The purpose of this study is to assess the safety and the body's immune response (body's defense against disease) to an experimental H1N1 influenza vaccine in people with asthma. The study will enroll 350, and possibly up to 400 healthy adults ages 12 and older with mild, moderate, or severe asthma. Participants will be randomly assigned to 1 of 2 possible vaccine groups: group 1 will receive 15 mcg of H1N1 vaccine; group 2 will receive 30 mcg of H1N1 vaccine given as two 15 mcg injections. Both groups will receive vaccine injections on days 0 and 21. Study procedures include: medical history, physical exam, spirometry, maintaining a memory aid and, and blood sample collection. Participants will be involved in study related procedures for approximately 7 months.
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Percentage of Participants With Serious Adverse Events (SAEs) Attributed To Vaccination
Timeframe: Measured at Baseline Visit and Days 1, 8, 21, 28, 41, 80, 120, and 201
Percentage of Participants With Reactogenicity Adverse Events (AEs) Status Post Vaccine 1
Timeframe: Days 1 through 8
Percentage of Participants With Reactogenicity Adverse Events (AEs) Status Post Vaccine 2
Timeframe: Days 21 through 28
Percentage of Participants With Asthma Exacerbations Status Post Vaccine 1
Timeframe: Days 1 to 8
Percentage of Participants With Asthma Exacerbations Status Post Vaccination 2
Timeframe: Days 21 to 28
Percentage of Participants With Seroconversion at Day 28 Following Two Administrations of Vaccination, Mild-Moderate Asthmatics
Timeframe: Days 1 to 28
Percentage of Participants With Seroconversion at Day 28 Following Two Administrations of Vaccination, Severe Asthmatics
Timeframe: Days 1 to 28
Percentage of Participants With Seroconversion at Day 41 Following Two Administrations of Vaccination, Mild-Moderate Asthmatics
Timeframe: Days 1 to 41
Percentage of Participants With Seroconversion at Day 41 Following Two Administrations of Vaccination, Severe Asthmatics
Timeframe: Days 1 to 41
Percentage of Participants With Seroprotection at Day 28 Following Two Administrations of Vaccination, Mild-Moderate Asthmatics
Timeframe: Days 1 to 28
Percentage of Participants With Seroprotection at Day 28 Following Two Administrations of Vaccination, Severe Asthmatics
Timeframe: Days 1 to 28
Percentage of Participants With Seroprotection at Day 41 Following Two Administrations of Vaccination, Mild-Moderate Asthmatics
Timeframe: Days 1 to 41
Percentage of Participants With Seroprotection at Day 41 Following Two Administrations of Vaccination, Severe Asthmatics
Timeframe: Days 1 to 41