ClinicalTrials.gov
ClinicalTrials.gov Menu

Atopic Dermatitis Research Network (ADRN) Influenza Vaccine Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01737710
Recruitment Status : Completed
First Posted : November 29, 2012
Results First Posted : January 6, 2017
Last Update Posted : March 29, 2017
Sponsor:
Collaborator:
Atopic Dermatitis Research Network
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Dermatitis, Atopic
Interventions Biological: Fluzone® Intradermal Vaccine
Biological: Fluzone® (Intramuscular) vaccine
Enrollment 368

Recruitment Details 464 participants between the ages of 18 to 64 years were recruited and 368 of those participants were enrolled at 5 sites in the US between 10/2012 and 03/2013
Pre-assignment Details  
Arm/Group Title Non-AD, Intradermal Moderate to Severe AD, Intradermal Moderate to Severe AD, Intramuscular Non-AD, Intramuscular Mild AD, Intradermal
Hide Arm/Group Description Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL). Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL). Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials. Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials Mild atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
Period Title: Overall Study
Started 114 105 105 23 21
Completed 112 101 102 23 21
Not Completed 2 4 3 0 0
Reason Not Completed
Lost to Follow-up             0             2             2             0             0
Withdrawal by Subject             1             1             1             0             0
Vaccinated in Error/Ineligible             1             1             0             0             0
Arm/Group Title Non-AD, Intradermal Moderate to Severe AD, Intradermal Moderate to Severe AD, Intramuscular Non-AD, Intramuscular Mild AD, Intradermal Total
Hide Arm/Group Description Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL). Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL). Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials. Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials Mild atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL). Total of all reporting groups
Overall Number of Baseline Participants 114 105 105 23 21 368
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 114 participants 105 participants 105 participants 23 participants 21 participants 368 participants
<=18 years
0
   0.0%
2
   1.9%
4
   3.8%
0
   0.0%
1
   4.8%
7
   1.9%
Between 18 and 65 years
114
 100.0%
103
  98.1%
101
  96.2%
23
 100.0%
20
  95.2%
361
  98.1%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 114 participants 105 participants 105 participants 23 participants 21 participants 368 participants
38.82  (11.96) 35.11  (11.29) 36.39  (12.04) 34.30  (9.79) 36.43  (14.14) 36.65  (11.85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 114 participants 105 participants 105 participants 23 participants 21 participants 368 participants
Female
67
  58.8%
58
  55.2%
60
  57.1%
12
  52.2%
10
  47.6%
207
  56.3%
Male
47
  41.2%
47
  44.8%
45
  42.9%
11
  47.8%
11
  52.4%
161
  43.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 114 participants 105 participants 105 participants 23 participants 21 participants 368 participants
Hispanic or Latino
10
   8.8%
9
   8.6%
11
  10.5%
7
  30.4%
4
  19.0%
41
  11.1%
Not Hispanic or Latino
104
  91.2%
96
  91.4%
94
  89.5%
16
  69.6%
17
  81.0%
327
  88.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 114 participants 105 participants 105 participants 23 participants 21 participants 368 participants
American Indian or Alaska Native
2
   1.8%
1
   1.0%
1
   1.0%
1
   4.3%
0
   0.0%
5
   1.4%
Asian
5
   4.4%
8
   7.6%
5
   4.8%
2
   8.7%
0
   0.0%
20
   5.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
22
  19.3%
33
  31.4%
43
  41.0%
3
  13.0%
11
  52.4%
112
  30.4%
White
80
  70.2%
57
  54.3%
53
  50.5%
16
  69.6%
10
  47.6%
216
  58.7%
More than one race
3
   2.6%
5
   4.8%
2
   1.9%
0
   0.0%
0
   0.0%
10
   2.7%
Unknown or Not Reported
2
   1.8%
1
   1.0%
1
   1.0%
1
   4.3%
0
   0.0%
5
   1.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 114 participants 105 participants 105 participants 23 participants 21 participants 368 participants
114 105 105 23 21 368
Seroprotected at Baseline – influenza B   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 114 participants 105 participants 105 participants 23 participants 21 participants 368 participants
9
   7.9%
5
   4.8%
11
  10.5%
5
  21.7%
1
   4.8%
31
   8.4%
[1]
Measure Description: The number of participants that achieved seroprotection against influenza B at baseline prior to vaccination. Seroprotection is defined as having a serum hemagglutination-inhibition [HAI] antibody titer of 1:40 or greater, which represents a sufficient antibody amount to avoid disease in half of the individuals infected with influenza B. The goal of the study was to examine the immune response to influenza vaccination against influenza B. Participants who were already seroprotected against influenza B prior to vaccination were excluded from all relevant analyses for influenza B.
Seroprotected at Baseline – influenza H1N1   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 114 participants 105 participants 105 participants 23 participants 21 participants 368 participants
52
  45.6%
45
  42.9%
55
  52.4%
12
  52.2%
9
  42.9%
173
  47.0%
[1]
Measure Description: The number of participants that achieved seroprotection against influenza H1N1 at baseline prior to vaccination. Seroprotection is defined as having a serum hemagglutination-inhibition [HAI] antibody titer of 1:40 or greater, which represents a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H1N1. The goal of the study was to examine the immune response to influenza vaccination against influenza H1N1. Participants who were already seroprotected against influenza H1N1 prior to vaccination were excluded from all relevant analyses for influenza H1N1.
Seroprotected at Baseline – influenza H3N2   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 114 participants 105 participants 105 participants 23 participants 21 participants 368 participants
51
  44.7%
45
  42.9%
55
  52.4%
12
  52.2%
9
  42.9%
172
  46.7%
[1]
Measure Description: The number of participants that achieved seroprotection against influenza H3N2 at baseline prior to vaccination. Seroprotection is defined as having a serum hemagglutination-inhibition [HAI] antibody titer of 1:40 or greater, which represents a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H3N2. The goal of the study was to examine the immune response to influenza vaccination against influenza H3N2. Participants who were already seroprotected against influenza H3N2 prior to vaccination were excluded from all relevant analyses for influenza H3N2.
1.Primary Outcome
Title Seroprotection, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal – Influenza B
Hide Description The difference in the percent of participants that achieved seroprotection against influenza B at Day 28 between non-AD and moderate to severe AD participants, following a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone Intradermal vaccine. Seroprotection is defined as having a serum hemagglutination-inhibition (HAI) antibody titer of 1:40 or greater, which represents a sufficient antibody amount to avoid disease in half of the individuals infected with influenza B. Participants who achieved seroprotection prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percent of participants who achieved seroprotection at Day 28 who were not seroprotected prior to vaccination.
Time Frame Day 28 post vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subset of the per protocol population that were not seroprotected against influenza B at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations
Arm/Group Title Moderate to Severe AD, Intradermal Non-AD, Intradermal
Hide Arm/Group Description:
Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
Overall Number of Participants Analyzed 96 102
Measure Type: Number
Unit of Measure: percentage of participants
34.4 22.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moderate to Severe AD, Intradermal, Non-AD, Intradermal
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.082
Comments Null hypothesis: no difference in the percent of participants that were seroprotected against influenza B at Day 28 between the two groups.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.80
Confidence Interval (2-Sided) 95%
0.92 to 3.55
Estimation Comments [Not Specified]
2.Primary Outcome
Title Seroprotection, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal – Influenza H1N1
Hide Description The difference in the percentage of participants that achieved seroprotection against influenza H1N1 at Day 28 between non-AD and moderate to severe AD participants, following a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone Intradermal vaccine. Seroprotection is defined as having a serum hemagglutination-inhibition (HAI) antibody titer of 1:40 or greater, which represents a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H1N1. Participants who achieved seroprotection prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroprotection at Day 28 who were not seroprotected prior to vaccination.
Time Frame Day 28 Post Vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subset of the per protocol population that were not seroprotected against influenza H1N1 at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.
Arm/Group Title Moderate to Severe AD, Intradermal Non-AD, Intradermal
Hide Arm/Group Description:
Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
Overall Number of Participants Analyzed 63 59
Measure Type: Number
Unit of Measure: percentage of participants
84.1 86.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moderate to Severe AD, Intradermal, Non-AD, Intradermal
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.801
Comments Null hypothesis: no difference in the percent of participants that were seroprotected against influenza H1N1 at Day 28 between the two groups
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.83
Confidence Interval (2-Sided) 95%
0.26 to 2.56
Estimation Comments [Not Specified]
3.Primary Outcome
Title Seroprotection, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal – Influenza H3N2
Hide Description The difference in the percentage of participants that achieved seroprotection against influenza H3N2 at Day 28 between non-AD and moderate to severe AD participants, following a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone Intradermal vaccine. Seroprotection is defined as having a serum hemagglutination-inhibition (HAI) antibody titer of 1:40 or greater, which represents a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H3N2. Participants who achieved seroprotection prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroprotection at Day 28 who were not seroprotected prior to vaccination.
Time Frame Day 28 Post Vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subset of the per protocol population that were not seroprotected against influenza H3N2 at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.
Arm/Group Title Moderate to Severe AD, Intradermal Non-AD, Intradermal
Hide Arm/Group Description:
Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
Overall Number of Participants Analyzed 59 60
Measure Type: Number
Unit of Measure: percentage of participants
84.7 73.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moderate to Severe AD, Intradermal, Non-AD, Intradermal
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.177
Comments Null hypothesis: no difference in the percentage of participants that were seroprotected against influenza H3N2 at Day 28 between the two groups.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.02
Confidence Interval (2-Sided) 95%
0.75 to 5.71
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Fold-difference in Geometric Mean Serum Hemagglutination-inhibition (HAI) Antibody Titers, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal – Influenza B
Hide Description The fold-difference (defined as a ratio to describe the change from baseline to Day 28) in geometric mean serum HAI antibody titers against influenza B between non-AD and moderate to severe AD participants, following a single dose of the seasonal 2012-2013 Fluzone Intradermal vaccine. A fold-difference of greater than 1 indicated an increase in HAI antibody titers against influenza B as a result of vaccination; therefore, higher numbers indicate a greater probability of avoiding disease if infected with influenza B. Participants who achieved seroprotection (which is defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza B) prior to vaccination were excluded from the analysis.
Time Frame Day 28 post vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subset of the per protocol population that were not seroprotected against influenza B at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.
Arm/Group Title Moderate to Severe AD, Intradermal Non-AD, Intradermal
Hide Arm/Group Description:
Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
Overall Number of Participants Analyzed 96 102
Geometric Mean (95% Confidence Interval)
Unit of Measure: HAI antibody titers
2.6
(2.0 to 3.2)
2.0
(1.6 to 2.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moderate to Severe AD, Intradermal, Non-AD, Intradermal
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.092
Comments Null hypothesis: the fold differences in geometric mean titers against influenza B are not different between the two groups.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.25
Confidence Interval (2-Sided) 95%
0.96 to 1.61
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Fold-difference in Geometric Mean Serum Hemagglutination-inhibition (HAI) Antibody Titers, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal – Influenza H1N1
Hide Description The fold-difference (defined as a ratio to describe the change from baseline to Day 28) in geometric mean serum HAI antibody titers against influenza H1N1 between non-AD and moderate to severe AD participants, following a single dose of the seasonal 2012-2013 Fluzone Intradermal vaccine. A fold-difference of greater than or equal to 1 indicated an increase in HAI antibody titers against influenza H1N1 as a result of vaccination; therefore, higher numbers indicate a greater probability of avoiding disease if infected with influenza H1N1. Participants who achieved seroprotection prior to vaccination were excluded from the analysis, which is defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H1N1.
Time Frame Day 28 post vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subset of the per protocol population that were not seroprotected against influenza H1N1 at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations
Arm/Group Title Moderate to Severe AD, Intradermal Non-AD, Intradermal
Hide Arm/Group Description:
Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
Overall Number of Participants Analyzed 63 59
Geometric Mean (95% Confidence Interval)
Unit of Measure: HAI antibody titers
22.4
(12.8 to 39.3)
37.7
(21.6 to 65.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moderate to Severe AD, Intradermal, Non-AD, Intradermal
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.103
Comments Null hypothesis: the fold differences in geometric mean titers against influenza H1N1 are not different between the two groups.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.59
Confidence Interval (2-Sided) 95%
0.32 to 1.11
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Fold-difference in Geometric Mean Serum Hemagglutination-inhibition (HAI) Antibody Titers, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal – Influenza H3N2
Hide Description The fold-difference (defined as a ratio to describe the change from baseline to Day 28) in geometric mean serum HAI antibody titers against influenza H3N2 between non-AD and moderate to severe AD participants, following a single dose of the seasonal 2012-2013 Fluzone Intradermal vaccine. A fold-difference of greater than or equal to 1 indicated an increase in HAI antibody titers against influenza H3N2 as a result of vaccination; therefore, higher numbers indicate a greater probability of avoiding disease if infected with influenza H3N2 Participants who achieved seroprotection prior to vaccination were excluded from the analysis, which is defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H3N2.
Time Frame Day 28 post vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subset of the per protocol population that were not seroprotected against influenza H3N2 at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.
Arm/Group Title Moderate to Severe AD, Intradermal Non-AD, Intradermal
Hide Arm/Group Description:
Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
Overall Number of Participants Analyzed 59 60
Geometric Mean (95% Confidence Interval)
Unit of Measure: HAI antibody titers
10.1
(6.2 to 16.4)
9.7
(6.0 to 15.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moderate to Severe AD, Intradermal, Non-AD, Intradermal
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.895
Comments Null hypothesis: the fold differences in geometric mean titers against influenza H3N2 are not different between the two groups.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
0.60 to 1.80
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Seroprotection, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular – Influenza B
Hide Description The difference in the percentage of moderate to severe AD participants that achieved seroprotection against influenza B at Day 28 between those given a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone Intradermal vaccine and those given a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone (Intramuscular) vaccine. Seroprotection is defined as having a serum hemagglutination-inhibition (HAI) antibody titer of 1:40 or greater, which represents a sufficient antibody amount to avoid disease in half of the individuals infected with influenza B. Participants who achieved seroprotection prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroprotection at Day 28 who were not seroprotected prior to vaccination.
Time Frame Day 28 post vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subset of the per protocol population that were not seroprotected against influenza B at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.
Arm/Group Title Moderate to Severe AD, Intradermal Moderate to Severe AD, Intramuscular
Hide Arm/Group Description:
Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials.
Overall Number of Participants Analyzed 96 92
Measure Type: Number
Unit of Measure: percentage of participants
34.4 33.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moderate to Severe AD, Intradermal, Moderate to Severe AD, Intramuscular
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.999
Comments Null hypothesis: no difference in the percentage of participants that were seroprotected against influenza B at Day 28 between the two groups.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
0.54 to 1.97
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Seroprotection, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular – Influenza H1N1
Hide Description The difference in the percentage of moderate to severe AD participants that achieved seroprotection against influenza H1N1 at Day 28 between those given a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone Intradermal vaccine and those given a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone (Intramuscular) vaccine. Seroprotection is defined as having a serum hemagglutination-inhibition (HAI) antibody titer of 1:40 or greater, which represents a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H1N1. Participants who achieved seroprotection prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroprotection at Day 28 who were not seroprotected prior to vaccination.
Time Frame Day 28 Post Vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subset of the per protocol population that were not seroprotected against influenza H1N1 at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.
Arm/Group Title Moderate to Severe AD, Intradermal Moderate to Severe AD, Intramuscular
Hide Arm/Group Description:
Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials.
Overall Number of Participants Analyzed 63 53
Measure Type: Number
Unit of Measure: percentage of participants
84.1 92.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moderate to Severe AD, Intradermal, Moderate to Severe AD, Intramuscular
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.253
Comments Null hypothesis: no difference in the percentage of participants that were seroprotected against influenza H1N1 at Day 28 between the two groups.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.43
Confidence Interval (2-Sided) 95%
0.09 to 1.63
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Seroprotection, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular – Influenza H3N2
Hide Description The difference in the percentage of moderate to severe AD participants that achieved seroprotection against influenza H3N2 at Day 28 between those given a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone Intradermal vaccine and those given a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone (Intramuscular) vaccine. Seroprotection is defined as having a serum hemagglutination-inhibition (HAI) antibody titer of 1:40 or greater, which represents a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H3N2. Participants who achieved seroprotection prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroprotection at Day 28 who were not seroprotected prior to vaccination.
Time Frame Day 28 Post Vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subset of the per protocol population that were not seroprotected against influenza H3N2 at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.
Arm/Group Title Moderate to Severe AD, Intradermal Moderate to Severe AD, Intramuscular
Hide Arm/Group Description:
Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials.
Overall Number of Participants Analyzed 59 49
Measure Type: Number
Unit of Measure: percentage of participants
84.7 93.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moderate to Severe AD, Intradermal, Moderate to Severe AD, Intramuscular
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.218
Comments Null hypothesis: no difference in the percentage of participants that were seroprotected against influenza H3N2 at Day 28 between the two groups.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.36
Confidence Interval (2-Sided) 95%
0.06 to 1.58
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Seroconversion, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal – Influenza B
Hide Description The difference in the percentage of participants that achieved seroconversion at Day 28 between non-AD and moderate to severe AD participants, following a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone Intradermal vaccine. Seroconversion is defined as a 4-fold or greater increase in serum hemagglutination-inhibition [HAI] antibody titers against influenza B compared to baseline values, which represents the minimum intended effect of vaccination. Participants who achieved seroprotection, defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza B, prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroconversion at Day 28 who were not seroprotected prior to vaccination.
Time Frame Day 28 Post Vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subset of the per protocol population that were not seroprotected against influenza B at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.
Arm/Group Title Moderate to Severe AD, Intradermal Non-AD, Intradermal
Hide Arm/Group Description:
Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
Overall Number of Participants Analyzed 96 102
Measure Type: Number
Unit of Measure: percentage of participants
40.6 30.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moderate to Severe AD, Intradermal, Non-AD, Intradermal
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.140
Comments Null hypothesis: no difference in the percentage of participants that were seroconverted against influenza B at Day 28 between the two groups.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.57
Confidence Interval (2-Sided) 95%
0.84 to 2.94
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Seroconversion, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe AD, Intradermal – Influenza H1N1
Hide Description The difference in the percentage of participants that achieved seroconversion at Day 28 between non-AD and moderate to severe AD participants, following a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone Intradermal vaccine. Seroconversion is defined as a 4-fold or greater increase in serum hemagglutination-inhibition [HAI] antibody titers against influenza H1N1 compared to baseline values, which represents the minimum intended effect of vaccination. Participants who achieved seroprotection, defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H1N1, prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroconversion at Day 28 who were not seroprotected prior to vaccination.
Time Frame Day 28 Post Vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subset of the per protocol population that were not seroprotected against influenza H1N1 at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.
Arm/Group Title Moderate to Severe AD, Intradermal Non-AD, Intradermal
Hide Arm/Group Description:
Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
Overall Number of Participants Analyzed 63 59
Measure Type: Number
Unit of Measure: percentage of participants
85.7 88.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moderate to Severe AD, Intradermal, Non-AD, Intradermal
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.791
Comments Null hypothesis: no difference in the percentage of participants that were seroconverted against influenza H1N1 at Day 28 between the two groups.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.81
Confidence Interval (2-Sided) 95%
0.24 to 2.65
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Seroconversion, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal – Influenza H3N2
Hide Description The difference in the percentage of participants that achieved seroconversion at Day 28 between non-AD and moderate to severe AD participants, following a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone Intradermal vaccine. Seroconversion is defined as a 4-fold or greater increase in serum hemagglutination-inhibition [HAI] antibody titers against influenza H3N2 compared to baseline values, which represents the minimum intended effect of vaccination. Participants who achieved seroprotection, defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H3N2, prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroconversion at Day 28 who were not seroprotected prior to vaccination.
Time Frame Day 28 Post Vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subset of the per protocol population that were not seroprotected against influenza H3N2 at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.
Arm/Group Title Moderate to Severe AD, Intradermal Non-AD, Intradermal
Hide Arm/Group Description:
Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
Overall Number of Participants Analyzed 59 60
Measure Type: Number
Unit of Measure: percentage of participants
76.3 73.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moderate to Severe AD, Intradermal, Non-AD, Intradermal
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.833
Comments Null hypothesis: no difference in the percentage of participants that were seroconverted against influenza H3N2 at Day 28 between the two groups.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.17
Confidence Interval (2-Sided) 95%
0.47 to 2.92
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Seroconversion, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular – Influenza B
Hide Description The difference in the percentage of moderate to severe AD participants that achieved seroconversion at Day 28 between those given a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone Intradermal vaccine and those given a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone (Intramuscular) vaccine. Seroconversion is defined as a 4-fold or greater increase in serum hemagglutination-inhibition [HAI] antibody titers against influenza B compared to baseline values, which represents the minimum intended effect of vaccination. Participants who achieved seroprotection, defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza B, prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroconversion at Day 28 who were not seroprotected prior to vaccination.
Time Frame Day 28 Post Vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subset of the per protocol population that were not seroprotected against influenza B at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.
Arm/Group Title Moderate to Severe AD, Intradermal Moderate to Severe AD, Intramuscular
Hide Arm/Group Description:
Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials.
Overall Number of Participants Analyzed 96 92
Measure Type: Number
Unit of Measure: percentage of participants
40.6 47.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moderate to Severe AD, Intradermal, Moderate to Severe AD, Intramuscular
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.378
Comments Null hypothesis: no difference in the percentage of participants that were seroconverted against influenza B at Day 28 between the two groups.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.75
Confidence Interval (2-Sided) 95%
0.40 to 1.38
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Seroconversion, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular – Influenza H1N1
Hide Description The difference in the percentage of moderate to severe AD participants that achieved seroconversion at Day 28 between those given a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone Intradermal vaccine and those given a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone (Intramuscular) vaccine. Seroconversion is defined as a 4-fold or greater increase in serum hemagglutination-inhibition [HAI] antibody titers against influenza H1N1 compared to baseline values, which represents the minimum intended effect of vaccination. Participants who achieved seroprotection, defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H1N1, prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroconversion at Day 28 who were not seroprotected prior to vaccination.
Time Frame Day 28 Post Vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subset of the per protocol population that were not seroprotected against influenza H1N1 at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.
Arm/Group Title Moderate to Severe AD, Intradermal Moderate to Severe AD, Intramuscular
Hide Arm/Group Description:
Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials.
Overall Number of Participants Analyzed 63 53
Measure Type: Number
Unit of Measure: percentage of participants
85.7 88.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moderate to Severe AD, Intradermal, Moderate to Severe AD, Intramuscular
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.783
Comments Null hypothesis: no difference in the percentage of participants that were seroconverted against influenza H1N1 at Day 28 between the two groups.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.77
Confidence Interval (2-Sided) 95%
0.21 to 2.62
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Seroconversion, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular – Influenza H3N2
Hide Description The difference in the percentage of moderate to severe AD participants that achieved seroconversion at Day 28 between those given a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone Intradermal vaccine and those given a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone (Intramuscular) vaccine. Seroconversion is defined as a 4-fold or greater increase in serum hemagglutination-inhibition [HAI] antibody titers against influenza H3N2 compared to baseline values, which represents the minimum intended effect of vaccination. Participants who achieved seroprotection, defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H3N2, prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroconversion at Day 28 who were not seroprotected prior to vaccination.
Time Frame Day 28 Post Vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subset of the per protocol population that were not seroprotected against influenza H3N2 at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.
Arm/Group Title Moderate to Severe AD, Intradermal Moderate to Severe AD, Intramuscular
Hide Arm/Group Description:
Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials.
Overall Number of Participants Analyzed 59 49
Measure Type: Number
Unit of Measure: percentage of participants
76.3 87.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moderate to Severe AD, Intradermal, Moderate to Severe AD, Intramuscular
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.143
Comments [Not Specified]
Method Fisher Exact
Comments Null hypothesis: no difference in the percentage of participants that were seroconverted against influenza H3N2 at Day 28 between the two groups.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.45
Confidence Interval (2-Sided) 95%
0.13 to 1.39
Estimation Comments [Not Specified]
Time Frame From start of the study through end of the study (up to Day 28 visit).
Adverse Event Reporting Description

Only adverse events that fit the following criteria have been collected:

  • Reactogenicity events of grade 3 or higher severity occurring between Day 0 and Day 7
  • Adverse events of grade 3 or higher severity through Day 28 visit
  • Serious adverse events through Day 28 visit
 
Arm/Group Title Non-AD, Intradermal Moderate to Severe AD, Intradermal Moderate to Severe AD, Intramuscular Non-AD, Intramuscular Mild AD, Intradermal
Hide Arm/Group Description Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL). Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL). Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials. Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials Mild atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
All-Cause Mortality
Non-AD, Intradermal Moderate to Severe AD, Intradermal Moderate to Severe AD, Intramuscular Non-AD, Intramuscular Mild AD, Intradermal
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Non-AD, Intradermal Moderate to Severe AD, Intradermal Moderate to Severe AD, Intramuscular Non-AD, Intramuscular Mild AD, Intradermal
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/114 (0.88%)      1/105 (0.95%)      0/105 (0.00%)      0/23 (0.00%)      0/21 (0.00%)    
Infections and infestations           
Skin infection  1  1/114 (0.88%)  1 0/105 (0.00%)  0 0/105 (0.00%)  0 0/23 (0.00%)  0 0/21 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Asthma  1  0/114 (0.00%)  0 1/105 (0.95%)  1 0/105 (0.00%)  0 0/23 (0.00%)  0 0/21 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Non-AD, Intradermal Moderate to Severe AD, Intradermal Moderate to Severe AD, Intramuscular Non-AD, Intramuscular Mild AD, Intradermal
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/114 (0.00%)      0/105 (0.00%)      1/105 (0.95%)      0/23 (0.00%)      0/21 (0.00%)    
Gastrointestinal disorders           
Diarrhoea  1  0/114 (0.00%)  0 0/105 (0.00%)  0 1/105 (0.95%)  1 0/23 (0.00%)  0 0/21 (0.00%)  0
Vomiting  1  0/114 (0.00%)  0 0/105 (0.00%)  0 1/105 (0.95%)  1 0/23 (0.00%)  0 0/21 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Director, Clinical Research Operations Program
Organization: DAIT/NIAID
Phone: 301-594-7669
Other Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01737710     History of Changes
Other Study ID Numbers: DAIT ADRN-05
First Submitted: November 27, 2012
First Posted: November 29, 2012
Results First Submitted: November 8, 2016
Results First Posted: January 6, 2017
Last Update Posted: March 29, 2017