Timeframe: baseline, 2 monthsMeasured by a grip dynamometer as reported in units of pounds.
Outcome measures
| Measure |
Entolimod 1 mcg
n=20 Participants
Subjects received entolimod as a single dose administered intramuscularly (1mcg)
Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
Entolimod 3 mcg
n=19 Participants
Subjects received entolimod as a single dose administered intramuscularly (3mcg)
Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
Entolimod 10 mcg
n=6 Participants
Subjects received entolimod as a single dose administered intramuscularly (10mcg)
Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
Placebo
n=16 Participants
Subjects received a placebo as a single dose administered intramuscularly (no study drug); placebo that looks exactly like the study drug, but contains no active ingredient.
Placebo: Intramuscular (IM) single dose administration, no active ingredient. A matching placebo was provided as a sterile, clear, colorless to slightly yellow liquid for IM injection in prefilled vials that are identical in appearance to the vials containing active drug.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
|---|---|---|---|---|
|
Change in Grip Strength
|
4.6 pounds
Standard Deviation 17.20
|
1.1 pounds
Standard Deviation 4.87
|
0.0 pounds
Standard Deviation 1.79
|
-0.7 pounds
Standard Deviation 2.68
|
SECONDARY outcome
Timeframe: baseline, 2 monthsSubject's BMI calculated as weight in kilograms divided by height in meters squared. Uses measurements of height and weight obtained during study (with appropriate metric conversions)
Outcome measures
| Measure |
Entolimod 1 mcg
n=20 Participants
Subjects received entolimod as a single dose administered intramuscularly (1mcg)
Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
Entolimod 3 mcg
n=19 Participants
Subjects received entolimod as a single dose administered intramuscularly (3mcg)
Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
Entolimod 10 mcg
n=6 Participants
Subjects received entolimod as a single dose administered intramuscularly (10mcg)
Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
Placebo
n=16 Participants
Subjects received a placebo as a single dose administered intramuscularly (no study drug); placebo that looks exactly like the study drug, but contains no active ingredient.
Placebo: Intramuscular (IM) single dose administration, no active ingredient. A matching placebo was provided as a sterile, clear, colorless to slightly yellow liquid for IM injection in prefilled vials that are identical in appearance to the vials containing active drug.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
|---|---|---|---|---|
|
Change in Body Mass Index (BMI)
|
0.3 kg/m^2
Standard Deviation 0.58
|
0.1 kg/m^2
Standard Deviation 0.67
|
-0.2 kg/m^2
Standard Deviation 0.97
|
0.1 kg/m^2
Standard Deviation 0.57
|
Adverse Events
Entolimod 1 mcg
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Entolimod 3 mcg
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Entolimod 10 mcg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Entolimod 1 mcg
n=20 participants at risk
Subjects received entolimod as a single dose administered intramuscularly (1mcg)
Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
Entolimod 3 mcg
n=19 participants at risk
Subjects received entolimod as a single dose administered intramuscularly (3mcg)
Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
Entolimod 10 mcg
n=6 participants at risk
Subjects received entolimod as a single dose administered intramuscularly (10mcg)
Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
Placebo
n=16 participants at risk
Subjects received a placebo as a single dose administered intramuscularly (no study drug); placebo that looks exactly like the study drug, but contains no active ingredient.
Placebo: Intramuscular (IM) single dose administration, no active ingredient. A matching placebo was provided as a sterile, clear, colorless to slightly yellow liquid for IM injection in prefilled vials that are identical in appearance to the vials containing active drug.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
6.2%
1/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
Other adverse events
| Measure |
Entolimod 1 mcg
n=20 participants at risk
Subjects received entolimod as a single dose administered intramuscularly (1mcg)
Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
Entolimod 3 mcg
n=19 participants at risk
Subjects received entolimod as a single dose administered intramuscularly (3mcg)
Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
Entolimod 10 mcg
n=6 participants at risk
Subjects received entolimod as a single dose administered intramuscularly (10mcg)
Entolimod: Intramuscular (IM) single dose administration. Entolimod was provided as a sterile, clear, colorless or slightly yellow liquid for IM injection.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
Placebo
n=16 participants at risk
Subjects received a placebo as a single dose administered intramuscularly (no study drug); placebo that looks exactly like the study drug, but contains no active ingredient.
Placebo: Intramuscular (IM) single dose administration, no active ingredient. A matching placebo was provided as a sterile, clear, colorless to slightly yellow liquid for IM injection in prefilled vials that are identical in appearance to the vials containing active drug.
Influenza vaccine: Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
6.2%
1/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
6.2%
1/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
6.2%
1/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Blood and lymphatic system disorders
Anemia
|
5.0%
1/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Musculoskeletal and connective tissue disorders
Ankle fracture
|
5.0%
1/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Nervous system disorders
Anosmia
|
5.0%
1/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
6.2%
1/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
6.2%
1/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
0.00%
0/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
50.0%
3/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
18.8%
3/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Injury, poisoning and procedural complications
Bruising
|
10.0%
2/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
21.1%
4/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
6.2%
1/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Cardiac disorders
Cardiac disorders
|
5.0%
1/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
General disorders
Chills
|
5.0%
1/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
10.5%
2/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
16.7%
1/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.0%
3/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
10.5%
2/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
6.2%
1/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
5.3%
1/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
16.7%
1/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
6.2%
1/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Gastrointestinal disorders
Dysgeusia
|
5.0%
1/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Reproductive system and breast disorders
Dyspareunia
|
5.0%
1/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
5.3%
1/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
General disorders
Edema limbs
|
0.00%
0/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
16.7%
1/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Eye disorders
Eye disorders
|
0.00%
0/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
10.5%
2/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
16.7%
1/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
5.3%
1/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
General disorders
Fatigue
|
25.0%
5/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
42.1%
8/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
33.3%
2/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
25.0%
4/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
General disorders
Fever
|
0.00%
0/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
16.7%
1/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Gastrointestinal disorders
Flatulence
|
5.0%
1/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
General disorders
Flu like symptoms
|
5.0%
1/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
5.3%
1/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
16.7%
1/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
6.2%
1/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
10.0%
2/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
5.3%
1/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
0.00%
0/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
5.3%
1/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Nervous system disorders
Headache
|
30.0%
6/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
31.6%
6/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
16.7%
1/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
31.2%
5/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Vascular disorders
Hematoma
|
10.0%
2/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
15.8%
3/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
16.7%
1/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Renal and urinary disorders
Hemoglobinuria
|
5.0%
1/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Vascular disorders
Hot flashes
|
0.00%
0/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
5.3%
1/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
6.2%
1/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
6.2%
1/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Cardiac disorders
Hypertension
|
30.0%
6/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
42.1%
8/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
16.7%
1/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
25.0%
4/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Cardiac disorders
Hypotension
|
5.0%
1/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
15.8%
3/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
50.0%
3/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
6.2%
1/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Infections and infestations
Infections and infestations
|
5.0%
1/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
General disorders
Injection site reaction
|
65.0%
13/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
47.4%
9/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
50.0%
3/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
31.2%
5/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Injury, poisoning and procedural complications
Injury and poisoning and procedural complications
|
0.00%
0/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
16.7%
1/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
5.3%
1/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
12.5%
2/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
50.0%
3/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
General disorders
Localized edema
|
0.00%
0/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
6.2%
1/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
0.00%
0/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
12.5%
2/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
General disorders
Malaise
|
5.0%
1/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
10.5%
2/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
12.5%
2/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
0.00%
0/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
6.2%
1/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder
|
0.00%
0/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
6.2%
1/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
2/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
21.1%
4/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
33.3%
2/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
18.8%
3/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.0%
2/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
10.5%
2/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
6.2%
1/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
General disorders
Nausea
|
5.0%
1/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
6.2%
1/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
General disorders
Non-cardiac chest pain
|
5.0%
1/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
General disorders
Pain
|
0.00%
0/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
5.3%
1/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
15.0%
3/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
5.3%
1/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
6.2%
1/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Nervous system disorders
Paresthesia
|
5.0%
1/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
6.2%
1/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
10.0%
2/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
10.5%
2/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
0.00%
0/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
6.2%
1/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Renal and urinary disorders
Proteinuria
|
5.0%
1/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
16.7%
1/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
6.2%
1/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders
|
5.0%
1/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory and thoracic and mediastinal disorders
|
0.00%
0/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
33.3%
2/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Eye disorders
Retinal tear
|
0.00%
0/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
6.2%
1/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
5.0%
1/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
6.2%
1/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
10.5%
2/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
16.7%
1/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
10.0%
2/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
6.2%
1/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Infections and infestations
Skin infection
|
5.0%
1/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
0.00%
0/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
6.2%
1/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
6.2%
1/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
5.0%
1/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
10.5%
2/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Nervous system disorders
Tremor
|
5.0%
1/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
0.00%
0/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
5.3%
1/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
5.3%
1/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Renal and urinary disorders
Urinary tract infection
|
5.0%
1/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
5.3%
1/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
6.2%
1/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
10.0%
2/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
21.1%
4/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
18.8%
3/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Ear and labyrinth disorders
Vertigo
|
5.0%
1/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
5.3%
1/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
10.5%
2/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Musculoskeletal and connective tissue disorders
Wrist fracture
|
0.00%
0/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
6.2%
1/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
|
Cardiac disorders
Electrocardiogram T wave abnormal
|
0.00%
0/20 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/19 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
0.00%
0/6 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
6.2%
1/16 • Adverse events were collected from baseline to end of study for approximately 1 year for all subjects.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place