Sanofi H1N1 Influenza Vaccine Administered at Two Dose Levels in Adult and Elderly Populations

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00943631
• Collaborator: (none)
• Enrollment: 406
• Locations: 3
• Arms: 2
• Duration (Months): 7
• Patients Per Site: 135.3
• Patients Per Site Per Month: 19.4

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the safety and the body's immune response (body's defense against disease) to an experimental H1N1 influenza vaccine in healthy adult and elderly populations. The study will enroll up to 450 healthy adults ages 18 and older with no history of H1N1 infection or vaccination. Two hundred individuals will be 18-64 years old, and the other 200 will be greater than or equal to 65 years of age. Participants will be randomly assigned to 1 of 2 possible vaccine groups: group 1 will receive 15 mcg of H1N1 vaccine; group 2 will receive 30 mcg of H1N1 vaccine. Both groups will receive vaccine injections on days 0 and 21 in the arm muscle. Study procedures include: medical history, physical exam, maintaining a memory aid, and blood sample collection. Participants will be involved in study related procedures for approximately 7 months.

Condition or Disease	Intervention/Treatment	Phase
Influenza	Biological: Inactivated H1N1 Vaccine	Phase 2

Detailed Description

Recently, a novel swine-origin influenza A/H1N1 virus was identified as a significant cause of febrile respiratory illnesses in Mexico and the United States. It rapidly spread to many countries around the world, prompting the World Health Organization (WHO) to declare a pandemic on June 11, 2009. Data from several cohorts in different age groups that received licensed trivalent seasonal influenza vaccines suggest that these vaccines are unlikely to provide protection against the new virus. In addition, adults are more likely to have measurable levels of serum hemagglutination inhibition assay (HAI) or neutralizing antibody than are children. These data indicate the need to develop vaccines against the new H1N1 strain and suggest that different vaccine strategies (e.g., number of doses, need for adjuvant) may be appropriate for persons in different age groups. The primary safety objective of this study is to assess the safety of the unadjuvanted, inactivated H1N1 vaccine when administered at the 15 or 30 mcg dose. The primary immunogenicity objective is to assess the antibody response following a single dose of unadjuvanted, inactivated H1N1 vaccine, stratified by age of recipient, when administered at the 15 or 30 mcg dose. The secondary immunogenicity objective is to assess the antibody response following 2 doses of unadjuvanted, inactivated H1N1 vaccine, stratified by age of recipient, when administered at the 15 or 30 mcg dose. Participants will include up to 450 healthy adults age 18 and older who have no history of novel influenza H1N1 2009 infection or novel influenza H1N1 2009 vaccination. This is a randomized, double-blinded, Phase II study in healthy males and non-pregnant females designed to investigate the safety, reactogenicity, and immunogenicity of an inactivated influenza H1N1 virus vaccine at 2 dose levels. Subjects will be randomized into 2 dose groups, stratified by age (200 subjects per dose group with 100 subjects per age stratum, 18-64 or greater than or equal to 65 years of age) to receive intramuscular influenza H1N1 vaccine at 15 mcg (Group 1) or 30 mcg (Group 2). The H1N1 vaccine will be administered at Day 0 and Day 21. Following immunization, safety will be measured by assessment of adverse events through 21 days following the last vaccination (Day 42 for those receiving both doses and Day 21 for those who do not receive the second dose), serious adverse events and new-onset chronic medical conditions through 7 months post first vaccination (Day 201), and reactogenicity to the vaccine for 8 days following each vaccination (Day 0-7). Immunogenicity testing will include HAI and neutralizing antibody testing on serum obtained on the day of each vaccination (prior to vaccination), on Day 8-10 after each vaccination, and 21 days following the second vaccination (Day 42).

Study Design

• Study Type: Interventional
• Actual Enrollment: 406 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: A Phase II Study in Healthy Adult and Elderly Populations to Assess the Safety and Immunogenicity of an Unadjuvanted Sanofi Pasteur H1N1 Influenza Vaccine Administered at Two Dose Levels
• Study Start Date: Aug 1, 2009
• Actual Primary Completion Date: Mar 1, 2010
• Actual Study Completion Date: Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 2: H1N1 Vaccine 30 mcg 200 subjects (100 subjects ages 18-64 and 100 subjects greater than or equal to age 65) to receive 30 mcg of H1N1 vaccine on Days 0 and 21.	Biological: Inactivated H1N1 Vaccine; Two doses of inactivated influenza H1N1 vaccine delivered intramuscularly as 15 or 30 mcg per dose.
Experimental: Group 1: H1N1 Vaccine 15 mcg 200 subjects (100 subjects ages 18-64 and 100 subjects greater than or equal to age 65) to receive 15 mcg of H1N1 vaccine on Days 0 and 21.	Biological: Inactivated H1N1 Vaccine; Two doses of inactivated influenza H1N1 vaccine delivered intramuscularly as 15 or 30 mcg per dose.

Outcome Measures

Primary Outcome Measures

1. Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs) [Day 0 through Day 180 after last vaccination]

   Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; resulted in a congenital anomaly/birth defect; or may have jeopardized the participant or required intervention to prevent one of these outcomes. Association to vaccination was determined by a study clinician licensed to make medical diagnoses.

2. Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the First Vaccination [Day 0-7 after first vaccination]

   Participants maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.

3. Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the Second Vaccination [Day 0-7 after second vaccination]

   Participants maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.

4. Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness After the First Vaccination [Day 0-7 after first vaccination]

   Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.

5. Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness After the Second Vaccination [Day 0-7 after second vaccination]

   Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.

6. Number of Participants Reporting Solicited Systemic Reactions Based on the Functional Grading Scale After the First Vaccination [Day 0-7 after first vaccination]

   Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.

7. Number of Participants Reporting Solicited Systemic Reactions Based on the Functional Grading Scale After the Second Vaccination [Day 0-7 after second vaccination]

   Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.

8. Number of Participants Reporting Fever After the First Vaccination [Day 0-7 after first vaccination]

   Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 38.0 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 38.0 degrees Celsius or higher on any of the 8 days.

9. Number of Participants Reporting Fever After the Second Vaccination [Day 0-7 after second vaccination]

   Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 38.0 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 38.0 degrees Celsius or higher on any of the 8 days.

10. Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 1 Dose of Vaccine [Baseline and Day 8-10 after first vaccination]

    Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.

11. Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 1 Dose of Vaccine [Baseline and Day 8-10 after first vaccination]

    Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.

12. Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of Vaccine [Baseline and Day 21 after first vaccination]

    Blood was collected from all participants prior to vaccination and at the 21 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.

13. Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of Vaccine [Baseline and Day 21 after first vaccination]

    Blood was collected from all participants prior to vaccination and at the 21 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.

14. Number of Participants in the 18-64 Year Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Prior to and at 8-10 Days Following 1 Dose of H1N1 Vaccine [Day 0 prior to and Day 8-10 after first vaccination]

    Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

15. Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Prior to and at 8-10 Days Following 1 Dose of H1N1 Vaccine [Day 0 prior to and Day 8-10 after first vaccination]

    Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

16. Number of Participants in the 18-64 Year Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of H1N1 Vaccine [Day 21 after first vaccination]

    Blood was collected from all participants at the 21 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

17. Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of H1N1 Vaccine [Day 21 after first vaccination]

    Blood was collected from all participants at the 21 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

Secondary Outcome Measures

1. Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 and 21 Days Following 2 Doses of H1N1 Vaccine [Baseline and Day 8-10 and 21 after the second vaccination]

   Blood was collected from all participants prior to the initial vaccination as well as 8-10 and 21 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 post vaccination 2 titer was an increase by 4-fold or more.

2. Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine [Baseline and Day 8-10 after the second vaccination]

   Blood was collected from all participants prior to the initial vaccination and 8-10 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 post vaccination 2 titer was an increase by 4-fold or more.

3. Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine [Baseline and Day 21 after the second vaccination]

   Blood was collected from all participants prior to the initial vaccination and 21 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 post vaccination 2 titer was an increase by 4-fold or more.

4. Number of Participants in the 18-64 Year Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 8-10 and 21 Days Following 2 Doses of H1N1 Vaccine [Day 8-10 and Day 21 after the second vaccination]

   Blood was collected from all participants at Day 8-10 and Day 21 post second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

5. Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine [Day 8-10 after the second vaccination]

   Blood was collected from all participants at Day 8-10 post second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

6. Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine [Day 21 after the second vaccination]

   Blood was collected from all participants at Day 21 post second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Are males or non-pregnant females age 18 and older, inclusive.

• Women of child-bearing potential (not surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who are not postmenopausal for greater than or equal to 1 year) 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.

• Are in good health, as determined by vital signs, medical history to ensure any existing medical diagnoses or conditions are stable and not considered clinically significant, and targeted physical examination based on medical history. A stable chronic medical condition is defined as no change in prescription medication, dose, or frequency of medication in the last 3 months and health outcomes of the specific disease are considered to be within acceptable limits in the last 6 months. Any change that is due to change of health care provider, insurance company etc, or that is done for financial reasons, as long as in the same class of medication will not be considered a violation of this inclusion criterion. Any change in prescription medication due to improvement of a disease outcome will not be considered a violation of this inclusion criterion.

• Are able to understand and comply with planned study procedures.

• Provide written informed consent prior to initiation of any study procedures.

Exclusion Criteria:

• Have a known allergy to eggs or other components of the vaccine (including gelatin, formaldehyde, octoxinol, thimerosal, and chicken protein).

• Have a positive urine or serum pregnancy test within 24 hours prior to vaccination (if female of childbearing potential), or women who are breastfeeding.

• Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy (cytotoxic) within the preceding 36 months.

• Have an active neoplastic disease or a history of any hematologic malignancy.

• Have long term use of glucocorticoids including oral, parenteral or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months. (Nasal and topical steroids are allowed.)

• Have a diagnosis of schizophrenia, bipolar disease, or other major psychiatric diagnosis.

• Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others, within the past 10 years.

• Are receiving psychiatric drugs (aripiprazole, clozapine, ziprasidone, haloperidol, molindone, loxapine, thioridazine, thiothixene, pimozide, fluphenazine, risperidone, mesoridazine, quetiapine, trifluoperazine, chlorprothixene, chlorpromazine, perphenazine, trifluopromazine, olanzapine, carbamazepine, divalproex sodium, lithium carbonate or lithium citrate). Subjects who are receiving a single antidepressant drug and are stable for at least 3 months prior to enrollment, without de-compensating symptoms will be allowed to be enrolled in the study.

• Have a history of receiving immunoglobulin or other blood product within the 3 months prior to vaccination in this study.

• 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 201 follow-up call - 180 days after the second vaccination).

• Have 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. This is inclusive of seasonal influenza vaccines.

• Have an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe, or would interfere with the evaluation of responses.

• Have a history of severe reactions following previous immunization with influenza virus vaccines.

• Have an acute illness, including an oral temperature greater than 100.4 degrees Fahrenheit, within 3 days prior to vaccination.

• Have any condition that would, in the opinion of the site investigator, place them at an unacceptable risk of injury or render them unable to meet the requirements of the protocol.

• Participated in a novel influenza H1N1 2009 vaccine study in the past two years or have a history of novel influenza H1N1 2009 infection prior to enrollment.

• Have known active human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C infection.

• Have a history of alcohol or drug abuse in the last 5 years.

• Plan to travel outside of North America in the time between the first vaccination and 42 days following the first vaccination.

• Have a history of Guillain-Barré Syndrome.

• Have any condition that the investigator believes may interfere with successful completion of the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Maryland School of Medicine - Center for Vaccine Development - Baltimore	Baltimore	Maryland	United States	21201
2	Duke Translational Medicine Institute - Clinical Vaccine Unit	Durham	North Carolina	United States	27704
3	Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center	Nashville	Tennessee	United States	37232-2573

Sponsors and Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
• ClinicalTrials.gov Identifier: NCT00943631
• Other Study ID Numbers: 09-0053; N01AI80057C
• First Posted: Jul 22, 2009
• Last Update Posted: Oct 31, 2012
• Last Verified: Mar 1, 2010

• Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID): H1N1, influenza A viruses, vaccine, elderly
• Additional relevant MeSH terms: Influenza, Human

Study Results

Participant Flow

Recruitment Details	Participants were healthy adult males and females recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled and vaccinated between 07AUG2009 and 18AUG2009.

Arm/Group Title	H1N1 Vaccine 15 Mcg	H1N1 Vaccine 30 Mcg
Arm/Group Description	Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.	Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Period Title: Overall Study
STARTED	202	204
COMPLETED	198	202
NOT COMPLETED	4	2

Baseline Characteristics

Arm/Group Title	H1N1 Vaccine 15 Mcg	H1N1 Vaccine 30 Mcg	Total
Arm/Group Description	Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.	Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.	Total of all reporting groups
Overall Participants	202	204	406
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	102 50.5%	100 49%	202 49.8%
>=65 years	100 49.5%	104 51%	204 50.2%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.7 (17.1)	59.6 (16.4)	59.1 (16.7)
Sex: Female, Male (Count of Participants)
Female	103 51%	112 54.9%	215 53%
Male	99 49%	92 45.1%	191 47%
Region of Enrollment (participants) [Number]
United States	202 100%	204 100%	406 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)
Description	Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; resulted in a congenital anomaly/birth defect; or may have jeopardized the participant or required intervention to prevent one of these outcomes. Association to vaccination was determined by a study clinician licensed to make medical diagnoses.
Time Frame	Day 0 through Day 180 after last vaccination

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	H1N1 Vaccine 15 Mcg	H1N1 Vaccine 30 Mcg
Arm/Group Description	Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.	Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Measure Participants	202	204
Number [Participants]	0 0%	0 0%

2. Primary Outcome

Title	Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the First Vaccination
Description	Participants maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.
Time Frame	Day 0-7 after first vaccination

Outcome Measure Data

Analysis Population Description

All participants receiving the first vaccination are included in the safety ITT cohort.

Arm/Group Title	H1N1 Vaccine 15 Mcg	H1N1 Vaccine 30 Mcg
Arm/Group Description	Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.	Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Measure Participants	202	204
Pain	36 17.8%	34 16.7%
Tenderness	58 28.7%	75 36.8%
Swelling	27 13.4%	16 7.8%

3. Primary Outcome

Title	Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the Second Vaccination
Description	Participants maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.
Time Frame	Day 0-7 after second vaccination

Outcome Measure Data

Analysis Population Description

All participants receiving the second vaccination are included in the safety ITT cohort.

Arm/Group Title	H1N1 Vaccine 15 Mcg	H1N1 Vaccine 30 Mcg
Arm/Group Description	Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.	Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Measure Participants	192	197
Pain	27 13.4%	27 13.2%
Tenderness	54 26.7%	63 30.9%
Swelling	10 5%	18 8.8%

4. Primary Outcome

Title	Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness After the First Vaccination
Description	Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.
Time Frame	Day 0-7 after first vaccination

Outcome Measure Data

Analysis Population Description

All participants receiving the first vaccination are included in the safety ITT cohort.

Arm/Group Title	H1N1 Vaccine 15 Mcg	H1N1 Vaccine 30 Mcg
Arm/Group Description	Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.	Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Measure Participants	202	204
Swelling	31 15.3%	22 10.8%
Redness	39 19.3%	32 15.7%

5. Secondary Outcome

Title	Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 and 21 Days Following 2 Doses of H1N1 Vaccine
Description	Blood was collected from all participants prior to the initial vaccination as well as 8-10 and 21 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 post vaccination 2 titer was an increase by 4-fold or more.
Time Frame	Baseline and Day 8-10 and 21 after the second vaccination

Outcome Measure Data

Analysis Population Description

Participants were included in the analyses if they received the both vaccinations and had blood collected at the timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.

Arm/Group Title	H1N1 Vaccine 15 Mcg	H1N1 Vaccine 30 Mcg
Arm/Group Description	Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.	Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Measure Participants	95	95
Day 8-10	86 42.6%	83 40.7%
Day 21	84 41.6%	82 40.2%

6. Secondary Outcome

Title	Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine
Description	Blood was collected from all participants prior to the initial vaccination and 8-10 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 post vaccination 2 titer was an increase by 4-fold or more.
Time Frame	Baseline and Day 8-10 after the second vaccination

Outcome Measure Data

Analysis Population Description

Participants were included in the analyses if they received the both vaccinations and had blood collected at the timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum. One subject was excluded due to receipt of a non-study vaccine prior to the clinic visit.

Arm/Group Title	H1N1 Vaccine 15 Mcg	H1N1 Vaccine 30 Mcg
Arm/Group Description	Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.	Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Measure Participants	94	100
Number [Participants]	68 33.7%	84 41.2%

7. Primary Outcome

Title	Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness After the Second Vaccination
Description	Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.
Time Frame	Day 0-7 after second vaccination

Outcome Measure Data

Analysis Population Description

All participants receiving the second vaccination are included in the safety ITT cohort.

Arm/Group Title	H1N1 Vaccine 15 Mcg	H1N1 Vaccine 30 Mcg
Arm/Group Description	Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.	Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Measure Participants	192	197
Swelling	11 5.4%	18 8.8%
Redness	33 16.3%	25 12.3%

8. Primary Outcome

Title	Number of Participants Reporting Solicited Systemic Reactions Based on the Functional Grading Scale After the First Vaccination
Description	Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.
Time Frame	Day 0-7 after first vaccination

Outcome Measure Data

Analysis Population Description

All participants receiving the first vaccination are included in the safety ITT cohort.

Arm/Group Title	H1N1 Vaccine 15 Mcg	H1N1 Vaccine 30 Mcg
Arm/Group Description	Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.	Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Measure Participants	202	204
Feverishness	11 5.4%	5 2.5%
Malaise	31 15.3%	30 14.7%
Myalgia	23 11.4%	22 10.8%
Headache	46 22.8%	42 20.6%
Nausea	5 2.5%	6 2.9%

9. Primary Outcome

Title	Number of Participants Reporting Solicited Systemic Reactions Based on the Functional Grading Scale After the Second Vaccination
Description	Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.
Time Frame	Day 0-7 after second vaccination

Outcome Measure Data

Analysis Population Description

All participants receiving the second vaccination are included in the safety ITT cohort.

Arm/Group Title	H1N1 Vaccine 15 Mcg	H1N1 Vaccine 30 Mcg
Arm/Group Description	Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.	Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Measure Participants	192	197
Feverishness	11 5.4%	10 4.9%
Malaise	32 15.8%	25 12.3%
Myalgia	25 12.4%	18 8.8%
Headache	20 9.9%	33 16.2%
Nausea	10 5%	11 5.4%

10. Primary Outcome

Title	Number of Participants Reporting Fever After the First Vaccination
Description	Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 38.0 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 38.0 degrees Celsius or higher on any of the 8 days.
Time Frame	Day 0-7 after first vaccination

Outcome Measure Data

Analysis Population Description

All participants receiving the first vaccination are included in the safety ITT cohort.

Arm/Group Title	H1N1 Vaccine 15 Mcg	H1N1 Vaccine 30 Mcg
Arm/Group Description	Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.	Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Measure Participants	202	204
Number [Participants]	2 1%	1 0.5%

11. Primary Outcome

Title	Number of Participants Reporting Fever After the Second Vaccination
Description	Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 38.0 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 38.0 degrees Celsius or higher on any of the 8 days.
Time Frame	Day 0-7 after second vaccination

Outcome Measure Data

Analysis Population Description

All participants receiving the second vaccination are included in the safety ITT cohort.

Arm/Group Title	H1N1 Vaccine 15 Mcg	H1N1 Vaccine 30 Mcg
Arm/Group Description	Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.	Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Measure Participants	192	197
Number [Participants]	2 1%	0 0%

12. Primary Outcome

Title	Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 1 Dose of Vaccine
Description	Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.
Time Frame	Baseline and Day 8-10 after first vaccination

Outcome Measure Data

Analysis Population Description

Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.

Arm/Group Title	H1N1 Vaccine 15 Mcg	H1N1 Vaccine 30 Mcg
Arm/Group Description	Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.	Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Measure Participants	101	100
Number [Participants]	80 39.6%	85 41.7%

13. Primary Outcome

Title	Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 1 Dose of Vaccine
Description	Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.
Time Frame	Baseline and Day 8-10 after first vaccination

Outcome Measure Data

Analysis Population Description

Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.

Arm/Group Title	H1N1 Vaccine 15 Mcg	H1N1 Vaccine 30 Mcg
Arm/Group Description	Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.	Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Measure Participants	100	104
Number [Participants]	63 31.2%	69 33.8%

14. Primary Outcome

Title	Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of Vaccine
Description	Blood was collected from all participants prior to vaccination and at the 21 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.
Time Frame	Baseline and Day 21 after first vaccination

Outcome Measure Data

Analysis Population Description

Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.

Arm/Group Title	H1N1 Vaccine 15 Mcg	H1N1 Vaccine 30 Mcg
Arm/Group Description	Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.	Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Measure Participants	100	98
Number [Participants]	86 42.6%	87 42.6%

15. Primary Outcome

Title	Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of Vaccine
Description	Blood was collected from all participants prior to vaccination and at the 21 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.
Time Frame	Baseline and Day 21 after first vaccination

Outcome Measure Data

Analysis Population Description

Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum. One participant was excluded due to the blood being collected after administration of the second vaccination.

Arm/Group Title	H1N1 Vaccine 15 Mcg	H1N1 Vaccine 30 Mcg
Arm/Group Description	Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.	Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Measure Participants	98	103
Number [Participants]	66 32.7%	83 40.7%

16. Primary Outcome

Title	Number of Participants in the 18-64 Year Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Prior to and at 8-10 Days Following 1 Dose of H1N1 Vaccine
Description	Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Time Frame	Day 0 prior to and Day 8-10 after first vaccination

Outcome Measure Data

Analysis Population Description

Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.

Arm/Group Title	H1N1 Vaccine 15 Mcg	H1N1 Vaccine 30 Mcg
Arm/Group Description	Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.	Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Measure Participants	101	100
Day 0	14 6.9%	9 4.4%
Day 8	85 42.1%	89 43.6%

17. Secondary Outcome

Title	Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine
Description	Blood was collected from all participants prior to the initial vaccination and 21 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 post vaccination 2 titer was an increase by 4-fold or more.
Time Frame	Baseline and Day 21 after the second vaccination

Outcome Measure Data

Analysis Population Description

Participants were included in the analyses if they received the both vaccinations and had blood collected at the timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum. One subject was excluded due to receipt of a non-study vaccine prior to the clinic visit.

Arm/Group Title	H1N1 Vaccine 15 Mcg	H1N1 Vaccine 30 Mcg
Arm/Group Description	Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.	Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Measure Participants	95	101
Number [Participants]	70 34.7%	82 40.2%

18. Secondary Outcome

Title	Number of Participants in the 18-64 Year Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 8-10 and 21 Days Following 2 Doses of H1N1 Vaccine
Description	Blood was collected from all participants at Day 8-10 and Day 21 post second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Time Frame	Day 8-10 and Day 21 after the second vaccination

Outcome Measure Data

Analysis Population Description

Participants were included in the analyses if they received both vaccinations and had blood collected at the timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.

Arm/Group Title	H1N1 Vaccine 15 Mcg	H1N1 Vaccine 30 Mcg
Arm/Group Description	Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.	Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Measure Participants	95	95
Day 8-10	88 43.6%	86 42.2%
Day 21	88 43.6%	87 42.6%

19. Primary Outcome

Title	Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Prior to and at 8-10 Days Following 1 Dose of H1N1 Vaccine
Description	Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Time Frame	Day 0 prior to and Day 8-10 after first vaccination

Outcome Measure Data

Analysis Population Description

Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.

Arm/Group Title	H1N1 Vaccine 15 Mcg	H1N1 Vaccine 30 Mcg
Arm/Group Description	Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.	Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Measure Participants	100	104
Day 0	24 11.9%	25 12.3%
Day 8	80 39.6%	84 41.2%

20. Primary Outcome

Title	Number of Participants in the 18-64 Year Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of H1N1 Vaccine
Description	Blood was collected from all participants at the 21 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Time Frame	Day 21 after first vaccination

Outcome Measure Data

Analysis Population Description

Participants were included in the analyses if they received the first vaccination and had blood collected at the timepoint. Participants were analyzed as treated. This outcome measure restricts to age stratum.

Arm/Group Title	H1N1 Vaccine 15 Mcg	H1N1 Vaccine 30 Mcg
Arm/Group Description	Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.	Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Measure Participants	100	98
Number [Participants]	90 44.6%	90 44.1%

21. Primary Outcome

Title	Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of H1N1 Vaccine
Description	Blood was collected from all participants at the 21 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Time Frame	Day 21 after first vaccination

Outcome Measure Data

Analysis Population Description

Participants were included in the analyses if they received the first vaccination and had blood collected at the timepoint. Participants were analyzed as treated. This outcome measure restricts to age stratum. One participant was excluded due to the blood being collected after administration of the second vaccination.

Arm/Group Title	H1N1 Vaccine 15 Mcg	H1N1 Vaccine 30 Mcg
Arm/Group Description	Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.	Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Measure Participants	98	103
Number [Participants]	79 39.1%	94 46.1%

22. Secondary Outcome

Title	Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine
Description	Blood was collected from all participants at Day 8-10 post second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Time Frame	Day 8-10 after the second vaccination

Outcome Measure Data

Analysis Population Description

Participants were included in the analyses if they received both vaccinations and had blood collected at the timepoint. Participants were analyzed as treated. This outcome measure restricts to age stratum. One subject was excluded due to receipt of an non-study vaccine prior to the clinic visit.

Arm/Group Title	H1N1 Vaccine 15 Mcg	H1N1 Vaccine 30 Mcg
Arm/Group Description	Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.	Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Measure Participants	94	100
Number [Participants]	80 39.6%	92 45.1%

23. Secondary Outcome

Title	Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine
Description	Blood was collected from all participants at Day 21 post second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Time Frame	Day 21 after the second vaccination

Outcome Measure Data

Analysis Population Description

Participants were included in the analyses if they received both vaccinations and had blood collected at the timepoint. Participants were analyzed as treated. This outcome measure restricts to age stratum. One subject was excluded due to receipt of an non-study vaccine prior to the clinic visit.

Arm/Group Title	H1N1 Vaccine 15 Mcg	H1N1 Vaccine 30 Mcg
Arm/Group Description	Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.	Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Measure Participants	95	101
Number [Participants]	79 39.1%	93 45.6%

Adverse Events

Time Frame	Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
Adverse Event Reporting Description	For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Arm/Group Title	H1N1 Vaccine 15 Mcg		H1N1 Vaccine 30 Mcg
Arm/Group Description	Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.		Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
All Cause Mortality
	H1N1 Vaccine 15 Mcg		H1N1 Vaccine 30 Mcg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	H1N1 Vaccine 15 Mcg		H1N1 Vaccine 30 Mcg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/202 (3%)		5/204 (2.5%)
Cardiac disorders
Ischaemic cardiomyopathy	1/202 (0.5%)	1	0/204 (0%)	0
Atrial fibrillation	0/202 (0%)	0	1/204 (0.5%)	1
Gastrointestinal disorders
Umbilical hernia, obstructive	0/202 (0%)	0	1/204 (0.5%)	1
General disorders
Chest pain	0/202 (0%)	0	1/204 (0.5%)	1
Infections and infestations
Clostridium difficile colitis	1/202 (0.5%)	1	0/204 (0%)	0
Injury, poisoning and procedural complications
Post procedural complication	1/202 (0.5%)	1	0/204 (0%)	0
Musculoskeletal and connective tissue disorders
Osteoarthritis	1/202 (0.5%)	1	0/204 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma	1/202 (0.5%)	1	0/204 (0%)	0
Nervous system disorders
Syncope	0/202 (0%)	0	1/204 (0.5%)	1
Renal and urinary disorders
Renal cyst	1/202 (0.5%)	1	0/204 (0%)	0
Urinary incontinence	0/202 (0%)	0	1/204 (0.5%)	1
Respiratory, thoracic and mediastinal disorders
Respiratory failure	0/202 (0%)	0	1/204 (0.5%)	1
Pulmonary embolism	0/202 (0%)	0	1/204 (0.5%)	1
Surgical and medical procedures
Thoracotomy	1/202 (0.5%)	1	0/204 (0%)	0
Other (Not Including Serious) Adverse Events
	H1N1 Vaccine 15 Mcg		H1N1 Vaccine 30 Mcg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	149/202 (73.8%)		150/204 (73.5%)
Gastrointestinal disorders
Nausea	13/202 (6.4%)	15	17/204 (8.3%)	17
General disorders
Feeling hot	21/202 (10.4%)	22	14/204 (6.9%)	15
Malaise	54/202 (26.7%)	63	48/204 (23.5%)	55
Injection site pain	49/202 (24.3%)	63	48/204 (23.5%)	61
Tenderness	86/202 (42.6%)	112	94/204 (46.1%)	138
Injection site erythema	57/202 (28.2%)	72	42/204 (20.6%)	57
Injection site swelling (functional grading)	31/202 (15.3%)	37	29/204 (14.2%)	34
Injection site swelling (measured)	36/202 (17.8%)	42	35/204 (17.2%)	40
Infections and infestations
Upper respiratory tract infection	12/202 (5.9%)	12	10/204 (4.9%)	10
Musculoskeletal and connective tissue disorders
Myalgia	42/202 (20.8%)	48	34/204 (16.7%)	40
Nervous system disorders
Headache	57/202 (28.2%)	66	59/204 (28.9%)	75

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.