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Trial record 1 of 21 for:    H1N1 AND asthma
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Safety and Efficacy of an H1N1 Influenza Vaccine in People With Asthma

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ClinicalTrials.gov Identifier: NCT00978120
Recruitment Status : Completed
First Posted : September 16, 2009
Results First Posted : August 6, 2012
Last Update Posted : August 10, 2012
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition H1N1 Influenza Virus
Interventions Biological: H1N1 vaccine high dose
Biological: H1N1 vaccine low dose
Enrollment 390

Recruitment Details Study participants were recruited from October 16 to November 13, 2009 at the seven National Heart, Lung, and Blood Institute (NHLBI)- funded Severe Asthma Research Program sites.
Pre-assignment Details  
Arm/Group Title Mild/Moderate Asthma, Low Dose Vaccine (15mcg) Mild/Moderate Asthma, High Dose Vaccine (30mcg) Severe Asthma, Low Dose Vaccine (15mcg) Severe Asthma, High Dose Vaccine (30mcg)
Hide Arm/Group Description Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21. Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21. Participants with severe asthma received one 15 mcg dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.

Participants with severe asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.

[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)

Period Title: Overall Study
Started 110 107 87 86
Completed 108 107 84 84
Not Completed 2 0 3 2
Reason Not Completed
Death             0             0             0             1
Lost to Follow-up             0             0             3             0
Withdrawal by Subject             2             0             0             0
Moved out of state             0             0             0             1
Arm/Group Title Mild/Moderate Asthma, Low Dose Vaccine (15mcg) Mild/Moderate Asthma, High Dose Vaccine (30mcg) Severe Asthma, Low Dose Vaccine (15mcg) Severe Asthma, High Dose Vaccine (30mcg) Total
Hide Arm/Group Description Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21. Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21. Participants with severe asthma received one 15 mcg dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.

Participants with severe asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.

[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)

Total of all reporting groups
Overall Number of Baseline Participants 110 107 87 86 390
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants 107 participants 87 participants 86 participants 390 participants
<=18 years
22
  20.0%
23
  21.5%
12
  13.8%
10
  11.6%
67
  17.2%
Between 18 and 65 years
80
  72.7%
79
  73.8%
67
  77.0%
68
  79.1%
294
  75.4%
>=65 years
8
   7.3%
5
   4.7%
8
   9.2%
8
   9.3%
29
   7.4%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 110 participants 107 participants 87 participants 86 participants 390 participants
39.1  (18.1) 36.3  (17.0) 45.2  (17.0) 46.5  (17.3) 41.3  (17.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants 107 participants 87 participants 86 participants 390 participants
Female
72
  65.5%
62
  57.9%
52
  59.8%
45
  52.3%
231
  59.2%
Male
38
  34.5%
45
  42.1%
35
  40.2%
41
  47.7%
159
  40.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 110 participants 107 participants 87 participants 86 participants 390 participants
110 107 87 86 390
Age at Asthma Onset   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 110 participants 107 participants 87 participants 86 participants 390 participants
17.1  (17.0) 16.4  (14.9) 21.9  (19.7) 21.9  (20.1) 19.0  (17.9)
[1]
Measure Description: The age at asthma onset is the age defined in years when the participant was told by a physician that he/she has asthma. This was calculated by subtracting the participant’s age at the baseline visit (visit 1) from the number of years the participant reported to have known having asthma.
Asthma Duration   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 110 participants 107 participants 87 participants 86 participants 390 participants
21.9  (13.9) 19.9  (13.4) 23.3  (16.5) 24.6  (17.8) 22.3  (15.3)
[1]
Measure Description: Asthma duration is the number of years since the participant was told by a physician that he/she has asthma as reported at the baseline visit, visit 1.
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 110 participants 107 participants 87 participants 86 participants 390 participants
29.5  (8.5) 28.5  (6.8) 31.8  (9.7) 30.1  (8.0) 29.9  (8.3)
[1]
Measure Description:

BMI is a number calculated from a person’s height and weight that provides a reliable indicator of body fatness for most people. Higher values reflect greater amount of body fat. [1] In adults, a BMI less than 18.5 is underweight; 18.5 to 24.9 is a normal or healthy weight; greater than or equal to 25.0 is overweight. The height and weight was collected at baseline only.

[1]: Healthy Weight , Assessing Your Weight , Body Mass Index http://www.cdc.gov/healthyweight/assessing/bmi/index.html

Forced Expiratory Volume in 1 second (FEV1) % Predicted   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage
Number Analyzed 110 participants 107 participants 87 participants 86 participants 390 participants
83.8  (16.3) 86.6  (17.6) 72.6  (19.4) 69.8  (20.8) 79.0  (19.7)
[1]
Measure Description: FEV1 is air volume exhaled in 1 second during spirometry. Asthma severity classification for trial: mild--pre-bronchodilator FEV1 ≥ 80% predicted requiring no/ low-moderate dose of inhaled glucocorticoids; moderate--pre-bronchodilator FEV1 <80% predicted requiring no/ low-moderate dose of inhaled glucocorticoids; severe--requiring high-dose inhaled glucocorticoids with/without continuous/near continuous oral glucocorticoids, or uncontrolled despite treatment. FEV1 percent of predicted value is FEV1 converted to a percentage of normal, based on height, weight, and race.
Forced Vital Capacity (FVC) % Predicted   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage
Number Analyzed 110 participants 107 participants 87 participants 86 participants 390 participants
92.6  (14.3) 94.3  (16.1) 85.0  (17.1) 80.9  (18.7) 88.8  (17.3)
[1]
Measure Description: FVC is a lung function test that measures the total amount of air exhaled. The percent of predicted value is FVC converted to a percentage of normal, based on height, weight, and race. Estimates of severity of abnormalities in flow volume measured by FVC: Mild-65-80% of predicted value; Moderate-50-65% of predicted value; Severe-<50% of predicted value.
FEV1/FVC Ratio   [1] 
Mean (Standard Deviation)
Unit of measure:  Ratio (x 100)
Number Analyzed 110 participants 107 participants 87 participants 86 participants 390 participants
74.5  (9.07) 75.7  (8.99) 68.4  (10.91) 68.4  (11.76) 72.1  (10.62)
[1]
Measure Description:

The FEV1 (forced expiratory volume 1))/ FVC (forced vital capacity) ratio is used to evaluate airways obstructions since pure restrictive ventilatory defects cause an equal reduction in the FEV1 and the FVC. An FEV1/FVC ratio below 80% indicates airflow obstruction. Normal FEV1/FVC: 8 – 19 years of age=85%; 20-39 years of age=80%; 40- 59 years of age 75%; 60-80 years of age 70% [1]

[1]: National Asthma Education and Prevention Program Expert Panel Report 3, Guidelines for the Diagnosis and Management of Asthma. Oct. 2007. http://www.nhlbi.nih.gov/guidelines/asthma/asthsumm.pdf

1.Primary Outcome
Title Percentage of Participants With Serious Adverse Events (SAEs) Attributed To Vaccination
Hide Description Percentage of participants with serious adverse events (SAEs) attributed to vaccination, as determined by site investigators at the time of reporting.
Time Frame Measured at Baseline Visit and Days 1, 8, 21, 28, 41, 80, 120, and 201
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mild/Moderate Asthma, Low Dose Vaccine (15mcg) Mild/Moderate Asthma, High Dose Vaccine (30mcg) Severe Asthma, Low Dose Vaccine (15mcg) Severe Asthma, High Dose Vaccine (30mcg)
Hide Arm/Group Description:
Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
Participants with severe asthma received one 15 mcg dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.

Participants with severe asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.

[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)

Overall Number of Participants Analyzed 110 107 87 86
Measure Type: Number
Unit of Measure: percentage of participants
1 0 3 0
2.Primary Outcome
Title Percentage of Participants With Reactogenicity Adverse Events (AEs) Status Post Vaccine 1
Hide Description Percentage of participants with reactogenicity AEs, local (erythema, ecchymosis, induration, pain and tenderness at the injection sites) and systemic (feverishness, chills, fatigue, myalgias, arthralgias, headache and nausea), within 8 Days After Vaccination 1 by Dose Level Group.
Time Frame Days 1 through 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mild/Moderate Asthma, Low Dose Vaccine (15mcg) Mild/Moderate Asthma, High Dose Vaccine (30mcg) Severe Asthma, Low Dose Vaccine (15mcg) Severe Asthma, High Dose Vaccine (30mcg)
Hide Arm/Group Description:
Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
Participants with severe asthma received one 15 mcg dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.

Participants with severe asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.

[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)

Overall Number of Participants Analyzed 110 107 87 86
Measure Type: Number
Unit of Measure: percentage of participants
Systemic 58 63 64 74
Local 55 54 33 52
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mild/Moderate Asthma, Low Dose Vaccine (15mcg), Mild/Moderate Asthma, High Dose Vaccine (30mcg), Severe Asthma, Low Dose Vaccine (15mcg), Severe Asthma, High Dose Vaccine (30mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
3.Primary Outcome
Title Percentage of Participants With Reactogenicity Adverse Events (AEs) Status Post Vaccine 2
Hide Description Percentage of participants with reactogenicity AEs, local (erythema, ecchymosis, induration, pain and tenderness at the injection sites) and systemic (feverishness, chills, fatigue, myalgias, arthralgias, headache and nausea), within 8 Days After Vaccination 2 by Dose Level Group.
Time Frame Days 21 through 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mild/Moderate Asthma, Low Dose Vaccine (15mcg) Mild/Moderate Asthma, High Dose Vaccine (30mcg) Severe Asthma, Low Dose Vaccine (15mcg) Severe Asthma, High Dose Vaccine (30mcg)
Hide Arm/Group Description:
Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
Participants with severe asthma received one 15 mcg dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.

Participants with severe asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.

[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)

Overall Number of Participants Analyzed 102 99 80 76
Measure Type: Number
Unit of Measure: percentage of participants
Systemic 47 47 48 42
Local 46 60 29 38
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mild/Moderate Asthma, Low Dose Vaccine (15mcg), Mild/Moderate Asthma, High Dose Vaccine (30mcg), Severe Asthma, Low Dose Vaccine (15mcg), Severe Asthma, High Dose Vaccine (30mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
4.Primary Outcome
Title Percentage of Participants With Asthma Exacerbations Status Post Vaccine 1
Hide Description Percentage of participants with asthma exacerbations within 8 days after vaccination 1. Any of the following events are considered asthma exacerbation: Increase in the daily use of bronchodilator rescue medication for 2 consecutive days; an increase is defined as ≥6puffs of bronchodilator from a metered-dose inhaler or ≥2 uses of nebulized albuterol above average use reported in the two weeks prior to Visit 1. Increase in use of systemic corticosteroids or the addition of systemic corticosteroids to treatment regimen for asthma. Unscheduled use of health care for the treatment of asthma.
Time Frame Days 1 to 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mild/Moderate Asthma, Low Dose Vaccine (15mcg) Mild/Moderate Asthma, High Dose Vaccine (30mcg) Severe Asthma, Low Dose Vaccine (15mcg) Severe Asthma, High Dose Vaccine (30mcg)
Hide Arm/Group Description:
Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
Participants with severe asthma received one 15 mcg dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.

Participants with severe asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.

[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)

Overall Number of Participants Analyzed 110 107 87 86
Measure Type: Number
Unit of Measure: percentage of participants
4 2 8 3
5.Primary Outcome
Title Percentage of Participants With Asthma Exacerbations Status Post Vaccination 2
Hide Description Percentage of participants with asthma exacerbations within 8 days after vaccination 2. Any of the following events are considered asthma exacerbation: Increase in the daily use of bronchodilator rescue medication for 2 consecutive days; an increase is defined as ≥6puffs of bronchodilator from a metered-dose inhaler or ≥2 uses of nebulized albuterol above average use reported in the two weeks prior to Visit 1. Increase in use of systemic corticosteroids or the addition of systemic corticosteroids to treatment regimen for asthma. Unscheduled use of health care for the treatment of asthma.
Time Frame Days 21 to 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mild/Moderate Asthma, Low Dose Vaccine (15mcg) Mild/Moderate Asthma, High Dose Vaccine (30mcg) Severe Asthma, Low Dose Vaccine (15mcg) Severe Asthma, High Dose Vaccine (30mcg)
Hide Arm/Group Description:
Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
Participants with severe asthma received one 15 mcg dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.

Participants with severe asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.

[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)

Overall Number of Participants Analyzed 102 99 80 76
Measure Type: Number
Unit of Measure: percentage of participants
4 1 3 6
6.Primary Outcome
Title Percentage of Participants With Seroconversion at Day 28 Following Two Administrations of Vaccination, Mild-Moderate Asthmatics
Hide Description Seroconversion: The percentage of participants with a four-fold or greater hemagglutination inhibition assay (HAI) antibody titer increase compared to baseline against the novel influenza hemagglutinin type 1 and neuraminidase type 1 (H1N1) 2009 virus following two administrations of Novartis H1N1 vaccine at each dose, combined across age groups.
Time Frame Days 1 to 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mild/Moderate Asthma, Low Dose Vaccine (15mcg) Mild/Moderate Asthma, High Dose Vaccine (30mcg)
Hide Arm/Group Description:
Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.

Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.

[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)

Overall Number of Participants Analyzed 103 97
Measure Type: Number
Unit of Measure: percentage of participants
80.6 86.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mild/Moderate Asthma, Low Dose Vaccine (15mcg), Mild/Moderate Asthma, High Dose Vaccine (30mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.341
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
7.Primary Outcome
Title Percentage of Participants With Seroconversion at Day 28 Following Two Administrations of Vaccination, Severe Asthmatics
Hide Description Seroconversion: The percentage of participants with a four-fold or greater hemagglutination inhibition assay (HAI) antibody titer increase compared to baseline against the novel influenza hemagglutinin type 1 and neuraminidase type 1 (H1N1) 2009 virus following two administrations of Novartis H1N1 vaccine at each dose, combined across age groups.
Time Frame Days 1 to 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Severe Asthma, Low Dose Vaccine (15mcg) Severe Asthma, High Dose Vaccine (30mcg)
Hide Arm/Group Description:
Participants with severe asthma received one 15 mcg dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.

Participants with severe asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.

[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)

Overall Number of Participants Analyzed 77 76
Measure Type: Number
Unit of Measure: percentage of participants
68.8 85.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Severe Asthma, Low Dose Vaccine (15mcg), Severe Asthma, High Dose Vaccine (30mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.020
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
8.Primary Outcome
Title Percentage of Participants With Seroconversion at Day 41 Following Two Administrations of Vaccination, Mild-Moderate Asthmatics
Hide Description Seroconversion: The percentage of participants with a four-fold or greater hemagglutination inhibition assay (HAI) antibody titer increase compared to baseline against the novel influenza hemagglutinin type 1 and neuraminidase type 1 (H1N1) 2009 virus following two administrations of Novartis H1N1 vaccine at each dose, combined across age groups.
Time Frame Days 1 to 41
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mild/Moderate Asthma, Low Dose Vaccine (15mcg) Mild/Moderate Asthma, High Dose Vaccine (30mcg)
Hide Arm/Group Description:
Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.

Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.

[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)

Overall Number of Participants Analyzed 103 99
Measure Type: Number
Unit of Measure: percentage of participants
73.8 80.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mild/Moderate Asthma, Low Dose Vaccine (15mcg), Mild/Moderate Asthma, High Dose Vaccine (30mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.245
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
9.Primary Outcome
Title Percentage of Participants With Seroconversion at Day 41 Following Two Administrations of Vaccination, Severe Asthmatics
Hide Description Seroconversion: The percentage of participants with a four-fold or greater hemagglutination inhibition assay (HAI) antibody titer increase compared to baseline against the novel influenza hemagglutinin type 1 and neuraminidase type 1 (H1N1) 2009 virus following two administrations of Novartis H1N1 vaccine at each dose, combined across age groups.
Time Frame Days 1 to 41
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Severe Asthma, Low Dose Vaccine (15mcg) Severe Asthma, High Dose Vaccine (30mcg)
Hide Arm/Group Description:
Participants with severe asthma received one 15 mcg dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.

Participants with severe asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.

[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)

Overall Number of Participants Analyzed 76 76
Measure Type: Number
Unit of Measure: percentage of participants
72.4 82.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Severe Asthma, Low Dose Vaccine (15mcg), Severe Asthma, High Dose Vaccine (30mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.173
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
10.Primary Outcome
Title Percentage of Participants With Seroprotection at Day 28 Following Two Administrations of Vaccination, Mild-Moderate Asthmatics
Hide Description Seroprotection: The percentage of participants with a hemagglutination inhibition assay (HAI) antibody titer of 1:40 or greater against influenza H1N1 2009 virus following two administrations of the H1N1 vaccine at each dose, combined across age groups.
Time Frame Days 1 to 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mild/Moderate Asthma, Low Dose Vaccine (15mcg) Mild/Moderate Asthma, High Dose Vaccine (30mcg)
Hide Arm/Group Description:
Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.

Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.

[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)

Overall Number of Participants Analyzed 103 97
Measure Type: Number
Unit of Measure: percentage of participants
87.4 91.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mild/Moderate Asthma, Low Dose Vaccine (15mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.362
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
11.Primary Outcome
Title Percentage of Participants With Seroprotection at Day 28 Following Two Administrations of Vaccination, Severe Asthmatics
Hide Description Percentage of participants with seroprotection defined as a hemagglutination inhibition assay (HAI) antibody titer of 1:40 or greater against influenza H1N1 2009 virus following two administrations of the H1N1 vaccine at each dose, combined across age groups.
Time Frame Days 1 to 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Severe Asthma, Low Dose Vaccine (15mcg) Severe Asthma, High Dose Vaccine (30mcg)
Hide Arm/Group Description:
Participants with severe asthma received one 15 mcg dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.

Participants with severe asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.

[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)

Overall Number of Participants Analyzed 77 76
Measure Type: Number
Unit of Measure: percentage of participants
76.6 93.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Severe Asthma, Low Dose Vaccine (15mcg), Severe Asthma, High Dose Vaccine (30mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
12.Primary Outcome
Title Percentage of Participants With Seroprotection at Day 41 Following Two Administrations of Vaccination, Mild-Moderate Asthmatics
Hide Description Percentage of participants with seroprotection defined as a hemagglutination inhibition assay (HAI) antibody titer of 1:40 or greater against influenza H1N1 2009 virus following two administrations of the H1N1 vaccine at each dose, combined across age groups.
Time Frame Days 1 to 41
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mild/Moderate Asthma, Low Dose Vaccine (15mcg) Mild/Moderate Asthma, High Dose Vaccine (30mcg)
Hide Arm/Group Description:
Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.

Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.

[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)

Overall Number of Participants Analyzed 103 99
Measure Type: Number
Unit of Measure: percentage of participants
82.5 93.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mild/Moderate Asthma, Low Dose Vaccine (15mcg), Mild/Moderate Asthma, High Dose Vaccine (30mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
13.Primary Outcome
Title Percentage of Participants With Seroprotection at Day 41 Following Two Administrations of Vaccination, Severe Asthmatics
Hide Description Percentage of participants with seroprotection defined as a hemagglutination inhibition assay (HAI) antibody titer of 1:40 or greater against influenza H1N1 2009 virus following two administrations of the H1N1 vaccine at each dose, combined across age groups.
Time Frame Days 1 to 41
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Severe Asthma, Low Dose Vaccine (15mcg) Severe Asthma, High Dose Vaccine (30mcg)
Hide Arm/Group Description:
Participants with severe asthma received one 15 mcg dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.

Participants with severe asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.

[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)

Overall Number of Participants Analyzed 76 76
Measure Type: Number
Unit of Measure: percentage of participants
75.0 89.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Severe Asthma, Low Dose Vaccine (15mcg), Severe Asthma, High Dose Vaccine (30mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.032
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
14.Secondary Outcome
Title Percentage of Participants With Seroconversion at Day 21 Following Single Administration of Vaccination, Mild-Moderate Asthmatics
Hide Description Percentage of participants with seroconversion defined as a four-fold or greater hemagglutination inhibition assay (HAI) antibody titer increase compared to baseline against the novel influenza hemagglutinin type 1 and neuraminidase type 1 (H1N1) 2009 virus following a single administration of Novartis H1N1 vaccine at each dose, combined across age groups.
Time Frame Days 1 to 21
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mild/Moderate Asthma, Low Dose Vaccine (15mcg) Mild/Moderate Asthma, High Dose Vaccine (30mcg)
Hide Arm/Group Description:
Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.

Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.

[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)

Overall Number of Participants Analyzed 107 107
Measure Type: Number
Unit of Measure: percentage of participants
80.4 85.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mild/Moderate Asthma, Low Dose Vaccine (15mcg), Mild/Moderate Asthma, High Dose Vaccine (30mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.470
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
15.Secondary Outcome
Title Percentage of Participants With Seroconversion at Day 21 Following Single Administration of Vaccination, Severe Asthmatics
Hide Description Percentage of participants with seroconversion defined as a four-fold or greater hemagglutination inhibition assay(HAI) antibody titer increase compared to baseline against the novel influenza hemagglutinin type 1 and neuraminidase type 1 (H1N1) 2009 virus following a single administration of Novartis H1N1 vaccine at each dose, combined across age groups.
Time Frame Days 1 to 21
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Severe Asthma, Low Dose Vaccine (15mcg) Severe Asthma, High Dose Vaccine (30mcg)
Hide Arm/Group Description:
Participants with severe asthma received one 15 mcg dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.

Participants with severe asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.

[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)

Overall Number of Participants Analyzed 86 85
Measure Type: Number
Unit of Measure: percentage of participants
75.6 85.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Severe Asthma, Low Dose Vaccine (15mcg), Severe Asthma, High Dose Vaccine (30mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.120
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
16.Secondary Outcome
Title Percentage of Participants With Seroprotection at Day 21 Following Single Administration of Vaccination, Mild-Moderate Asthmatics
Hide Description Percentage of participants with seroprotection defined as hemagglutination inhibition assay (HAI) antibody titer of 1:40 or greater against influenza H1N1 2009 virus following a single administration of the H1N1 vaccine at each dose, combined across age groups.
Time Frame Days 1 to 21
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mild/Moderate Asthma, Low Dose Vaccine (15mcg) Mild/Moderate Asthma, High Dose Vaccine (30mcg)
Hide Arm/Group Description:
Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.

Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.

[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)

Overall Number of Participants Analyzed 107 107
Measure Type: Number
Unit of Measure: percentage of participants
90.7 95.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mild/Moderate Asthma, Low Dose Vaccine (15mcg), Mild/Moderate Asthma, High Dose Vaccine (30mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.284
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
17.Secondary Outcome
Title Percentage of Participants With Seroprotection at Day 21 Following Single Administration of Vaccination, Severe Asthmatics
Hide Description Percentage of participants with seroprotection defined as hemagglutination inhibition assay (HAI) antibody titer of 1:40 or greater against influenza H1N1 2009 virus following a single administration of the H1N1 vaccine at each dose, combined across age groups.
Time Frame Days 1 to 21
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Severe Asthma, Low Dose Vaccine (15mcg) Severe Asthma, High Dose Vaccine (30mcg)
Hide Arm/Group Description:
Participants with severe asthma received one 15 mcg dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.

Participants with severe asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.

[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)

Overall Number of Participants Analyzed 86 85
Measure Type: Number
Unit of Measure: percentage of participants
77.9 94.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Severe Asthma, Low Dose Vaccine (15mcg), Severe Asthma, High Dose Vaccine (30mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame Enrollment through last day of followup (Day 201, target last day)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mild/Moderate Asthma, Low Dose Vaccine (15 Mcg) Mild/Moderate Asthma, High Dose Vaccine (30mcg) Severe Asthma, Low Dose Vaccine (15mcg) Severe Asthma, High Dose Vaccine (30mcg)
Hide Arm/Group Description Participants with mild/moderate asthma received one 15 mcg dose of unadjuvanted, inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21. Participants with mild/moderate asthma received two 15 mcg doses of unadjuvanted, inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21. Participants with severe asthma received one 15 mcg dose of unadjuvanted, inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21. Participants with severe asthma received two 15 mcg doses of unadjuvanted, inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
All-Cause Mortality
Mild/Moderate Asthma, Low Dose Vaccine (15 Mcg) Mild/Moderate Asthma, High Dose Vaccine (30mcg) Severe Asthma, Low Dose Vaccine (15mcg) Severe Asthma, High Dose Vaccine (30mcg)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Mild/Moderate Asthma, Low Dose Vaccine (15 Mcg) Mild/Moderate Asthma, High Dose Vaccine (30mcg) Severe Asthma, Low Dose Vaccine (15mcg) Severe Asthma, High Dose Vaccine (30mcg)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4.0/110.0 (3.64%)      4.0/107.0 (3.74%)      12.0/87.0 (13.79%)      6.0/86.0 (6.98%)    
Cardiac disorders         
Atrial flutter  1  1/110 (0.91%)  1 0/107 (0.00%)  0 0/87 (0.00%)  0 0/86 (0.00%)  0
Gastrointestinal disorders         
Pancreatitis  1  0/110 (0.00%)  0 0/107 (0.00%)  0 0/87 (0.00%)  0 1/86 (1.16%)  1
Small intestinal obstruction  1  0/110 (0.00%)  0 0/107 (0.00%)  0 1/87 (1.15%)  1 0/86 (0.00%)  0
Umbilical hernia  1  0/110 (0.00%)  0 0/107 (0.00%)  0 0/87 (0.00%)  0 1/86 (1.16%)  1
General disorders         
Abasia  1  0/110 (0.00%)  0 0/107 (0.00%)  0 1/87 (1.15%)  1 0/86 (0.00%)  0
Chest pain  1  0/110 (0.00%)  0 0/107 (0.00%)  0 1/87 (1.15%)  1 0/86 (0.00%)  0
Death  1  0/110 (0.00%)  0 0/107 (0.00%)  0 0/87 (0.00%)  0 1/86 (1.16%)  1
Infections and infestations         
Diverticulitis  1  0/110 (0.00%)  0 0/107 (0.00%)  0 1/87 (1.15%)  1 0/86 (0.00%)  0
Localised infection  1  0/110 (0.00%)  0 0/107 (0.00%)  0 1/87 (1.15%)  1 0/86 (0.00%)  0
Pneumonia  1  1/110 (0.91%)  1 1/107 (0.93%)  1 0/87 (0.00%)  0 0/86 (0.00%)  0
Injury, poisoning and procedural complications         
Road traffic accident  1  0/110 (0.00%)  0 1/107 (0.93%)  1 0/87 (0.00%)  0 0/86 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Pain in extremity  1  0/110 (0.00%)  0 1/107 (0.93%)  1 0/87 (0.00%)  0 0/86 (0.00%)  0
Spinal osteoarthritis  1  1/110 (0.91%)  1 0/107 (0.00%)  0 0/87 (0.00%)  0 0/86 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Breast cancer  1  0/110 (0.00%)  0 0/107 (0.00%)  0 1/87 (1.15%)  1 0/86 (0.00%)  0
Thyroid cancer  1  0/110 (0.00%)  0 0/107 (0.00%)  0 1/87 (1.15%)  1 0/86 (0.00%)  0
Reproductive system and breast disorders         
Ovarian cyst  1  0/110 (0.00%)  0 1/107 (0.93%)  1 0/87 (0.00%)  0 0/86 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Asthma  1  1/110 (0.91%)  1 0/107 (0.00%)  0 7/87 (8.05%)  7 3/86 (3.49%)  3
Surgical and medical procedures         
Drug rehabilitation  1  0/110 (0.00%)  0 0/107 (0.00%)  0 1/87 (1.15%)  1 0/86 (0.00%)  0
Hysterectomy  1  0/110 (0.00%)  0 1/107 (0.93%)  1 0/87 (0.00%)  0 0/86 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Mild/Moderate Asthma, Low Dose Vaccine (15 Mcg) Mild/Moderate Asthma, High Dose Vaccine (30mcg) Severe Asthma, Low Dose Vaccine (15mcg) Severe Asthma, High Dose Vaccine (30mcg)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   29.0/110.0 (26.36%)      15.0/107.0 (14.02%)      25.0/87.0 (28.74%)      25.0/86.0 (29.07%)    
Infections and infestations         
Upper respiratory tract infection  1  12/110 (10.91%)  12 9/107 (8.41%)  9 11/87 (12.64%)  11 8/86 (9.30%)  8
Investigations         
Forced expiratory volume decreased  1  4/110 (3.64%)  4 1/107 (0.93%)  2 7/87 (8.05%)  9 8/86 (9.30%)  13
Respiratory, thoracic and mediastinal disorders         
Asthma  1  8/110 (7.27%)  8 3/107 (2.80%)  4 10/87 (11.49%)  11 9/86 (10.47%)  9
Oropharyngeal pain  1  9/110 (8.18%)  9 4/107 (3.74%)  4 1/87 (1.15%)  1 5/86 (5.81%)  7
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Associate Director, Clinical Research Program
Organization: DAIT/NIAID
Phone: 301-594-7669
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00978120     History of Changes
Other Study ID Numbers: DAIT-AAIB-flu-001
First Submitted: September 15, 2009
First Posted: September 16, 2009
Results First Submitted: June 27, 2012
Results First Posted: August 6, 2012
Last Update Posted: August 10, 2012