Dermatitis, Atopic
Conditions
Keywords
Influenza Vaccines, Dermatitis, Injections, Intradermal, Injections, Intramuscular, Skin Diseases, Skin Diseases, Eczematous, Hypersensitivity, Immediate, Hypersensitivity, Immune System Diseases, Genetic Diseases, Inborn, Skin Diseases, Genetic
Brief summary
Atopic dermatitis, also called eczema, is a disease in which the skin is dry and scaly with severe itching. People who have atopic dermatitis often have complications from skin infections; these can include eczema herpeticum after herpes simplex virus infection or eczema vaccinatum after smallpox vaccination. People with atopic dermatitis may suffer from skin infections and may therefore respond differently to vaccinations. A new flu vaccine which is injected into the skin instead of into muscle has recently been approved by the Food and Drug Administration for vaccination of the general population including patients with atopic dermatitis. This new vaccine has been shown to work as well as the vaccine which is injected into muscle when tested in people without atopic dermatitis. The main purpose of this study is to compare how people with atopic dermatitis respond to this new flu vaccine compared to non-atopic volunteers without atopic dermatitis. The second purpose is to look at how people with atopic dermatitis respond to the new vaccine which is injected into the skin compared to the vaccine which is injected into muscle.
Interventions
BIOLOGICALFluzone® Intradermal Vaccine
A 0.1mL single-dose, in a latex-free, pre-filled microinjection system with an ultra-fine micro-needle. The active substance is prepared from influenza viruses propagated in embryonated chicken eggs. Fluzone® Intradermal is approved for use in persons 18 through 64 years of age and will be purchased from Sanofi Pasteur, Inc.
BIOLOGICALFluzone® (Intramuscular) vaccine
A 0.5 mL single-dose delivered via syringe using single-dose vials. The active substance is prepared from influenza viruses propagated in embryonated chicken eggs. Fluzone® for intramuscular injection is approved for persons 6 months and older and will be purchased from Sanofi Pasteur, Inc.
Sponsors
Atopic Dermatitis Research Network
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Enrolled in the ADRN Registry study; * Active, mild to severe AD (lesions present) with or without a history of eczema herpeticum or who are non-atopic as diagnosed using the ADRN Standard Diagnostic Criteria; and * Willing to sign the informed consent form prior to initiation of any study procedure.
Exclusion criteria
* Pregnant or lactating. Women of child bearing potential must avoid becoming pregnant (use of an effective method of contraception or abstinence) for the duration of their participation in the study; * Have a known allergy to any component of the Fluzone® Intradermal or Fluzone® (Intramuscular) vaccines, including egg protein, or have had a severe allergic reaction to a previous dose of any influenza vaccine; * known or suspected congenital or acquired immunodeficiency or who have had immunosuppressive therapy (excluding steroids) such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; * Received systemic steroid therapy for 2 or more weeks at a dose ≥ 20 mg/day prednisone equivalent within 1 month prior to the day of vaccination or expect to receive within 3 weeks post-vaccination; * Received a cumulative dose of inhaled and/or intranasally administered corticosteroids ≥ 880 mcg/day fluticasone equivalent for 2 or more weeks within 1 month prior to the day of vaccination or expect to receive within 3 weeks post-vaccination; * A chronic illness, including but not limited to, cardiac, renal, or auto-immune disorders, or diabetes, at a stage that could interfere with study conduct or completion, based on the opinion of the Investigator. Asthma and underlying allergic conditions such as allergic rhinitis are not exclusionary; * A neoplastic disease or any hematologic malignancy. Participants who have been disease free for at least six months will not be excluded; * Participated in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the four weeks preceding the study vaccination or who plan to participate in another clinical trial during the present study period; * Any skin disease other than AD that might compromise the stratum corneum barrier (e.g., bullous disease, psoriasis, cutaneous T cell lymphoma \[also called Mycosis Fungoides or Sezary syndrome\], dermatitis herpetiformis, Hailey-Hailey, or Darier's disease); * Received blood or blood-derived products that might interfere with the assessment of immune response in the past 3 months prior to vaccination or who plan to receive such products during the study period; * Received previous vaccination (Fluzone® or another vaccine) against influenza in the past 6 months prior to vaccination; * Received any other live vaccines within 4 weeks or inactivated vaccines within 2 weeks prior to study vaccination or who plan to receive any vaccination during the study period; * Thrombocytopenia or bleeding disorder in the 3 weeks preceding vaccination; * Personal or family history of Guillain-Barré Syndrome; * A first degree relative already enrolled in the study; * Determined to be ineligible based on the opinion of the Investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seroprotection, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza B | Day 28 post vaccination | 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. |
| Seroprotection, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza H1N1 | Day 28 Post Vaccination | 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. |
| Seroprotection, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza H3N2 | Day 28 Post Vaccination | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Seroprotection, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza B | Day 28 post vaccination | 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. |
| Seroprotection, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza H1N1 | Day 28 Post Vaccination | 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. |
| Seroprotection, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza H3N2 | Day 28 Post Vaccination | 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. |
| Seroconversion, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza B | Day 28 Post Vaccination | 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. |
| 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 | Day 28 post vaccination | 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. |
| Seroconversion, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza H3N2 | Day 28 Post Vaccination | 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. |
| Seroconversion, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza B | Day 28 Post Vaccination | 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. |
| Seroconversion, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza H1N1 | Day 28 Post Vaccination | 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. |
| Seroconversion, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza H3N2 | Day 28 Post Vaccination | 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. |
| Seroconversion, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe AD, Intradermal - Influenza H1N1 | Day 28 Post Vaccination | 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. |
| 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 | Day 28 post vaccination | 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. |
| 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 | Day 28 post vaccination | 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. |
Countries
United States
Participant flow
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
Participants by arm
| Arm | Count |
|---|---|
| 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). | 114 |
| 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). | 105 |
| 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. | 105 |
| 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 | 23 |
| 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). | 21 |
| Total | 368 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 2 | 2 | 0 | 0 |
| Overall Study | Vaccinated in Error/Ineligible | 1 | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Non-AD, Intradermal | Moderate to Severe AD, Intradermal | Moderate to Severe AD, Intramuscular | Non-AD, Intramuscular | Mild AD, Intradermal | Total |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 2 Participants | 4 Participants | 0 Participants | 1 Participants | 7 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 114 Participants | 103 Participants | 101 Participants | 23 Participants | 20 Participants | 361 Participants |
| Age, Continuous | 38.82 years STANDARD_DEVIATION 11.96 | 35.11 years STANDARD_DEVIATION 11.29 | 36.39 years STANDARD_DEVIATION 12.04 | 34.30 years STANDARD_DEVIATION 9.79 | 36.43 years STANDARD_DEVIATION 14.14 | 36.65 years STANDARD_DEVIATION 11.85 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 9 Participants | 11 Participants | 7 Participants | 4 Participants | 41 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 104 Participants | 96 Participants | 94 Participants | 16 Participants | 17 Participants | 327 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 8 Participants | 5 Participants | 2 Participants | 0 Participants | 20 Participants |
| Race (NIH/OMB) Black or African American | 22 Participants | 33 Participants | 43 Participants | 3 Participants | 11 Participants | 112 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 5 Participants | 2 Participants | 0 Participants | 0 Participants | 10 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) White | 80 Participants | 57 Participants | 53 Participants | 16 Participants | 10 Participants | 216 Participants |
| Region of Enrollment United States | 114 participants | 105 participants | 105 participants | 23 participants | 21 participants | 368 participants |
| Seroprotected at Baseline - influenza B | 9 Participants | 5 Participants | 11 Participants | 5 Participants | 1 Participants | 31 Participants |
| Seroprotected at Baseline - influenza H1N1 | 52 Participants | 45 Participants | 55 Participants | 12 Participants | 9 Participants | 173 Participants |
| Seroprotected at Baseline - influenza H3N2 | 51 Participants | 45 Participants | 55 Participants | 12 Participants | 9 Participants | 172 Participants |
| Sex: Female, Male Female | 67 Participants | 58 Participants | 60 Participants | 12 Participants | 10 Participants | 207 Participants |
| Sex: Female, Male Male | 47 Participants | 47 Participants | 45 Participants | 11 Participants | 11 Participants | 161 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 114 | 0 / 105 | 1 / 105 | 0 / 23 | 0 / 21 |
| serious Total, serious adverse events | 1 / 114 | 1 / 105 | 0 / 105 | 0 / 23 | 0 / 21 |
Outcome results
Primary
Seroprotection, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza B
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Moderate to Severe AD, Intradermal | Seroprotection, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza B | 34.4 percentage of participants |
| Non-AD, Intradermal | Seroprotection, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza B | 22.5 percentage of participants |
p-value: 0.08295% CI: [0.92, 3.55]Fisher Exact
Primary
Seroprotection, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza H1N1
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Moderate to Severe AD, Intradermal | Seroprotection, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza H1N1 | 84.1 percentage of participants |
| Non-AD, Intradermal | Seroprotection, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza H1N1 | 86.4 percentage of participants |
p-value: 0.80195% CI: [0.26, 2.56]Fisher Exact
Primary
Seroprotection, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza H3N2
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Moderate to Severe AD, Intradermal | Seroprotection, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza H3N2 | 84.7 percentage of participants |
| Non-AD, Intradermal | Seroprotection, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza H3N2 | 73.3 percentage of participants |
p-value: 0.17795% CI: [0.75, 5.71]Fisher Exact
Secondary
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
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
Population: 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 | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Moderate to Severe AD, Intradermal | 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 |
| Non-AD, Intradermal | 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 | 2.0 HAI antibody titers |
p-value: 0.09295% CI: [0.96, 1.61]ANCOVA
Secondary
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
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
Population: 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 | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Moderate to Severe AD, Intradermal | 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 |
| Non-AD, Intradermal | 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 | 37.7 HAI antibody titers |
p-value: 0.10395% CI: [0.32, 1.11]ANCOVA
Secondary
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
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
Population: 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 | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Moderate to Severe AD, Intradermal | 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 |
| Non-AD, Intradermal | 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 | 9.7 HAI antibody titers |
p-value: 0.89595% CI: [0.6, 1.8]ANCOVA
Secondary
Seroconversion, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza B
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Moderate to Severe AD, Intradermal | Seroconversion, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza B | 40.6 percentage of participants |
| Non-AD, Intradermal | Seroconversion, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza B | 47.8 percentage of participants |
p-value: 0.37895% CI: [0.4, 1.38]Fisher Exact
Secondary
Seroconversion, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza H1N1
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Moderate to Severe AD, Intradermal | Seroconversion, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza H1N1 | 85.7 percentage of participants |
| Non-AD, Intradermal | Seroconversion, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza H1N1 | 88.7 percentage of participants |
p-value: 0.78395% CI: [0.21, 2.62]Fisher Exact
Secondary
Seroconversion, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza H3N2
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Moderate to Severe AD, Intradermal | Seroconversion, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza H3N2 | 76.3 percentage of participants |
| Non-AD, Intradermal | Seroconversion, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza H3N2 | 87.8 percentage of participants |
p-value: 0.14395% CI: [0.13, 1.39]Fisher Exact
Secondary
Seroconversion, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe AD, Intradermal - Influenza H1N1
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Moderate to Severe AD, Intradermal | Seroconversion, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe AD, Intradermal - Influenza H1N1 | 85.7 percentage of participants |
| Non-AD, Intradermal | Seroconversion, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe AD, Intradermal - Influenza H1N1 | 88.1 percentage of participants |
p-value: 0.79195% CI: [0.24, 2.65]Fisher Exact
Secondary
Seroconversion, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza B
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Moderate to Severe AD, Intradermal | Seroconversion, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza B | 40.6 percentage of participants |
| Non-AD, Intradermal | Seroconversion, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza B | 30.4 percentage of participants |
p-value: 0.1495% CI: [0.84, 2.94]Fisher Exact
Secondary
Seroconversion, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza H3N2
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Moderate to Severe AD, Intradermal | Seroconversion, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza H3N2 | 76.3 percentage of participants |
| Non-AD, Intradermal | Seroconversion, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza H3N2 | 73.3 percentage of participants |
p-value: 0.83395% CI: [0.47, 2.92]Fisher Exact
Secondary
Seroprotection, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza B
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Moderate to Severe AD, Intradermal | Seroprotection, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza B | 34.4 percentage of participants |
| Non-AD, Intradermal | Seroprotection, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza B | 33.7 percentage of participants |
p-value: >0.99995% CI: [0.54, 1.97]Fisher Exact
Secondary
Seroprotection, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza H1N1
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Moderate to Severe AD, Intradermal | Seroprotection, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza H1N1 | 84.1 percentage of participants |
| Non-AD, Intradermal | Seroprotection, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza H1N1 | 92.5 percentage of participants |
p-value: 0.25395% CI: [0.09, 1.63]Fisher Exact
Secondary
Seroprotection, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza H3N2
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Moderate to Severe AD, Intradermal | Seroprotection, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza H3N2 | 84.7 percentage of participants |
| Non-AD, Intradermal | Seroprotection, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza H3N2 | 93.9 percentage of participants |
p-value: 0.21895% CI: [0.06, 1.58]Fisher Exact