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

This study has been completed.
Sponsor:
Collaborator:
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
Results First Received: June 27, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   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
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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
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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


  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 ]

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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


  Serious Adverse Events


  Other Adverse Events


  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