Trial Outcomes & Findings for Atopic Dermatitis Research Network (ADRN) Influenza Vaccine Study (NCT NCT01737710)
NCT ID: NCT01737710
Last Updated: 2017-03-29
Results Overview
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.
COMPLETED
NA
368 participants
Day 28 post vaccination
2017-03-29
Participant Flow
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
Participant milestones
| Measure |
Non-AD, Intradermal
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 AD, Intradermal
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 AD, Intramuscular
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-AD, Intramuscular
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 AD, Intradermal
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).
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
114
|
105
|
105
|
23
|
21
|
|
Overall Study
COMPLETED
|
112
|
101
|
102
|
23
|
21
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
3
|
0
|
0
|
Reasons for withdrawal
| Measure |
Non-AD, Intradermal
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 AD, Intradermal
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 AD, Intramuscular
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-AD, Intramuscular
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 AD, Intradermal
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).
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
2
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
1
|
0
|
0
|
|
Overall Study
Vaccinated in Error/Ineligible
|
1
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Atopic Dermatitis Research Network (ADRN) Influenza Vaccine Study
Baseline characteristics by cohort
| Measure |
Non-AD, Intradermal
n=114 Participants
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 AD, Intradermal
n=105 Participants
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 AD, Intramuscular
n=105 Participants
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-AD, Intramuscular
n=23 Participants
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 AD, Intradermal
n=21 Participants
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
n=368 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
7 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
114 Participants
n=99 Participants
|
103 Participants
n=107 Participants
|
101 Participants
n=206 Participants
|
23 Participants
n=7 Participants
|
20 Participants
n=31 Participants
|
361 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Age, Continuous
|
38.82 years
STANDARD_DEVIATION 11.96 • n=99 Participants
|
35.11 years
STANDARD_DEVIATION 11.29 • n=107 Participants
|
36.39 years
STANDARD_DEVIATION 12.04 • n=206 Participants
|
34.30 years
STANDARD_DEVIATION 9.79 • n=7 Participants
|
36.43 years
STANDARD_DEVIATION 14.14 • n=31 Participants
|
36.65 years
STANDARD_DEVIATION 11.85 • n=30 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
207 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
161 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
41 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
104 Participants
n=99 Participants
|
96 Participants
n=107 Participants
|
94 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
17 Participants
n=31 Participants
|
327 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
20 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
112 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
80 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
216 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
10 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
|
Region of Enrollment
United States
|
114 participants
n=99 Participants
|
105 participants
n=107 Participants
|
105 participants
n=206 Participants
|
23 participants
n=7 Participants
|
21 participants
n=31 Participants
|
368 participants
n=30 Participants
|
|
Seroprotected at Baseline - influenza B
|
9 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
31 Participants
n=30 Participants
|
|
Seroprotected at Baseline - influenza H1N1
|
52 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
173 Participants
n=30 Participants
|
|
Seroprotected at Baseline - influenza H3N2
|
51 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
172 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: Day 28 post vaccinationPopulation: 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
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.
Outcome measures
| Measure |
Moderate to Severe AD, Intradermal
n=96 Participants
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-AD, Intradermal
n=102 Participants
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).
|
|---|---|---|
|
Seroprotection, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza B
|
34.4 percentage of participants
|
22.5 percentage of participants
|
PRIMARY outcome
Timeframe: Day 28 Post VaccinationPopulation: 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.
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.
Outcome measures
| Measure |
Moderate to Severe AD, Intradermal
n=63 Participants
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-AD, Intradermal
n=59 Participants
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).
|
|---|---|---|
|
Seroprotection, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza H1N1
|
84.1 percentage of participants
|
86.4 percentage of participants
|
PRIMARY outcome
Timeframe: Day 28 Post VaccinationPopulation: 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.
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.
Outcome measures
| Measure |
Moderate to Severe AD, Intradermal
n=59 Participants
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-AD, Intradermal
n=60 Participants
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).
|
|---|---|---|
|
Seroprotection, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza H3N2
|
84.7 percentage of participants
|
73.3 percentage of participants
|
SECONDARY outcome
Timeframe: Day 28 post vaccinationPopulation: 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.
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.
Outcome measures
| Measure |
Moderate to Severe AD, Intradermal
n=96 Participants
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-AD, Intradermal
n=102 Participants
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).
|
|---|---|---|
|
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
|
2.6 HAI antibody titers
Interval 2.0 to 3.2
|
2.0 HAI antibody titers
Interval 1.6 to 2.6
|
SECONDARY outcome
Timeframe: Day 28 post vaccinationPopulation: 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
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.
Outcome measures
| Measure |
Moderate to Severe AD, Intradermal
n=63 Participants
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-AD, Intradermal
n=59 Participants
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).
|
|---|---|---|
|
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
|
22.4 HAI antibody titers
Interval 12.8 to 39.3
|
37.7 HAI antibody titers
Interval 21.6 to 65.8
|
SECONDARY outcome
Timeframe: Day 28 post vaccinationPopulation: 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.
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.
Outcome measures
| Measure |
Moderate to Severe AD, Intradermal
n=59 Participants
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-AD, Intradermal
n=60 Participants
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).
|
|---|---|---|
|
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
|
10.1 HAI antibody titers
Interval 6.2 to 16.4
|
9.7 HAI antibody titers
Interval 6.0 to 15.8
|
SECONDARY outcome
Timeframe: Day 28 post vaccinationPopulation: 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.
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.
Outcome measures
| Measure |
Moderate to Severe AD, Intradermal
n=96 Participants
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-AD, Intradermal
n=92 Participants
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).
|
|---|---|---|
|
Seroprotection, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza B
|
34.4 percentage of participants
|
33.7 percentage of participants
|
SECONDARY outcome
Timeframe: Day 28 Post VaccinationPopulation: 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.
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.
Outcome measures
| Measure |
Moderate to Severe AD, Intradermal
n=63 Participants
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-AD, Intradermal
n=53 Participants
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).
|
|---|---|---|
|
Seroprotection, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza H1N1
|
84.1 percentage of participants
|
92.5 percentage of participants
|
SECONDARY outcome
Timeframe: Day 28 Post VaccinationPopulation: 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.
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.
Outcome measures
| Measure |
Moderate to Severe AD, Intradermal
n=59 Participants
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-AD, Intradermal
n=49 Participants
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).
|
|---|---|---|
|
Seroprotection, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza H3N2
|
84.7 percentage of participants
|
93.9 percentage of participants
|
SECONDARY outcome
Timeframe: Day 28 Post VaccinationPopulation: 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.
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.
Outcome measures
| Measure |
Moderate to Severe AD, Intradermal
n=96 Participants
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-AD, Intradermal
n=102 Participants
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).
|
|---|---|---|
|
Seroconversion, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza B
|
40.6 percentage of participants
|
30.4 percentage of participants
|
SECONDARY outcome
Timeframe: Day 28 Post VaccinationPopulation: 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.
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.
Outcome measures
| Measure |
Moderate to Severe AD, Intradermal
n=63 Participants
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-AD, Intradermal
n=59 Participants
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).
|
|---|---|---|
|
Seroconversion, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe AD, Intradermal - Influenza H1N1
|
85.7 percentage of participants
|
88.1 percentage of participants
|
SECONDARY outcome
Timeframe: Day 28 Post VaccinationPopulation: 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.
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.
Outcome measures
| Measure |
Moderate to Severe AD, Intradermal
n=59 Participants
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-AD, Intradermal
n=60 Participants
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).
|
|---|---|---|
|
Seroconversion, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza H3N2
|
76.3 percentage of participants
|
73.3 percentage of participants
|
SECONDARY outcome
Timeframe: Day 28 Post VaccinationPopulation: 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.
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.
Outcome measures
| Measure |
Moderate to Severe AD, Intradermal
n=96 Participants
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-AD, Intradermal
n=92 Participants
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).
|
|---|---|---|
|
Seroconversion, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza B
|
40.6 percentage of participants
|
47.8 percentage of participants
|
SECONDARY outcome
Timeframe: Day 28 Post VaccinationPopulation: 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.
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.
Outcome measures
| Measure |
Moderate to Severe AD, Intradermal
n=63 Participants
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-AD, Intradermal
n=53 Participants
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).
|
|---|---|---|
|
Seroconversion, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza H1N1
|
85.7 percentage of participants
|
88.7 percentage of participants
|
SECONDARY outcome
Timeframe: Day 28 Post VaccinationPopulation: 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.
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.
Outcome measures
| Measure |
Moderate to Severe AD, Intradermal
n=59 Participants
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-AD, Intradermal
n=49 Participants
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).
|
|---|---|---|
|
Seroconversion, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza H3N2
|
76.3 percentage of participants
|
87.8 percentage of participants
|
Adverse Events
Non-AD, Intradermal
Moderate to Severe AD, Intradermal
Moderate to Severe AD, Intramuscular
Non-AD, Intramuscular
Mild AD, Intradermal
Serious adverse events
| Measure |
Non-AD, Intradermal
n=114 participants at risk
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 AD, Intradermal
n=105 participants at risk
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 AD, Intramuscular
n=105 participants at risk
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-AD, Intramuscular
n=23 participants at risk
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 AD, Intradermal
n=21 participants at risk
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).
|
|---|---|---|---|---|---|
|
Infections and infestations
Skin infection
|
0.88%
1/114 • Number of events 1 • From start of the study through end of the study (up to Day 28 visit).
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
|
0.00%
0/105 • From start of the study through end of the study (up to Day 28 visit).
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
|
0.00%
0/105 • From start of the study through end of the study (up to Day 28 visit).
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
|
0.00%
0/23 • From start of the study through end of the study (up to Day 28 visit).
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
|
0.00%
0/21 • From start of the study through end of the study (up to Day 28 visit).
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
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/114 • From start of the study through end of the study (up to Day 28 visit).
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
|
0.95%
1/105 • Number of events 1 • From start of the study through end of the study (up to Day 28 visit).
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
|
0.00%
0/105 • From start of the study through end of the study (up to Day 28 visit).
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
|
0.00%
0/23 • From start of the study through end of the study (up to Day 28 visit).
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
|
0.00%
0/21 • From start of the study through end of the study (up to Day 28 visit).
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
|
Other adverse events
| Measure |
Non-AD, Intradermal
n=114 participants at risk
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 AD, Intradermal
n=105 participants at risk
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 AD, Intramuscular
n=105 participants at risk
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-AD, Intramuscular
n=23 participants at risk
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 AD, Intradermal
n=21 participants at risk
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).
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/114 • From start of the study through end of the study (up to Day 28 visit).
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
|
0.00%
0/105 • From start of the study through end of the study (up to Day 28 visit).
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
|
0.95%
1/105 • Number of events 1 • From start of the study through end of the study (up to Day 28 visit).
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
|
0.00%
0/23 • From start of the study through end of the study (up to Day 28 visit).
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
|
0.00%
0/21 • From start of the study through end of the study (up to Day 28 visit).
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
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/114 • From start of the study through end of the study (up to Day 28 visit).
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
|
0.00%
0/105 • From start of the study through end of the study (up to Day 28 visit).
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
|
0.95%
1/105 • Number of events 1 • From start of the study through end of the study (up to Day 28 visit).
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
|
0.00%
0/23 • From start of the study through end of the study (up to Day 28 visit).
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
|
0.00%
0/21 • From start of the study through end of the study (up to Day 28 visit).
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
|
Additional Information
Director, Clinical Research Operations Program
DAIT/NIAID
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place