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| ID | Type | Description | Link |
|---|---|---|---|
| N01AI80008C |
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The purpose of this study is to assess the safety and 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 micrograms (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.
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 microgram (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 inactivated 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: H1N1 Vaccine 15 mcg | Experimental | 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. |
|
| Group 2: H1N1 Vaccine 30 mcg | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inactivated H1N1 Vaccine | Biological | Two doses of inactivated influenza H1N1 vaccine delivered intramuscularly as 15 or 30 mcg per dose. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the 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, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days. | Day 0-7 after first vaccination |
| Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the 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, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days. | Day 0-7 after second vaccination |
| Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness After the 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. | Day 0-7 after first vaccination |
| Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness After the 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 2 Doses of H1N1 Vaccine. | 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 8-10 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 8-10 post vaccination 2 titer was an increase by 4-fold or more. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa | Iowa City | Iowa | 52242 | United States | ||
| Cincinnati Children's Hospital Medical Center - Infectious Diseases |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22537984 | Result | Chen WH, Winokur PL, Edwards KM, Jackson LA, Wald A, Walter EB, Noah DL, Wolff M, Kotloff KL; Pandemic H1N1 Vaccine Adult Study Group. Phase 2 assessment of the safety and immunogenicity of two inactivated pandemic monovalent H1N1 vaccines in adults as a component of the U.S. pandemic preparedness plan in 2009. Vaccine. 2012 Jun 13;30(28):4240-8. doi: 10.1016/j.vaccine.2012.04.044. Epub 2012 Apr 23. |
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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 between 07AUG2009 and 21AUG2009
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| ID | Title | Description |
|---|---|---|
| FG000 | H1N1 Vaccine 15 Mcg | Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21. |
| FG001 | H1N1 Vaccine 30 Mcg | Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | H1N1 Vaccine 15 Mcg | Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21. |
| BG001 | H1N1 Vaccine 30 Mcg | Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the 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, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days. | All participants receiving the first vaccination are included in the safety ITT cohort | Posted | Number | Participants | Day 0-7 after first vaccination |
|
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.
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | H1N1 Vaccine 15 Mcg | Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellullitis | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site haematoma | General disorders | MedDRA (13.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patricia Winokur, MD | Carver College of Medicine, University of Iowa | 319-384-1735 | patricia-winokur@uiowa.edu |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| Day 0-7 after second vaccination |
| Number of Participants Reporting Solicited Systemic Symptoms Based on the Functional Grading Scale After the 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, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days. | Day 0-7 after first vaccination |
| Number of Participants Reporting Solicited Systemic Symptoms Based on the Functional Grading Scale After the 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, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days. | Day 0-7 after second vaccination |
| Number of Participants Reporting Fever After the 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. | Day 0-7 after first vaccination |
| Number of Participants Reporting Fever After the 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. | Day 0-7 after second vaccination |
| 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 8-10 Days Following 1 Dose of H1N1 Vaccine | 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. | Day 0 prior to and Day 8-10 after first vaccination |
| 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 8-10 Days Following 1 Dose of H1N1 Vaccine | 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. | Day 0 prior to and Day 8-10 after first vaccination |
| 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 | 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. | Day 21 after first vaccination |
| 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 | 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. | Day 21 after first vaccination |
| Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs) | 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. | Day 0 through Day 180 after last vaccination |
| 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 | 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. | Day 0 prior to and Day 8-10 after first vaccination |
| 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 | 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. | Day 0 prior to and Day 8-10 after first vaccination |
| 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 | 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 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. | Day 0 prior to and Day 21 after first vaccination |
| 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 | 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 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. | Day 0 prior to and Day 21 after first vaccination |
| Day 0 prior to first vaccination and Day 8-10 after the second vaccination |
| 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. | 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 8-10 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 8-10 post vaccination 2 titer was an increase by 4-fold or more. | Day 0 prior to first vaccination and Day 8-10 after the second vaccination |
| 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 2 Doses of H1N1 Vaccine. | 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. | Day 0 prior to first vaccination and Day 21 after the second vaccination |
| 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. | 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. | Day 0 prior to first vaccination and Day 21 after the second vaccination |
| Number of Participants in the 18-64 Year Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine. | 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. | Day 8-10 after the second vaccination |
| Number of Participants in the 65 Years and Older Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine. | 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. | Day 8-10 after the second vaccination |
| Number of Participants in the 18-64 Year Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine. | 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. | Day 21 after the second vaccination |
| Number of Participants in the 65 Years and Older Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine. | 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. | Day 21 after the second vaccination |
| Cincinnati |
| Ohio |
| 45231 |
| United States |
| Group Health Cooperative | Seattle | Washington | 98101 | United States |
| University of Washington | Seattle | Washington | 98104 | United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | H1N1 Vaccine 30 Mcg | Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21. |
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| Primary | Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the 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, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days. | All participants receiving the second vaccination are included in the safety ITT cohort | Posted | Number | Participants | Day 0-7 after second vaccination |
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| Primary | Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness After the 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. | All participants receiving the first vaccination are included in the safety ITT cohort | Posted | Number | Participants | Day 0-7 after first vaccination |
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| Primary | Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness After the 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. | All participants receiving the second vaccination are included in the safety ITT cohort | Posted | Number | Participants | Day 0-7 after second vaccination |
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| Secondary | 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 2 Doses of H1N1 Vaccine. | 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 8-10 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 8-10 post vaccination 2 titer was an increase by 4-fold or more. | Participants were included in the analyses if they received both vaccinations, with the second vaccination given within 4 days of the window, and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum. | Posted | Number | Participants | Day 0 prior to first vaccination and Day 8-10 after the second vaccination |
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| Secondary | 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. | 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 8-10 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 8-10 post vaccination 2 titer was an increase by 4-fold or more. | Participants were included in the analyses if they received the both vaccinations, with the second within 4 days of the window, and had blood collected at the timepoint. Analysis was as treated, restricted to age stratum. One participant was excluded due to presumed H1N1 infection, and three due to receiving non-study vaccines prior to the visit. | Posted | Number | Participants | Day 0 prior to first vaccination and Day 8-10 after the second vaccination |
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| Primary | Number of Participants Reporting Solicited Systemic Symptoms Based on the Functional Grading Scale After the 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, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days. | All participants receiving the first vaccination are included in the safety ITT cohort | Posted | Number | Participants | Day 0-7 after first vaccination |
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| Primary | Number of Participants Reporting Solicited Systemic Symptoms Based on the Functional Grading Scale After the 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, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days. | All participants receiving the second vaccination are included in the safety ITT cohort | Posted | Number | Participants | Day 0-7 after second vaccination |
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| Primary | Number of Participants Reporting Fever After the 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. | All participants receiving the first vaccination are included in the safety ITT cohort | Posted | Number | Participants | Day 0-7 after first vaccination |
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| Primary | Number of Participants Reporting Fever After the 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. | All participants receiving the second vaccination are included in the safety ITT cohort | Posted | Number | Participants | Day 0-7 after second vaccination |
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| Primary | 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 8-10 Days Following 1 Dose of H1N1 Vaccine | 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. | 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. | Posted | Number | Participants | Day 0 prior to and Day 8-10 after first vaccination |
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| Primary | 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 8-10 Days Following 1 Dose of H1N1 Vaccine | 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. | 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 presumed natural Influenza H1N1 infection prior to the Day 8-10 visit. | Posted | Number | Participants | Day 0 prior to and Day 8-10 after first vaccination |
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| Primary | 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 | 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. | 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. | Posted | Number | Participants | Day 21 after first vaccination |
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| Primary | 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 | 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. | Participants were included in the analyses if they received the first vaccination and had blood collected at the timepoint. Participants were analyzed as treated and restricted to age stratum. One participant was excluded due to presumed natural Influenza H1N1 infection, and two were excluded due to receiving non-study vaccines prior to the visit. | Posted | Number | Participants | Day 21 after first vaccination |
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| Primary | Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs) | 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. | All participants receiving the first vaccination are included in the safety ITT cohort | Posted | Number | Participants | Day 0 through Day 180 after last vaccination |
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| Primary | 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 | 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. | 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. | Posted | Number | Participants | Day 0 prior to and Day 8-10 after first vaccination |
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| Primary | 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 | 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. | 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 presumed natural Influenza H1N1 infection prior to the Day 8-10 visit. | Posted | Number | Participants | Day 0 prior to and Day 8-10 after first vaccination |
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| Primary | 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 | 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 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. | 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. | Posted | Number | Participants | Day 0 prior to and Day 21 after first vaccination |
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| Primary | 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 | 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 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. | Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated and restricted to age stratum. One participant was excluded due to presumed natural Influenza H1N1 infection, and two due to receiving non-study vaccines prior to the visit. | Posted | Number | Participants | Day 0 prior to and Day 21 after first vaccination |
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| Secondary | 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 2 Doses of H1N1 Vaccine. | 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. | Participants were included in the analyses if they received both vaccinations, with the second vaccination given within 4 days of the window, and had blood collected at both timepoints. Participants were analyzed as treated and restricted to age stratum. One participant was excluded due to receiving a non-study vaccine prior to the visit. | Posted | Number | Participants | Day 0 prior to first vaccination and Day 21 after the second vaccination |
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| Secondary | 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. | 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. | Participants were included in the analyses if they received the first vaccination and had blood collected at the timepoint. Participants were analyzed as treated and restricted to age stratum. One participant was excluded due to presumed natural Influenza H1N1 infection, and four due to receiving non-study vaccines prior to the visit. | Posted | Number | Participants | Day 0 prior to first vaccination and Day 21 after the second vaccination |
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| Secondary | Number of Participants in the 18-64 Year Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine. | 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. | Participants were included in the analyses if they received both vaccinations, with the second vaccination given within 4 days of the window, and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum. | Posted | Number | Participants | Day 8-10 after the second vaccination |
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| Secondary | Number of Participants in the 65 Years and Older Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine. | 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. | Participants were included in the analyses if they received the both vaccinations, with the second within 4 days of the window, and had blood collected at the timepoint. Analysis was as treated, restricted to age stratum. One participant was excluded due to presumed H1N1 infection, and three due to receiving non-study vaccines prior to the visit. | Posted | Number | Participants | Day 8-10 after the second vaccination |
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| Secondary | Number of Participants in the 18-64 Year Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine. | 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. | Participants were included in the analyses if they received both vaccinations, with the second vaccination given within 4 days of the window, and had blood collected at both timepoints. Participants were analyzed as treated and restricted to age stratum. One participant was excluded due to receiving a non-study vaccine prior to the visit. | Posted | Number | Participants | Day 21 after the second vaccination |
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| Secondary | Number of Participants in the 65 Years and Older Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine. | 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. | Participants were included in the analyses if they received the both vaccinations, with the second within 4 days of the window, and had blood collected at the timepoint. Analysis was as treated, restricted to age stratum. One participant was excluded due to presumed H1N1 infection, and four due to receiving non-study vaccines prior to the visit. | Posted | Number | Participants | Day 21 after the second vaccination |
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| 7 |
| 204 |
| 158 |
| 204 |
| EG001 | H1N1 Vaccine 30 Mcg | Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21. | 7 | 204 | 168 | 204 |
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
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| Chest discomfort | General disorders | MedDRA (13.0) | Non-systematic Assessment |
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| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
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| Loss of consciousness | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
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| Aortic stenosis | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
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| Chest pain | General disorders | MedDRA (13.0) | Non-systematic Assessment |
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| Cholecystectomy | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
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| Cerebral haemorrhage | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
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| Breast mass | Reproductive system and breast disorders | MedDRA (13.0) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
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| Mycosis fungoides | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
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| Surgery | Surgical and medical procedures | MedDRA (13.0) | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
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| Feeling hot | General disorders | MedDRA (13.0) | Systematic Assessment |
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| Malaise | General disorders | MedDRA (13.0) | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA (13.0) | Systematic Assessment |
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| Tenderness | General disorders | MedDRA (13.0) | Systematic Assessment | Tenderness was solicited as a reaction at the vaccination site |
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| Injection site erythema | General disorders | MedDRA (13.0) | Systematic Assessment |
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| Injection site swelling (functional grading) | General disorders | MedDRA (13.0) | Systematic Assessment | Injection site swelling was solicited separately for functional grading of impact on daily activities and as a measured reaction. |
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| Injection site swelling (measured) | General disorders | MedDRA (13.0) | Systematic Assessment | Injection site swelling was solicited separately for functional grading of impact on daily activities and as a measured reaction. |
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Not provided
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| Swelling |
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| Myalgia |
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| Headache |
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| Nausea |
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| Myalgia |
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| Headache |
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| Nausea |
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