Trial Outcomes & Findings for Safety and Efficacy of an H1N1 Influenza Vaccine in People With Asthma (NCT NCT00978120)
NCT ID: NCT00978120
Last Updated: 2012-08-10
Results Overview
Percentage of participants with serious adverse events (SAEs) attributed to vaccination, as determined by site investigators at the time of reporting.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
390 participants
Primary outcome timeframe
Measured at Baseline Visit and Days 1, 8, 21, 28, 41, 80, 120, and 201
Results posted on
2012-08-10
Participant Flow
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.
Participant milestones
| Measure |
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)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
110
|
107
|
87
|
86
|
|
Overall Study
COMPLETED
|
108
|
107
|
84
|
84
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
3
|
2
|
Reasons for withdrawal
| Measure |
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)
|
|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
0
|
|
Overall Study
Moved out of state
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Safety and Efficacy of an H1N1 Influenza Vaccine in People With Asthma
Baseline characteristics by cohort
| Measure |
Mild/Moderate Asthma, Low Dose Vaccine (15mcg)
n=110 Participants
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)
n=107 Participants
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)
n=87 Participants
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)
n=86 Participants
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
n=390 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
67 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
80 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
294 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Age Continuous
|
39.1 years
STANDARD_DEVIATION 18.1 • n=5 Participants
|
36.3 years
STANDARD_DEVIATION 17.0 • n=7 Participants
|
45.2 years
STANDARD_DEVIATION 17.0 • n=5 Participants
|
46.5 years
STANDARD_DEVIATION 17.3 • n=4 Participants
|
41.3 years
STANDARD_DEVIATION 17.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
231 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
159 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
110 participants
n=5 Participants
|
107 participants
n=7 Participants
|
87 participants
n=5 Participants
|
86 participants
n=4 Participants
|
390 participants
n=21 Participants
|
|
Age at Asthma Onset
|
17.1 years
STANDARD_DEVIATION 17.0 • n=5 Participants
|
16.4 years
STANDARD_DEVIATION 14.9 • n=7 Participants
|
21.9 years
STANDARD_DEVIATION 19.7 • n=5 Participants
|
21.9 years
STANDARD_DEVIATION 20.1 • n=4 Participants
|
19.0 years
STANDARD_DEVIATION 17.9 • n=21 Participants
|
|
Asthma Duration
|
21.9 years
STANDARD_DEVIATION 13.9 • n=5 Participants
|
19.9 years
STANDARD_DEVIATION 13.4 • n=7 Participants
|
23.3 years
STANDARD_DEVIATION 16.5 • n=5 Participants
|
24.6 years
STANDARD_DEVIATION 17.8 • n=4 Participants
|
22.3 years
STANDARD_DEVIATION 15.3 • n=21 Participants
|
|
Body Mass Index (BMI)
|
29.5 kg/m^2
STANDARD_DEVIATION 8.5 • n=5 Participants
|
28.5 kg/m^2
STANDARD_DEVIATION 6.8 • n=7 Participants
|
31.8 kg/m^2
STANDARD_DEVIATION 9.7 • n=5 Participants
|
30.1 kg/m^2
STANDARD_DEVIATION 8.0 • n=4 Participants
|
29.9 kg/m^2
STANDARD_DEVIATION 8.3 • n=21 Participants
|
|
Forced Expiratory Volume in 1 second (FEV1) % Predicted
|
83.8 percentage
STANDARD_DEVIATION 16.3 • n=5 Participants
|
86.6 percentage
STANDARD_DEVIATION 17.6 • n=7 Participants
|
72.6 percentage
STANDARD_DEVIATION 19.4 • n=5 Participants
|
69.8 percentage
STANDARD_DEVIATION 20.8 • n=4 Participants
|
79.0 percentage
STANDARD_DEVIATION 19.7 • n=21 Participants
|
|
Forced Vital Capacity (FVC) % Predicted
|
92.6 percentage
STANDARD_DEVIATION 14.3 • n=5 Participants
|
94.3 percentage
STANDARD_DEVIATION 16.1 • n=7 Participants
|
85.0 percentage
STANDARD_DEVIATION 17.1 • n=5 Participants
|
80.9 percentage
STANDARD_DEVIATION 18.7 • n=4 Participants
|
88.8 percentage
STANDARD_DEVIATION 17.3 • n=21 Participants
|
|
FEV1/FVC Ratio
|
74.5 Ratio (x 100)
STANDARD_DEVIATION 9.07 • n=5 Participants
|
75.7 Ratio (x 100)
STANDARD_DEVIATION 8.99 • n=7 Participants
|
68.4 Ratio (x 100)
STANDARD_DEVIATION 10.91 • n=5 Participants
|
68.4 Ratio (x 100)
STANDARD_DEVIATION 11.76 • n=4 Participants
|
72.1 Ratio (x 100)
STANDARD_DEVIATION 10.62 • n=21 Participants
|
PRIMARY outcome
Timeframe: Measured at Baseline Visit and Days 1, 8, 21, 28, 41, 80, 120, and 201Percentage of participants with serious adverse events (SAEs) attributed to vaccination, as determined by site investigators at the time of reporting.
Outcome measures
| Measure |
Mild/Moderate Asthma, Low Dose Vaccine (15mcg)
n=110 Participants
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)
n=107 Participants
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)
n=87 Participants
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)
n=86 Participants
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)
|
|---|---|---|---|---|
|
Percentage of Participants With Serious Adverse Events (SAEs) Attributed To Vaccination
|
1 percentage of participants
|
0 percentage of participants
|
3 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Days 1 through 8Percentage 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.
Outcome measures
| Measure |
Mild/Moderate Asthma, Low Dose Vaccine (15mcg)
n=110 Participants
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)
n=107 Participants
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)
n=87 Participants
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)
n=86 Participants
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)
|
|---|---|---|---|---|
|
Percentage of Participants With Reactogenicity Adverse Events (AEs) Status Post Vaccine 1
Local
|
55 percentage of participants
|
54 percentage of participants
|
33 percentage of participants
|
52 percentage of participants
|
|
Percentage of Participants With Reactogenicity Adverse Events (AEs) Status Post Vaccine 1
Systemic
|
58 percentage of participants
|
63 percentage of participants
|
64 percentage of participants
|
74 percentage of participants
|
PRIMARY outcome
Timeframe: Days 21 through 28Percentage 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.
Outcome measures
| Measure |
Mild/Moderate Asthma, Low Dose Vaccine (15mcg)
n=102 Participants
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)
n=99 Participants
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)
n=80 Participants
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)
n=76 Participants
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)
|
|---|---|---|---|---|
|
Percentage of Participants With Reactogenicity Adverse Events (AEs) Status Post Vaccine 2
Local
|
46 percentage of participants
|
60 percentage of participants
|
29 percentage of participants
|
38 percentage of participants
|
|
Percentage of Participants With Reactogenicity Adverse Events (AEs) Status Post Vaccine 2
Systemic
|
47 percentage of participants
|
47 percentage of participants
|
48 percentage of participants
|
42 percentage of participants
|
PRIMARY outcome
Timeframe: Days 1 to 8Percentage 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.
Outcome measures
| Measure |
Mild/Moderate Asthma, Low Dose Vaccine (15mcg)
n=110 Participants
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)
n=107 Participants
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)
n=87 Participants
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)
n=86 Participants
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)
|
|---|---|---|---|---|
|
Percentage of Participants With Asthma Exacerbations Status Post Vaccine 1
|
4 percentage of participants
|
2 percentage of participants
|
8 percentage of participants
|
3 percentage of participants
|
PRIMARY outcome
Timeframe: Days 21 to 28Percentage 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.
Outcome measures
| Measure |
Mild/Moderate Asthma, Low Dose Vaccine (15mcg)
n=102 Participants
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)
n=99 Participants
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)
n=80 Participants
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)
n=76 Participants
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)
|
|---|---|---|---|---|
|
Percentage of Participants With Asthma Exacerbations Status Post Vaccination 2
|
4 percentage of participants
|
1 percentage of participants
|
3 percentage of participants
|
6 percentage of participants
|
PRIMARY outcome
Timeframe: Days 1 to 28Seroconversion: 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.
Outcome measures
| Measure |
Mild/Moderate Asthma, Low Dose Vaccine (15mcg)
n=103 Participants
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)
n=97 Participants
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)
|
|---|---|---|---|---|
|
Percentage of Participants With Seroconversion at Day 28 Following Two Administrations of Vaccination, Mild-Moderate Asthmatics
|
80.6 percentage of participants
|
86.6 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1 to 28Seroconversion: 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.
Outcome measures
| Measure |
Mild/Moderate Asthma, Low Dose Vaccine (15mcg)
n=77 Participants
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)
n=76 Participants
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)
|
|---|---|---|---|---|
|
Percentage of Participants With Seroconversion at Day 28 Following Two Administrations of Vaccination, Severe Asthmatics
|
68.8 percentage of participants
|
85.5 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1 to 41Seroconversion: 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.
Outcome measures
| Measure |
Mild/Moderate Asthma, Low Dose Vaccine (15mcg)
n=103 Participants
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)
n=99 Participants
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)
|
|---|---|---|---|---|
|
Percentage of Participants With Seroconversion at Day 41 Following Two Administrations of Vaccination, Mild-Moderate Asthmatics
|
73.8 percentage of participants
|
80.8 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1 to 41Seroconversion: 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.
Outcome measures
| Measure |
Mild/Moderate Asthma, Low Dose Vaccine (15mcg)
n=76 Participants
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)
n=76 Participants
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)
|
|---|---|---|---|---|
|
Percentage of Participants With Seroconversion at Day 41 Following Two Administrations of Vaccination, Severe Asthmatics
|
72.4 percentage of participants
|
82.9 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1 to 28Seroprotection: 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.
Outcome measures
| Measure |
Mild/Moderate Asthma, Low Dose Vaccine (15mcg)
n=103 Participants
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)
n=97 Participants
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)
|
|---|---|---|---|---|
|
Percentage of Participants With Seroprotection at Day 28 Following Two Administrations of Vaccination, Mild-Moderate Asthmatics
|
87.4 percentage of participants
|
91.8 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1 to 28Percentage 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.
Outcome measures
| Measure |
Mild/Moderate Asthma, Low Dose Vaccine (15mcg)
n=77 Participants
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)
n=76 Participants
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)
|
|---|---|---|---|---|
|
Percentage of Participants With Seroprotection at Day 28 Following Two Administrations of Vaccination, Severe Asthmatics
|
76.6 percentage of participants
|
93.4 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1 to 41Percentage 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.
Outcome measures
| Measure |
Mild/Moderate Asthma, Low Dose Vaccine (15mcg)
n=103 Participants
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)
n=99 Participants
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)
|
|---|---|---|---|---|
|
Percentage of Participants With Seroprotection at Day 41 Following Two Administrations of Vaccination, Mild-Moderate Asthmatics
|
82.5 percentage of participants
|
93.9 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1 to 41Percentage 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.
Outcome measures
| Measure |
Mild/Moderate Asthma, Low Dose Vaccine (15mcg)
n=76 Participants
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)
n=76 Participants
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)
|
|---|---|---|---|---|
|
Percentage of Participants With Seroprotection at Day 41 Following Two Administrations of Vaccination, Severe Asthmatics
|
75.0 percentage of participants
|
89.5 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 to 21Percentage 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.
Outcome measures
| Measure |
Mild/Moderate Asthma, Low Dose Vaccine (15mcg)
n=107 Participants
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)
n=107 Participants
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)
|
|---|---|---|---|---|
|
Percentage of Participants With Seroconversion at Day 21 Following Single Administration of Vaccination, Mild-Moderate Asthmatics
|
80.4 percentage of participants
|
85.0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 to 21Percentage 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.
Outcome measures
| Measure |
Mild/Moderate Asthma, Low Dose Vaccine (15mcg)
n=86 Participants
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)
n=85 Participants
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)
|
|---|---|---|---|---|
|
Percentage of Participants With Seroconversion at Day 21 Following Single Administration of Vaccination, Severe Asthmatics
|
75.6 percentage of participants
|
85.9 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 to 21Percentage 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.
Outcome measures
| Measure |
Mild/Moderate Asthma, Low Dose Vaccine (15mcg)
n=107 Participants
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)
n=107 Participants
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)
|
|---|---|---|---|---|
|
Percentage of Participants With Seroprotection at Day 21 Following Single Administration of Vaccination, Mild-Moderate Asthmatics
|
90.7 percentage of participants
|
95.3 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 to 21Percentage 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.
Outcome measures
| Measure |
Mild/Moderate Asthma, Low Dose Vaccine (15mcg)
n=86 Participants
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)
n=85 Participants
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)
|
|---|---|---|---|---|
|
Percentage of Participants With Seroprotection at Day 21 Following Single Administration of Vaccination, Severe Asthmatics
|
77.9 percentage of participants
|
94.1 percentage of participants
|
—
|
—
|
Adverse Events
Mild/Moderate Asthma, Low Dose Vaccine (15 Mcg)
Serious events: 4 serious events
Other events: 29 other events
Deaths: 0 deaths
Mild/Moderate Asthma, High Dose Vaccine (30mcg)
Serious events: 4 serious events
Other events: 15 other events
Deaths: 0 deaths
Severe Asthma, Low Dose Vaccine (15mcg)
Serious events: 12 serious events
Other events: 25 other events
Deaths: 0 deaths
Severe Asthma, High Dose Vaccine (30mcg)
Serious events: 6 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mild/Moderate Asthma, Low Dose Vaccine (15 Mcg)
n=110 participants at risk
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.
|
Mild/Moderate Asthma, High Dose Vaccine (30mcg)
n=107 participants at risk
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.
|
Severe Asthma, Low Dose Vaccine (15mcg)
n=87 participants at risk
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.
|
Severe Asthma, High Dose Vaccine (30mcg)
n=86 participants at risk
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.
|
|---|---|---|---|---|
|
Cardiac disorders
Atrial flutter
|
0.91%
1/110 • Number of events 1 • Enrollment through last day of followup (Day 201, target last day)
|
0.00%
0/107 • Enrollment through last day of followup (Day 201, target last day)
|
0.00%
0/87 • Enrollment through last day of followup (Day 201, target last day)
|
0.00%
0/86 • Enrollment through last day of followup (Day 201, target last day)
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/110 • Enrollment through last day of followup (Day 201, target last day)
|
0.00%
0/107 • Enrollment through last day of followup (Day 201, target last day)
|
0.00%
0/87 • Enrollment through last day of followup (Day 201, target last day)
|
1.2%
1/86 • Number of events 1 • Enrollment through last day of followup (Day 201, target last day)
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/110 • Enrollment through last day of followup (Day 201, target last day)
|
0.00%
0/107 • Enrollment through last day of followup (Day 201, target last day)
|
1.1%
1/87 • Number of events 1 • Enrollment through last day of followup (Day 201, target last day)
|
0.00%
0/86 • Enrollment through last day of followup (Day 201, target last day)
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/110 • Enrollment through last day of followup (Day 201, target last day)
|
0.00%
0/107 • Enrollment through last day of followup (Day 201, target last day)
|
0.00%
0/87 • Enrollment through last day of followup (Day 201, target last day)
|
1.2%
1/86 • Number of events 1 • Enrollment through last day of followup (Day 201, target last day)
|
|
General disorders
Abasia
|
0.00%
0/110 • Enrollment through last day of followup (Day 201, target last day)
|
0.00%
0/107 • Enrollment through last day of followup (Day 201, target last day)
|
1.1%
1/87 • Number of events 1 • Enrollment through last day of followup (Day 201, target last day)
|
0.00%
0/86 • Enrollment through last day of followup (Day 201, target last day)
|
|
General disorders
Chest pain
|
0.00%
0/110 • Enrollment through last day of followup (Day 201, target last day)
|
0.00%
0/107 • Enrollment through last day of followup (Day 201, target last day)
|
1.1%
1/87 • Number of events 1 • Enrollment through last day of followup (Day 201, target last day)
|
0.00%
0/86 • Enrollment through last day of followup (Day 201, target last day)
|
|
General disorders
Death
|
0.00%
0/110 • Enrollment through last day of followup (Day 201, target last day)
|
0.00%
0/107 • Enrollment through last day of followup (Day 201, target last day)
|
0.00%
0/87 • Enrollment through last day of followup (Day 201, target last day)
|
1.2%
1/86 • Number of events 1 • Enrollment through last day of followup (Day 201, target last day)
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/110 • Enrollment through last day of followup (Day 201, target last day)
|
0.00%
0/107 • Enrollment through last day of followup (Day 201, target last day)
|
1.1%
1/87 • Number of events 1 • Enrollment through last day of followup (Day 201, target last day)
|
0.00%
0/86 • Enrollment through last day of followup (Day 201, target last day)
|
|
Infections and infestations
Localised infection
|
0.00%
0/110 • Enrollment through last day of followup (Day 201, target last day)
|
0.00%
0/107 • Enrollment through last day of followup (Day 201, target last day)
|
1.1%
1/87 • Number of events 1 • Enrollment through last day of followup (Day 201, target last day)
|
0.00%
0/86 • Enrollment through last day of followup (Day 201, target last day)
|
|
Infections and infestations
Pneumonia
|
0.91%
1/110 • Number of events 1 • Enrollment through last day of followup (Day 201, target last day)
|
0.93%
1/107 • Number of events 1 • Enrollment through last day of followup (Day 201, target last day)
|
0.00%
0/87 • Enrollment through last day of followup (Day 201, target last day)
|
0.00%
0/86 • Enrollment through last day of followup (Day 201, target last day)
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/110 • Enrollment through last day of followup (Day 201, target last day)
|
0.93%
1/107 • Number of events 1 • Enrollment through last day of followup (Day 201, target last day)
|
0.00%
0/87 • Enrollment through last day of followup (Day 201, target last day)
|
0.00%
0/86 • Enrollment through last day of followup (Day 201, target last day)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/110 • Enrollment through last day of followup (Day 201, target last day)
|
0.93%
1/107 • Number of events 1 • Enrollment through last day of followup (Day 201, target last day)
|
0.00%
0/87 • Enrollment through last day of followup (Day 201, target last day)
|
0.00%
0/86 • Enrollment through last day of followup (Day 201, target last day)
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.91%
1/110 • Number of events 1 • Enrollment through last day of followup (Day 201, target last day)
|
0.00%
0/107 • Enrollment through last day of followup (Day 201, target last day)
|
0.00%
0/87 • Enrollment through last day of followup (Day 201, target last day)
|
0.00%
0/86 • Enrollment through last day of followup (Day 201, target last day)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/110 • Enrollment through last day of followup (Day 201, target last day)
|
0.00%
0/107 • Enrollment through last day of followup (Day 201, target last day)
|
1.1%
1/87 • Number of events 1 • Enrollment through last day of followup (Day 201, target last day)
|
0.00%
0/86 • Enrollment through last day of followup (Day 201, target last day)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/110 • Enrollment through last day of followup (Day 201, target last day)
|
0.00%
0/107 • Enrollment through last day of followup (Day 201, target last day)
|
1.1%
1/87 • Number of events 1 • Enrollment through last day of followup (Day 201, target last day)
|
0.00%
0/86 • Enrollment through last day of followup (Day 201, target last day)
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/110 • Enrollment through last day of followup (Day 201, target last day)
|
0.93%
1/107 • Number of events 1 • Enrollment through last day of followup (Day 201, target last day)
|
0.00%
0/87 • Enrollment through last day of followup (Day 201, target last day)
|
0.00%
0/86 • Enrollment through last day of followup (Day 201, target last day)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.91%
1/110 • Number of events 1 • Enrollment through last day of followup (Day 201, target last day)
|
0.00%
0/107 • Enrollment through last day of followup (Day 201, target last day)
|
8.0%
7/87 • Number of events 7 • Enrollment through last day of followup (Day 201, target last day)
|
3.5%
3/86 • Number of events 3 • Enrollment through last day of followup (Day 201, target last day)
|
|
Surgical and medical procedures
Drug rehabilitation
|
0.00%
0/110 • Enrollment through last day of followup (Day 201, target last day)
|
0.00%
0/107 • Enrollment through last day of followup (Day 201, target last day)
|
1.1%
1/87 • Number of events 1 • Enrollment through last day of followup (Day 201, target last day)
|
0.00%
0/86 • Enrollment through last day of followup (Day 201, target last day)
|
|
Surgical and medical procedures
Hysterectomy
|
0.00%
0/110 • Enrollment through last day of followup (Day 201, target last day)
|
0.93%
1/107 • Number of events 1 • Enrollment through last day of followup (Day 201, target last day)
|
0.00%
0/87 • Enrollment through last day of followup (Day 201, target last day)
|
0.00%
0/86 • Enrollment through last day of followup (Day 201, target last day)
|
Other adverse events
| Measure |
Mild/Moderate Asthma, Low Dose Vaccine (15 Mcg)
n=110 participants at risk
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.
|
Mild/Moderate Asthma, High Dose Vaccine (30mcg)
n=107 participants at risk
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.
|
Severe Asthma, Low Dose Vaccine (15mcg)
n=87 participants at risk
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.
|
Severe Asthma, High Dose Vaccine (30mcg)
n=86 participants at risk
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.
|
|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
10.9%
12/110 • Number of events 12 • Enrollment through last day of followup (Day 201, target last day)
|
8.4%
9/107 • Number of events 9 • Enrollment through last day of followup (Day 201, target last day)
|
12.6%
11/87 • Number of events 11 • Enrollment through last day of followup (Day 201, target last day)
|
9.3%
8/86 • Number of events 8 • Enrollment through last day of followup (Day 201, target last day)
|
|
Investigations
Forced expiratory volume decreased
|
3.6%
4/110 • Number of events 4 • Enrollment through last day of followup (Day 201, target last day)
|
0.93%
1/107 • Number of events 2 • Enrollment through last day of followup (Day 201, target last day)
|
8.0%
7/87 • Number of events 9 • Enrollment through last day of followup (Day 201, target last day)
|
9.3%
8/86 • Number of events 13 • Enrollment through last day of followup (Day 201, target last day)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
7.3%
8/110 • Number of events 8 • Enrollment through last day of followup (Day 201, target last day)
|
2.8%
3/107 • Number of events 4 • Enrollment through last day of followup (Day 201, target last day)
|
11.5%
10/87 • Number of events 11 • Enrollment through last day of followup (Day 201, target last day)
|
10.5%
9/86 • Number of events 9 • Enrollment through last day of followup (Day 201, target last day)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.2%
9/110 • Number of events 9 • Enrollment through last day of followup (Day 201, target last day)
|
3.7%
4/107 • Number of events 4 • Enrollment through last day of followup (Day 201, target last day)
|
1.1%
1/87 • Number of events 1 • Enrollment through last day of followup (Day 201, target last day)
|
5.8%
5/86 • Number of events 7 • Enrollment through last day of followup (Day 201, target last day)
|
Additional Information
Associate Director, Clinical Research Program
DAIT/NIAID
Phone: 301-594-7669
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place