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Influenza pandemics are caused by viruses that possess an Hemagglutinin molecule to which most of the population lacks immunity. If such virus is pathogenic to human and demonstrates the ability to transmit from person to person, the result is a global outbreak of disease that affects a high percentage of individuals in a short period of time and is likely to cause substantially increased mortality and morbidity in all countries of the world. Recently, purely avian influenza viruses, including the H5N1, H9N2 and H7N7 subtypes, have been directly transmitted to humans, raising concern over the possibility of a new influenza pandemic among the world's immunologically naive populations. In order to face this kind of situation, a pandemic influenza vaccine has to be developed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SB218352_15 Group | Experimental | Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21. |
|
| SB218352_8 Group | Experimental | Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21. |
|
| SB218352_4 Group | Experimental | Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21. |
|
| SB218352_2 Group | Experimental | Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21. |
|
| SB218352_8AL Group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SB218352_15 | Biological | Non-adjuvanted pandemic influenza A formulation 1 vaccine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Haemagglutination-inhibition (HI) Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) | Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs). | At Day 10 post Dose 1 |
| Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) | Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs). | At Day 21 post Dose 1 |
| Number of Seroconverted Subjects Against Influenza A Subtype H9N2 | Seroconversion rate was defined as the percentage of vaccinees who had a pre-vaccination HI titer lower than (<) 1:10 and a post-vaccination titre higher than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four-fold increase in post-vaccination titer | At Day 10 post Dose 1 |
| Number of Seroconverted Subjects Against Influenza A Subtype H9N2 | Seroconversion rate was defined as the percentage of vaccinees who had a pre-vaccination HI titer < 1:10 and a post-vaccination titre ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four-fold increase in post-vaccination titer | At Day 21 post Dose 1 |
| Seroconversion Factor for Influenza A Subtype H9N2 | Seroconversion factor was defined as the fold increase in serum HI GMTs on day 10 compared to day 0. | At Day 10 post Dose 1 |
| Seroconversion Factor for Influenza A Subtype H9N2 | Seroconversion factor was defined as the fold increase in serum HI GMTs on day 21 compared to day 0. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Unsolicited Adverse Events (AEs) | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Finsterwalde | Brandenburg | 03238 | Germany | ||
| GSK Investigational Site |
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| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 102499 | Individual Participant Data Set | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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After Part I, the core study (study period from Visit 1 on Day 0 up to the phone contact on Day 51), the enrolled subjects were stratified into Subset 1 (Part II - Visit 5 on Day 189 to study conclusion, i.e ., Visit 7 on Day 365) or Subset 2 (Part II - Visit 6 on Day 365 to study conclusion, i.e ., phone contact on Day 395).
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| ID | Title | Description |
|---|---|---|
| FG000 | SB218352_15 Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Study Part I |
|
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| Experimental |
Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21. |
|
| SB218352_4AL Group | Experimental | Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21. |
|
| SB218352_2AL Group | Experimental | Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21. |
|
| SB218352_8 |
| Biological |
Non-adjuvanted pandemic influenza A formulation 2 vaccine |
|
| SB218352_4 | Biological | Non-adjuvanted pandemic influenza A formulation 3 vaccine |
|
| SB218352_2 | Biological | Non-adjuvanted pandemic influenza A formulation 4 vaccine |
|
| SB218352_8AL | Biological | Pandemic influenza A formulation 2 aluminium-adjuvanted vaccine |
|
| SB218352_4AL | Biological | Pandemic influenza A formulation 3 aluminium-adjuvanted vaccine |
|
| SB218352_2AL | Biological | Pandemic influenza A formulation 4 aluminium-adjuvanted vaccine |
|
| At Day 21 post Dose 1 |
| Number of Seroprotected Subjects Against H9N2 | Seroprotection rate was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually was accepted as indicating protection. | At Day 10 post Dose 1 |
| Number of Seroprotected Subjects Against H9N2 | Seroprotection rate was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually was accepted as indicating protection. | At Day 21 post Dose 1 |
| Number of Subjects With Seroprotection Power Against H9N2 | Seroprotection power was defined as the proportion of subjects who were unprotected prior to the vaccination (HI titer < 1:40 on day 0) and had a protective post-vaccination titer of ≥ 1:40. | At Day 10 post Dose 1 |
| Number of Subjects With Seroprotection Power Against H9N2 | Seroprotection power was defined as the proportion of subjects who were unprotected prior to the vaccination (HI titer < 1:40 on day 0) and had a protective post-vaccination titer of ≥ 1:40. | At Day 21 post Dose 1 |
| Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) | Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs). | At Day 21 post Dose 2 (Day 42) |
| Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) | Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs). | At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups) |
| Number of Seroconverted Subjects Against Influenza A Subtype H9N2 | Seroconversion rate was defined as the percentage of vaccinees who had a pre-vaccination HI titer < 1:10 and a post-vaccination titre ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four-fold increase in postvaccination titer | At Day 21 post Dose 2 (Day 42) |
| Number of Seroconverted Subjects Against Influenza A Subtype H9N2 | Seroconversion rate was defined as the percentage of vaccinees who had a pre-vaccination HI titer < 1:10 and a post-vaccination titre ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four-fold increase in post-vaccination titer | At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups) |
| Seroconversion Factor for Influenza A Subtype H9N2 | Seroconversion factor defined as the fold increase in serum HI GMTs on day 21 post Dose 3 (Day 42) compared to day 0. | At Day 21 post Dose 2 (Day 42) |
| Seroconversion Factor for Influenza A Subtype H9N2 | Seroconversion factor was defined as the fold increase in serum HI GMTs on day 21 post Dose 3 (Day 210 for Subset 1 and Day 386 for Subset 2) compared to day 0. | At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups) |
| Number of Seroprotected Subjects Against H9N2 | Seroprotection rate was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually was accepted as indicating protection. | At Day 21 post Dose 2 (Day 42) |
| Number of Seroprotected Subjects Against H9N2 | Seroprotection rate was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually was accepted as indicating protection. | At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups) |
| Number of Subjects With Seroprotection Power Against H9N2 | Seroprotection power was defined as the proportion of subjects who were unprotected prior to the vaccination (HI titer < 1:40 on day 0) and had a protective post-vaccination titer of ≥ 1:40. | At Day 21 post Dose 2 (Day 42) |
| Number of Subjects With Seroprotection Power Against H9N2 | Seroprotection power was defined as the proportion of subjects who were unprotected prior to the vaccination (HI titer < 1:40 on day 0) and had a protective post-vaccination titer of ≥ 1:40. | At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups) |
| During the 30-days (Day 0-30) post vaccination |
| Number of Subjects With Serious Adverse Events (SAEs) | A SAE was any untoward medical occurrence which resulted in death, was life-threatening, resulted in hospitalization or prolongation of hospitalization, resulted in permanent of serious physical disability or incapacity, caused a congenital anomaly or birth defect in the offspring of a subject or might have put the subject at risk based on medical or scientific judgment or necessitated intervention to prevent such an event (e.q. invasive or malignant cancers, intensive treatment in an emergency room or at home for bronchospasm, blood dyscrasias, or convulsion that do not resulted in hospitalization). | From Day 0 to Day 51 |
| Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | Among expressed immune markers were interferon-gamma (IFN-γ) and cluster of differentiation 40 - ligand (CD40-L). | At Days 0, 10, 21 and 42 post vaccination |
| Frequency of Antigen-specific CD4 T-cells | Among expressed immune markers were interleukin-2 (IL-2) and tumour necrosis factor-alpha (TNF-α). | At Days 0, 10, 21 and 42 post-vaccination |
| Cytokine-positive CD4 T-cells Frequency | Among expressed immune markers were interleukin-2 (IL-2), interferon-gamma (IFN-γ), tumour necrosis factor-alpha (TNF-α) and cluster of differentiation 40 - ligand (CD40-L). Descriptive comparison of the CMI response after Dose 1 and Dose 2 of the monovalent candidate pandemic influenza A vaccine. CMI response was determined in terms of the proportion of lymphocytes (CD4+ and CD8+ per million T cells) activated in vitro by the vaccine antigen on Days 10 and 21 after the Dose 1 and on Day 21 after Dose 2 as compared to Day 0 (pre-vaccination). The results were calculated based on the individual difference between each post-vaccination timepoint (Day 10, Day 21, Day 42) and Day 0. | At Days 10, 21 and 42 post-vaccination |
| Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | Among expressed immune markers were interferon-gamma (IFN-γ) and cluster of differentiation 40 - ligand (CD40-L). | At Days 0, 10, 21 and 42 post-vaccination |
| Frequency of Antigen-specific CD8 T-cells | Among expressed immune markers were interleukin-2 (IL-2) and tumour necrosis factor-alpha (TNF-α). | At Days 0, 10, 21 and 42 post-vaccination |
| Cytokine-positive CD8 T-cells Frequency | Among expressed immune markers were interleukin-2 (IL-2), interferon-gamma (IFN-γ), tumour necrosis factor-alpha (TNF-α) and cluster of differentiation 40 - ligand (CD40-L). Descriptive comparison of the CMI response after Dose 1 and Dose 2 of the monovalent candidate pandemic influenza A vaccine. CMI response was determined in terms of the proportion of lymphocytes (CD4+ and CD8+ per million T cells) activated in vitro by the vaccine antigen on Days 10 and 21 after the Dose 1 and on Day 21 after Dose 2 as compared to Day 0 (pre-vaccination). The results were calculated based on the individual difference between each post-vaccination timepoint (Day 10, Day 21, Day 42) and Day 0. | At Days 10, 21 and 42 post-vaccination |
| Number of Subjects With Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness, swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = pain which prevents normal everyday activities. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm). | During the 4-days post Dose 1 (Days 0-3), post Dose 2 (Days 21-24) and across these doses |
| Number of Subjects With Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness, swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = pain which prevents normal everyday activities. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm). | During the 4 Days post Dose 3 (Days 189-192 for Subset 1 groups and Days 365-368 for Subset 2 groups) |
| Number of Subjects With Solicited General Symptoms | Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature higher than (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to the study vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 fever = axillary temperature higher than (>) 39°C. Related symptom = symptom assessed by the investigator as being casually related to the study vaccination. | During the 4-days (Day 0-3) post Dose 1 |
| Number of Subjects With Solicited General Symptoms | Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature higher than (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to the study vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 fever = axillary temperature higher than (>) 39°C. Related symptom = symptom assessed by the investigator as being casually related to the study vaccination. | During the 4-days post Dose 2 (Days 21-24) |
| Number of Subjects With Solicited General Symptoms | Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature higher than (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to the study vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 fever = axillary temperature higher than (>) 39°C. Related symptom = symptom assessed by the investigator as being casually related to the study vaccination. | During the 4-Days (Day 0-3) across doses 1 and 2 |
| Number of Subjects With Solicited General Symptoms | Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axilar temperature higher than (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to the study vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 fever = fever higher than (>) 39°C. Related symptom = symptom assessed by the investigator as being casually related to the study vaccination. | During the 4 Days post Dose 3 (Days 189-192 for Subset 1 groups and Days 365-368 for Subset 2 groups) |
| Number of Subjects With Unsolicited AEs | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. | During the 30-days post Dose 3 (Days 189-219 for Subset 1 groups and Days 365-395 for Subset 2 groups) |
| Number of Subjects With SAEs | A SAE was any untoward medical occurrence which resulted in death, was life-threatening, resulted in hospitalization or prolongation of hospitalization, resulted in permanent of serious physical disability or incapacity, caused a congenital anomaly or birth defect in the offspring of a subject or might have put the subject at risk based on medical or scientific judgment or necessitated intervention to prevent such an event (e.q. invasive or malignant cancers, intensive treatment in an emergency room or at home for bronchospasm, blood dyscrasias, or convulsion that do not resulted in hospitalization). | Within the 365-day post-vaccination period (Days 0-364 for Subset 1 groups) and within the 395-day post-vaccination period (Days 0-394 for Subset 2 groups) |
| Number of Subjects With Any SAEs | A SAE was any untoward medical occurrence which resulted in death, was life-threatening, resulted in hospitalization or prolongation of hospitalization, resulted in permanent of serious physical disability or incapacity, caused a congenital anomaly or birth defect in the offspring of a subject or might have put the subject at risk based on medical or scientific judgment or necessitated intervention to prevent such an event (e.q. invasive or malignant cancers, intensive treatment in an emergency room or at home for bronchospasm, blood dyscrasias, or convulsion that do not resulted in hospitalization). Only Subset 2 groups had available data for the specified time frame. | Up to 30-day post Dose 3 (Days 365-394) |
| Number of Subjects With Antibody Persistence | Antibody persistence was evaluated in terms of seroprotection rate (SPR) against influenza A subtype H9N2 and seroconversion rate (SCR) against influenza A subtype H9N2. | At Days 189 and 365 |
| Seroconversion Factor (SCF) for Influenza A Subtype H9N2. | SCF was defined as the fold increase in serum HI GMTs at the post-vaccination time points compared to Day 0, for each vaccine strain. | At Days 189 and 365 |
| Ketzin |
| Brandenburg |
| 14669 |
| Germany |
| GSK Investigational Site | Tostedt | Lower Saxony | 21255 | Germany |
| GSK Investigational Site | Dresden | Saxony | 01219 | Germany |
| GSK Investigational Site | Dresden | Saxony | 01307 | Germany |
| GSK Investigational Site | Geringswalde | Saxony | 09326 | Germany |
| GSK Investigational Site | Schmiedeberg | Saxony | 01762 | Germany |
| GSK Investigational Site | Bad Bramstedt | Schleswig-Holstein | 24576 | Germany |
| GSK Investigational Site | Bad Segeberg | Schleswig-Holstein | 23795 | Germany |
| GSK Investigational Site | Elmshorn | Schleswig-Holstein | 25335 | Germany |
For additional information about this study please refer to the GSK Clinical Study Register |
| 102499 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 102499 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 102499 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 102499 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FG001 |
| SB218352_8 Group: |
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| FG002 | SB218352_4 Group: | Male and fem le subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| FG003 | SB218352_2 Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| FG004 | SB218352_8AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| FG005 | SB218352_4AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| FG006 | SB218352_2AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Da y 189 for subjects in Subs t I and at Day 0, Day 21 and Da y 365 for subjects in Subset 2. |
| COMPLETED |
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| NOT COMPLETED |
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|
| Study Part II for Subset 1 |
|
| Study Part II for Subset 2 |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SB218352_15 Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| BG001 | SB218352_8 Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| BG002 | SB218352_4 Group: | Male and fem le subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| BG003 | SB218352_2 Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| BG004 | SB218352_8AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| BG005 | SB218352_4AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| BG006 | SB218352_2AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Da y 189 for subjects in Subs t I and at Day 0, Day 21 and Da y 365 for subjects in Subset 2. |
| BG007 | Total | Total of all reporting groups |
| 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, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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 | Serum Haemagglutination-inhibition (HI) Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) | Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs). | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At Day 10 post Dose 1 |
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| Primary | Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) | Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs). | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 21 post Dose 1 |
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| Primary | Number of Seroconverted Subjects Against Influenza A Subtype H9N2 | Seroconversion rate was defined as the percentage of vaccinees who had a pre-vaccination HI titer lower than (<) 1:10 and a post-vaccination titre higher than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four-fold increase in post-vaccination titer | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Count of Participants | Participants | At Day 10 post Dose 1 |
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| Primary | Number of Seroconverted Subjects Against Influenza A Subtype H9N2 | Seroconversion rate was defined as the percentage of vaccinees who had a pre-vaccination HI titer < 1:10 and a post-vaccination titre ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four-fold increase in post-vaccination titer | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Count of Participants | Participants | At Day 21 post Dose 1 |
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| Primary | Seroconversion Factor for Influenza A Subtype H9N2 | Seroconversion factor was defined as the fold increase in serum HI GMTs on day 10 compared to day 0. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Fold change | At Day 10 post Dose 1 |
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| Primary | Seroconversion Factor for Influenza A Subtype H9N2 | Seroconversion factor was defined as the fold increase in serum HI GMTs on day 21 compared to day 0. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Fold change | At Day 21 post Dose 1 |
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| Primary | Number of Seroprotected Subjects Against H9N2 | Seroprotection rate was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually was accepted as indicating protection. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Count of Participants | Participants | At Day 10 post Dose 1 |
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| Primary | Number of Seroprotected Subjects Against H9N2 | Seroprotection rate was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually was accepted as indicating protection. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Count of Participants | Participants | At Day 21 post Dose 1 |
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| Primary | Number of Subjects With Seroprotection Power Against H9N2 | Seroprotection power was defined as the proportion of subjects who were unprotected prior to the vaccination (HI titer < 1:40 on day 0) and had a protective post-vaccination titer of ≥ 1:40. | The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning persistence of the immune response induced by the vaccine were available for the specified time points. | Posted | Count of Participants | Participants | At Day 10 post Dose 1 |
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| Primary | Number of Subjects With Seroprotection Power Against H9N2 | Seroprotection power was defined as the proportion of subjects who were unprotected prior to the vaccination (HI titer < 1:40 on day 0) and had a protective post-vaccination titer of ≥ 1:40. | The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning persistence of the immune response induced by the vaccine were available for the specified time points. | Posted | Count of Participants | Participants | At Day 21 post Dose 1 |
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| Secondary | Number of Subjects With Unsolicited Adverse Events (AEs) | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. | The analysis was performed on the Total Vaccinated Cohort (TVc), which included all vaccinated subjects. | Posted | Count of Participants | Participants | During the 30-days (Day 0-30) post vaccination |
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| Secondary | Number of Subjects With Serious Adverse Events (SAEs) | A SAE was any untoward medical occurrence which resulted in death, was life-threatening, resulted in hospitalization or prolongation of hospitalization, resulted in permanent of serious physical disability or incapacity, caused a congenital anomaly or birth defect in the offspring of a subject or might have put the subject at risk based on medical or scientific judgment or necessitated intervention to prevent such an event (e.q. invasive or malignant cancers, intensive treatment in an emergency room or at home for bronchospasm, blood dyscrasias, or convulsion that do not resulted in hospitalization). | The analysis was performed on the Total Vaccinated Cohort (TVc), which included all vaccinated subjects. | Posted | Count of Participants | Participants | From Day 0 to Day 51 |
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| Secondary | Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells | Among expressed immune markers were interferon-gamma (IFN-γ) and cluster of differentiation 40 - ligand (CD40-L). | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Median | Inter-Quartile Range | T-cells/million cells | At Days 0, 10, 21 and 42 post vaccination |
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| Secondary | Frequency of Antigen-specific CD4 T-cells | Among expressed immune markers were interleukin-2 (IL-2) and tumour necrosis factor-alpha (TNF-α). | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Median | Inter-Quartile Range | T-cells/million cells | At Days 0, 10, 21 and 42 post-vaccination |
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| Secondary | Cytokine-positive CD4 T-cells Frequency | Among expressed immune markers were interleukin-2 (IL-2), interferon-gamma (IFN-γ), tumour necrosis factor-alpha (TNF-α) and cluster of differentiation 40 - ligand (CD40-L). Descriptive comparison of the CMI response after Dose 1 and Dose 2 of the monovalent candidate pandemic influenza A vaccine. CMI response was determined in terms of the proportion of lymphocytes (CD4+ and CD8+ per million T cells) activated in vitro by the vaccine antigen on Days 10 and 21 after the Dose 1 and on Day 21 after Dose 2 as compared to Day 0 (pre-vaccination). The results were calculated based on the individual difference between each post-vaccination timepoint (Day 10, Day 21, Day 42) and Day 0. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Median | Inter-Quartile Range | CD4+ T-cells/million cells | At Days 10, 21 and 42 post-vaccination |
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| Secondary | Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells | Among expressed immune markers were interferon-gamma (IFN-γ) and cluster of differentiation 40 - ligand (CD40-L). | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Median | Inter-Quartile Range | CD8+ T-cells/million cells | At Days 0, 10, 21 and 42 post-vaccination |
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| Secondary | Frequency of Antigen-specific CD8 T-cells | Among expressed immune markers were interleukin-2 (IL-2) and tumour necrosis factor-alpha (TNF-α). | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Median | Inter-Quartile Range | CD8+ T-cells/million cells | At Days 0, 10, 21 and 42 post-vaccination |
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| Secondary | Cytokine-positive CD8 T-cells Frequency | Among expressed immune markers were interleukin-2 (IL-2), interferon-gamma (IFN-γ), tumour necrosis factor-alpha (TNF-α) and cluster of differentiation 40 - ligand (CD40-L). Descriptive comparison of the CMI response after Dose 1 and Dose 2 of the monovalent candidate pandemic influenza A vaccine. CMI response was determined in terms of the proportion of lymphocytes (CD4+ and CD8+ per million T cells) activated in vitro by the vaccine antigen on Days 10 and 21 after the Dose 1 and on Day 21 after Dose 2 as compared to Day 0 (pre-vaccination). The results were calculated based on the individual difference between each post-vaccination timepoint (Day 10, Day 21, Day 42) and Day 0. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Median | Inter-Quartile Range | CD8+ T-cells/million cells | At Days 10, 21 and 42 post-vaccination |
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| Primary | Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) | Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs). | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 21 post Dose 2 (Day 42) |
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| Primary | Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) | Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs). | The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning persistence of the immune response induced by the vaccine were available for the specified time points. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups) |
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| Primary | Number of Seroconverted Subjects Against Influenza A Subtype H9N2 | Seroconversion rate was defined as the percentage of vaccinees who had a pre-vaccination HI titer < 1:10 and a post-vaccination titre ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four-fold increase in postvaccination titer | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Count of Participants | Participants | At Day 21 post Dose 2 (Day 42) |
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| Primary | Number of Seroconverted Subjects Against Influenza A Subtype H9N2 | Seroconversion rate was defined as the percentage of vaccinees who had a pre-vaccination HI titer < 1:10 and a post-vaccination titre ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four-fold increase in post-vaccination titer | The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning persistence of the immune response induced by the vaccine were available for the specified time points. | Posted | Count of Participants | Participants | At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups) |
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| Primary | Seroconversion Factor for Influenza A Subtype H9N2 | Seroconversion factor defined as the fold increase in serum HI GMTs on day 21 post Dose 3 (Day 42) compared to day 0. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Fold change | At Day 21 post Dose 2 (Day 42) |
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| Primary | Seroconversion Factor for Influenza A Subtype H9N2 | Seroconversion factor was defined as the fold increase in serum HI GMTs on day 21 post Dose 3 (Day 210 for Subset 1 and Day 386 for Subset 2) compared to day 0. | The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning persistence of the immune response induced by the vaccine were available for the specified time points. | Posted | Number | 95% Confidence Interval | Fold change | At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups) |
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| Primary | Number of Seroprotected Subjects Against H9N2 | Seroprotection rate was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually was accepted as indicating protection. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Posted | Count of Participants | Participants | At Day 21 post Dose 2 (Day 42) |
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| Primary | Number of Seroprotected Subjects Against H9N2 | Seroprotection rate was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually was accepted as indicating protection. | The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning persistence of the immune response induced by the vaccine were available for the specified time points. | Posted | Count of Participants | Participants | At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups) |
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| Primary | Number of Subjects With Seroprotection Power Against H9N2 | Seroprotection power was defined as the proportion of subjects who were unprotected prior to the vaccination (HI titer < 1:40 on day 0) and had a protective post-vaccination titer of ≥ 1:40. | The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning persistence of the immune response induced by the vaccine were available for the specified time points. | Posted | Count of Participants | Participants | At Day 21 post Dose 2 (Day 42) |
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| Primary | Number of Subjects With Seroprotection Power Against H9N2 | Seroprotection power was defined as the proportion of subjects who were unprotected prior to the vaccination (HI titer < 1:40 on day 0) and had a protective post-vaccination titer of ≥ 1:40. | The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning persistence of the immune response induced by the vaccine were available for the specified time points. | Posted | Count of Participants | Participants | At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups) |
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| Secondary | Number of Subjects With Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness, swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = pain which prevents normal everyday activities. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm). | The analysis was performed on the Total Vaccinated Cohort (TVc) included all vaccinated subjects (for whom diary card was available). | Posted | Count of Participants | Participants | During the 4-days post Dose 1 (Days 0-3), post Dose 2 (Days 21-24) and across these doses |
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| Secondary | Number of Subjects With Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness, swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = pain which prevents normal everyday activities. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm). | The analysis was performed on the Total Vaccinated Cohort (TVc) of Subsets, which included all vaccinated subjects (for whom the diary card was available). | Posted | Count of Participants | Participants | During the 4 Days post Dose 3 (Days 189-192 for Subset 1 groups and Days 365-368 for Subset 2 groups) |
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| Secondary | Number of Subjects With Solicited General Symptoms | Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature higher than (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to the study vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 fever = axillary temperature higher than (>) 39°C. Related symptom = symptom assessed by the investigator as being casually related to the study vaccination. | The analysis was performed on the Total Vaccinated Cohort (TVc) included all vaccinated subjects (for whom diary card was available). | Posted | Count of Participants | Participants | During the 4-days (Day 0-3) post Dose 1 |
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| Secondary | Number of Subjects With Solicited General Symptoms | Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature higher than (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to the study vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 fever = axillary temperature higher than (>) 39°C. Related symptom = symptom assessed by the investigator as being casually related to the study vaccination. | The analysis was performed on the Total Vaccinated Cohort (TVc) included all vaccinated subjects (for whom diary card was available). | Posted | Count of Participants | Participants | During the 4-days post Dose 2 (Days 21-24) |
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| Secondary | Number of Subjects With Solicited General Symptoms | Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature higher than (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to the study vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 fever = axillary temperature higher than (>) 39°C. Related symptom = symptom assessed by the investigator as being casually related to the study vaccination. | The analysis was performed on the Total Vaccinated Cohort (TVc) included all vaccinated subjects (for whom diary card was available). | Posted | Count of Participants | Participants | During the 4-Days (Day 0-3) across doses 1 and 2 |
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| Secondary | Number of Subjects With Solicited General Symptoms | Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axilar temperature higher than (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to the study vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 fever = fever higher than (>) 39°C. Related symptom = symptom assessed by the investigator as being casually related to the study vaccination. | The analysis was performed on the Total Vaccinated Cohort (TVc) of Subsets, which included all vaccinated subjects (for whom the diary card was available). | Posted | Count of Participants | Participants | During the 4 Days post Dose 3 (Days 189-192 for Subset 1 groups and Days 365-368 for Subset 2 groups) |
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| Secondary | Number of Subjects With Unsolicited AEs | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. | The analysis was performed on the Total Vaccinated Cohort (TVc) of Subsets, which included all vaccinated subjects (for whom the diary card was available). | Posted | Count of Participants | Participants | During the 30-days post Dose 3 (Days 189-219 for Subset 1 groups and Days 365-395 for Subset 2 groups) |
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| Secondary | Number of Subjects With SAEs | A SAE was any untoward medical occurrence which resulted in death, was life-threatening, resulted in hospitalization or prolongation of hospitalization, resulted in permanent of serious physical disability or incapacity, caused a congenital anomaly or birth defect in the offspring of a subject or might have put the subject at risk based on medical or scientific judgment or necessitated intervention to prevent such an event (e.q. invasive or malignant cancers, intensive treatment in an emergency room or at home for bronchospasm, blood dyscrasias, or convulsion that do not resulted in hospitalization). | The analysis was performed on the Total Vaccinated Cohort (TVc) of Subsets, which included all vaccinated subjects (for whom the diary card was available). | Posted | Count of Participants | Participants | Within the 365-day post-vaccination period (Days 0-364 for Subset 1 groups) and within the 395-day post-vaccination period (Days 0-394 for Subset 2 groups) |
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| Secondary | Number of Subjects With Any SAEs | A SAE was any untoward medical occurrence which resulted in death, was life-threatening, resulted in hospitalization or prolongation of hospitalization, resulted in permanent of serious physical disability or incapacity, caused a congenital anomaly or birth defect in the offspring of a subject or might have put the subject at risk based on medical or scientific judgment or necessitated intervention to prevent such an event (e.q. invasive or malignant cancers, intensive treatment in an emergency room or at home for bronchospasm, blood dyscrasias, or convulsion that do not resulted in hospitalization). Only Subset 2 groups had available data for the specified time frame. | The analysis was performed on the Total Vaccinated Cohort (TVc) of Subset 2, which included all vaccinated subjects (for whom the diary card was available). | Posted | Count of Participants | Participants | Up to 30-day post Dose 3 (Days 365-394) |
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| Secondary | Number of Subjects With Antibody Persistence | Antibody persistence was evaluated in terms of seroprotection rate (SPR) against influenza A subtype H9N2 and seroconversion rate (SCR) against influenza A subtype H9N2. | The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning persistence of the immune response induced by the vaccine were available for the specified time points. | Posted | Count of Participants | Participants | At Days 189 and 365 |
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| Secondary | Seroconversion Factor (SCF) for Influenza A Subtype H9N2. | SCF was defined as the fold increase in serum HI GMTs at the post-vaccination time points compared to Day 0, for each vaccine strain. | The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning persistence of the immune response induced by the vaccine were available for the specified time points. | Posted | Geometric Mean | 95% Confidence Interval | fold increase | At Days 189 and 365 |
|
Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352_15 Group reported both SAE(s) included in the Adverse Events section.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SB218352_15 Group | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. | 0 | 55 | 1 | 55 | 26 | 55 |
| EG001 | SB218352_8 Group | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. | 0 | 55 | 0 | 55 | 16 | 55 |
| EG002 | SB218352_4 Group | Male and fem le subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm , at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. | 0 | 55 | 1 | 55 | 25 | 55 |
| EG003 | SB218352_2 Group | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. | 0 | 55 | 0 | 55 | 14 | 55 |
| EG004 | SB218352_8AL Group | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. | 0 | 55 | 0 | 55 | 28 | 55 |
| EG005 | SB218352_4AL Group | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-domina nt arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. | 0 | 55 | 0 | 55 | 22 | 55 |
| EG006 | SB218352_2AL Group | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-domina nt arm, at Day 0, Day 21 and Da y 189 for subjects in Subs t I and at Day 0, Day 21 and Da y 365 for subjects in Subset 2. | 0 | 55 | 1 | 55 | 24 | 55 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Vascular graft occlusion | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA 14.1 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| Male |
|
| White-Caucasian |
|
| SB218352_4 Group: |
Male and fem le subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG003 | SB218352_2 Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG004 | SB218352_8AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG005 | SB218352_4AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG006 | SB218352_2AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
|
|
| OG002 | SB218352_4 Group: | Male and fem le subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG003 | SB218352_2 Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG004 | SB218352_8AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG005 | SB218352_4AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG006 | SB218352_2AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
|
|
| OG002 | SB218352_4 Group: | Male and fem le subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG003 | SB218352_2 Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG004 | SB218352_8AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG005 | SB218352_4AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG006 | SB218352_2AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
|
|
| SB218352_4 Group: |
Male and fem le subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG003 | SB218352_2 Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG004 | SB218352_8AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG005 | SB218352_4AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG006 | SB218352_2AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
|
|
| SB218352_4 Group: |
Male and fem le subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG003 | SB218352_2 Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG004 | SB218352_8AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG005 | SB218352_4AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG006 | SB218352_2AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
|
|
| OG002 | SB218352_4 Group: | Male and fem le subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG003 | SB218352_2 Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG004 | SB218352_8AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG005 | SB218352_4AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG006 | SB218352_2AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
|
|
| OG002 | SB218352_4 Group: | Male and fem le subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG003 | SB218352_2 Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG004 | SB218352_8AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG005 | SB218352_4AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG006 | SB218352_2AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
|
|
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
| OG003 | SB218352_2 Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG004 | SB218352_8AL Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG005 | SB218352_4AL Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG006 | SB218352_2AL Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG007 | SB218352_15 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG008 | SB218352_8 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG009 | SB218352_4 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG010 | SB218352_2 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG011 | SB218352_8AL Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG012 | SB218352_4AL Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG013 | SB218352_2AL Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
|
|
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
| OG003 | SB218352_2 Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG004 | SB218352_8AL Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG005 | SB218352_4AL Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG006 | SB218352_2AL Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG007 | SB218352_15 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG008 | SB218352_8 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG009 | SB218352_4 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG010 | SB218352_2 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG011 | SB218352_8AL Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG012 | SB218352_4AL Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG013 | SB218352_2AL Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
|
|
| OG002 | SB218352_4 Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG003 | SB218352_2 Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG004 | SB218352_8AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG005 | SB218352_4AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG006 | SB218352_2AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
|
|
| OG002 | SB218352_4 Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG003 | SB218352_2 Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG004 | SB218352_8AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG005 | SB218352_4AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG006 | SB218352_2AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
|
|
| OG002 | SB218352_4 Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG003 | SB218352_2 Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG004 | SB218352_8AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG005 | SB218352_4AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG006 | SB218352_2AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
|
|
| SB218352_4 Group: |
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG003 | SB218352_2 Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG004 | SB218352_8AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG005 | SB218352_4AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG006 | SB218352_2AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
|
|
| SB218352_8 Group: |
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG002 | SB218352_4 Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG003 | SB218352_2 Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG004 | SB218352_8AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG005 | SB218352_4AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG006 | SB218352_2AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
|
|
| OG002 | SB218352_4 Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG003 | SB218352_2 Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG004 | SB218352_8AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG005 | SB218352_4AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG006 | SB218352_2AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
|
|
| OG002 |
| SB218352_4 Group |
Male and fem le subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm , at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG003 | SB218352_2 Group | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG004 | SB218352_8AL Group | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG005 | SB218352_4AL Group | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-domina nt arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG006 | SB218352_2AL Group | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-domina nt arm, at Day 0, Day 21 and Da y 189 for subjects in Subs t I and at Day 0, Day 21 and Da y 365 for subjects in Subset 2. |
|
|
| SB218352_8 Group |
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG002 | SB218352_4 Group | Male and fem le subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm , at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG003 | SB218352_2 Group | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG004 | SB218352_8AL Group | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG005 | SB218352_4AL Group | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-domina nt arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG006 | SB218352_2AL Group | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-domina nt arm, at Day 0, Day 21 and Da y 189 for subjects in Subs t I and at Day 0, Day 21 and Da y 365 for subjects in Subset 2. |
|
|
| OG002 |
| SB218352_4 Group: |
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG003 | SB218352_2 Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG004 | SB218352_8AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG005 | SB218352_4AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG006 | SB218352_2AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
|
|
| OG003 | SB218352_2 Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG004 | SB218352_8AL Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG005 | SB218352_4AL Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG006 | SB218352_2AL Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG007 | SB218352_15 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG008 | SB218352_8 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG009 | SB218352_4 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG010 | SB218352_2 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG011 | SB218352_8AL Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG012 | SB218352_4AL Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG013 | SB218352_2AL Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
|
|
| OG002 | SB218352_4 Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG003 | SB218352_2 Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG004 | SB218352_8AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG005 | SB218352_4AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG006 | SB218352_2AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
|
|
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG003 | SB218352_2 Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG004 | SB218352_8AL Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG005 | SB218352_4AL Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG006 | SB218352_2AL Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG007 | SB218352_15 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG008 | SB218352_8 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG009 | SB218352_4 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG010 | SB218352_2 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG011 | SB218352_8AL Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG012 | SB218352_4AL Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG013 | SB218352_2AL Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
|
|
| OG002 |
| SB218352_4 Group: |
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG003 | SB218352_2 Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG004 | SB218352_8AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG005 | SB218352_4AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG006 | SB218352_2AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
|
|
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
| OG003 | SB218352_2 Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG004 | SB218352_8AL Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG005 | SB218352_4AL Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG006 | SB218352_2AL Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG007 | SB218352_15 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG008 | SB218352_8 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG009 | SB218352_4 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG010 | SB218352_2 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG011 | SB218352_8AL Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG012 | SB218352_4AL Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG013 | SB218352_2AL Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
|
|
| OG002 | SB218352_4 Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG003 | SB218352_2 Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG004 | SB218352_8AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG005 | SB218352_4AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG006 | SB218352_2AL Group: | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
|
|
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
| OG003 | SB218352_2 Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG004 | SB218352_8AL Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG005 | SB218352_4AL Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG006 | SB218352_2AL Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG007 | SB218352_15 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG008 | SB218352_8 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG009 | SB218352_4 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG010 | SB218352_2 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG011 | SB218352_8AL Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG012 | SB218352_4AL Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG013 | SB218352_2AL Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
|
|
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
| OG003 | SB218352_2 Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG004 | SB218352_8AL Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG005 | SB218352_4AL Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG006 | SB218352_2AL Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG007 | SB218352_15 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG008 | SB218352_8 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG009 | SB218352_4 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG010 | SB218352_2 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG011 | SB218352_8AL Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG012 | SB218352_4AL Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG013 | SB218352_2AL Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
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|
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG003 | SB218352_2 Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG004 | SB218352_8AL Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG005 | SB218352_4AL Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG006 | SB218352_2AL Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG007 | SB218352_15 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG008 | SB218352_8 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG009 | SB218352_4 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG010 | SB218352_2 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG011 | SB218352_8AL Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG012 | SB218352_4AL Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG013 | SB218352_2AL Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
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|
| OG002 |
| SB218352_4 Group |
Male and fem le subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm , at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG003 | SB218352_2 Group | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG004 | SB218352_8AL Group | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG005 | SB218352_4AL Group | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-domina nt arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG006 | SB218352_2AL Group | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-domina nt arm, at Day 0, Day 21 and Da y 189 for subjects in Subs t I and at Day 0, Day 21 and Da y 365 for subjects in Subset 2. |
|
|
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG003 | SB218352_2 Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG004 | SB218352_8AL Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG005 | SB218352_4AL Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG006 | SB218352_2AL Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG007 | SB218352_15 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG008 | SB218352_8 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG009 | SB218352_4 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG010 | SB218352_2 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG011 | SB218352_8AL Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG012 | SB218352_4AL Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG013 | SB218352_2AL Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
|
|
| OG002 | SB218352_4 Group | Male and fem le subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm , at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG003 | SB218352_2 Group | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG004 | SB218352_8AL Group | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG005 | SB218352_4AL Group | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-domina nt arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG006 | SB218352_2AL Group | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-domina nt arm, at Day 0, Day 21 and Da y 189 for subjects in Subs t I and at Day 0, Day 21 and Da y 365 for subjects in Subset 2. |
|
|
| OG002 | SB218352_4 Group | Male and fem le subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm , at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG003 | SB218352_2 Group | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG004 | SB218352_8AL Group | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG005 | SB218352_4AL Group | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-domina nt arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG006 | SB218352_2AL Group | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-domina nt arm, at Day 0, Day 21 and Da y 189 for subjects in Subs t I and at Day 0, Day 21 and Da y 365 for subjects in Subset 2. |
|
|
| OG002 | SB218352_4 Group | Male and fem le subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm , at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG003 | SB218352_2 Group | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG004 | SB218352_8AL Group | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG005 | SB218352_4AL Group | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-domina nt arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2. |
| OG006 | SB218352_2AL Group | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-domina nt arm, at Day 0, Day 21 and Da y 189 for subjects in Subs t I and at Day 0, Day 21 and Da y 365 for subjects in Subset 2. |
|
|
| OG002 | SB218352_4 Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG003 | SB218352_2 Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG004 | SB218352_8AL Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG005 | SB218352_4AL Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG006 | SB218352_2AL Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG007 | SB218352_15 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG008 | SB218352_8 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG009 | SB218352_4 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG010 | SB218352_2 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG011 | SB218352_8AL Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG012 | SB218352_4AL Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG013 | SB218352_2AL Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
|
|
| OG002 | SB218352_4 Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG003 | SB218352_2 Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG004 | SB218352_8AL Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG005 | SB218352_4AL Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG006 | SB218352_2AL Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG007 | SB218352_15 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG008 | SB218352_8 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG009 | SB218352_4 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG010 | SB218352_2 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG011 | SB218352_8AL Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG012 | SB218352_4AL Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG013 | SB218352_2AL Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
|
|
| OG002 | SB218352_4 Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG003 | SB218352_2 Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG004 | SB218352_8AL Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG005 | SB218352_4AL Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG006 | SB218352_2AL Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG007 | SB218352_15 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG008 | SB218352_8 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG009 | SB218352_4 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG010 | SB218352_2 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG011 | SB218352_8AL Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG012 | SB218352_4AL Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG013 | SB218352_2AL Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
|
|
| OG002 | SB218352_4 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG003 | SB218352_2 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG004 | SB218352_8AL Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG005 | SB218352_4AL Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG006 | SB218352_2AL Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
|
|
| OG003 | SB218352_2 Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG004 | SB218352_8AL Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG005 | SB218352_4AL Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG006 | SB218352_2AL Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG007 | SB218352_15 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG008 | SB218352_8 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG009 | SB218352_4 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG010 | SB218352_2 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG011 | SB218352_8AL Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG012 | SB218352_4AL Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG013 | SB218352_2AL Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
|
|
| OG003 | SB218352_2 Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG004 | SB218352_8AL Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG005 | SB218352_4AL Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG006 | SB218352_2AL Subset 1 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189. |
| OG007 | SB218352_15 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG008 | SB218352_8 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG009 | SB218352_4 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG010 | SB218352_2 Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG011 | SB218352_8AL Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG012 | SB218352_4AL Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
| OG013 | SB218352_2AL Subset 2 | Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365. |
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