Trial Outcomes & Findings for Immune Response to Yellow Fever Vaccination in Adults With Atopic Dermatitis (NCT NCT00723489)
NCT ID: NCT00723489
Last Updated: 2014-01-13
Results Overview
Log10 Neutralization Index (LNI) is the Log10 difference in virus titer (measurement of amount of virus) between pre-vaccination and post-vaccination. An LNI greater than or equal to 0.7 suggests that a person has active immunity against Yellow Fever virus.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
82 participants
Primary outcome timeframe
30 days after Yellow Fever (YF) immunization (Acceptable Blood Draw Range: Day 28 - Day 35 after YF immunization)
Results posted on
2014-01-13
Participant Flow
From August 2008 to March 2011, three centers in the United States recruited participants ages 27 to 43 years who fulfilled eligibility criteria. Refer to the Eligibility Section for more details.
Participant milestones
| Measure |
YFV-17D SC - (Non-AD)
Healthy volunteer participants who did not have atopic dermatitis defined by Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of the Yellow Fever vaccine (YFV-17D) by subcutaneous (SC) administration in the right deltoid and one dose of placebo by transcutaneous (TC) administration in the left deltoid.
|
YFV-17D SC - (AD)
Participants classified as atopic dermatitis (AD) defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of YFV-17D by subcutaneous administration in the right deltoid and one dose of placebo by transcutaneous administration in the left deltoid.
|
YFV-17D TC - (Non-AD)
Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
|
YFV-17D TC - (AD)
Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
21
|
19
|
19
|
23
|
|
Overall Study
COMPLETED
|
20
|
15
|
19
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
0
|
3
|
Reasons for withdrawal
| Measure |
YFV-17D SC - (Non-AD)
Healthy volunteer participants who did not have atopic dermatitis defined by Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of the Yellow Fever vaccine (YFV-17D) by subcutaneous (SC) administration in the right deltoid and one dose of placebo by transcutaneous (TC) administration in the left deltoid.
|
YFV-17D SC - (AD)
Participants classified as atopic dermatitis (AD) defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of YFV-17D by subcutaneous administration in the right deltoid and one dose of placebo by transcutaneous administration in the left deltoid.
|
YFV-17D TC - (Non-AD)
Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
|
YFV-17D TC - (AD)
Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
|
|---|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
|
Overall Study
Pregnancy
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
|
Overall Study
Seropositive at baseline
|
1
|
0
|
0
|
0
|
|
Overall Study
Prohibited Medication
|
0
|
0
|
0
|
1
|
|
Overall Study
Samples Collected Out of Window
|
0
|
3
|
0
|
0
|
Baseline Characteristics
Immune Response to Yellow Fever Vaccination in Adults With Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
YFV-17D SC - (Non-AD)
n=20 Participants
Healthy volunteer participants who did not have atopic dermatitis defined by Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of the Yellow Fever vaccine (YFV-17D) by subcutaneous (SC) administration in the right deltoid and one dose of placebo by transcutaneous (TC) administration in the left deltoid.
|
YFV-17D SC - (AD)
n=15 Participants
Participants classified as atopic dermatitis (AD) defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of YFV-17D by subcutaneous administration in the right deltoid and one dose of placebo by transcutaneous administration in the left deltoid.
|
YFV-17D TC - (Non-AD)
n=19 Participants
Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
|
YFV-17D TC - (AD)
n=20 Participants
Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
32.0 years
STANDARD_DEVIATION 4.5 • n=5 Participants
|
34.7 years
STANDARD_DEVIATION 6.2 • n=7 Participants
|
33.9 years
STANDARD_DEVIATION 4.7 • n=5 Participants
|
32.8 years
STANDARD_DEVIATION 4.3 • n=4 Participants
|
33.3 years
STANDARD_DEVIATION 4.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
15 participants
n=7 Participants
|
19 participants
n=5 Participants
|
20 participants
n=4 Participants
|
74 participants
n=21 Participants
|
|
Total Serum Immunoglobulin E (IgE; kU/L)
|
35.4 kU/L
STANDARD_DEVIATION 40.3 • n=5 Participants
|
1166.4 kU/L
STANDARD_DEVIATION 3609.5 • n=7 Participants
|
73.6 kU/L
STANDARD_DEVIATION 115.7 • n=5 Participants
|
2742.1 kU/L
STANDARD_DEVIATION 8262.5 • n=4 Participants
|
1006.0 kU/L
STANDARD_DEVIATION 4646.1 • n=21 Participants
|
|
Percent Eosinophils in Blood
|
2.6 Percent Eosinophils
STANDARD_DEVIATION 1.9 • n=5 Participants
|
3.7 Percent Eosinophils
STANDARD_DEVIATION 2.1 • n=7 Participants
|
2.4 Percent Eosinophils
STANDARD_DEVIATION 2.0 • n=5 Participants
|
3.8 Percent Eosinophils
STANDARD_DEVIATION 3.2 • n=4 Participants
|
3.1 Percent Eosinophils
STANDARD_DEVIATION 2.4 • n=21 Participants
|
PRIMARY outcome
Timeframe: 30 days after Yellow Fever (YF) immunization (Acceptable Blood Draw Range: Day 28 - Day 35 after YF immunization)Population: All participants who completed the study; and seroconverted
Log10 Neutralization Index (LNI) is the Log10 difference in virus titer (measurement of amount of virus) between pre-vaccination and post-vaccination. An LNI greater than or equal to 0.7 suggests that a person has active immunity against Yellow Fever virus.
Outcome measures
| Measure |
YFV-17D TC - (AD)
n=18 Participants
Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
|
YFV-17D TC - (Non-AD)
n=14 Participants
Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
|
|---|---|---|
|
Comparison of Anti-YF Antibody Levels by Measurement of Log10 Neutralization Index (LNI): YFV-17D TC- (AD) Participants Compared to YFV-17D TC- (Non-AD) Participants
|
1.8 LNI
Standard Deviation 0.4
|
1.8 LNI
Standard Deviation 0.4
|
PRIMARY outcome
Timeframe: 30 days after YF immunization (Acceptable Blood Draw Range: Day 28 - Day 35 after Yellow Fever immunization)Population: All participants who completed the study; and seroconverted
Log10 Neutralization Index (LNI) is the Log10 difference in virus titer (measurement of amount of virus) between pre-vaccination and post-vaccination. An LNI greater than or equal to 0.7 suggests that a person has active immunity against Yellow Fever virus.
Outcome measures
| Measure |
YFV-17D TC - (AD)
n=14 Participants
Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
|
YFV-17D TC - (Non-AD)
n=20 Participants
Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
|
|---|---|---|
|
Comparison of Anti-YF Antibody Levels by Measurement of Log10 Neutralization Index (LNI): YFV-17D SC - (AD) Participants Compared to YFV-17D SC- (Non-AD) Participants
|
1.8 Log10 Neutralization Index (LNI)
Standard Deviation 0.3
|
1.8 Log10 Neutralization Index (LNI)
Standard Deviation 0.3
|
PRIMARY outcome
Timeframe: 30 days after Yellow Fever (YF) immunization (Acceptable Blood Draw Range: Day 28 - Day 35 after YF immunization)Population: All participants who completed the study; and seroconverted
Neutralization titer (NT50) is the dilution of serum (antibody) that results in a 50% reduction in the amount of virus. A higher NT50 number reflects the presence of more protective antibody levels against the Yellow Fever virus. Some studies have used an NT50 titer of 1:10 or 1:20 as the minimum level to suggest that a person has active immunity against the Yellow Fever virus.
Outcome measures
| Measure |
YFV-17D TC - (AD)
n=18 Participants
Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
|
YFV-17D TC - (Non-AD)
n=14 Participants
Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
|
|---|---|---|
|
Comparison of Anti-YF Antibody Levels by Measurement of Log10 Neutralizing Titer 50 (NT50): YFV-17D TC - (AD) Participants Compared to YFV-17D TC - (Non - AD) Participants
|
3.5 Log10 (NT50)
Standard Deviation 0.4
|
3.8 Log10 (NT50)
Standard Deviation 0.3
|
PRIMARY outcome
Timeframe: 30 days after Yellow Fever (YF) immunization (Acceptable Blood Draw Range: Day 28 - Day 35 after YF immunization)Population: All participants who completed the study; and seroconverted
Neutralization titer (NT50) is the dilution of serum (antibody) that results in a 50% reduction in the amount of virus. A higher NT50 number reflects the presence of more protective antibody levels against the Yellow Fever virus. Some studies have used an NT50 titer of 1:10 or 1:20 as the minimum level to suggest that a person has active immunity against the Yellow Fever virus.
Outcome measures
| Measure |
YFV-17D TC - (AD)
n=14 Participants
Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
|
YFV-17D TC - (Non-AD)
n=20 Participants
Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
|
|---|---|---|
|
Comparison of Anti-YF Antibody Levels by Measurement of Log10 Neutralizing Titer 50 (NT50): YFV-17D SC - (AD) Participants Compared to YFV-17D SC - (Non-AD) Participants
|
3.6 Log10 (NT50)
Standard Deviation 0.4
|
3.5 Log10 (NT50)
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: Day 0 to Day 30 (Acceptable Post-Vaccination Blood Draw Range: Day 28 - Day 35)Population: Includes all participants who completed the study; seroconverters as well as non-seroconverters
Seroconversion is defined as a Log10 Neutralization Index (LNI) of 0.7 or higher. A value greater than or equal to 0.7 suggests that a person has active immunity against Yellow Fever virus.
Outcome measures
| Measure |
YFV-17D TC - (AD)
n=20 Participants
Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
|
YFV-17D TC - (Non-AD)
n=19 Participants
Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
|
|---|---|---|
|
Comparison of Count of Seroconverters: YFV-17D TC- (AD) Participants Compared to YFV-17D TC - (Non-AD) Participants
Did not seroconvert
|
2 participants
|
5 participants
|
|
Comparison of Count of Seroconverters: YFV-17D TC- (AD) Participants Compared to YFV-17D TC - (Non-AD) Participants
Seroconverted
|
18 participants
|
14 participants
|
SECONDARY outcome
Timeframe: Day 0 to Day 30 (Acceptable Post-Vaccination Blood Draw Range: Day 28 - Day 35)Population: Includes all participants who completed the study; seroconverters as well as non-seroconverters
Seroconversion is defined as a Log10 Neutralization Index (LNI) of 0.7 or higher. A value greater than or equal to 0.7 suggests that a person has active immunity against Yellow Fever virus.
Outcome measures
| Measure |
YFV-17D TC - (AD)
n=15 Participants
Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
|
YFV-17D TC - (Non-AD)
n=20 Participants
Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
|
|---|---|---|
|
Comparison of Count of Seroconverters: YFV-17D SC - (AD) Participants Compared to YFV-17D SC - (Non-AD) Participants
Did not seroconvert
|
1 participants
|
0 participants
|
|
Comparison of Count of Seroconverters: YFV-17D SC - (AD) Participants Compared to YFV-17D SC - (Non-AD) Participants
Seroconverted
|
14 participants
|
20 participants
|
SECONDARY outcome
Timeframe: Day 30 (Day 28-35)Population: Analysis excludes 1 SC-(AD) participant who did not seroconvert, 1 SC-(Non-AD) participant whose samples were collected out of window, and 3 SC (Non-AD) and 1 SC-(AD) due to problems with sample processing
Comparison by designated reporting groups: the Log10 transformed lymphocyte count of CD4 Positive T-cells expressing IFN-gamma and TNF-alpha in every 10\^6 CD4 Positive T-cells on Day 30 (acceptable blood draw window: Day 28 - 35).
Outcome measures
| Measure |
YFV-17D TC - (AD)
n=13 Participants
Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
|
YFV-17D TC - (Non-AD)
n=16 Participants
Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
|
|---|---|---|
|
Comparison in Log10 Transformed Lymphocyte Count on Day 30 Post YF Immunization: IFN-gamma Positive, Tumor Necrosis Factor- Alpha (TNF Alpha) Positive, CD4 Positive T-cells, YFV-17D SC - (AD) Compared to YFV-17D SC - (Non- AD) Participants
|
2.8 Log10 cell count/10^6 cells
Standard Deviation 0.4
|
2.7 Log10 cell count/10^6 cells
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: Day 30 (Day 28-35)Population: Participants who did not seroconvert were excluded from this analysis (2 TC-(AD) and 5 TC-(Non-AD)). T-cell data from 4 TC-(AD) and 3 TC-(Non-AD) subjects was excluded due to problems with sample processing
Comparison by designated reporting groups: the Log10 transformed count of CD4 Positive T-cells that express IFN-gamma and TNF-alpha in every 10\^6 CD4 Positive T- Cells (Day 30). A higher count reflects a better immune response to Yellow Fever virus.
Outcome measures
| Measure |
YFV-17D TC - (AD)
n=14 Participants
Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
|
YFV-17D TC - (Non-AD)
n=11 Participants
Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
|
|---|---|---|
|
Comparison in Log10 Transformed Lymphocyte Count on Day 30 Post YF Immunization: IFN-gamma Positive, Tumor Necrosis Factor- Alpha (TNF Alpha) Positive , CD4 Positive T-cells, YFV-17D TC - (AD) Compared to YFV-17D TC - (Non-AD) Participants
|
2.5 Log10 cell count/10^6 cells
Standard Deviation 0.3
|
2.7 Log10 cell count/10^6 cells
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: Day 30 (Day 28-35)Population: Analysis excludes 1 SC-(AD) participant who did not seroconvert, 1 SC-(AD) participant whose samples were collected out of window, and 3 SC (Non-AD) and 1 SC-(AD) due to problems with sample processing
Comparison by designated reporting groups: the Log10 transformed lymphocyte count of CD8 Positive T-cells expressing IFN-gamma and TNF-alpha in every 10\^6 CD8 Positive T-cells.
Outcome measures
| Measure |
YFV-17D TC - (AD)
n=13 Participants
Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
|
YFV-17D TC - (Non-AD)
n=16 Participants
Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
|
|---|---|---|
|
Comparison in Log10 Transformed Lymphocyte Count on Day 30 Post YF Immunization: IFN-gamma Positive, Tumor Necrosis Factor- Alpha (TNF Alpha) Positive, CD8 Positive T-cells, YFV-17D SC -(AD) Compared to YFV-17D SC - (Non-AD) Participants
|
3.4 Log10 cell count/10^6 cells
Standard Deviation 0.3
|
3.3 Log10 cell count/10^6 cells
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Day 30 (Day 28-35)Population: Participants who did not seroconvert were excluded from this analysis (2 TC-(AD) and 5 TC-(Non-AD)). T-cell data from 4 TC-(AD) and 3 TC-(Non-AD) subjects was excluded due to problems with sample processing
Comparison by designated reporting groups: the Log10 transformed count of CD8 Positive T-cells expressing IFN-gamma and TNF-alpha in every 10\^6 CD8 Positive T-cells.
Outcome measures
| Measure |
YFV-17D TC - (AD)
n=14 Participants
Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
|
YFV-17D TC - (Non-AD)
n=11 Participants
Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
|
|---|---|---|
|
Comparison in Log10 Transformed Lymphocyte Count on Day 30 Post YF Immunization: IFN-gamma Positive, Tumor Necrosis Factor- Alpha (TNF Alpha) Positive, CD8 Positive T-cells, YFV-17D TC - (AD) Compared to YFV-17D TC - (Non-AD) Participants
|
3.0 Log10 cell count/10^6 cells
Standard Deviation 0.5
|
3.3 Log10 cell count/10^6 cells
Standard Deviation 0.5
|
Adverse Events
YFV-17D SC - (Non-AD)
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
YFV-17D SC - (AD)
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
YFV-17D TC - (Non-AD)
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
YFV-17D TC - (AD)
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
YFV-17D SC - (Non-AD)
n=21 participants at risk
Healthy volunteer participants who did not have atopic dermatitis defined by Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of the Yellow Fever vaccine (YFV-17D) by subcutaneous (SC) administration in the right deltoid and one dose of placebo by transcutaneous (TC) administration in the left deltoid.
|
YFV-17D SC - (AD)
n=19 participants at risk
Participants classified as atopic dermatitis (AD) defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of YFV-17D by subcutaneous administration in the right deltoid and one dose of placebo by transcutaneous administration in the left deltoid.
|
YFV-17D TC - (Non-AD)
n=19 participants at risk
Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
|
YFV-17D TC - (AD)
n=23 participants at risk
Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
|
|---|---|---|---|---|
|
Investigations
Blood magnesium decreased
|
23.8%
5/21 • Number of events 5
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
10.5%
2/19 • Number of events 3
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
47.4%
9/19 • Number of events 11
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
17.4%
4/23 • Number of events 5
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Investigations
Haemoglobin decreased
|
14.3%
3/21 • Number of events 3
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
15.8%
3/19 • Number of events 3
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
5.3%
1/19 • Number of events 1
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
4.3%
1/23 • Number of events 1
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Investigations
Alanine aminotransferase increased
|
9.5%
2/21 • Number of events 2
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
15.8%
3/19 • Number of events 3
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
5.3%
1/19 • Number of events 1
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
4.3%
1/23 • Number of events 1
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/21
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
10.5%
2/19 • Number of events 2
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
10.5%
2/19 • Number of events 2
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
8.7%
2/23 • Number of events 2
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Investigations
Blood cholesterol increased
|
19.0%
4/21 • Number of events 4
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
26.3%
5/19 • Number of events 6
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
21.1%
4/19 • Number of events 5
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
13.0%
3/23 • Number of events 3
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Investigations
Blood glucose decreased
|
14.3%
3/21 • Number of events 3
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
15.8%
3/19 • Number of events 3
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
15.8%
3/19 • Number of events 3
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
8.7%
2/23 • Number of events 2
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Investigations
Blood glucose increased
|
9.5%
2/21 • Number of events 2
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
5.3%
1/19 • Number of events 1
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
21.1%
4/19 • Number of events 5
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
21.7%
5/23 • Number of events 5
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
14.3%
3/21 • Number of events 4
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
10.5%
2/19 • Number of events 2
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
26.3%
5/19 • Number of events 6
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
8.7%
2/23 • Number of events 3
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
14.3%
3/21 • Number of events 3
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
10.5%
2/19 • Number of events 2
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
15.8%
3/19 • Number of events 4
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
4.3%
1/23 • Number of events 1
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
38.1%
8/21 • Number of events 11
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
21.1%
4/19 • Number of events 5
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
10.5%
2/19 • Number of events 2
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
26.1%
6/23 • Number of events 7
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
4.8%
1/21 • Number of events 1
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
10.5%
2/19 • Number of events 2
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
10.5%
2/19 • Number of events 2
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
0.00%
0/23
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
3/21 • Number of events 3
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
21.1%
4/19 • Number of events 4
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
0.00%
0/19
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
8.7%
2/23 • Number of events 2
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.8%
1/21 • Number of events 1
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
15.8%
3/19 • Number of events 3
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
5.3%
1/19 • Number of events 1
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
21.7%
5/23 • Number of events 6
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.3%
3/21 • Number of events 3
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
21.1%
4/19 • Number of events 4
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
0.00%
0/19
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
8.7%
2/23 • Number of events 3
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Nervous system disorders
Headache
|
4.8%
1/21 • Number of events 1
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
26.3%
5/19 • Number of events 6
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
0.00%
0/19
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
17.4%
4/23 • Number of events 5
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Investigations
Lymph node palpable
|
9.5%
2/21 • Number of events 2
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
5.3%
1/19 • Number of events 1
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
0.00%
0/19
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
8.7%
2/23 • Number of events 2
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Investigations
Lymphocyte count decreased
|
9.5%
2/21 • Number of events 2
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
21.1%
4/19 • Number of events 4
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
15.8%
3/19 • Number of events 3
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
21.7%
5/23 • Number of events 5
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Investigations
Neutrophil count decreased
|
42.9%
9/21 • Number of events 9
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
26.3%
5/19 • Number of events 5
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
26.3%
5/19 • Number of events 6
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
21.7%
5/23 • Number of events 5
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Investigations
White blood cell count decreased
|
9.5%
2/21 • Number of events 2
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
15.8%
3/19 • Number of events 3
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
21.1%
4/19 • Number of events 4
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
13.0%
3/23 • Number of events 3
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/21
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
15.8%
3/19 • Number of events 3
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
0.00%
0/19
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
13.0%
3/23 • Number of events 3
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
General disorders
Fatigue
|
14.3%
3/21 • Number of events 3
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
36.8%
7/19 • Number of events 9
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
0.00%
0/19
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
30.4%
7/23 • Number of events 8
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
General disorders
Injection site pain
|
19.0%
4/21 • Number of events 4
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
10.5%
2/19 • Number of events 3
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
0.00%
0/19
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
4.3%
1/23 • Number of events 1
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/21
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
5.3%
1/19 • Number of events 1
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
5.3%
1/19 • Number of events 1
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
13.0%
3/23 • Number of events 3
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Gastrointestinal disorders
Nausea
|
4.8%
1/21 • Number of events 1
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
21.1%
4/19 • Number of events 4
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
0.00%
0/19
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
13.0%
3/23 • Number of events 3
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
General disorders
Application site pain
|
0.00%
0/21
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
5.3%
1/19 • Number of events 1
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
5.3%
1/19 • Number of events 1
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
13.0%
3/23 • Number of events 3
This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
Additional Information
Associate Director, Clinical Research Operations Program
DAIT/NIAID
Phone: 301-594-7669
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place