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Atopic Dermatitis Research Network (ADRN) Influenza Vaccine Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01737710
First Posted: November 29, 2012
Last Update Posted: March 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Atopic Dermatitis Research Network
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
Results First Submitted: November 8, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Dermatitis, Atopic
Interventions: Biological: Fluzone® Intradermal Vaccine
Biological: Fluzone® (Intramuscular) vaccine

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
464 participants between the ages of 18 to 64 years were recruited and 368 of those participants were enrolled at 5 sites in the US between 10/2012 and 03/2013

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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).

Participant Flow:   Overall Study
    Non-AD, Intradermal   Moderate to Severe AD, Intradermal   Moderate to Severe AD, Intramuscular   Non-AD, Intramuscular   Mild AD, Intradermal
STARTED   114   105   105   23   21 
COMPLETED   112   101   102   23   21 
NOT COMPLETED   2   4   3   0   0 
Lost to Follow-up                0                2                2                0                0 
Withdrawal by Subject                1                1                1                0                0 
Vaccinated in Error/Ineligible                1                1                0                0                0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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).
Total Total of all reporting groups

Baseline Measures
   Non-AD, Intradermal   Moderate to Severe AD, Intradermal   Moderate to Severe AD, Intramuscular   Non-AD, Intramuscular   Mild AD, Intradermal   Total 
Overall Participants Analyzed 
[Units: Participants]
 114   105   105   23   21   368 
Age 
[Units: Participants]
Count of Participants
           
<=18 years      0   0.0%      2   1.9%      4   3.8%      0   0.0%      1   4.8%      7   1.9% 
Between 18 and 65 years      114 100.0%      103  98.1%      101  96.2%      23 100.0%      20  95.2%      361  98.1% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 38.82  (11.96)   35.11  (11.29)   36.39  (12.04)   34.30  (9.79)   36.43  (14.14)   36.65  (11.85) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
           
Female      67  58.8%      58  55.2%      60  57.1%      12  52.2%      10  47.6%      207  56.3% 
Male      47  41.2%      47  44.8%      45  42.9%      11  47.8%      11  52.4%      161  43.8% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
           
Hispanic or Latino      10   8.8%      9   8.6%      11  10.5%      7  30.4%      4  19.0%      41  11.1% 
Not Hispanic or Latino      104  91.2%      96  91.4%      94  89.5%      16  69.6%      17  81.0%      327  88.9% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
           
American Indian or Alaska Native      2   1.8%      1   1.0%      1   1.0%      1   4.3%      0   0.0%      5   1.4% 
Asian      5   4.4%      8   7.6%      5   4.8%      2   8.7%      0   0.0%      20   5.4% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      22  19.3%      33  31.4%      43  41.0%      3  13.0%      11  52.4%      112  30.4% 
White      80  70.2%      57  54.3%      53  50.5%      16  69.6%      10  47.6%      216  58.7% 
More than one race      3   2.6%      5   4.8%      2   1.9%      0   0.0%      0   0.0%      10   2.7% 
Unknown or Not Reported      2   1.8%      1   1.0%      1   1.0%      1   4.3%      0   0.0%      5   1.4% 
Region of Enrollment 
[Units: Participants]
           
United States   114   105   105   23   21   368 
Seroprotected at Baseline – influenza B [1] 
[Units: Participants]
Count of Participants
 9   5   11   5   1   31 
[1] The number of participants that achieved seroprotection against influenza B at baseline prior to vaccination. Seroprotection is defined as having a serum hemagglutination-inhibition [HAI] antibody titer of 1:40 or greater, which represents a sufficient antibody amount to avoid disease in half of the individuals infected with influenza B. The goal of the study was to examine the immune response to influenza vaccination against influenza B. Participants who were already seroprotected against influenza B prior to vaccination were excluded from all relevant analyses for influenza B.
Seroprotected at Baseline – influenza H1N1 [1] 
[Units: Participants]
Count of Participants
 52   45   55   12   9   173 
[1] The number of participants that achieved seroprotection against influenza H1N1 at baseline prior to vaccination. Seroprotection is defined as having a serum hemagglutination-inhibition [HAI] antibody titer of 1:40 or greater, which represents a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H1N1. The goal of the study was to examine the immune response to influenza vaccination against influenza H1N1. Participants who were already seroprotected against influenza H1N1 prior to vaccination were excluded from all relevant analyses for influenza H1N1.
Seroprotected at Baseline – influenza H3N2 [1] 
[Units: Participants]
Count of Participants
 51   45   55   12   9   172 
[1] The number of participants that achieved seroprotection against influenza H3N2 at baseline prior to vaccination. Seroprotection is defined as having a serum hemagglutination-inhibition [HAI] antibody titer of 1:40 or greater, which represents a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H3N2. The goal of the study was to examine the immune response to influenza vaccination against influenza H3N2. Participants who were already seroprotected against influenza H3N2 prior to vaccination were excluded from all relevant analyses for influenza H3N2.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Seroprotection, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal – Influenza B   [ Time Frame: Day 28 post vaccination ]

2.  Primary:   Seroprotection, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal – Influenza H1N1   [ Time Frame: Day 28 Post Vaccination ]

3.  Primary:   Seroprotection, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal – Influenza H3N2   [ Time Frame: Day 28 Post Vaccination ]

4.  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   [ Time Frame: Day 28 post vaccination ]

5.  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   [ Time Frame: Day 28 post vaccination ]

6.  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   [ Time Frame: Day 28 post vaccination ]

7.  Secondary:   Seroprotection, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular – Influenza B   [ Time Frame: Day 28 post vaccination ]

8.  Secondary:   Seroprotection, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular – Influenza H1N1   [ Time Frame: Day 28 Post Vaccination ]

9.  Secondary:   Seroprotection, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular – Influenza H3N2   [ Time Frame: Day 28 Post Vaccination ]

10.  Secondary:   Seroconversion, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal – Influenza B   [ Time Frame: Day 28 Post Vaccination ]

11.  Secondary:   Seroconversion, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe AD, Intradermal – Influenza H1N1   [ Time Frame: Day 28 Post Vaccination ]

12.  Secondary:   Seroconversion, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal – Influenza H3N2   [ Time Frame: Day 28 Post Vaccination ]

13.  Secondary:   Seroconversion, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular – Influenza B   [ Time Frame: Day 28 Post Vaccination ]

14.  Secondary:   Seroconversion, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular – Influenza H1N1   [ Time Frame: Day 28 Post Vaccination ]

15.  Secondary:   Seroconversion, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular – Influenza H3N2   [ Time Frame: Day 28 Post Vaccination ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Director, Clinical Research Operations Program
Organization: DAIT/NIAID
phone: 301-594-7669
e-mail: DAITClinicalTrialsGov@niaid.nih.gov


Publications of Results:
Other Publications:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01737710     History of Changes
Other Study ID Numbers: DAIT ADRN-05
First Submitted: November 27, 2012
First Posted: November 29, 2012
Results First Submitted: November 8, 2016
Results First Posted: January 6, 2017
Last Update Posted: March 29, 2017