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Safety and Efficacy of an H1N1 Influenza Vaccine in People With Asthma

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00978120
First received: September 15, 2009
Last updated: August 8, 2012
Last verified: August 2012
History of Changes
Results First Received: June 27, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: H1N1 Influenza Virus
Interventions: Biological: H1N1 vaccine high dose
Biological: H1N1 vaccine low dose

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

Reporting Groups
  Description
Mild/Moderate Asthma, Low Dose Vaccine (15mcg) 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.
Mild/Moderate Asthma, High Dose Vaccine (30mcg) 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.
Severe Asthma, Low Dose Vaccine (15mcg) 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.
Severe Asthma, High Dose Vaccine (30mcg)

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)

Participant Flow:   Overall Study
    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)
STARTED   110   107   87   86 
COMPLETED   108   107   84   84 
NOT COMPLETED   2   0   3   2 
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 



  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
Mild/Moderate Asthma, Low Dose Vaccine (15mcg) 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.
Mild/Moderate Asthma, High Dose Vaccine (30mcg) 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.
Severe Asthma, Low Dose Vaccine (15mcg) 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.
Severe Asthma, High Dose Vaccine (30mcg)

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 Total of all reporting groups

Baseline Measures
   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 
Overall Participants Analyzed 
[Units: Participants]
 		 110   107   87   86   390 
Age 
[Units: Participants]
 		         
<=18 years   22   23   12   10   67 
Between 18 and 65 years   80   79   67   68   294 
>=65 years   8   5   8   8   29 
Age 
[Units: Years]
Mean (Standard Deviation) 		 39.1  (18.1)   36.3  (17.0)   45.2  (17.0)   46.5  (17.3)   41.3  (17.8) 
Gender 
[Units: Participants]
 		         
Female   72   62   52   45   231 
Male   38   45   35   41   159 
Region of Enrollment 
[Units: Participants]
 		         
United States   110   107   87   86   390 
Age at Asthma Onset [1] 
[Units: Years]
Mean (Standard Deviation) 		 17.1  (17.0)   16.4  (14.9)   21.9  (19.7)   21.9  (20.1)   19.0  (17.9) 
[1] 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] 
[Units: Years]
Mean (Standard Deviation) 		 21.9  (13.9)   19.9  (13.4)   23.3  (16.5)   24.6  (17.8)   22.3  (15.3) 
[1] 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] 
[Units: Kg/m^2]
Mean (Standard Deviation) 		 29.5  (8.5)   28.5  (6.8)   31.8  (9.7)   30.1  (8.0)   29.9  (8.3) 
[1]

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] 
[Units: Percentage]
Mean (Standard Deviation) 		 83.8  (16.3)   86.6  (17.6)   72.6  (19.4)   69.8  (20.8)   79.0  (19.7) 
[1] 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] 
[Units: Percentage]
Mean (Standard Deviation) 		 92.6  (14.3)   94.3  (16.1)   85.0  (17.1)   80.9  (18.7)   88.8  (17.3) 
[1] 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] 
[Units: Ratio (x 100)]
Mean (Standard Deviation) 		 74.5  (9.07)   75.7  (8.99)   68.4  (10.91)   68.4  (11.76)   72.1  (10.62) 
[1]

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


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Serious Adverse Events (SAEs) Attributed To Vaccination   [ Time Frame: Measured at Baseline Visit and Days 1, 8, 21, 28, 41, 80, 120, and 201 ]
  Show Outcome Measure 1

2.  Primary:   Percentage of Participants With Reactogenicity Adverse Events (AEs) Status Post Vaccine 1   [ Time Frame: Days 1 through 8 ]
  Show Outcome Measure 2

3.  Primary:   Percentage of Participants With Reactogenicity Adverse Events (AEs) Status Post Vaccine 2   [ Time Frame: Days 21 through 28 ]
  Show Outcome Measure 3

4.  Primary:   Percentage of Participants With Asthma Exacerbations Status Post Vaccine 1   [ Time Frame: Days 1 to 8 ]
  Show Outcome Measure 4

5.  Primary:   Percentage of Participants With Asthma Exacerbations Status Post Vaccination 2   [ Time Frame: Days 21 to 28 ]
  Show Outcome Measure 5

6.  Primary:   Percentage of Participants With Seroconversion at Day 28 Following Two Administrations of Vaccination, Mild-Moderate Asthmatics   [ Time Frame: Days 1 to 28 ]
  Show Outcome Measure 6

7.  Primary:   Percentage of Participants With Seroconversion at Day 28 Following Two Administrations of Vaccination, Severe Asthmatics   [ Time Frame: Days 1 to 28 ]
  Show Outcome Measure 7

8.  Primary:   Percentage of Participants With Seroconversion at Day 41 Following Two Administrations of Vaccination, Mild-Moderate Asthmatics   [ Time Frame: Days 1 to 41 ]
  Show Outcome Measure 8

9.  Primary:   Percentage of Participants With Seroconversion at Day 41 Following Two Administrations of Vaccination, Severe Asthmatics   [ Time Frame: Days 1 to 41 ]
  Show Outcome Measure 9

10.  Primary:   Percentage of Participants With Seroprotection at Day 28 Following Two Administrations of Vaccination, Mild-Moderate Asthmatics   [ Time Frame: Days 1 to 28 ]
  Show Outcome Measure 10

11.  Primary:   Percentage of Participants With Seroprotection at Day 28 Following Two Administrations of Vaccination, Severe Asthmatics   [ Time Frame: Days 1 to 28 ]
  Show Outcome Measure 11

12.  Primary:   Percentage of Participants With Seroprotection at Day 41 Following Two Administrations of Vaccination, Mild-Moderate Asthmatics   [ Time Frame: Days 1 to 41 ]
  Show Outcome Measure 12

13.  Primary:   Percentage of Participants With Seroprotection at Day 41 Following Two Administrations of Vaccination, Severe Asthmatics   [ Time Frame: Days 1 to 41 ]
  Show Outcome Measure 13

14.  Secondary:   Percentage of Participants With Seroconversion at Day 21 Following Single Administration of Vaccination, Mild-Moderate Asthmatics   [ Time Frame: Days 1 to 21 ]
  Show Outcome Measure 14

15.  Secondary:   Percentage of Participants With Seroconversion at Day 21 Following Single Administration of Vaccination, Severe Asthmatics   [ Time Frame: Days 1 to 21 ]
  Show Outcome Measure 15

16.  Secondary:   Percentage of Participants With Seroprotection at Day 21 Following Single Administration of Vaccination, Mild-Moderate Asthmatics   [ Time Frame: Days 1 to 21 ]
  Hide Outcome Measure 16

Measure Type Secondary
Measure Title Percentage of Participants With Seroprotection at Day 21 Following Single Administration of Vaccination, Mild-Moderate Asthmatics
Measure 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  

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
Mild/Moderate Asthma, Low Dose Vaccine (15mcg) 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.
Mild/Moderate Asthma, High Dose Vaccine (30mcg)

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)

Measured Values
   Mild/Moderate Asthma, Low Dose Vaccine (15mcg)   Mild/Moderate Asthma, High Dose Vaccine (30mcg) 
Participants Analyzed 
[Units: Participants]
 		 107   107 
Percentage of Participants With Seroprotection at Day 21 Following Single Administration of Vaccination, Mild-Moderate Asthmatics 
[Units: Percentage of participants]
 		 90.7   95.3 


Statistical Analysis 1 for Percentage of Participants With Seroprotection at Day 21 Following Single Administration of Vaccination, Mild-Moderate Asthmatics
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Fisher Exact
P Value [4] 0.284
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



17.  Secondary:   Percentage of Participants With Seroprotection at Day 21 Following Single Administration of Vaccination, Severe Asthmatics   [ Time Frame: Days 1 to 21 ]
  Show Outcome Measure 17


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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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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