Trial Outcomes & Findings for Effect of Adjuvant & Route of Administration on Safety & Immunogenicity of NDV-3 Vaccine (NCT NCT01447407)
NCT ID: NCT01447407
Last Updated: 2020-03-04
Results Overview
The primary objective of this study is to assess the safety of a single dose of NDV-3 vaccine, administered either IM with or without alum adjuvant at one dose level or ID at a lower dose level, compared to placebo. Clinical evaluations will be assessed on each subject at selected time points up to 90 days post-vaccination.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
164 participants
Primary outcome timeframe
Up to 90 days post-vaccination
Results posted on
2020-03-04
Participant Flow
Four subjects withdrew before completing Day 28 and were replaced. One subject withdrew before the last visit. While this subject is not considered to have completed the study, data from this subject are included in the immunogenicity and culture results.
Participant milestones
| Measure |
NDV-3 Vaccine With Alum
NDV-3 (300 ug Als3) vaccine with alum administered IM: One dose administered IM
|
NDV-3 Vaccine Without Alum
NDV-3 (300 ug Als3) vaccine without alum administered IM: One dose administered IM
|
Placebo
Placebo administered ID: One dose saline placebo administered ID
|
NDV-3 Vaccine ID
NDV-3 (30 ug Als3) vaccine without alum administered ID: One dose administered ID
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
41
|
40
|
41
|
42
|
|
Overall Study
COMPLETED
|
39
|
40
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
1
|
2
|
Reasons for withdrawal
| Measure |
NDV-3 Vaccine With Alum
NDV-3 (300 ug Als3) vaccine with alum administered IM: One dose administered IM
|
NDV-3 Vaccine Without Alum
NDV-3 (300 ug Als3) vaccine without alum administered IM: One dose administered IM
|
Placebo
Placebo administered ID: One dose saline placebo administered ID
|
NDV-3 Vaccine ID
NDV-3 (30 ug Als3) vaccine without alum administered ID: One dose administered ID
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Effect of Adjuvant & Route of Administration on Safety & Immunogenicity of NDV-3 Vaccine
Baseline characteristics by cohort
| Measure |
NDV-3 Vaccine With Alum
n=41 Participants
NDV-3 (300 ug Als3) vaccine with alum administered IM: One dose administered IM
|
NDV-3 Vaccine Without Alum
n=40 Participants
NDV-3 (300 ug Als3) vaccine without alum administered IM: One dose administered IM
|
Placebo
n=41 Participants
Placebo administered ID: One dose saline placebo administered ID
|
NDV-3 Vaccine ID
n=42 Participants
NDV-3 (30 ug Als3) vaccine without alum administered ID: One dose administered ID
|
Total
n=164 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
41 Participants
n=7 Participants
|
163 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Continuous
|
31.8 years
n=99 Participants
|
30.1 years
n=107 Participants
|
32.3 years
n=206 Participants
|
31.0 years
n=7 Participants
|
31.3 years
n=31 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
34 Participants
n=7 Participants
|
134 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
30 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
38 Participants
n=7 Participants
|
149 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Up to 90 days post-vaccinationPopulation: All subjects completing study. Additionally, a subject in Group 4 withdrew from the study before the very last visit, so while this subject is not considered to have completed the study, immunogenicity and culture data for this subject were included.
The primary objective of this study is to assess the safety of a single dose of NDV-3 vaccine, administered either IM with or without alum adjuvant at one dose level or ID at a lower dose level, compared to placebo. Clinical evaluations will be assessed on each subject at selected time points up to 90 days post-vaccination.
Outcome measures
| Measure |
NDV-3 Vaccine With Alum
n=39 Participants
NDV-3 (300 ug Als3) vaccine with alum administered IM: One dose administered IM
|
NDV-3 Vaccine Without Alum
n=40 Participants
NDV-3 (300 ug Als3) vaccine without alum administered IM: One dose administered IM
|
Placebo
n=40 Participants
Placebo administered ID: One dose saline placebo administered ID
|
NDV-3 Vaccine ID
n=40 Participants
NDV-3 (30 ug Als3) vaccine without alum administered ID: One dose administered ID
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events
>=1 TEAE
|
35 participants
|
33 participants
|
30 participants
|
36 participants
|
|
Number of Participants With Treatment Emergent Adverse Events
>=1 severe TEAE
|
2 participants
|
0 participants
|
4 participants
|
2 participants
|
|
Number of Participants With Treatment Emergent Adverse Events
>=1 severe drug-related TEAE
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment Emergent Adverse Events
DIscontinued for >=1 TEAE
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Day 14, Day 28, Day 90/ExitA secondary objective is to compare the serum IgG immune response between the 2 dose levels, routes of administration, and effects of alum adjuvant, at selected time points up to 90 days post-vaccination. Serum IgG will be evaluated by ELISA on serial-diluted samples, resulting in titer values of reciprocal dilution at which the ELISA readout is three times greater than the assay background value.
Outcome measures
| Measure |
NDV-3 Vaccine With Alum
n=39 Participants
NDV-3 (300 ug Als3) vaccine with alum administered IM: One dose administered IM
|
NDV-3 Vaccine Without Alum
n=40 Participants
NDV-3 (300 ug Als3) vaccine without alum administered IM: One dose administered IM
|
Placebo
n=40 Participants
Placebo administered ID: One dose saline placebo administered ID
|
NDV-3 Vaccine ID
n=40 Participants
NDV-3 (30 ug Als3) vaccine without alum administered ID: One dose administered ID
|
|---|---|---|---|---|
|
Immunogenicity - Serum Anti-Als3 IgG
Baseline
|
372 Titer
Standard Deviation 3.12
|
320 Titer
Standard Deviation 3.07
|
363 Titer
Standard Deviation 2.93
|
375 Titer
Standard Deviation 3.53
|
|
Immunogenicity - Serum Anti-Als3 IgG
Day 7
|
4447 Titer
Standard Deviation 6.31
|
3070 Titer
Standard Deviation 6.71
|
365 Titer
Standard Deviation 2.81
|
874 Titer
Standard Deviation 5.25
|
|
Immunogenicity - Serum Anti-Als3 IgG
Day 14
|
44675 Titer
Standard Deviation 3.04
|
22675 Titer
Standard Deviation 6.58
|
370 Titer
Standard Deviation 2.89
|
5153 Titer
Standard Deviation 6.97
|
|
Immunogenicity - Serum Anti-Als3 IgG
Day 28
|
38898 Titer
Standard Deviation 2.83
|
19220 Titer
Standard Deviation 6.00
|
377 Titer
Standard Deviation 2.93
|
4513 Titer
Standard Deviation 6.60
|
|
Immunogenicity - Serum Anti-Als3 IgG
Day 90/Exit
|
20853 Titer
Standard Deviation 3.24
|
11771 Titer
Standard Deviation 5.93
|
347 Titer
Standard Deviation 2.71
|
3282 Titer
Standard Deviation 5.55
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Day 14, Day 28, Day 90/ExitA secondary objective is to compare the serum IgA1 immune response between the 2 dose levels, routes of administration, and effects of alum adjuvant, at selected time points up to 90 days post-vaccination. Serum IgA1 will be evaluated by ELISA on serial-diluted samples, resulting in titer values of reciprocal dilution at which the ELISA readout is three times greater than the assay background value.
Outcome measures
| Measure |
NDV-3 Vaccine With Alum
n=39 Participants
NDV-3 (300 ug Als3) vaccine with alum administered IM: One dose administered IM
|
NDV-3 Vaccine Without Alum
n=40 Participants
NDV-3 (300 ug Als3) vaccine without alum administered IM: One dose administered IM
|
Placebo
n=40 Participants
Placebo administered ID: One dose saline placebo administered ID
|
NDV-3 Vaccine ID
n=40 Participants
NDV-3 (30 ug Als3) vaccine without alum administered ID: One dose administered ID
|
|---|---|---|---|---|
|
Immunogenicity - Serum Anti-Als3 IgA1
Baseline
|
573 Titer
Standard Deviation 4.07
|
480 Titer
Standard Deviation 3.44
|
418 Titer
Standard Deviation 3.72
|
550 Titer
Standard Deviation 4.93
|
|
Immunogenicity - Serum Anti-Als3 IgA1
Day 7
|
7643 Titer
Standard Deviation 6.61
|
5497 Titer
Standard Deviation 7.01
|
431 Titer
Standard Deviation 3.69
|
1640 Titer
Standard Deviation 6.56
|
|
Immunogenicity - Serum Anti-Als3 IgA1
Day 14
|
69616 Titer
Standard Deviation 3.1
|
34946 Titer
Standard Deviation 6.77
|
429 Titer
Standard Deviation 3.93
|
9356 Titer
Standard Deviation 6014
|
|
Immunogenicity - Serum Anti-Als3 IgA1
Day 28
|
43790 Titer
Standard Deviation 2.59
|
19999 Titer
Standard Deviation 5.36
|
412 Titer
Standard Deviation 3.86
|
7400 Titer
Standard Deviation 6.33
|
|
Immunogenicity - Serum Anti-Als3 IgA1
Day 90/Exit
|
20656 Titer
Standard Deviation 2.51
|
10698 Titer
Standard Deviation 4.61
|
404 Titer
Standard Deviation 3.78
|
3641 Titer
Standard Deviation 5.18
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Day 14, Day 28, Day 90/ExitA secondary objective is to compare the cervicovaginal wash IgG immune response between the 2 dose levels, routes of administration, and effects of alum adjuvant, at selected time points up to 90 days post-vaccination. Cervicovaginal wash IgG will be evaluated by ELISA on serial-diluted samples, resulting in titer values of reciprocal dilution at which the ELISA readout is three times greater than the assay background value.
Outcome measures
| Measure |
NDV-3 Vaccine With Alum
n=39 Participants
NDV-3 (300 ug Als3) vaccine with alum administered IM: One dose administered IM
|
NDV-3 Vaccine Without Alum
n=40 Participants
NDV-3 (300 ug Als3) vaccine without alum administered IM: One dose administered IM
|
Placebo
n=40 Participants
Placebo administered ID: One dose saline placebo administered ID
|
NDV-3 Vaccine ID
n=40 Participants
NDV-3 (30 ug Als3) vaccine without alum administered ID: One dose administered ID
|
|---|---|---|---|---|
|
Immunogenicity - Cervicovaginal Wash Anti-Als3 IgG
Baseline
|
2 Titer
Standard Deviation 1.5
|
2 Titer
Standard Deviation 1.55
|
3 Titer
Standard Deviation 2.12
|
3 Titer
Standard Deviation 1.98
|
|
Immunogenicity - Cervicovaginal Wash Anti-Als3 IgG
Day 7
|
4 Titer
Standard Deviation 3.98
|
6 Titer
Standard Deviation 5.84
|
2 Titer
Standard Deviation 1.61
|
3 Titer
Standard Deviation 2.45
|
|
Immunogenicity - Cervicovaginal Wash Anti-Als3 IgG
Day 14
|
78 Titer
Standard Deviation 7.12
|
26 Titer
Standard Deviation 7.50
|
3 Titer
Standard Deviation 1.99
|
8 Titer
Standard Deviation 4.27
|
|
Immunogenicity - Cervicovaginal Wash Anti-Als3 IgG
Day 28
|
44 Titer
Standard Deviation 5.85
|
26 Titer
Standard Deviation 7.09
|
3 Titer
Standard Deviation 2.20
|
8 Titer
Standard Deviation 4.63
|
|
Immunogenicity - Cervicovaginal Wash Anti-Als3 IgG
Day 90/Exit
|
20 Titer
Standard Deviation 4.93
|
13 Titer
Standard Deviation 4.65
|
3 Titer
Standard Deviation 2.11
|
6 Titer
Standard Deviation 4.35
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Day 14, Day 28, Day 90/ExitA secondary objective is to compare the cervicovaginal wash IgA1 immune response between the 2 dose levels, routes of administration, and effects of alum adjuvant, at selected time points up to 90 days post-vaccination. Cervicovaginal wash IgA1 will be evaluated by ELISA on serial-diluted samples, resulting in titer values of reciprocal dilution at which the ELISA readout is three times greater than the assay background value.
Outcome measures
| Measure |
NDV-3 Vaccine With Alum
n=39 Participants
NDV-3 (300 ug Als3) vaccine with alum administered IM: One dose administered IM
|
NDV-3 Vaccine Without Alum
n=40 Participants
NDV-3 (300 ug Als3) vaccine without alum administered IM: One dose administered IM
|
Placebo
n=40 Participants
Placebo administered ID: One dose saline placebo administered ID
|
NDV-3 Vaccine ID
n=40 Participants
NDV-3 (30 ug Als3) vaccine without alum administered ID: One dose administered ID
|
|---|---|---|---|---|
|
Immunogenicity - Cervicovaginal Wash Anti-Als3 IgA1
Day 90/Exit
|
15 Titer
Standard Deviation 3.18
|
8 Titer
Standard Deviation 3.27
|
3 Titer
Standard Deviation 1.98
|
5 Titer
Standard Deviation 3.40
|
|
Immunogenicity - Cervicovaginal Wash Anti-Als3 IgA1
Baseline
|
3 Titer
Standard Deviation 2.03
|
3 Titer
Standard Deviation 2.08
|
3 Titer
Standard Deviation 2.24
|
3 Titer
Standard Deviation 2.5
|
|
Immunogenicity - Cervicovaginal Wash Anti-Als3 IgA1
Day 7
|
5 Titer
Standard Deviation 2.87
|
7 Titer
Standard Deviation 6.64
|
3 Titer
Standard Deviation 1.45
|
4 Titer
Standard Deviation 2.71
|
|
Immunogenicity - Cervicovaginal Wash Anti-Als3 IgA1
Day 14
|
83 Titer
Standard Deviation 4.50
|
29 Titer
Standard Deviation 6.48
|
3 Titer
Standard Deviation 1.64
|
12 Titer
Standard Deviation 4.23
|
|
Immunogenicity - Cervicovaginal Wash Anti-Als3 IgA1
Day 28
|
36 Titer
Standard Deviation 3.82
|
25 Titer
Standard Deviation 6.72
|
3 Titer
Standard Deviation 2.40
|
8 Titer
Standard Deviation 4.56
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Day 14, Day 28, Day 90/ExitA secondary objective is to compare the cellular immune response for Als3-specific production of IFN-g from PBMCs between the 2 dose levels, routes of administration, and effects of alum adjuvant, at selected time points up to 90 days post-vaccination. The IFN-g cellular immune responses will be evaluated by ELISpot using approximately 200,000 PBMCs per well. A positive response was defined as a sample with greater than 20 spot forming units per 10\^6 PBMCs.
Outcome measures
| Measure |
NDV-3 Vaccine With Alum
n=39 Participants
NDV-3 (300 ug Als3) vaccine with alum administered IM: One dose administered IM
|
NDV-3 Vaccine Without Alum
n=40 Participants
NDV-3 (300 ug Als3) vaccine without alum administered IM: One dose administered IM
|
Placebo
n=40 Participants
Placebo administered ID: One dose saline placebo administered ID
|
NDV-3 Vaccine ID
n=40 Participants
NDV-3 (30 ug Als3) vaccine without alum administered ID: One dose administered ID
|
|---|---|---|---|---|
|
Immunogenicity - Number of Participants Positive for Peripheral Blood Mononuclear Cells (PBMCs) Producing Als3-specific Interferon-gamma (IFN-g)
Baseline
|
7 Participants
|
9 Participants
|
7 Participants
|
5 Participants
|
|
Immunogenicity - Number of Participants Positive for Peripheral Blood Mononuclear Cells (PBMCs) Producing Als3-specific Interferon-gamma (IFN-g)
Day 7
|
27 Participants
|
25 Participants
|
10 Participants
|
20 Participants
|
|
Immunogenicity - Number of Participants Positive for Peripheral Blood Mononuclear Cells (PBMCs) Producing Als3-specific Interferon-gamma (IFN-g)
Day 14
|
19 Participants
|
21 Participants
|
5 Participants
|
20 Participants
|
|
Immunogenicity - Number of Participants Positive for Peripheral Blood Mononuclear Cells (PBMCs) Producing Als3-specific Interferon-gamma (IFN-g)
Day 90/Exit
|
25 Participants
|
18 Participants
|
9 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Day 14, Day 28, Day 90/ExitA secondary objective is to compare the cellular immune response for Als3-specific production of IL-17A from PBMCs between the 2 dose levels, routes of administration, and effects of alum adjuvant, at selected time points up to 90 days post-vaccination. The IL-17A cellular immune responses will be evaluated by ELISpot using approximately 200,000 PBMCs per well. A positive response was defined as a sample with greater than 20 spot forming units per 10\^6 PBMCs.
Outcome measures
| Measure |
NDV-3 Vaccine With Alum
n=39 Participants
NDV-3 (300 ug Als3) vaccine with alum administered IM: One dose administered IM
|
NDV-3 Vaccine Without Alum
n=40 Participants
NDV-3 (300 ug Als3) vaccine without alum administered IM: One dose administered IM
|
Placebo
n=40 Participants
Placebo administered ID: One dose saline placebo administered ID
|
NDV-3 Vaccine ID
n=40 Participants
NDV-3 (30 ug Als3) vaccine without alum administered ID: One dose administered ID
|
|---|---|---|---|---|
|
Immunogenicity - Number of Participants Positive for Peripheral Blood Mononuclear Cells (PBMCs) Producing Als3-specific Interleukin-17A (IL-17A)
Baseline
|
6 Participants
|
10 Participants
|
12 Participants
|
9 Participants
|
|
Immunogenicity - Number of Participants Positive for Peripheral Blood Mononuclear Cells (PBMCs) Producing Als3-specific Interleukin-17A (IL-17A)
Day 7
|
22 Participants
|
19 Participants
|
8 Participants
|
13 Participants
|
|
Immunogenicity - Number of Participants Positive for Peripheral Blood Mononuclear Cells (PBMCs) Producing Als3-specific Interleukin-17A (IL-17A)
Day 14
|
15 Participants
|
17 Participants
|
7 Participants
|
16 Participants
|
|
Immunogenicity - Number of Participants Positive for Peripheral Blood Mononuclear Cells (PBMCs) Producing Als3-specific Interleukin-17A (IL-17A)
Day 90/Exit
|
17 Participants
|
15 Participants
|
18 Participants
|
23 Participants
|
Adverse Events
NDV-3 Vaccine With Alum
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
NDV-3 Vaccine Without Alum
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
NDV-3 Vaccine ID
Serious events: 0 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NDV-3 Vaccine With Alum
n=41 participants at risk
NDV-3 (300 ug Als3) vaccine with alum administered IM: One dose administered IM
|
NDV-3 Vaccine Without Alum
n=40 participants at risk
NDV-3 (300 ug Als3) vaccine without alum administered IM: One dose administered IM
|
Placebo
n=41 participants at risk
Placebo administered ID: One dose saline placebo administered ID
|
NDV-3 Vaccine ID
n=42 participants at risk
NDV-3 (30 ug Als3) vaccine without alum administered ID: One dose administered ID
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
4.9%
2/41 • Number of events 2 • 90 days
|
5.0%
2/40 • Number of events 2 • 90 days
|
7.3%
3/41 • Number of events 3 • 90 days
|
7.1%
3/42 • Number of events 3 • 90 days
|
|
Gastrointestinal disorders
Nausea
|
12.2%
5/41 • Number of events 5 • 90 days
|
5.0%
2/40 • Number of events 2 • 90 days
|
2.4%
1/41 • Number of events 1 • 90 days
|
16.7%
7/42 • Number of events 7 • 90 days
|
|
General disorders
Fatigue
|
9.8%
4/41 • Number of events 4 • 90 days
|
10.0%
4/40 • Number of events 4 • 90 days
|
9.8%
4/41 • Number of events 4 • 90 days
|
31.0%
13/42 • Number of events 13 • 90 days
|
|
General disorders
Injection site erythema
|
2.4%
1/41 • Number of events 1 • 90 days
|
2.5%
1/40 • Number of events 1 • 90 days
|
0.00%
0/41 • 90 days
|
19.0%
8/42 • Number of events 8 • 90 days
|
|
General disorders
Injection site pain
|
78.0%
32/41 • Number of events 32 • 90 days
|
45.0%
18/40 • Number of events 18 • 90 days
|
7.3%
3/41 • Number of events 3 • 90 days
|
35.7%
15/42 • Number of events 15 • 90 days
|
|
General disorders
Injection site pruritus
|
2.4%
1/41 • Number of events 1 • 90 days
|
2.5%
1/40 • Number of events 1 • 90 days
|
0.00%
0/41 • 90 days
|
19.0%
8/42 • Number of events 8 • 90 days
|
|
General disorders
Injection site swelling
|
2.4%
1/41 • Number of events 1 • 90 days
|
5.0%
2/40 • Number of events 2 • 90 days
|
0.00%
0/41 • 90 days
|
2.4%
1/42 • Number of events 1 • 90 days
|
|
Infections and infestations
Nasopharyngitis
|
7.3%
3/41 • Number of events 3 • 90 days
|
10.0%
4/40 • Number of events 4 • 90 days
|
2.4%
1/41 • Number of events 1 • 90 days
|
0.00%
0/42 • 90 days
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
0.00%
0/41 • 90 days
|
2.5%
1/40 • Number of events 1 • 90 days
|
2.4%
1/41 • Number of events 1 • 90 days
|
7.1%
3/42 • Number of events 3 • 90 days
|
|
Investigations
Alanine aminotransferase increased
|
2.4%
1/41 • Number of events 1 • 90 days
|
5.0%
2/40 • Number of events 2 • 90 days
|
7.3%
3/41 • Number of events 3 • 90 days
|
2.4%
1/42 • Number of events 1 • 90 days
|
|
Investigations
Blood albumin decreased
|
0.00%
0/41 • 90 days
|
5.0%
2/40 • Number of events 2 • 90 days
|
2.4%
1/41 • Number of events 1 • 90 days
|
0.00%
0/42 • 90 days
|
|
Investigations
Blood glucose increased
|
7.3%
3/41 • Number of events 3 • 90 days
|
2.5%
1/40 • Number of events 1 • 90 days
|
12.2%
5/41 • Number of events 5 • 90 days
|
14.3%
6/42 • Number of events 6 • 90 days
|
|
Investigations
Protein total decreased
|
4.9%
2/41 • Number of events 2 • 90 days
|
20.0%
8/40 • Number of events 8 • 90 days
|
7.3%
3/41 • Number of events 3 • 90 days
|
16.7%
7/42 • Number of events 7 • 90 days
|
|
Investigations
Protein urine present
|
9.8%
4/41 • Number of events 4 • 90 days
|
0.00%
0/40 • 90 days
|
9.8%
4/41 • Number of events 4 • 90 days
|
9.5%
4/42 • Number of events 4 • 90 days
|
|
Investigations
Red blood cells urine positive
|
12.2%
5/41 • Number of events 5 • 90 days
|
17.5%
7/40 • Number of events 7 • 90 days
|
22.0%
9/41 • Number of events 9 • 90 days
|
16.7%
7/42 • Number of events 7 • 90 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.4%
1/41 • Number of events 1 • 90 days
|
2.5%
1/40 • Number of events 1 • 90 days
|
2.4%
1/41 • Number of events 1 • 90 days
|
19.0%
8/42 • Number of events 8 • 90 days
|
|
Nervous system disorders
Headache
|
24.4%
10/41 • Number of events 10 • 90 days
|
17.5%
7/40 • Number of events 7 • 90 days
|
22.0%
9/41 • Number of events 9 • 90 days
|
45.2%
19/42 • Number of events 19 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.4%
1/41 • Number of events 1 • 90 days
|
2.5%
1/40 • Number of events 1 • 90 days
|
7.3%
3/41 • Number of events 3 • 90 days
|
7.1%
3/42 • Number of events 3 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.9%
2/41 • Number of events 2 • 90 days
|
10.0%
4/40 • Number of events 4 • 90 days
|
4.9%
2/41 • Number of events 2 • 90 days
|
4.8%
2/42 • Number of events 2 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.9%
2/41 • Number of events 2 • 90 days
|
5.0%
2/40 • Number of events 2 • 90 days
|
2.4%
1/41 • Number of events 1 • 90 days
|
7.1%
3/42 • Number of events 3 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
2.4%
1/41 • Number of events 1 • 90 days
|
5.0%
2/40 • Number of events 2 • 90 days
|
2.4%
1/41 • Number of events 1 • 90 days
|
7.1%
3/42 • Number of events 3 • 90 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place