Safety and Efficacy of an H1N1 Influenza Vaccine in Peopl... | NCT00978120

NCT00978120

Status Module

Sponsor/Collaborators Module

Name	Class
National Heart, Lung, and Blood Institute (NHLBI)	NIH

Oversight Module

No data available

No data is available for this block.

Description Module

Detailed Description

A new swine-origin influenza A/H1N1 virus was recently identified as a significant cause of respiratory illness in Mexico and the United States. In response, the World Health Organization (WHO) declared a pandemic on June 11, 2009. Current data indicates that licensed seasonal influenza vaccines are not likely to provide protection against the new H1N1 virus. Development and deployment of a vaccine for the new H1N1 virus, particularly to at-risk populations, is essential.

Groups at risk for influenza yearly include the elderly and those with asthma, and current guidelines from the Advisory Committee on Immunization Practices (ACIP) recommend vaccination of adults and children with asthma. Early, unpublished data on US patients hospitalized by H1N1 infection indicates that many had underlying asthma, and it is expected people with asthma will be on a priority list for H1N1 influenza vaccination. Data also indicate that increased dosage of vaccines may increase development of antibodies and that use of certain inhalers may affect immunization. This study will test the safety and immunogenicity of an unadjuvanted, inactivated H1N1 vaccine at two dosage levels in people with asthma.

Participation in this study will last approximately 34 weeks. Participants will be stratified into two groups: those with mild to moderate versus those with severe asthma. All participants will be randomly assigned to receive either a high dose (30 mcg) or low dose (15 mcg) H1N1 vaccine. Both vaccine dosages will be administered in two intramuscular injections 21 days apart. Participants assigned to the higher dose (30 mcg) will receive two injections of the 15 mcg vaccine at each administration.

Participants will complete study visits at entry, administration of the vaccines on Days 1 and 21, follow-ups a week after each vaccine injection, and 21 days after the second injection. Measurements at these visits will include spirometry (measurement of air entering and leaving the lungs), a questionnaire about asthma, a targeted physical examination, an adverse event and medication assessment, inspection of vaccination site, and collection of a blood sample. A urine sample will be collected for pregnancy test before each vaccination. In additions, for 8 days after each vaccination injection participants will keep a diary recording oral temperature, adverse events, asthma symptoms, and use of inhalers. These diaries will be reviewed at study visits. Participants will also receive follow-up phone calls to assess safety 60, 120, and 180 days after the last vaccine injection.

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
H1N1 vaccine high dose	Experimental	Participants will be stratified according to asthma severity and will receive the high dosage of the H1N1 vaccine.	Biological: H1N1 vaccine high dose
H1N1 vaccine low dose	Experimental	Participants will be stratified according to asthma severity and will receive the low dosage of the H1N1 vaccine.	Biological: H1N1 vaccine low dose

Interventions

Name	Type	Description	Arm Group Labels	Other Names
H1N1 vaccine high dose	Biological	30 mcg of unadjuvanted Novartis H1N1 vaccine delivered as two, 15 micrograms (mcg), intramuscular injections. Each 30 mcg dose is administered 21 days apart.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Serious Adverse Events (SAEs) Attributed To Vaccination	Percentage of participants with serious adverse events (SAEs) attributed to vaccination, as determined by site investigators at the time of reporting.	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	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.	Days 1 through 8
Percentage of Participants With Reactogenicity Adverse Events (AEs) Status Post Vaccine 2	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.	Days 21 through 28
Percentage of Participants With Asthma Exacerbations Status Post Vaccine 1	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.	Days 1 to 8
Percentage of Participants With Asthma Exacerbations Status Post Vaccination 2

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Seroconversion at Day 21 Following Single Administration of Vaccination, Mild-Moderate Asthmatics	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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of mild/moderate or severe asthma according to Severe Asthma Research Project (SARP) definitions and either a SARP participant or having prior participation in the studies or clinics of the investigators
Males and females age 12 (inclusive) and older
Females of child-bearing potential must not be pregnant and must agree to practice adequate contraception that may include, but is not limited to: abstinence, monogamous relationship with vasectomized partner, barrier methods such as condoms, diaphragms, spermicides, intrauterine devices, and licensed hormonal methods during the study for at least 30 days following the last vaccination.
Able to understand and comply with planned study procedures
Will provide written informed consent and assent (if age appropriate) prior to initiation of any study procedures

Exclusion Criteria:

Allergy to eggs or other components of the vaccine, including gelatin, formaldehyde, octoxinol, thimerosal, and chicken protein
Positive urine pregnancy test within 24 hours prior to vaccination, if a female of childbearing potential
Currently breastfeeding
History of smoking 20 pack-years or greater (current or former smokers with a history of less than 20 pack-years can be included in the study)
Has been previously diagnosed by a physician with chronic obstructive pulmonary disease, chronic bronchitis, emphysema, or cystic fibrosis
Has received anticancer chemotherapy or radiation therapy (cytotoxic) within the past 36 months
Has an active neoplastic disease or a history of any hematologic malignancy
Has a diagnosis of schizophrenia, bipolar disease, or other major psychiatric diagnosis
Has been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others within the past 10 years
Receiving psychiatric drugs (subjects who are receiving a single antidepressant drug and are stable for at least 3 months prior to study entry, without de-compensating symptoms, will be allowed to enroll)
History of receiving immunoglobulin, including anti-cytokine antibodies, or other blood product within the 3 months prior to vaccination in this study
Has received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to vaccination in this study or expect to receive an experimental agent during this study (prior to the Day 141 follow-up call - 100 days after the second vaccination)
Has received any live licensed vaccines within 4 weeks or inactivated licensed vaccines within 2 weeks prior to vaccination in this study, or plan receipt of such vaccines within 21 days following the second vaccination
Has a history of severe reactions following previous immunization with influenza virus vaccines
Has an acute illness, including an oral temperature greater than 100.4°F, within 1 week of either vaccination
Has a chronic neurologic or autoimmune disorder
Has a history of Guillain-Barré Syndrome
Has an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe, or would interfere with the evaluation of vaccine response
Has an ongoing asthma exacerbation or had an asthma exacerbation that was resolved less than 7 days prior to vaccination
Has any condition that would, in the opinion of the site investigator, place the participant at an unacceptable risk of injury, render the participant unable to meet the requirements of the protocol, or interfere with the successful completion of the study.
Participated in a novel influenza H1N1 2009 vaccine study in the past two years or has a history of novel influenza H1N1 2009 infection or treatment
Has known active HIV, Hepatitis B or Hepatitis C infection
Has a history of alcohol or drug abuse in the last 5 years
Plans to travel outside of North America in the time between the first vaccination and 42 days following the first vaccination
Does not speak English primarily

Contacts/Locations Module

Name	Affiliation	Role
William Busse, MD	University of Wisconsin Medical School	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Emory University		Atlanta	Georgia		United States
Washington University School of Medicine

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19423869	Background	Novel Swine-Origin Influenza A (H1N1) Virus Investigation Team; Dawood FS, Jain S, Finelli L, Shaw MW, Lindstrom S, Garten RJ, Gubareva LV, Xu X, Bridges CB, Uyeki TM. Emergence of a novel swine-origin influenza A (H1N1) virus in humans. N Engl J Med. 2009 Jun 18;360(25):2605-15. doi: 10.1056/NEJMoa0903810. Epub 2009 May 7.
9240686

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.
FG001	Mild/Moderate Asthma, High Dose Vaccine (30mcg)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

H1N1 vaccine high dose

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	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.
BG003	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)
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG00022 BG00123 BG00212 BG003

Age Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00039.1± 18.1 BG00136.3± 17.0 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00072 BG00162 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG000110 BG001107 BG002

Age at Asthma Onset

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.

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00017.1± 17.0 BG001

Asthma Duration

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.

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00021.9± 13.9 BG00119.9

Body Mass Index (BMI)

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

Mean

Standard Deviation

kg/m^2

Title

Denominators

Categories

Title	Measurements
	BG00029.5± 8.5 BG001

Forced Expiratory Volume in 1 second (FEV1) % Predicted

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.

Mean

Standard Deviation

percentage

Title

Denominators

Categories

Title	Measurements
	BG00083.8± 16.3 BG001

Forced Vital Capacity (FVC) % Predicted

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.

Mean

Standard Deviation

percentage

Title

Denominators

Categories

Title	Measurements
	BG00092.6± 14.3 BG001

FEV1/FVC Ratio

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

Mean

Standard Deviation

Ratio (x 100)

Title

Denominators

Categories

Title	Measurements
	BG00074.5± 9.07 BG001

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With Serious Adverse Events (SAEs) Attributed To Vaccination

Percentage of participants with serious adverse events (SAEs) attributed to vaccination, as determined by site investigators at the time of reporting.

Posted

Number

percentage of participants

Measured at Baseline Visit and Days 1, 8, 21, 28, 41, 80, 120, and 201

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.
OG003	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)

Units	Counts
Participants	OG000110 OG001107 OG00287 OG003

Title

Denominators

Categories

Title	Measurements
	OG0001 OG0010 OG0023 OG003

Primary

Percentage of Participants With Reactogenicity Adverse Events (AEs) Status Post Vaccine 1

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.

Posted

Number

percentage of participants

Days 1 through 8

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Primary

Percentage of Participants With Reactogenicity Adverse Events (AEs) Status Post Vaccine 2

Posted

Number

percentage of participants

Days 21 through 28

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Primary

Percentage of Participants With Asthma Exacerbations Status Post Vaccine 1

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.

Posted

Number

percentage of participants

Days 1 to 8

ID	Title	Description
OG000	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.
OG001	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.
OG002	Severe Asthma, Low Dose Vaccine (15mcg)

Primary

Percentage of Participants With Asthma Exacerbations Status Post Vaccination 2

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.

Posted

Number

percentage of participants

Days 21 to 28

ID	Title	Description
OG000	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.
OG001	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.
OG002	Severe Asthma, Low Dose Vaccine (15mcg)

Secondary

Percentage of Participants With Seroconversion at Day 21 Following Single Administration of Vaccination, Mild-Moderate Asthmatics

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.

Posted

Number

percentage of participants

Days 1 to 21

ID	Title	Description
OG000	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.
OG001	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)

Secondary

Percentage of Participants With Seroconversion at Day 21 Following Single Administration of Vaccination, Severe Asthmatics

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.

Posted

Number

percentage of participants

Days 1 to 21

ID	Title	Description
OG000	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.
OG001	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)

Units	Counts

Secondary

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

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.

Posted

Number

percentage of participants

Days 1 to 21

ID	Title	Description
OG000	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.
OG001	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)

Units	Counts

Secondary

Percentage of Participants With Seroprotection at Day 21 Following Single Administration of Vaccination, Severe Asthmatics

Posted

Number

percentage of participants

Days 1 to 21

ID	Title	Description
OG000	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.
OG001	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)

Units	Counts
Participants

Primary

Percentage of Participants With Seroconversion at Day 28 Following Two Administrations of Vaccination, Mild-Moderate Asthmatics

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.

Posted

Number

percentage of participants

Days 1 to 28

ID	Title	Description
OG000	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.
OG001	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)

Primary

Percentage of Participants With Seroconversion at Day 28 Following Two Administrations of Vaccination, Severe Asthmatics

Posted

Number

percentage of participants

Days 1 to 28

ID	Title	Description
OG000	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.
OG001	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)

Units	Counts

Primary

Percentage of Participants With Seroconversion at Day 41 Following Two Administrations of Vaccination, Mild-Moderate Asthmatics

Posted

Number

percentage of participants

Days 1 to 41

ID	Title	Description
OG000	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.
OG001	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)

Primary

Percentage of Participants With Seroconversion at Day 41 Following Two Administrations of Vaccination, Severe Asthmatics

Posted

Number

percentage of participants

Days 1 to 41

ID	Title	Description
OG000	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.
OG001	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)

Units	Counts

Primary

Percentage of Participants With Seroprotection at Day 28 Following Two Administrations of Vaccination, Mild-Moderate Asthmatics

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.

Posted

Number

percentage of participants

Days 1 to 28

ID	Title	Description
OG000	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.
OG001	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)

Units	Counts

Primary

Percentage of Participants With Seroprotection at Day 28 Following Two Administrations of Vaccination, Severe Asthmatics

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.

Posted

Number

percentage of participants

Days 1 to 28

ID	Title	Description
OG000	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.
OG001	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)

Units	Counts
Participants

Primary

Percentage of Participants With Seroprotection at Day 41 Following Two Administrations of Vaccination, Mild-Moderate Asthmatics

Posted

Number

percentage of participants

Days 1 to 41

ID	Title	Description
OG000	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.
OG001	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)

Units	Counts

Primary

Percentage of Participants With Seroprotection at Day 41 Following Two Administrations of Vaccination, Severe Asthmatics

Posted

Number

percentage of participants

Days 1 to 41

ID	Title	Description
OG000	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.
OG001	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)

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Mild/Moderate Asthma, Low Dose Vaccine (15 Mcg)	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.	4	110	29	110
EG001	Mild/Moderate Asthma, High Dose Vaccine (30mcg)	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.	4	107	15	107
EG002	Severe Asthma, Low Dose Vaccine (15mcg)	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.	12	87	25	87
EG003	Severe Asthma, High Dose Vaccine (30mcg)	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.	6	86	25	86

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Atrial flutter	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected110 at risk EG0010 events0 affected107 at risk EG0020 events0 affected87 at risk EG0030 events0 affected86 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected107 at risk EG0020 events0 affected87 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected107 at risk EG0021 events1 affected87 at risk EG003
Umbilical hernia	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected107 at risk EG0020 events0 affected87 at risk EG003
Abasia	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected107 at risk EG0021 events1 affected87 at risk EG003
Chest pain	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected107 at risk EG0021 events1 affected87 at risk EG003
Death	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected107 at risk EG0020 events0 affected87 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected107 at risk EG0021 events1 affected87 at risk EG003
Localised infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected107 at risk EG0021 events1 affected87 at risk EG003
Pneumonia	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected110 at risk EG0011 events1 affected107 at risk EG0020 events0 affected87 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected110 at risk EG0011 events1 affected107 at risk EG0020 events0 affected87 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected110 at risk EG0011 events1 affected107 at risk EG0020 events0 affected87 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected110 at risk EG0010 events0 affected107 at risk EG0020 events0 affected87 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected107 at risk EG0021 events1 affected87 at risk EG003
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected107 at risk EG0021 events1 affected87 at risk EG003
Ovarian cyst	Reproductive system and breast disorders	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected110 at risk EG0011 events1 affected107 at risk EG0020 events0 affected87 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 events1 affected110 at risk EG0010 events0 affected107 at risk EG0027 events7 affected87 at risk EG003
Drug rehabilitation	Surgical and medical procedures	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected110 at risk EG0010 events0 affected107 at risk EG0021 events1 affected87 at risk EG003
Hysterectomy	Surgical and medical procedures	MedDRA 12.1	Systematic Assessment	EG0000 events0 affected110 at risk EG0011 events1 affected107 at risk EG0020 events0 affected87 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Upper respiratory tract infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG00012 events12 affected110 at risk EG0019 events9 affected107 at risk EG00211 events11 affected87 at risk EG0038 events8 affected86 at risk
Forced expiratory volume decreased	Investigations	MedDRA 12.1	Systematic Assessment	EG0004 events4 affected110 at risk EG0012 events1 affected107 at risk EG0029 events7 affected87 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0008 events8 affected110 at risk EG0014 events3 affected107 at risk EG00211 events10 affected87 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0009 events9 affected110 at risk EG0014 events4 affected107 at risk EG0021 events1 affected87 at risk EG003

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.