Immunogenicity and Safety Study to Evaluate Different Formulations of GSK Biologicals' Influenza Vaccine GSK576389A
Official Title
Observer Blind Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Influenza Vaccine GSK576389A With Various Formulations in Adults Aged 65 Years and Above
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Oct 2016
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 8, 2007
Primary Completion Date
Jun 10, 2008Actual
Completion Date
Jun 10, 2008Actual
First Submitted Date
Oct 5, 2007
First Submission Date that Met QC Criteria
Oct 5, 2007
First Posted Date
Oct 8, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 26, 2012
Results First Submitted that Met QC Criteria
Apr 26, 2012
Results First Posted Date
May 30, 2012Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
May 20, 2009
Certification/Extension First Submitted that Passed QC Review
May 21, 2009
Certification/Extension First Posted Date
Sep 30, 2009Estimated
Last Update Submitted Date
May 9, 2018
Last Update Posted Date
Jun 8, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
In order to find the formulation leading to a maximal increase of the immune response while maintaining an acceptable safety profile, this study is designed to evaluate the immunogenicity, safety and reactogenicity of the different formulations of GSK Biologicals' influenza vaccine administered in adults aged 65 years and older compared to Fluarix.
Detailed Description
There are 10 parallel groups: 9 observer blinded groups with subjects 65 years and older receiving an investigational vaccine or Fluarix, and 1 open group with subjects between 18 and 40 years old receiving Fluarix. CMI response will be determined for a subset only.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Conditions Module
Conditions
Influenza
Keywords
Influenza vaccine GSK576389A
Influenza infection
Fluarix
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
2,007Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Influenza vaccine GSK576389A formulation 1 Group
Experimental
Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
Single dose, Intramuscular injection, 8 different formulations were tested (one per group)
Influenza vaccine GSK576389A formulation 1 Group
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Haemagglutination Inhibition (HI) Antibody Titers
Antibody titers were expressed as Geometric mean titers (GMTs) against each of the 3 vaccine strains in greater than or equal to 65 years age groups only. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
At Day 21
Secondary Outcomes
Measure
Description
Time Frame
HI Antibody Titers at Day 0 and Day 21
Antibody titers were expressed as GMTs in all the vaccine groups. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
At Day 0 and 21
HI Antibody Titers at Day 180
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
A male or female aged 18-40 years old or 65 years or older at the time of the vaccination.
Written informed consent obtained from the subject.
Free of an acute aggravation of the health status as established by clinical evaluation (medical history and medical history directed examination) before entering into the study.
If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
Exclusion Criteria:
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to vaccination, or planned use during the study period.
Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study.
Planned administration of a vaccine not foreseen by the study protocol during the entire study period.
Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
Vaccination against influenza since January 2007 (with 2007/2008 or 2006/2007 influenza vaccine).
Administration of more than 14 days of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
Hypersensitivity to a previous dose of influenza vaccine.
Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. axillary temperature<37.5ºC (99.5ºF).
Administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the study vaccine or planned administration during the study.
Any medical conditions in which IM injections are contraindicated.
Lactating female or female planning to become pregnant or to discontinue contraceptive precautions
Rumke HC, Richardus JH, Rombo L, Pauksens K, Plassmann G, Durand C, Devaster JM, Dewe W, Oostvogels L. Selection of an adjuvant for seasonal influenza vaccine in elderly people: modelling immunogenicity from a randomized trial. BMC Infect Dis. 2013 Jul 26;13:348. doi: 10.1186/1471-2334-13-348.
See Also Links
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.
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Influenza Vaccine GSK576389A Formulation 1 Group
Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
Subjects aged ≥65 years received one dose of Fluarix vaccine.
Biological: Fluarix
Fluarix young Group
Active Comparator
Subjects aged 18-40 years received one dose of Fluarix vaccine.
Biological: Fluarix
Influenza vaccine GSK576389A formulation 2 Group
Influenza vaccine GSK576389A formulation 3 Group
Influenza vaccine GSK576389A formulation 4 Group
Influenza vaccine GSK576389A formulation 5 Group
Influenza vaccine GSK576389A formulation 6 Group
Influenza vaccine GSK576389A formulation 7 Group
Influenza vaccine GSK576389A formulation 8 Group
Fluarix
Biological
Single dose, Intramuscular injection
Fluarix elderly Group
Fluarix young Group
Antibody titers were expressed as GMTs in all the vaccine groups. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
At Day 180
The Number of Subjects Seroconverted to HI Antibodies at Day 21
A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
At Day 21
The Number of Subjects Seroconverted to HI Antibodies at Day 180
A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
At Day 180
HI Antibody Seroconversion Factors at Day 21
Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
At Day 21
HI Antibody Seroconversion Factors at Day 180
Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
At Day 180
The Number of Subjects Seroprotected to HI Antibodies at Day 0 and 21
A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
At Day 0 and 21
The Number of Subjects Seroprotected to HI Antibodies at Day 180
A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
At Day 180
The Geometric Mean (GM) Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Days 0 and 21
The markers assessed were Cluster of Differentiation 4-All doubles i.e. CD4-All doubles, CD4-CD40Ligand(L), CD4-interferon gamma (CD4-IFNγ), CD4-interleukin 2 (CD4-IL2) and CD4-tumor necrosis factor alpha (CD4-TNFα). The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
At Days 0 and 21
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Day 180
The markers assessed were CD4-All doubles, CD4-CD40L, CD4-IFNγ, CD4-IL2 and CD4-TNFα. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
At Day 180
The GM Number of Influenza-specific CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Days 0 and 21
The markers assessed were Cluster of Differentiation 8-All doubles i.e. CD8-All doubles, CD8-CD40L, CD8-IFNγ, CD8-IL2 and CD8-TNFα. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
At Days 0 and 21
The GM Number of Influenza-specific CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Day 180
The markers assessed were CD8-All doubles, CD8-CD40L, CD8-IFNγ, CD8-IL2 and CD8-TNFα. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
At Day 180
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Grade 3 ecchymosis, pain, redness and swelling was greater than 100 millimeter (mm) i.e. > 100 mm and grade 3 pain was considerable pain at rest that prevented normal everyday activities. Any was occurrence of any local symptom regardless of their intensity grade. Any for ecchymosis, redness and swelling was >20mm.
During a 7-day follow-up period (Day 0-6) after vaccination
Duration of Solicited Local AEs
Duration was defined as number of days with any grade of local symptoms.
During a 7-day follow-up period (Day 0-6) after vaccination
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Any Fever was defined as axillary temperature greater than or equal to 38.0 degree centigrade i.e.≥ 38.0°C, grade 3 fever was axillary temperature >40°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a general symptom that prevented normal activity. Related was a general symptom assessed by the investigator as causally related to the study vaccination.
During a 7-day follow-up period (Day 0-6) after vaccination
Duration of Solicited General AEs
Duration was defined as number of days with any grade of general symptoms.
During a 7-day follow-up period (Day 0-6) after vaccination
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs
Unsolicited AE covers any AE 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 occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.
During a 21-day follow-up period (Day 0-20) after vaccination
Number of Subjects Reporting Any, Grade 3 and Related Adverse Events Resulting in Medically Attended Visit Between Day 0 and Day 20
For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a symptom that prevented normal activity. Related was a symptom assessed by the investigator as causally related to the study vaccination.
Between Day 0 and Day 20 after vaccination
Number of Subjects Reporting Any, Grade 3 and Related Adverse Events Resulting in Medically Attended Visit Between Day 21 and Day 179
For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a symptom that prevented normal activity. Related was a symptom assessed by the investigator as causally related to the study vaccination.
Between Day 21 and Day 179 after vaccination
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 0 and Day 20
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Between Day 0 and Day 20 after vaccination
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 21 and Day 179
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Between Day 21 and Day 179 after vaccination
Mannheim
Baden-Wurttemberg
68161
Germany
GSK Investigational Site
Rudersberg
Baden-Wurttemberg
73635
Germany
GSK Investigational Site
Weinheim
Baden-Wurttemberg
69469
Germany
GSK Investigational Site
Augsburg
Bavaria
86150
Germany
GSK Investigational Site
Cologne
North Rhine-Westphalia
51069
Germany
GSK Investigational Site
Essen
North Rhine-Westphalia
45359
Germany
GSK Investigational Site
Mainz
Rhineland-Palatinate
55131
Germany
GSK Investigational Site
Rhaunen
Rhineland-Palatinate
55624
Germany
GSK Investigational Site
Dresden
Saxony
01067
Germany
GSK Investigational Site
Freital
Saxony
01705
Germany
GSK Investigational Site
Leipzig
Saxony
04103
Germany
GSK Investigational Site
Magdeburg
Saxony-Anhalt
39112
Germany
GSK Investigational Site
Wolmirstedt
Saxony-Anhalt
39326
Germany
GSK Investigational Site
Berlin
10435
Germany
GSK Investigational Site
Berlin
12627
Germany
GSK Investigational Site
Berlin
13347
Germany
GSK Investigational Site
Berlin
13359
Germany
GSK Investigational Site
Hamburg
22335
Germany
GSK Investigational Site
Hamburg
22415
Germany
GSK Investigational Site
Rotterdam
3011 EN
Netherlands
GSK Investigational Site
Rotterdam
3015 GE
Netherlands
GSK Investigational Site
Eskilstuna
SE-631 88
Sweden
GSK Investigational Site
Karlskrona
SE-371 41
Sweden
GSK Investigational Site
Uppsala
SE-751 85
Sweden
GSK Investigational Site
Reading
Berkshire
RG2 0TG
United Kingdom
GSK Investigational Site
Buckshaw Village, Chorley
Lancashire
PR7 7NA
United Kingdom
GSK Investigational Site
Clydebank, Glasgow
G81 2DR
United Kingdom
GSK Investigational Site
Edgbaston, Birmingham
B15 2SQ
United Kingdom
GSK Investigational Site
Waterloo, Liverpool
L22 0LG
United Kingdom
For additional information about this study please refer to the GSK Clinical Study Register
For additional information about this study please refer to the GSK Clinical Study Register
Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
FG002
Influenza Vaccine GSK576389A Formulation 3 Group
Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
FG003
Influenza Vaccine GSK576389A Formulation 4 Group
Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
FG004
Influenza Vaccine GSK576389A Formulation 5 Group
Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
FG005
Influenza Vaccine GSK576389A Formulation 6 Group
Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
FG006
Influenza Vaccine GSK576389A Formulation 7 Group
Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
FG007
Influenza Vaccine GSK576389A Formulation 8 Group
Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
FG008
Fluarix Elderly Group
Subjects aged ≥65 years received one dose of Fluarix vaccine.
FG009
Fluarix Young Group
Subjects aged 18-40 years received one dose of Fluarix vaccine.
FG000204 subjects
FG001202 subjects
FG002202 subjects
FG003202 subjects
FG004199 subjects
FG005198 subjects
FG006198 subjects
FG007199 subjects
FG008200 subjects
FG009203 subjects
Completed at Day 180
FG000200 subjects
FG001201 subjects
FG002197 subjects
FG003197 subjects
FG004195 subjects
FG005198 subjects
FG006196 subjects
FG007193 subjects
FG008198 subjects
FG009189 subjects
COMPLETED
FG000202 subjects
FG001201 subjects
FG002201 subjects
FG003201 subjects
FG004198 subjects
FG005198 subjects
FG006198 subjects
FG007198 subjects
FG008199 subjects
FG009201 subjects
NOT COMPLETED
FG0002 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0081 subjects
FG0092 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0081 subjects
FG0092 subjects
Lost to Follow-up
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Influenza Vaccine GSK576389A Formulation 1 Group
Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
BG001
Influenza Vaccine GSK576389A Formulation 2 Group
Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
BG002
Influenza Vaccine GSK576389A Formulation 3 Group
Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
BG003
Influenza Vaccine GSK576389A Formulation 4 Group
Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
BG004
Influenza Vaccine GSK576389A Formulation 5 Group
Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
BG005
Influenza Vaccine GSK576389A Formulation 6 Group
Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
BG006
Influenza Vaccine GSK576389A Formulation 7 Group
Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
BG007
Influenza Vaccine GSK576389A Formulation 8 Group
Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
BG008
Fluarix Elderly Group
Subjects aged ≥65 years received one dose of Fluarix vaccine.
BG009
Fluarix Young Group
Subjects aged 18-40 years received one dose of Fluarix vaccine.
BG010
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000204
BG001202
BG002202
BG003202
BG004199
BG005198
BG006198
BG007199
BG008200
BG009203
BG0102007
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00072.7± 5.75
BG00172.6± 5.16
BG00272.4± 5.62
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00095
BG001109
BG002
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
Haemagglutination Inhibition (HI) Antibody Titers
Antibody titers were expressed as Geometric mean titers (GMTs) against each of the 3 vaccine strains in greater than or equal to 65 years age groups only. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.
Posted
Geometric Mean
95% Confidence Interval
titer
At Day 21
ID
Title
Description
OG000
Influenza Vaccine GSK576389A Formulation 1 Group
Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
OG001
Influenza Vaccine GSK576389A Formulation 2 Group
Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
OG002
Influenza Vaccine GSK576389A Formulation 3 Group
Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
OG003
Influenza Vaccine GSK576389A Formulation 4 Group
Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
OG004
Influenza Vaccine GSK576389A Formulation 5 Group
Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
OG005
Influenza Vaccine GSK576389A Formulation 6 Group
Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
OG006
Influenza Vaccine GSK576389A Formulation 7 Group
Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
OG007
Influenza Vaccine GSK576389A Formulation 8 Group
Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
OG008
Fluarix Elderly Group
Subjects aged ≥65 years received one dose of Fluarix vaccine.
OG009
Fluarix Young Group
Subjects aged 18-40 years received one dose of Fluarix vaccine.
Units
Counts
Participants
OG000191
OG001192
OG002189
OG003
Title
Denominators
Categories
A/Solomon Islands strain
Title
Measurements
OG00082.3(69.7 to 97.1)
OG001102.2(87.0 to 119.9)
OG00298.2(84.3 to 114.3)
Secondary
HI Antibody Titers at Day 0 and Day 21
Antibody titers were expressed as GMTs in all the vaccine groups. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.
Posted
Geometric Mean
95% Confidence Interval
titer
At Day 0 and 21
ID
Title
Description
OG000
Influenza Vaccine GSK576389A Formulation 1 Group
Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
OG001
Influenza Vaccine GSK576389A Formulation 2 Group
Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
OG002
Influenza Vaccine GSK576389A Formulation 3 Group
Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
OG003
Influenza Vaccine GSK576389A Formulation 4 Group
Secondary
HI Antibody Titers at Day 180
Antibody titers were expressed as GMTs in all the vaccine groups. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Analysis was performed on According-to-Protocol (ATP) cohort for persistence for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 180.
Posted
Geometric Mean
95% Confidence Interval
titer
At Day 180
ID
Title
Description
OG000
Influenza Vaccine GSK576389A Formulation 1 Group
Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
OG001
Influenza Vaccine GSK576389A Formulation 2 Group
Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
OG002
Influenza Vaccine GSK576389A Formulation 3 Group
Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
OG003
Influenza Vaccine GSK576389A Formulation 4 Group
Secondary
The Number of Subjects Seroconverted to HI Antibodies at Day 21
A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.
Posted
Number
Subjects
At Day 21
ID
Title
Description
OG000
Influenza Vaccine GSK576389A Formulation 1 Group
Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
OG001
Influenza Vaccine GSK576389A Formulation 2 Group
Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
OG002
Influenza Vaccine GSK576389A Formulation 3 Group
Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
Secondary
The Number of Subjects Seroconverted to HI Antibodies at Day 180
A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Analysis was performed on According-to-Protocol (ATP) cohort for persistence for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 180.
Posted
Number
Subjects
At Day 180
ID
Title
Description
OG000
Influenza Vaccine GSK576389A Formulation 1 Group
Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
OG001
Influenza Vaccine GSK576389A Formulation 2 Group
Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
OG002
Influenza Vaccine GSK576389A Formulation 3 Group
Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
Secondary
HI Antibody Seroconversion Factors at Day 21
Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.
Posted
Geometric Mean
95% Confidence Interval
fold increase
At Day 21
ID
Title
Description
OG000
Influenza Vaccine GSK576389A Formulation 1 Group
Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
OG001
Influenza Vaccine GSK576389A Formulation 2 Group
Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
OG002
Influenza Vaccine GSK576389A Formulation 3 Group
Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
OG003
Influenza Vaccine GSK576389A Formulation 4 Group
Secondary
HI Antibody Seroconversion Factors at Day 180
Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Analysis was performed on According-to-Protocol (ATP) cohort for persistence for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 180.
Posted
Geometric Mean
95% Confidence Interval
fold increase
At Day 180
ID
Title
Description
OG000
Influenza Vaccine GSK576389A Formulation 1 Group
Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
OG001
Influenza Vaccine GSK576389A Formulation 2 Group
Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
OG002
Influenza Vaccine GSK576389A Formulation 3 Group
Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
OG003
Secondary
The Number of Subjects Seroprotected to HI Antibodies at Day 0 and 21
A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.
Posted
Number
Subjects
At Day 0 and 21
ID
Title
Description
OG000
Influenza Vaccine GSK576389A Formulation 1 Group
Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
OG001
Influenza Vaccine GSK576389A Formulation 2 Group
Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
OG002
Influenza Vaccine GSK576389A Formulation 3 Group
Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
OG003
Secondary
The Number of Subjects Seroprotected to HI Antibodies at Day 180
A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Analysis was performed on According-to-Protocol (ATP) cohort for persistence for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 180.
Posted
Number
Subjects
At Day 180
ID
Title
Description
OG000
Influenza Vaccine GSK576389A Formulation 1 Group
Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
OG001
Influenza Vaccine GSK576389A Formulation 2 Group
Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
OG002
Influenza Vaccine GSK576389A Formulation 3 Group
Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
OG003
Secondary
The Geometric Mean (GM) Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Days 0 and 21
The markers assessed were Cluster of Differentiation 4-All doubles i.e. CD4-All doubles, CD4-CD40Ligand(L), CD4-interferon gamma (CD4-IFNγ), CD4-interleukin 2 (CD4-IL2) and CD4-tumor necrosis factor alpha (CD4-TNFα). The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity cell mediated immunity (CMI) which included subjects for whom data concerning immunogenicity CMI outcome measures were available at day 21.
Posted
Geometric Mean
Standard Deviation
cells per million CD4 T-cells
At Days 0 and 21
ID
Title
Description
OG000
Influenza Vaccine GSK576389A Formulation 1 Group
Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
OG001
Influenza Vaccine GSK576389A Formulation 2 Group
Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
OG002
Influenza Vaccine GSK576389A Formulation 3 Group
Secondary
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Day 180
The markers assessed were CD4-All doubles, CD4-CD40L, CD4-IFNγ, CD4-IL2 and CD4-TNFα. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Analysis was performed on According-to-Protocol (ATP) cohort for persistence for cell mediated immunity (CMI) which included subjects for whom data concerning immunogenicity CMI outcome measures were available at day 180.
Posted
Geometric Mean
Standard Deviation
cells per million CD4 T-cells
At Day 180
ID
Title
Description
OG000
Influenza Vaccine GSK576389A Formulation 1 Group
Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
OG001
Influenza Vaccine GSK576389A Formulation 2 Group
Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
OG002
Influenza Vaccine GSK576389A Formulation 3 Group
Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
Secondary
The GM Number of Influenza-specific CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Days 0 and 21
The markers assessed were Cluster of Differentiation 8-All doubles i.e. CD8-All doubles, CD8-CD40L, CD8-IFNγ, CD8-IL2 and CD8-TNFα. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity cell mediated immunity (CMI) which included subjects for whom data concerning immunogenicity CMI outcome measures were available at day 21.
Posted
Geometric Mean
Standard Deviation
cells per million CD8 T-cells
At Days 0 and 21
ID
Title
Description
OG000
Influenza Vaccine GSK576389A Formulation 1 Group
Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
OG001
Influenza Vaccine GSK576389A Formulation 2 Group
Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
OG002
Influenza Vaccine GSK576389A Formulation 3 Group
Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
Secondary
The GM Number of Influenza-specific CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Day 180
The markers assessed were CD8-All doubles, CD8-CD40L, CD8-IFNγ, CD8-IL2 and CD8-TNFα. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Analysis was performed on According-to-Protocol (ATP) cohort for persistence for cell mediated immunity (CMI) which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at day 180.
Posted
Geometric Mean
Standard Deviation
cells per million CD8 T-cells
At Day 180
ID
Title
Description
OG000
Influenza Vaccine GSK576389A Formulation 1 Group
Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
OG001
Influenza Vaccine GSK576389A Formulation 2 Group
Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
OG002
Influenza Vaccine GSK576389A Formulation 3 Group
Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
Secondary
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Grade 3 ecchymosis, pain, redness and swelling was greater than 100 millimeter (mm) i.e. > 100 mm and grade 3 pain was considerable pain at rest that prevented normal everyday activities. Any was occurrence of any local symptom regardless of their intensity grade. Any for ecchymosis, redness and swelling was >20mm.
The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.
Posted
Number
Subjects
During a 7-day follow-up period (Day 0-6) after vaccination
ID
Title
Description
OG000
Influenza Vaccine GSK576389A Formulation 1 Group
Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
OG001
Influenza Vaccine GSK576389A Formulation 2 Group
Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
OG002
Influenza Vaccine GSK576389A Formulation 3 Group
Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
Secondary
Duration of Solicited Local AEs
Duration was defined as number of days with any grade of local symptoms.
The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom and completed information on duration in their symptom sheet.
Posted
Median
Full Range
Days
During a 7-day follow-up period (Day 0-6) after vaccination
ID
Title
Description
OG000
Influenza Vaccine GSK576389A Formulation 1 Group
Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
OG001
Influenza Vaccine GSK576389A Formulation 2 Group
Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
OG002
Influenza Vaccine GSK576389A Formulation 3 Group
Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
OG003
Influenza Vaccine GSK576389A Formulation 4 Group
Secondary
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Any Fever was defined as axillary temperature greater than or equal to 38.0 degree centigrade i.e.≥ 38.0°C, grade 3 fever was axillary temperature >40°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a general symptom that prevented normal activity. Related was a general symptom assessed by the investigator as causally related to the study vaccination.
The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.
Posted
Number
Subjects
During a 7-day follow-up period (Day 0-6) after vaccination
ID
Title
Description
OG000
Influenza Vaccine GSK576389A Formulation 1 Group
Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
OG001
Influenza Vaccine GSK576389A Formulation 2 Group
Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
OG002
Influenza Vaccine GSK576389A Formulation 3 Group
Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
Secondary
Duration of Solicited General AEs
Duration was defined as number of days with any grade of general symptoms.
The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom and completed information on duration in their symptom sheet.
Posted
Median
Full Range
Days
During a 7-day follow-up period (Day 0-6) after vaccination
ID
Title
Description
OG000
Influenza Vaccine GSK576389A Formulation 1 Group
Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
OG001
Influenza Vaccine GSK576389A Formulation 2 Group
Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
OG002
Influenza Vaccine GSK576389A Formulation 3 Group
Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
OG003
Influenza Vaccine GSK576389A Formulation 4 Group
Secondary
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs
Unsolicited AE covers any AE 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 occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.
The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
Posted
Number
Subjects
During a 21-day follow-up period (Day 0-20) after vaccination
ID
Title
Description
OG000
Influenza Vaccine GSK576389A Formulation 1 Group
Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
OG001
Influenza Vaccine GSK576389A Formulation 2 Group
Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
OG002
Influenza Vaccine GSK576389A Formulation 3 Group
Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
Secondary
Number of Subjects Reporting Any, Grade 3 and Related Adverse Events Resulting in Medically Attended Visit Between Day 0 and Day 20
For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a symptom that prevented normal activity. Related was a symptom assessed by the investigator as causally related to the study vaccination.
The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
Posted
Number
Subjects
Between Day 0 and Day 20 after vaccination
ID
Title
Description
OG000
Influenza Vaccine GSK576389A Formulation 1 Group
Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
OG001
Influenza Vaccine GSK576389A Formulation 2 Group
Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
OG002
Influenza Vaccine GSK576389A Formulation 3 Group
Secondary
Number of Subjects Reporting Any, Grade 3 and Related Adverse Events Resulting in Medically Attended Visit Between Day 21 and Day 179
For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a symptom that prevented normal activity. Related was a symptom assessed by the investigator as causally related to the study vaccination.
The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
Posted
Number
Subjects
Between Day 21 and Day 179 after vaccination
ID
Title
Description
OG000
Influenza Vaccine GSK576389A Formulation 1 Group
Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
OG001
Influenza Vaccine GSK576389A Formulation 2 Group
Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
OG002
Influenza Vaccine GSK576389A Formulation 3 Group
Secondary
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 0 and Day 20
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
Posted
Number
Subjects
Between Day 0 and Day 20 after vaccination
ID
Title
Description
OG000
Influenza Vaccine GSK576389A Formulation 1 Group
Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
OG001
Influenza Vaccine GSK576389A Formulation 2 Group
Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
OG002
Influenza Vaccine GSK576389A Formulation 3 Group
Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
Secondary
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 21 and Day 179
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
Posted
Number
Subjects
Between Day 21 and Day 179 after vaccination
ID
Title
Description
OG000
Influenza Vaccine GSK576389A Formulation 1 Group
Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
OG001
Influenza Vaccine GSK576389A Formulation 2 Group
Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
OG002
Influenza Vaccine GSK576389A Formulation 3 Group
Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
Time Frame
Serious adverse events were assessed from day 0 to day 20 and day 21 to day 179. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
Description
For the systematically assessed other (non-serious) adverse events,the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Influenza Vaccine GSK576389A Formulation 1 Group
Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
18
204
107
204
EG001
Influenza Vaccine GSK576389A Formulation 2 Group
Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
9
202
129
202
EG002
Influenza Vaccine GSK576389A Formulation 3 Group
Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
5
202
150
202
EG003
Influenza Vaccine GSK576389A Formulation 4 Group
Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
8
202
121
202
EG004
Influenza Vaccine GSK576389A Formulation 5 Group
Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
9
199
138
199
EG005
Influenza Vaccine GSK576389A Formulation 6 Group
Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
10
198
158
198
EG006
Influenza Vaccine GSK576389A Formulation 7 Group
Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
16
198
134
198
EG007
Influenza Vaccine GSK576389A Formulation 8 Group
Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
19
199
155
199
EG008
Fluarix Elderly Group
Subjects aged ≥65 years received one dose of Fluarix vaccine.
15
200
74
200
EG009
Fluarix Young Group
Subjects aged 18-40 years received one dose of Fluarix vaccine.
3
203
133
203
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Atrial fibrillation
Cardiac disorders
Non-systematic Assessment
Assessed between Day 0 and Day 20
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG0030 affected202 at risk
EG004
Bile duct stone
Hepatobiliary disorders
Non-systematic Assessment
Assessed between Day 0 and Day 20
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0021 affected202 at risk
EG003
Bladder cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-systematic Assessment
Assessed between Day 0 and Day 20
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Bradycardia
Cardiac disorders
Non-systematic Assessment
Assessed between Day 0 and Day 20
EG0000 affected204 at risk
EG0011 affected202 at risk
EG0020 affected202 at risk
EG003
Cerebrovascular accident
Nervous system disorders
Non-systematic Assessment
Assessed between Day 0 and Day 20
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Chest pain
General disorders
Non-systematic Assessment
Assessed between Day 0 and Day 20
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
Non-systematic Assessment
Assessed between Day 0 and Day 20
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0021 affected202 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
Assessed between Day 0 and Day 20
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
Assessed between Day 0 and Day 20
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
Assessed between Day 0 and Day 20
EG0000 affected204 at risk
EG0011 affected202 at risk
EG0020 affected202 at risk
EG003
Facial bones fracture
Injury, poisoning and procedural complications
Non-systematic Assessment
Assessed between Day 0 and Day 20
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Gastric ulcer haemorrhage
Gastrointestinal disorders
Non-systematic Assessment
Assessed between Day 0 and Day 20
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Goitre
Endocrine disorders
Non-systematic Assessment
Assessed between Day 0 and Day 20
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Gout
Metabolism and nutrition disorders
Non-systematic Assessment
Assessed between Day 0 and Day 20
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0021 affected202 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
Non-systematic Assessment
Assessed between Day 0 and Day 20
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Ischaemic stroke
Nervous system disorders
Non-systematic Assessment
Assessed between Day 0 and Day 20
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Multiple myeloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-systematic Assessment
Assessed between Day 0 and Day 20
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
Assessed between Day 0 and Day 20
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Myocardial infarction
Cardiac disorders
Non-systematic Assessment
Assessed between Day 0 and Day 20
EG0000 affected204 at risk
EG0011 affected202 at risk
EG0020 affected202 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
Assessed between Day 0 and Day 20
EG0000 affected204 at risk
EG0011 affected202 at risk
EG0020 affected202 at risk
EG003
Pancreatic neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-systematic Assessment
Assessed between Day 0 and Day 20
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Post procedural infection
Infections and infestations
Non-systematic Assessment
Assessed between Day 0 and Day 20
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Pyelonephritis
Infections and infestations
Non-systematic Assessment
Assessed between Day 0 and Day 20
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Skin injury
Injury, poisoning and procedural complications
Non-systematic Assessment
Assessed between Day 0 and Day 20
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0001 affected204 at risk
EG0012 affected202 at risk
EG0020 affected202 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0011 affected202 at risk
EG0020 affected202 at risk
EG003
Angina pectoris
Cardiac disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Arrhythmia
Cardiac disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0001 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Chest pain
General disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0001 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Cardiac failure
Cardiac disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Myocardial infarction
Cardiac disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0011 affected202 at risk
EG0020 affected202 at risk
EG003
Pancreatitis
Gastrointestinal disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0021 affected202 at risk
EG003
Peripheral arterial occlusive disease
Vascular disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0011 affected202 at risk
EG0020 affected202 at risk
EG003
Abdominal pain
Gastrointestinal disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Angina unstable
Cardiac disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0001 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Atrial fibrillation
Cardiac disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Cellulitis
Infections and infestations
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Depression
Psychiatric disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Haematoma
Vascular disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Left ventricular failure
Cardiac disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0001 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Pneumonia
Infections and infestations
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0002 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Syncope
Nervous system disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0001 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Uterine cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Abdominal adhesions
Gastrointestinal disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0001 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Anaemia
Blood and lymphatic system disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0001 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Atrioventricular block first degree
Cardiac disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0001 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Benign salivary gland neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Bifascicular block
Cardiac disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0001 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Biliary colic
Hepatobiliary disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Bleeding varicose vein
Vascular disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Carotid artery stenosis
Nervous system disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Cerebral infarction
Nervous system disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0011 affected202 at risk
EG0020 affected202 at risk
EG003
Cervical vertebral fracture
Injury, poisoning and procedural complications
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Cholecystitis chronic
Hepatobiliary disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0021 affected202 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0021 affected202 at risk
EG003
Chronic myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Chronic myelomonocytic leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Clavicle fracture
Injury, poisoning and procedural complications
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Coronary artery disease
Cardiac disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0001 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Coronary artery stenosis
Cardiac disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0021 affected202 at risk
EG003
Cystitis
Infections and infestations
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Deep vein thrombosis
Vascular disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Dehydration
Metabolism and nutrition disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Diverticulitis
Infections and infestations
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0001 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Emphysema
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0001 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Erysipelas
Infections and infestations
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Food poisoning
Gastrointestinal disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Gangrene
Infections and infestations
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Gastritis
Gastrointestinal disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Gastroenteritis norovirus
Infections and infestations
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0011 affected202 at risk
EG0020 affected202 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Glaucoma
Eye disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Gout
Metabolism and nutrition disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0021 affected202 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Headache
Nervous system disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0001 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Herpes Zoster
Infections and infestations
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Hydronephrosis
Renal and urinary disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0011 affected202 at risk
EG0020 affected202 at risk
EG003
Hypertension
Vascular disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0001 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Hypertensive cardiomyopathy
Cardiac disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0021 affected202 at risk
EG003
Hypertensive crisis
Vascular disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Hypovolaemic shock
Vascular disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Ileus
Gastrointestinal disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0001 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Incisional hernia
Injury, poisoning and procedural complications
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0011 affected202 at risk
EG0020 affected202 at risk
EG003
Jaw fracture
Injury, poisoning and procedural complications
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Multiple fractures
Injury, poisoning and procedural complications
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Nasal septum deviation
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Neuritis
Nervous system disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Osteoporotic fracture
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Panic attack
Psychiatric disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Pelvic fracture
Injury, poisoning and procedural complications
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Postmenopausal haemorrhage
Reproductive system and breast disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0001 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Prostate cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0011 affected202 at risk
EG0020 affected202 at risk
EG003
Prostatic adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0001 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Renal failure
Renal and urinary disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Reversible ischaemic neurological deficit
Nervous system disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Sick sinus syndrome
Cardiac disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Staphylococcal sepsis
Infections and infestations
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Syncope vasovagal
Nervous system disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0001 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Thyroid neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Transient ischaemic attack
Nervous system disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Ulcerative keratitis
Eye disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0001 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Upper respiratory tract infection
Infections and infestations
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Urinary tract infection
Infections and infestations
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Urosepsis
Infections and infestations
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Varicose vein
Vascular disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0011 affected202 at risk
EG0020 affected202 at risk
EG003
Vestibular disorder
Ear and labyrinth disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Vestibular neuronitis
Ear and labyrinth disorders
Non-systematic Assessment
Assessed between Day 21 and Day 179
EG0000 affected204 at risk
EG0010 affected202 at risk
EG0020 affected202 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Pain
General disorders
Systematic Assessment
EG00068 affected201 at risk
EG00182 affected201 at risk
EG002111 affected201 at risk
EG00384 affected201 at risk
EG00491 affected198 at risk
EG005119 affected197 at risk
EG00693 affected198 at risk
EG007106 affected198 at risk
EG00832 affected200 at risk
EG00993 affected201 at risk
Redness
General disorders
Systematic Assessment
EG00015 affected201 at risk
EG00116 affected201 at risk
EG00237 affected201 at risk
EG003
Swelling
General disorders
Systematic Assessment
EG00013 affected201 at risk
EG00112 affected201 at risk
EG00225 affected201 at risk
EG003
Arthralgia
General disorders
Systematic Assessment
EG00015 affected201 at risk
EG00123 affected201 at risk
EG00236 affected201 at risk
EG003
Fatigue
General disorders
Systematic Assessment
EG00034 affected201 at risk
EG00135 affected201 at risk
EG00254 affected201 at risk
EG003
Headache
General disorders
Systematic Assessment
EG00022 affected201 at risk
EG00138 affected201 at risk
EG00247 affected201 at risk
EG003
Myalgia
General disorders
Systematic Assessment
EG00020 affected201 at risk
EG00135 affected201 at risk
EG00257 affected201 at risk
EG003
Nausea
General disorders
Systematic Assessment
EG00010 affected201 at risk
EG00112 affected201 at risk
EG00219 affected201 at risk
EG003
Shivering
General disorders
Systematic Assessment
EG00013 affected201 at risk
EG00118 affected201 at risk
EG00237 affected201 at risk
EG003
Nasopharyngitis
Infections and infestations
Non-systematic Assessment
EG0009 affected204 at risk
EG0014 affected202 at risk
EG0027 affected202 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
Point of Contact
Title
Organization
Phone
Extension
Email
GSK Response Center
GlaxoSmithKline
866-435-7343
ID
Term
D007251
Influenza, Human
Ancestor Terms
ID
Term
D012141
Respiratory Tract Infections
D007239
Infections
D009976
Orthomyxoviridae Infections
D012327
RNA Virus Infections
D014777
Virus Diseases
D012140
Respiratory Tract Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C510903
fluarix
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
72.9
± 6.09
BG00472.6± 5.66
BG00572.7± 5.56
BG00672.6± 5.67
BG00773.0± 6.03
BG00872.7± 5.43
BG00927.4± 6.25
BG01068.11± 14.81
105
BG003100
BG00489
BG005102
BG00696
BG00795
BG00890
BG009103
BG010984
Male
BG000109
BG00193
BG00297
BG003102
BG004110
BG00596
BG006102
BG007104
BG008110
BG009100
BG0101023
194
OG004192
OG005193
OG006192
OG007189
OG008188
OG0090
OG003
91.7
(76.9 to 109.3)
OG004113.2(96.0 to 133.6)
OG005114.4(97.1 to 134.8)
OG00678.5(65.9 to 93.5)
OG007111.8(93.3 to 134.0)
OG00859.6(49.6 to 71.7)
A/Wisconsin strain
Title
Measurements
OG000276.2(238.8 to 319.6)
OG001350.2(298.0 to 411.4)
OG002351.3(304.8 to 404.8)
OG003309.2(264.9 to 361.0)
OG004331.1(289.6 to 378.6)
OG005438.1(379.7 to 505.4)
OG006263.3(225.3 to 307.7)
OG007347.5(296.4 to 407.3)
OG008186.7(158.0 to 220.7)
B/Malaysia strain
Title
Measurements
OG000147.1(129.1 to 167.6)
OG001163.1(142.5 to 186.6)
OG002172.1(149.9 to 197.6)
OG003152.4(134.4 to 172.7)
OG004181.4(158.9 to 207.1)
OG005202.0(179.7 to 227.1)
OG006155.7(134.8 to 179.8)
OG007174.6(152.0 to 200.7)
OG008153.0(135.2 to 173.1)
Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
OG004
Influenza Vaccine GSK576389A Formulation 5 Group
Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
OG005
Influenza Vaccine GSK576389A Formulation 6 Group
Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
OG006
Influenza Vaccine GSK576389A Formulation 7 Group
Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
OG007
Influenza Vaccine GSK576389A Formulation 8 Group
Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
OG008
Fluarix Elderly Group
Subjects aged ≥65 years received one dose of Fluarix vaccine.
OG009
Fluarix Young Group
Subjects aged 18-40 years received one dose of Fluarix vaccine.
Units
Counts
Participants
OG000191
OG001192
OG002189
OG003194
OG004192
OG005193
OG006192
OG007189
OG008188
OG009197
Title
Denominators
Categories
A/Solomon Islands strain at Day 0
Title
Measurements
OG00010.6(9.3 to 12.2)
OG00110.8(9.4 to 12.4)
OG00210.1(8.8 to 11.5)
OG00310.6(9.3 to 12.1)
OG00412.0(10.3 to 14.0)
OG0059.9(8.6 to 11.3)
OG00610.2(8.9 to 11.7)
OG00710.3(9.0 to 11.9)
OG00810.7(9.2 to 12.4)
OG00921.3(17.1 to 26.5)
A/Solomon Islands strain at Day 21
Title
Measurements
OG00082.3(69.7 to 97.1)
OG001102.2(87.0 to 119.9)
OG00298.2(84.3 to 114.3)
OG003
A/Wisconsin strain at Day 0
Title
Measurements
OG00059.9(49.5 to 72.4)
OG00151.2(41.9 to 62.4)
OG00244.4(36.5 to 54.0)
OG003
A/Wisconsin strain at Day 21
Title
Measurements
OG000276.2(238.8 to 319.6)
OG001350.2(298.0 to 411.4)
OG002351.3(304.8 to 404.8)
OG003
B/Malaysia strain at Day 0
Title
Measurements
OG00058.6(49.8 to 68.9)
OG00153.7(45.7 to 63.2)
OG00257.0(48.2 to 67.5)
OG003
B/Malaysia strain at Day 21
Title
Measurements
OG000147.1(129.1 to 167.6)
OG001163.1(142.5 to 186.6)
OG002172.1(149.9 to 197.6)
OG003
Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
OG004
Influenza Vaccine GSK576389A Formulation 5 Group
Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
OG005
Influenza Vaccine GSK576389A Formulation 6 Group
Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
OG006
Influenza Vaccine GSK576389A Formulation 7 Group
Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
OG007
Influenza Vaccine GSK576389A Formulation 8 Group
Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
OG008
Fluarix Elderly Group
Subjects aged ≥65 years received one dose of Fluarix vaccine.
OG009
Fluarix Young Group
Subjects aged 18-40 years received one dose of Fluarix vaccine.
Units
Counts
Participants
OG000186
OG001186
OG002180
OG003184
OG004180
OG005187
OG006187
OG007174
OG008181
OG009165
Title
Denominators
Categories
A/Solomon Islands strain
Title
Measurements
OG00030.6(25.8 to 36.3)
OG00135.1(29.7 to 41.5)
OG00236.3(30.7 to 42.8)
OG00332.5(27.6 to 38.2)
OG00440.4(34.1 to 47.9)
OG00533.7(28.6 to 39.7)
OG00629.9(25.5 to 35.0)
OG00739.8(33.6 to 47.2)
OG00823.7(20.3 to 27.7)
OG009114.7(91.8 to 143.5)
A/Wisconsin strain
Title
Measurements
OG000131.5(112.6 to 153.5)
OG001139.8(118.1 to 165.5)
OG002133.4(112.7 to 158.1)
OG003
B/Malaysia strain
Title
Measurements
OG00092.7(81.2 to 106.0)
OG00194.3(81.6 to 109.1)
OG002100.9(87.7 to 116.1)
OG003
OG003
Influenza Vaccine GSK576389A Formulation 4 Group
Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
OG004
Influenza Vaccine GSK576389A Formulation 5 Group
Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
OG005
Influenza Vaccine GSK576389A Formulation 6 Group
Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
OG006
Influenza Vaccine GSK576389A Formulation 7 Group
Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
OG007
Influenza Vaccine GSK576389A Formulation 8 Group
Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
OG008
Fluarix Elderly Group
Subjects aged ≥65 years received one dose of Fluarix vaccine.
OG009
Fluarix Young Group
Subjects aged 18-40 years received one dose of Fluarix vaccine.
Units
Counts
Participants
OG000191
OG001191
OG002189
OG003194
OG004192
OG005193
OG006192
OG007189
OG008187
OG009197
Title
Denominators
Categories
A/Solomon Islands strain
Title
Measurements
OG000133
OG001138
OG002154
OG003130
OG004142
OG005151
OG006129
OG007146
OG00899
OG009135
A/Wisconsin strain
Title
Measurements
OG000108
OG001124
OG002141
OG003
B/Malaysia strain
Title
Measurements
OG00047
OG00173
OG00265
OG003
OG003
Influenza Vaccine GSK576389A Formulation 4 Group
Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
OG004
Influenza Vaccine GSK576389A Formulation 5 Group
Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
OG005
Influenza Vaccine GSK576389A Formulation 6 Group
Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
OG006
Influenza Vaccine GSK576389A Formulation 7 Group
Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
OG007
Influenza Vaccine GSK576389A Formulation 8 Group
Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
OG008
Fluarix Elderly Group
Subjects aged ≥65 years received one dose of Fluarix vaccine.
OG009
Fluarix Young Group
Subjects aged 18-40 years received one dose of Fluarix vaccine.
Units
Counts
Participants
OG000186
OG001186
OG002180
OG003184
OG004180
OG005187
OG006187
OG007174
OG008180
OG009165
Title
Denominators
Categories
A/Solomon Islands strain
Title
Measurements
OG00064
OG00173
OG00274
OG00368
OG00460
OG00577
OG00660
OG00767
OG00842
OG00990
A/Wisconsin strain
Title
Measurements
OG00047
OG00159
OG00261
OG003
B/Malaysia strain
Title
Measurements
OG00023
OG00123
OG00225
OG003
Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
OG004
Influenza Vaccine GSK576389A Formulation 5 Group
Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
OG005
Influenza Vaccine GSK576389A Formulation 6 Group
Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
OG006
Influenza Vaccine GSK576389A Formulation 7 Group
Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
OG007
Influenza Vaccine GSK576389A Formulation 8 Group
Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
OG008
Fluarix Elderly Group
Subjects aged ≥65 years received one dose of Fluarix vaccine.
OG009
Fluarix Young Group
Subjects aged 18-40 years received one dose of Fluarix vaccine.
Units
Counts
Participants
OG000191
OG001191
OG002189
OG003194
OG004192
OG005193
OG006192
OG007189
OG008187
OG009197
Title
Denominators
Categories
A/Solomon Islands strain
Title
Measurements
OG0007.7(6.5 to 9.2)
OG0019.4(7.8 to 11.3)
OG0029.8(8.3 to 11.5)
OG0038.6(7.2 to 10.4)
OG0049.4(8.0 to 11.1)
OG00511.6(9.7 to 13.9)
OG0067.7(6.5 to 9.2)
OG00710.8(9.0 to 13.0)
OG0085.6(4.7 to 6.8)
OG00912.8(10.0 to 16.3)
A/Wisconsin strain
Title
Measurements
OG0004.6(3.9 to 5.4)
OG0016.8(5.6 to 8.1)
OG0027.9(6.6 to 9.5)
OG003
B/Malaysia strain
Title
Measurements
OG0002.5(2.2 to 2.8)
OG0013.0(2.6 to 3.5)
OG0023.0(2.6 to 3.5)
OG003
Influenza Vaccine GSK576389A Formulation 4 Group
Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
OG004
Influenza Vaccine GSK576389A Formulation 5 Group
Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
OG005
Influenza Vaccine GSK576389A Formulation 6 Group
Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
OG006
Influenza Vaccine GSK576389A Formulation 7 Group
Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
OG007
Influenza Vaccine GSK576389A Formulation 8 Group
Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
OG008
Fluarix Elderly Group
Subjects aged ≥65 years received one dose of Fluarix vaccine.
OG009
Fluarix Young Group
Subjects aged 18-40 years received one dose of Fluarix vaccine.
Units
Counts
Participants
OG000186
OG001186
OG002180
OG003184
OG004180
OG005187
OG006187
OG007174
OG008180
OG009165
Title
Denominators
Categories
A/Solomon Islands strain
Title
Measurements
OG0002.9(2.5 to 3.4)
OG0013.3(2.8 to 3.9)
OG0023.5(3.1 to 4.1)
OG0033.0(2.6 to 3.5)
OG0043.3(2.9 to 3.8)
OG0053.5(2.9 to 4.1)
OG0062.9(2.5 to 3.3)
OG0073.8(3.2 to 4.4)
OG0082.2(1.9 to 2.6)
OG0095.7(4.5 to 7.2)
A/Wisconsin strain
Title
Measurements
OG0002.2(1.9 to 2.6)
OG0012.7(2.3 to 3.1)
OG0022.9(2.5 to 3.3)
OG003
B/Malaysia strain
Title
Measurements
OG0001.7(1.5 to 1.9)
OG0011.7(1.5 to 1.9)
OG0021.7(1.5 to 1.9)
OG003
Influenza Vaccine GSK576389A Formulation 4 Group
Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
OG004
Influenza Vaccine GSK576389A Formulation 5 Group
Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
OG005
Influenza Vaccine GSK576389A Formulation 6 Group
Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
OG006
Influenza Vaccine GSK576389A Formulation 7 Group
Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
OG007
Influenza Vaccine GSK576389A Formulation 8 Group
Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
OG008
Fluarix Elderly Group
Subjects aged ≥65 years received one dose of Fluarix vaccine.
OG009
Fluarix Young Group
Subjects aged 18-40 years received one dose of Fluarix vaccine.
Units
Counts
Participants
OG000191
OG001192
OG002189
OG003194
OG004192
OG005193
OG006192
OG007189
OG008188
OG009197
Title
Denominators
Categories
A/Solomon Islands strain at Day 0
Title
Measurements
OG00027
OG00131
OG00225
OG00333
OG00444
OG00523
OG00622
OG00726
OG00831
OG00969
A/Solomon Islands strain at Day 21
Title
Measurements
OG000160
OG001168
OG002171
OG003
A/Wisconsin strain at Day 0
Title
Measurements
OG000133
OG001124
OG002113
OG003
A/Wisconsin strain at Day 21
Title
Measurements
OG000188
OG001189
OG002188
OG003
B/Malaysia strain at Day 0
Title
Measurements
OG000138
OG001140
OG002138
OG003
B/Malaysia strain at Day 21
Title
Measurements
OG000183
OG001183
OG002184
OG003
Influenza Vaccine GSK576389A Formulation 4 Group
Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
OG004
Influenza Vaccine GSK576389A Formulation 5 Group
Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
OG005
Influenza Vaccine GSK576389A Formulation 6 Group
Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
OG006
Influenza Vaccine GSK576389A Formulation 7 Group
Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
OG007
Influenza Vaccine GSK576389A Formulation 8 Group
Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
OG008
Fluarix Elderly Group
Subjects aged ≥65 years received one dose of Fluarix vaccine.
OG009
Fluarix Young Group
Subjects aged 18-40 years received one dose of Fluarix vaccine.
Units
Counts
Participants
OG000186
OG001186
OG002180
OG003184
OG004180
OG005187
OG006187
OG007174
OG008181
OG009165
Title
Denominators
Categories
A/Solomon Islands strain
Title
Measurements
OG00094
OG001111
OG002105
OG003105
OG004103
OG005104
OG006100
OG007100
OG00877
OG009135
A/Wisconsin strain
Title
Measurements
OG000172
OG001170
OG002162
OG003
B/Malaysia strain
Title
Measurements
OG000167
OG001166
OG002168
OG003
Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
OG003
Influenza Vaccine GSK576389A Formulation 4 Group
Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
OG004
Influenza Vaccine GSK576389A Formulation 5 Group
Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
OG005
Influenza Vaccine GSK576389A Formulation 6 Group
Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
OG006
Influenza Vaccine GSK576389A Formulation 7 Group
Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
OG007
Influenza Vaccine GSK576389A Formulation 8 Group
Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
OG008
Fluarix Elderly Group
Subjects aged ≥65 years received one dose of Fluarix vaccine.
OG009
Fluarix Young Group
Subjects aged 18-40 years received one dose of Fluarix vaccine.
Units
Counts
Participants
OG00024
OG00119
OG00225
OG00324
OG00424
OG00523
OG00623
OG00723
OG00823
OG00923
Title
Denominators
Categories
A/Solomon Islands [CD4-All doubles] at Day 0
Title
Measurements
OG000177.48± 278.18
OG001283.18± 319.74
OG002204.49± 236.05
OG003200.21± 480.41
OG004193.35± 324.34
OG005177.44± 297.52
OG006199.80± 310.58
OG007222.58± 282.91
OG008156.21± 518.89
OG009538.72± 442.78
A/Solomon Islands [CD4-All doubles] at Day 21
Title
Measurements
OG000441.16± 517.73
OG001856.00± 685.35
OG002704.14± 778.07
OG003
A/Wisconsin [CD4-All doubles] at Day 0
Title
Measurements
OG000583.77± 563.98
OG001488.70± 540.66
OG002584.25± 626.26
OG003
A/Wisconsin [CD4-All doubles] at Day 21
Title
Measurements
OG0001016.63± 990.97
OG0011491.86± 899.50
OG0021140.56± 955.61
OG003
B/Malaysia [CD4-All doubles] at Day 0
Title
Measurements
OG000407.18± 456.82
OG001596.53± 400.24
OG002500.81± 734.64
OG003
B/Malaysia [CD4-All doubles] at Day 21
Title
Measurements
OG0001025.01± 736.55
OG0011614.14± 953.74
OG0021005.72± 1314.69
OG003
A/Solomon Islands [CD4-CD40L] at Day 0
Title
Measurements
OG000187.19± 277.14
OG001285.19± 319.80
OG002193.56± 236.01
OG003
A/Solomon Islands [CD4-CD40L] at Day 21
Title
Measurements
OG000418.24± 523.39
OG001657.41± 684.48
OG002641.98± 752.95
OG003
A/Wisconsin [CD4-CD40L] at Day 0
Title
Measurements
OG000555.20± 555.43
OG001477.12± 531.36
OG002527.80± 613.23
OG003
A/Wisconsin [CD4-CD40L] at Day 21
Title
Measurements
OG000941.04± 994.45
OG0011438.93± 881.80
OG0021014.97± 933.09
OG003
B/Malaysia [CD4-CD40L] at Day 0
Title
Measurements
OG000387.03± 429.86
OG001587.72± 396.47
OG002446.80± 736.88
OG003
B/Malaysia [CD4-CD40L] at Day 21
Title
Measurements
OG000926.13± 749.19
OG0011570.30± 962.36
OG002958.63± 1315.41
OG003
A/Solomon Islands [CD4-IFNγ] at Day 0
Title
Measurements
OG000202.65± 195.65
OG001190.19± 245.89
OG002158.04± 192.23
OG003
A/Solomon Islands [CD4-IFNγ] at Day 21
Title
Measurements
OG000398.57± 370.41
OG001636.42± 570.57
OG002532.84± 488.63
OG003
A/Wisconsin [CD4-IFNγ] at Day 0
Title
Measurements
OG000361.99± 378.72
OG001350.04± 325.28
OG002332.39± 326.71
OG003
A/Wisconsin [CD4-IFNγ] at Day 21
Title
Measurements
OG000644.07± 707.63
OG001891.98± 719.87
OG002809.46± 590.21
OG003
B/Malaysia [CD4-IFNγ] at Day 0
Title
Measurements
OG000336.70± 352.20
OG001403.08± 319.99
OG002322.07± 631.98
OG003
B/Malaysia [CD4-IFNγ] at Day 21
Title
Measurements
OG000716.86± 601.16
OG0011163.80± 865.47
OG002855.95± 1073.89
OG003
A/Solomon Islands [CD4-IL2] at Day 0
Title
Measurements
OG000181.54± 242.60
OG001193.42± 297.22
OG002188.29± 215.39
OG003
A/Solomon Islands [CD4-IL2] at Day 21
Title
Measurements
OG000299.14± 421.84
OG001664.46± 582.79
OG002559.98± 642.32
OG003
A/Wisconsin [CD4-IL2] at Day 0
Title
Measurements
OG000406.48± 508.99
OG001382.61± 428.51
OG002516.80± 421.85
OG003
A/Wisconsin [CD4-IL2] at Day 21
Title
Measurements
OG000747.93± 778.49
OG0011082.78± 712.53
OG0021010.24± 772.39
OG003
B/Malaysia [CD4-IL2] at Day 0
Title
Measurements
OG000277.98± 394.46
OG001491.65± 369.85
OG002434.78± 621.10
OG003
B/Malaysia [CD4-IL2] at Day 21
Title
Measurements
OG000791.31± 616.06
OG0011295.22± 856.91
OG002992.50± 1134.21
OG003
A/Solomon Islands [CD4-TNFα] at Day 0
Title
Measurements
OG00091.32± 201.60
OG001155.22± 184.44
OG002130.19± 152.33
OG003
A/Solomon Islands [CD4-TNFα] at Day 21
Title
Measurements
OG000234.99± 298.31
OG001440.26± 451.77
OG002333.95± 487.76
OG003
A/Wisconsin [CD4-TNFα] at Day 0
Title
Measurements
OG000351.26± 450.82
OG001458.02± 373.43
OG002432.24± 487.63
OG003
A/Wisconsin [CD4-TNFα] at Day 21
Title
Measurements
OG000712.96± 700.26
OG001944.29± 589.91
OG002852.44± 637.30
OG003
B/Malaysia [CD4-TNFα] at Day 0
Title
Measurements
OG000203.89± 281.14
OG001239.73± 260.28
OG002225.66± 501.91
OG003
B/Malaysia [CD4-TNFα] at Day 21
Title
Measurements
OG000509.26± 451.20
OG001806.86± 561.77
OG002601.64± 763.90
OG003
OG003
Influenza Vaccine GSK576389A Formulation 4 Group
Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
OG004
Influenza Vaccine GSK576389A Formulation 5 Group
Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
OG005
Influenza Vaccine GSK576389A Formulation 6 Group
Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
OG006
Influenza Vaccine GSK576389A Formulation 7 Group
Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
OG007
Influenza Vaccine GSK576389A Formulation 8 Group
Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
OG008
Fluarix Elderly Group
Subjects aged ≥65 years received one dose of Fluarix vaccine.
OG009
Fluarix Young Group
Subjects aged 18-40 years received one dose of Fluarix vaccine.
Units
Counts
Participants
OG00021
OG00118
OG00220
OG00317
OG00421
OG00521
OG00619
OG00716
OG00816
OG00919
Title
Denominators
Categories
A/Solomon Islands [CD4-All doubles]
Title
Measurements
OG000393.50± 359.42
OG001348.12± 422.44
OG002666.01± 663.86
OG003394.45± 508.40
OG004432.70± 374.70
OG005421.08± 613.81
OG006357.66± 470.53
OG007224.47± 332.47
OG008714.85± 658.37
OG0091070.14± 874.71
A/Wisconsin [CD4-All doubles]
Title
Measurements
OG000802.04± 391.96
OG001603.15± 559.07
OG002720.91± 829.77
OG003
B/Malaysia [CD4-All doubles]
Title
Measurements
OG000679.05± 4150.67
OG001807.74± 629.48
OG002807.96± 901.44
OG003
A/Solomon Islands [CD4-CD40L]
Title
Measurements
OG000348.06± 342.53
OG001319.80± 403.11
OG002622.84± 626.39
OG003
A/Wisconsin [CD4-CD40L]
Title
Measurements
OG000733.96± 397.17
OG001576.04± 543.29
OG002682.43± 823.68
OG003
B/Malaysia [CD4-CD40L]
Title
Measurements
OG000621.50± 3427.50
OG001764.21± 613.38
OG002779.35± 887.41
OG003
A/Solomon Islands [CD4-IFNγ]
Title
Measurements
OG000244.53± 325.64
OG001375.03± 308.38
OG002392.18± 500.72
OG003
A/Wisconsin [CD4-IFNγ]
Title
Measurements
OG000492.75± 320.15
OG001476.37± 416.85
OG002548.14± 557.60
OG003
B/Malaysia [CD4-IFNγ]
Title
Measurements
OG000522.75± 3348.47
OG001510.43± 462.45
OG002457.89± 774.10
OG003
A/Solomon Islands [CD4-IL2]
Title
Measurements
OG000316.88± 297.00
OG001314.96± 372.22
OG002558.83± 549.83
OG003
A/Wisconsin [CD4-IL2]
Title
Measurements
OG000579.40± 330.85
OG001426.54± 422.19
OG002529.59± 677.44
OG003
B/Malaysia [CD4-IL2]
Title
Measurements
OG000549.00± 2767.21
OG001617.40± 602.01
OG002698.16± 823.21
OG003
A/Solomon Islands [CD4-TNFα]
Title
Measurements
OG000280.19± 284.35
OG001188.48± 325.58
OG002382.50± 490.32
OG003
A/Wisconsin [CD4-TNFα]
Title
Measurements
OG000722.29± 288.16
OG001600.27± 472.44
OG002626.23± 655.14
OG003
B/Malaysia [CD4-TNFα]
Title
Measurements
OG000538.21± 2445.31
OG001576.09± 352.91
OG002408.52± 712.70
OG003
OG003
Influenza Vaccine GSK576389A Formulation 4 Group
Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
OG004
Influenza Vaccine GSK576389A Formulation 5 Group
Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
OG005
Influenza Vaccine GSK576389A Formulation 6 Group
Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
OG006
Influenza Vaccine GSK576389A Formulation 7 Group
Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
OG007
Influenza Vaccine GSK576389A Formulation 8 Group
Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
OG008
Fluarix Elderly Group
Subjects aged ≥65 years received one dose of Fluarix vaccine.
OG009
Fluarix Young Group
Subjects aged 18-40 years received one dose of Fluarix vaccine.
Units
Counts
Participants
OG00024
OG00119
OG00225
OG00324
OG00424
OG00523
OG00623
OG00723
OG00823
OG00923
Title
Denominators
Categories
A/Solomon Islands [CD8-All doubles] at Day 0
Title
Measurements
OG0008.10± 135.40
OG00112.90± 151.71
OG00214.46± 122.65
OG0033.25± 53.78
OG0043.31± 91.60
OG0052.31± 47.88
OG0062.63± 98.13
OG0076.83± 67.42
OG00813.81± 116.94
OG0097.69± 91.40
A/Solomon Islands [CD8-All doubles] at Day 21
Title
Measurements
OG0007.45± 97.10
OG00112.20± 127.89
OG0029.54± 116.11
OG003
A/Wisconsin [CD8-All doubles] at Day 0
Title
Measurements
OG0009.69± 178.06
OG0016.81± 126.03
OG0029.85± 344.91
OG003
A/Wisconsin [CD8-All doubles] at Day 21
Title
Measurements
OG00031.08± 84.59
OG0017.54± 234.23
OG0029.77± 292.05
OG003
B/Malaysia [CD8-All doubles] at Day 0
Title
Measurements
OG00011.62± 200.31
OG00115.68± 423.52
OG00230.58± 282.37
OG003
B/Malaysia [CD8-All doubles] at Day 21
Title
Measurements
OG00042.50± 296.07
OG00144.96± 351.05
OG00220.54± 188.50
OG003
A/Solomon Islands [CD8-CD40L] at Day 0
Title
Measurements
OG0007.68± 76.49
OG0019.18± 141.09
OG0027.64± 81.73
OG003
A/Solomon Islands [CD8-CD40L] at Day 21
Title
Measurements
OG0003.76± 69.81
OG0013.41± 98.02
OG0028.71± 75.81
OG003
A/Wisconsin [CD8-CD40L] at Day 0
Title
Measurements
OG0004.63± 51.86
OG0012.17± 41.97
OG0025.20± 70.37
OG003
A/Wisconsin [CD8-CD40L] at Day 21
Title
Measurements
OG0003.09± 45.67
OG0015.72± 165.77
OG0024.19± 52.99
OG003
B/Malaysia [CD8-CD40L] at Day 0
Title
Measurements
OG0003.24± 54.73
OG0017.16± 290.97
OG0026.53± 132.89
OG003
B/Malaysia [CD8-CD40L] at Day 21
Title
Measurements
OG0002.68± 127.60
OG00112.06± 265.01
OG0023.74± 115.89
OG003
A/Solomon Islands [CD8-IFNγ] at Day 0
Title
Measurements
OG0007.38± 115.60
OG0018.63± 157.70
OG00210.16± 107.21
OG003
A/Solomon Islands [CD8-IFNγ] at Day 21
Title
Measurements
OG0007.37± 84.04
OG0019.19± 85.93
OG00211.15± 94.57
OG003
A/Wisconsin [CD8-IFNγ] at Day 0
Title
Measurements
OG0007.85± 103.62
OG0013.95± 78.12
OG0027.61± 309.89
OG003
A/Wisconsin [CD8-IFNγ] at Day 21
Title
Measurements
OG0008.27± 78.96
OG0018.63± 176.22
OG0029.89± 295.99
OG003
B/Malaysia [CD8-IFNγ] at Day 0
Title
Measurements
OG0005.56± 99.28
OG00110.71± 390.44
OG00215.15± 261.46
OG003
B/Malaysia [CD8-IFNγ] at Day 21
Title
Measurements
OG00011.69± 129.41
OG00117.80± 305.22
OG00214.44± 160.52
OG003
A/Solomon Islands [CD8-IL2] at Day 0
Title
Measurements
OG0003.52± 80.50
OG0013.10± 27.39
OG0025.50± 55.47
OG003
A/Solomon Islands [CD8-IL2] at Day 21
Title
Measurements
OG0004.80± 63.95
OG0014.30± 73.39
OG0027.50± 51.96
OG003
A/Wisconsin [CD8-IL2] at Day 0
Title
Measurements
OG0003.70± 113.92
OG0013.21± 91.01
OG0026.13± 99.85
OG003
A/Wisconsin [CD8-IL2] at Day 21
Title
Measurements
OG00012.45± 89.54
OG0015.93± 78.91
OG0027.70± 64.46
OG003
B/Malaysia [CD8-IL2] at Day 0
Title
Measurements
OG0008.66± 147.36
OG0014.40± 161.85
OG00210.05± 141.49
OG003
B/Malaysia [CD8-IL2] at Day 21
Title
Measurements
OG00017.85± 257.14
OG00132.92± 72.84
OG0029.72± 118.83
OG003
A/Solomon Islands [CD8-TNFα] at Day 0
Title
Measurements
OG0005.41± 91.54
OG0013.26± 34.12
OG0028.71± 71.14
OG003
A/Solomon Islands [CD8-TNFα] at Day 21
Title
Measurements
OG0003.79± 79.93
OG00112.15± 70.97
OG0022.76± 117.87
OG003
A/Wisconsin [CD8-TNFα] at Day 0
Title
Measurements
OG0005.04± 145.40
OG0013.70± 138.04
OG0025.31± 338.73
OG003
A/Wisconsin [CD8-TNFα] at Day 21
Title
Measurements
OG00014.64± 98.80
OG0015.75± 118.21
OG0025.74± 278.42
OG003
B/Malaysia [CD8-TNFα] at Day 0
Title
Measurements
OG00011.49± 167.40
OG00111.28± 215.17
OG00218.47± 194.16
OG003
B/Malaysia [CD8-TNFα] at Day 21
Title
Measurements
OG00028.50± 261.61
OG00113.76± 122.97
OG0029.28± 142.76
OG003
OG003
Influenza Vaccine GSK576389A Formulation 4 Group
Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
OG004
Influenza Vaccine GSK576389A Formulation 5 Group
Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
OG005
Influenza Vaccine GSK576389A Formulation 6 Group
Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
OG006
Influenza Vaccine GSK576389A Formulation 7 Group
Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
OG007
Influenza Vaccine GSK576389A Formulation 8 Group
Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
OG008
Fluarix Elderly Group
Subjects aged ≥65 years received one dose of Fluarix vaccine.
OG009
Fluarix Young Group
Subjects aged 18-40 years received one dose of Fluarix vaccine.
Units
Counts
Participants
OG00021
OG00118
OG00220
OG00317
OG00421
OG00520
OG00619
OG00716
OG00816
OG00919
Title
Denominators
Categories
A/Solomon Islands [CD8-All doubles]
Title
Measurements
OG0002.57± 89.78
OG00114.64± 96.62
OG0023.61± 143.10
OG0034.75± 74.09
OG0043.05± 107.06
OG0051.24± 15.43
OG0062.64± 47.18
OG0074.81± 90.76
OG0087.32± 115.74
OG0095.64± 98.76
A/Wisconsin [CD8-All doubles]
Title
Measurements
OG00021.14± 506.65
OG0019.63± 110.40
OG00218.10± 367.31
OG003
B/Malaysia [CD8-All doubles]
Title
Measurements
OG0009.92± 111.75
OG0017.10± 132.35
OG00212.14± 319.23
OG003
A/Solomon Islands [CD8-CD40L]
Title
Measurements
OG0002.92± 53.08
OG00112.64± 119.84
OG0022.95± 97.98
OG003
A/Wisconsin [CD8-CD40L]
Title
Measurements
OG00018.75± 312.61
OG0017.79± 60.25
OG00210.73± 230.49
OG003
B/Malaysia [CD8-CD40L]
Title
Measurements
OG0005.79± 103.71
OG0015.64± 75.90
OG00210.61± 125.46
OG003
A/Solomon Islands [CD8-IFNγ]
Title
Measurements
OG0002.00± 54.66
OG0013.12± 124.76
OG0023.13± 50.16
OG003
A/Wisconsin [CD8-IFNγ]
Title
Measurements
OG0004.21± 167.18
OG0012.68± 42.60
OG0022.32± 92.50
OG003
B/Malaysia [CD8-IFNγ]
Title
Measurements
OG00010.63± 76.06
OG0013.72± 66.40
OG0026.46± 183.07
OG003
A/Solomon Islands [CD8-IL2]
Title
Measurements
OG0001.97± 64.78
OG00110.49± 74.37
OG0022.82± 105.05
OG003
A/Wisconsin [CD8-IL2]
Title
Measurements
OG00020.60± 427.25
OG00115.24± 108.11
OG00214.05± 351.12
OG003
B/Malaysia [CD8-IL2]
Title
Measurements
OG0004.15± 92.98
OG0017.59± 100.66
OG00211.05± 217.46
OG003
A/Solomon Islands [CD8-TNFα]
Title
Measurements
OG0002.54± 60.55
OG0012.35± 31.14
OG0022.09± 62.82
OG003
A/Wisconsin [CD8-TNFα]
Title
Measurements
OG0007.78± 244.26
OG0014.42± 63.49
OG0029.25± 151.69
OG003
B/Malaysia [CD8-TNFα]
Title
Measurements
OG0004.05± 74.16
OG0015.66± 88.74
OG00214.08± 191.59
OG003
OG003
Influenza Vaccine GSK576389A Formulation 4 Group
Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
OG004
Influenza Vaccine GSK576389A Formulation 5 Group
Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
OG005
Influenza Vaccine GSK576389A Formulation 6 Group
Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
OG006
Influenza Vaccine GSK576389A Formulation 7 Group
Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
OG007
Influenza Vaccine GSK576389A Formulation 8 Group
Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
OG008
Fluarix Elderly Group
Subjects aged ≥65 years received one dose of Fluarix vaccine.
OG009
Fluarix Young Group
Subjects aged 18-40 years received one dose of Fluarix vaccine.
Units
Counts
Participants
OG000201
OG001201
OG002201
OG003201
OG004198
OG005197
OG006198
OG007198
OG008200
OG009201
Title
Denominators
Categories
Any ecchymosis
Title
Measurements
OG0003
OG0011
OG0025
OG0031
OG0042
OG0052
OG0064
OG0072
OG0083
OG0090
Grade 3 ecchymosis
Title
Measurements
OG0000
OG0010
OG0020
OG003
Any pain
Title
Measurements
OG00068
OG00182
OG002111
OG003
Grade 3 pain
Title
Measurements
OG0001
OG0011
OG0020
OG003
Any redness
Title
Measurements
OG00015
OG00116
OG00237
OG003
Grade 3 redness
Title
Measurements
OG0000
OG0011
OG0023
OG003
Any swelling
Title
Measurements
OG00013
OG00112
OG00225
OG003
Grade 3 swelling
Title
Measurements
OG0000
OG0010
OG0020
OG003
Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
OG004
Influenza Vaccine GSK576389A Formulation 5 Group
Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
OG005
Influenza Vaccine GSK576389A Formulation 6 Group
Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
OG006
Influenza Vaccine GSK576389A Formulation 7 Group
Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
OG007
Influenza Vaccine GSK576389A Formulation 8 Group
Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
OG008
Fluarix Elderly Group
Subjects aged ≥65 years received one dose of Fluarix vaccine.
OG009
Fluarix Young Group
Subjects aged 18-40 years received one dose of Fluarix vaccine.
Units
Counts
Participants
OG00068
OG00182
OG002111
OG00384
OG00491
OG005119
OG00693
OG007106
OG00832
OG00993
Title
Denominators
Categories
Ecchymosis (N=3;1;5;1;2;2;4;2;3;0)
Title
Measurements
OG0005.0(1.0 to 7.0)
OG0016.0(6.0 to 6.0)
OG0026.0(3.0 to 7.0)
OG0032.0(2.0 to 2.0)
OG0042.5(1.0 to 4.0)
OG0053.0(1.0 to 5.0)
OG0063.0(1.0 to 5.0)
OG0073.0(2.0 to 4.0)
OG0085.0(4.0 to 7.0)
OG009NA(NA to NA)None of the subjects in this group reported any ecchymosis.
Pain (N=68;82;111;84;91;119;93;106;32;93)
Title
Measurements
OG0002.0(1.0 to 7.0)
OG0012.0(1.0 to 7.0)
OG0022.0(1.0 to 6.0)
OG003
Redness (N=14;16;35;11;33;36;18;34;5;2)
Title
Measurements
OG0001.5(1.0 to 5.0)
OG0012.0(1.0 to 6.0)
OG0023.0(1.0 to 7.0)
OG003
Swelling (N=12;12;24;12;17;23;11;25;5;2)
Title
Measurements
OG0002.0(1.0 to 4.0)
OG0012.0(1.0 to 6.0)
OG0022.5(1.0 to 7.0)
OG003
OG003
Influenza Vaccine GSK576389A Formulation 4 Group
Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
OG004
Influenza Vaccine GSK576389A Formulation 5 Group
Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
OG005
Influenza Vaccine GSK576389A Formulation 6 Group
Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
OG006
Influenza Vaccine GSK576389A Formulation 7 Group
Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
OG007
Influenza Vaccine GSK576389A Formulation 8 Group
Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
OG008
Fluarix Elderly Group
Subjects aged ≥65 years received one dose of Fluarix vaccine.
OG009
Fluarix Young Group
Subjects aged 18-40 years received one dose of Fluarix vaccine.
Units
Counts
Participants
OG000201
OG001201
OG002201
OG003201
OG004198
OG005198
OG006198
OG007198
OG008200
OG009201
Title
Denominators
Categories
Any arthralgia
Title
Measurements
OG00015
OG00123
OG00236
OG00316
OG00421
OG00545
OG00628
OG00735
OG00816
OG00912
Grade 3 arthralgia
Title
Measurements
OG0003
OG0011
OG0022
OG003
Related arthralgia
Title
Measurements
OG00011
OG00115
OG00230
OG003
Any fatigue
Title
Measurements
OG00034
OG00135
OG00254
OG003
Grade 3 fatigue
Title
Measurements
OG0000
OG0011
OG0023
OG003
Related fatigue
Title
Measurements
OG00021
OG00124
OG00239
OG003
Any headache
Title
Measurements
OG00022
OG00138
OG00247
OG003
Grade 3 headache
Title
Measurements
OG0002
OG0011
OG0022
OG003
Related headache
Title
Measurements
OG00014
OG00123
OG00228
OG003
Any myalgia
Title
Measurements
OG00020
OG00135
OG00257
OG003
Grade 3 myalgia
Title
Measurements
OG0001
OG0011
OG0022
OG003
Related myalgia
Title
Measurements
OG00013
OG00129
OG00246
OG003
Any nausea
Title
Measurements
OG00010
OG00112
OG00219
OG003
Grade 3 nausea
Title
Measurements
OG0000
OG0012
OG0021
OG003
Related nausea
Title
Measurements
OG0006
OG0019
OG00210
OG003
Any shivering
Title
Measurements
OG00013
OG00118
OG00237
OG003
Grade 3 shivering
Title
Measurements
OG0001
OG0013
OG0022
OG003
Related shivering
Title
Measurements
OG0009
OG00114
OG00226
OG003
Any fever
Title
Measurements
OG0001
OG0011
OG0023
OG003
Grade 3 fever
Title
Measurements
OG0000
OG0010
OG0020
OG003
Related fever
Title
Measurements
OG0001
OG0011
OG0023
OG003
Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
OG004
Influenza Vaccine GSK576389A Formulation 5 Group
Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
OG005
Influenza Vaccine GSK576389A Formulation 6 Group
Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
OG006
Influenza Vaccine GSK576389A Formulation 7 Group
Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
OG007
Influenza Vaccine GSK576389A Formulation 8 Group
Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
OG008
Fluarix Elderly Group
Subjects aged ≥65 years received one dose of Fluarix vaccine.
OG009
Fluarix Young Group
Subjects aged 18-40 years received one dose of Fluarix vaccine.
Units
Counts
Participants
OG00034
OG00138
OG00257
OG00335
OG00447
OG00566
OG00646
OG00763
OG00824
OG00945
Title
Denominators
Categories
Arthralgia (N=15;23;36;16;21;45;28;35;16;12)
Title
Measurements
OG0003.0(1.0 to 7.0)
OG0012.0(1.0 to 7.0)
OG0022.0(1.0 to 7.0)
OG0032.0(1.0 to 7.0)
OG0042.0(1.0 to 6.0)
OG0052.0(1.0 to 7.0)
OG0062.0(1.0 to 7.0)
OG0072.0(1.0 to 7.0)
OG0083.0(1.0 to 7.0)
OG0092.0(1.0 to 6.0)
Fatigue (N=34;35;54;35;46;55;38;63;24;41)
Title
Measurements
OG0002.0(1.0 to 7.0)
OG0012.0(1.0 to 7.0)
OG0022.0(1.0 to 7.0)
OG003
Headache (N=22;38;47;35;39;55;36;48;23;45)
Title
Measurements
OG0001.5(1.0 to 7.0)
OG0011.0(1.0 to 7.0)
OG0022.0(1.0 to 7.0)
OG003
Myalgia (N=20;35;57;30;47;66;46;56;19;40)
Title
Measurements
OG0002.0(1.0 to 7.0)
OG0012.0(1.0 to 7.0)
OG0022.0(1.0 to 7.0)
OG003
Nausea (N=10;12;19;10;13;18;8;14;6;13)
Title
Measurements
OG0001.5(1.0 to 4.0)
OG0011.0(1.0 to 4.0)
OG0021.0(1.0 to 3.0)
OG003
Shivering (N=13;18;37;26;18;43;17;31;8;21)
Title
Measurements
OG0001.0(1.0 to 3.0)
OG0011.0(1.0 to 5.0)
OG0021.0(1.0 to 6.0)
OG003
Fever (N=4;3;9;4;3;14;6;12;0;1)
Title
Measurements
OG0001.0(1.0 to 1.0)
OG0013.0(3.0 to 3.0)
OG0021.5(1.0 to 2.0)
OG003
OG003
Influenza Vaccine GSK576389A Formulation 4 Group
Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
OG004
Influenza Vaccine GSK576389A Formulation 5 Group
Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
OG005
Influenza Vaccine GSK576389A Formulation 6 Group
Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
OG006
Influenza Vaccine GSK576389A Formulation 7 Group
Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
OG007
Influenza Vaccine GSK576389A Formulation 8 Group
Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
OG008
Fluarix Elderly Group
Subjects aged ≥65 years received one dose of Fluarix vaccine.
OG009
Fluarix Young Group
Subjects aged 18-40 years received one dose of Fluarix vaccine.
Units
Counts
Participants
OG000204
OG001202
OG002202
OG003202
OG004199
OG005198
OG006198
OG007199
OG008200
OG009203
Title
Denominators
Categories
Any AE(s)
Title
Measurements
OG00041
OG00132
OG00251
OG00339
OG00434
OG00542
OG00634
OG00743
OG00827
OG00944
Grade 3 AE(s)
Title
Measurements
OG0001
OG0013
OG0028
OG003
Related AE(s)
Title
Measurements
OG0005
OG0017
OG00215
OG003
Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
OG003
Influenza Vaccine GSK576389A Formulation 4 Group
Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
OG004
Influenza Vaccine GSK576389A Formulation 5 Group
Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
OG005
Influenza Vaccine GSK576389A Formulation 6 Group
Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
OG006
Influenza Vaccine GSK576389A Formulation 7 Group
Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
OG007
Influenza Vaccine GSK576389A Formulation 8 Group
Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
OG008
Fluarix Elderly Group
Subjects aged ≥65 years received one dose of Fluarix vaccine.
OG009
Fluarix Young Group
Subjects aged 18-40 years received one dose of Fluarix vaccine.
Units
Counts
Participants
OG000204
OG001202
OG002202
OG003202
OG004199
OG005198
OG006198
OG007199
OG008200
OG009203
Title
Denominators
Categories
Any AE(S)
Title
Measurements
OG00015
OG00110
OG00219
OG00315
OG00416
OG00514
OG00611
OG00713
OG00810
OG00913
Grade 3 AE(s)
Title
Measurements
OG0000
OG0012
OG0024
OG003
Related AE(s)
Title
Measurements
OG0000
OG0010
OG0024
OG003
Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
OG003
Influenza Vaccine GSK576389A Formulation 4 Group
Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
OG004
Influenza Vaccine GSK576389A Formulation 5 Group
Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
OG005
Influenza Vaccine GSK576389A Formulation 6 Group
Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
OG006
Influenza Vaccine GSK576389A Formulation 7 Group
Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
OG007
Influenza Vaccine GSK576389A Formulation 8 Group
Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
OG008
Fluarix Elderly Group
Subjects aged ≥65 years received one dose of Fluarix vaccine.
OG009
Fluarix Young Group
Subjects aged 18-40 years received one dose of Fluarix vaccine.
Units
Counts
Participants
OG000204
OG001202
OG002202
OG003202
OG004199
OG005198
OG006198
OG007199
OG008200
OG009203
Title
Denominators
Categories
Any AE (s)
Title
Measurements
OG00078
OG00160
OG00279
OG00371
OG00465
OG00567
OG00667
OG00769
OG00869
OG00962
Grade 3 AE(s)
Title
Measurements
OG00018
OG00111
OG00213
OG003
Related AE(s)
Title
Measurements
OG0000
OG0011
OG0020
OG003
OG003
Influenza Vaccine GSK576389A Formulation 4 Group
Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
OG004
Influenza Vaccine GSK576389A Formulation 5 Group
Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
OG005
Influenza Vaccine GSK576389A Formulation 6 Group
Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
OG006
Influenza Vaccine GSK576389A Formulation 7 Group
Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
OG007
Influenza Vaccine GSK576389A Formulation 8 Group
Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
OG008
Fluarix Elderly Group
Subjects aged ≥65 years received one dose of Fluarix vaccine.
OG009
Fluarix Young Group
Subjects aged 18-40 years received one dose of Fluarix vaccine.
Units
Counts
Participants
OG000204
OG001202
OG002202
OG003202
OG004199
OG005198
OG006198
OG007199
OG008200
OG009203
Title
Denominators
Categories
Any SAE(s)
Title
Measurements
OG0000
OG0013
OG0022
OG0032
OG0042
OG0054
OG0062
OG0074
OG0080
OG0090
Related SAE(s)
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG003
Influenza Vaccine GSK576389A Formulation 4 Group
Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
OG004
Influenza Vaccine GSK576389A Formulation 5 Group
Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
OG005
Influenza Vaccine GSK576389A Formulation 6 Group
Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
OG006
Influenza Vaccine GSK576389A Formulation 7 Group
Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
OG007
Influenza Vaccine GSK576389A Formulation 8 Group
Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
OG008
Fluarix Elderly Group
Subjects aged ≥65 years received one dose of Fluarix vaccine.
OG009
Fluarix Young Group
Subjects aged 18-40 years received one dose of Fluarix vaccine.
Units
Counts
Participants
OG000204
OG001202
OG002202
OG003202
OG004199
OG005198
OG006198
OG007199
OG008200
OG009203
Title
Denominators
Categories
Any SAE(s)
Title
Measurements
OG00018
OG0019
OG0025
OG0038
OG0049
OG00510
OG00616
OG00719
OG00815
OG0093
Related SAE(s)
Title
Measurements
OG0000
OG0010
OG0020
OG003
0 affected
199 at risk
EG0050 affected198 at risk
EG0061 affected198 at risk
EG0071 affected199 at risk
EG0080 affected200 at risk
EG0090 affected203 at risk
0 affected
202 at risk
EG0040 affected199 at risk
EG0050 affected198 at risk
EG0060 affected198 at risk
EG0070 affected199 at risk
EG0080 affected200 at risk
EG0090 affected203 at risk
0 affected
202 at risk
EG0040 affected199 at risk
EG0051 affected198 at risk
EG0060 affected198 at risk
EG0070 affected199 at risk
EG0080 affected200 at risk
EG0090 affected203 at risk
0 affected
202 at risk
EG0040 affected199 at risk
EG0050 affected198 at risk
EG0060 affected198 at risk
EG0070 affected199 at risk
EG0080 affected200 at risk
EG0090 affected203 at risk
0 affected
202 at risk
EG0040 affected199 at risk
EG0051 affected198 at risk
EG0060 affected198 at risk
EG0070 affected199 at risk
EG0080 affected200 at risk
EG0090 affected203 at risk
0 affected
202 at risk
EG0040 affected199 at risk
EG0050 affected198 at risk
EG0060 affected198 at risk
EG0071 affected199 at risk
EG0080 affected200 at risk
EG0090 affected203 at risk
0 affected
202 at risk
EG0040 affected199 at risk
EG0050 affected198 at risk
EG0060 affected198 at risk
EG0070 affected199 at risk
EG0080 affected200 at risk
EG0090 affected203 at risk
0 affected
202 at risk
EG0040 affected199 at risk
EG0051 affected198 at risk
EG0060 affected198 at risk
EG0070 affected199 at risk
EG0080 affected200 at risk
EG0090 affected203 at risk
0 affected
202 at risk
EG0040 affected199 at risk
EG0050 affected198 at risk
EG0060 affected198 at risk
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202 at risk
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202 at risk
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202 at risk
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202 at risk
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202 at risk
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202 at risk
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202 at risk
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202 at risk
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202 at risk
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202 at risk
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0 affected
202 at risk
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EG0060 affected198 at risk
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EG0080 affected200 at risk
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12 affected
201 at risk
EG00433 affected198 at risk
EG00536 affected197 at risk
EG00618 affected198 at risk
EG00734 affected198 at risk
EG0085 affected200 at risk
EG0092 affected201 at risk
13 affected
201 at risk
EG00418 affected198 at risk
EG00523 affected197 at risk
EG00611 affected198 at risk
EG00725 affected198 at risk
EG0085 affected200 at risk
EG0092 affected201 at risk
16 affected
201 at risk
EG00421 affected198 at risk
EG00545 affected198 at risk
EG00628 affected198 at risk
EG00735 affected198 at risk
EG00816 affected200 at risk
EG00912 affected201 at risk
35 affected
201 at risk
EG00446 affected198 at risk
EG00555 affected198 at risk
EG00638 affected198 at risk
EG00763 affected198 at risk
EG00824 affected200 at risk
EG00941 affected201 at risk
35 affected
201 at risk
EG00439 affected198 at risk
EG00555 affected198 at risk
EG00636 affected198 at risk
EG00748 affected198 at risk
EG00823 affected200 at risk
EG00945 affected201 at risk
30 affected
201 at risk
EG00447 affected198 at risk
EG00566 affected198 at risk
EG00646 affected198 at risk
EG00756 affected198 at risk
EG00819 affected200 at risk
EG00940 affected201 at risk
10 affected
201 at risk
EG00413 affected198 at risk
EG00518 affected198 at risk
EG0068 affected198 at risk
EG00714 affected198 at risk
EG0086 affected200 at risk
EG00913 affected201 at risk
26 affected
201 at risk
EG00418 affected198 at risk
EG00543 affected198 at risk
EG00617 affected198 at risk
EG00731 affected198 at risk
EG0088 affected200 at risk
EG00921 affected201 at risk
5 affected
202 at risk
EG0047 affected199 at risk
EG0058 affected198 at risk
EG0066 affected198 at risk
EG0077 affected199 at risk
EG0082 affected200 at risk
EG00911 affected203 at risk
91.7
(76.9 to 109.3)
OG004113.2(96.0 to 133.6)
OG005114.4(97.1 to 134.8)
OG00678.5(65.9 to 93.5)
OG007111.8(93.3 to 134.0)
OG00859.6(49.6 to 71.7)
OG009271.6(224.6 to 328.4)
65.7
(53.7 to 80.4)
OG00461.1(50.6 to 73.8)
OG00555.8(46.2 to 67.4)
OG00654.6(44.5 to 67.0)
OG00757.8(47.1 to 70.9)
OG00861.0(49.8 to 74.7)
OG00947.8(39.2 to 58.4)
309.2
(264.9 to 361.0)
OG004331.1(289.6 to 378.6)
OG005438.1(379.7 to 505.4)
OG006263.3(225.3 to 307.7)
OG007347.5(296.4 to 407.3)
OG008186.7(158.0 to 220.7)
OG009380.2(331.6 to 435.9)
62.6
(53.3 to 73.4)
OG00477.8(66.0 to 91.7)
OG00562.9(53.9 to 73.4)
OG00658.2(49.0 to 69.1)
OG00762.6(53.0 to 74.0)
OG00866.5(56.5 to 78.3)
OG00923.4(19.1 to 28.7)
152.4
(134.4 to 172.7)
OG004181.4(158.9 to 207.1)
OG005202.0(179.7 to 227.1)
OG006155.7(134.8 to 179.8)
OG007174.6(152.0 to 200.7)
OG008153.0(135.2 to 173.1)
OG009281.9(241.7 to 328.7)
134.0
(113.1 to 158.7)
OG004144.7(124.9 to 167.5)
OG005181.4(156.5 to 210.3)
OG006118.2(99.8 to 140.0)
OG007145.3(121.9 to 173.2)
OG00892.5(78.7 to 108.6)
OG009193.2(163.5 to 228.3)
87.4
(75.9 to 100.6)
OG004109.2(94.9 to 125.6)
OG005111.4(97.2 to 127.6)
OG00689.0(76.1 to 104.0)
OG00797.7(84.7 to 112.7)
OG00896.6(83.8 to 111.3)
OG009132.4(110.2 to 159.0)
104
OG004124
OG005142
OG006110
OG007131
OG00869
OG009130
44
OG00445
OG00579
OG00650
OG00755
OG00847
OG009147
46
OG00450
OG00574
OG00637
OG00749
OG00823
OG00974
19
OG00416
OG00532
OG00619
OG00720
OG00817
OG00990
4.7
(4.0 to 5.5)
OG0045.4(4.6 to 6.3)
OG0057.8(6.5 to 9.5)
OG0064.8(4.1 to 5.7)
OG0076.0(5.1 to 7.1)
OG0083.1(2.6 to 3.6)
OG0097.9(6.4 to 9.8)
2.4
(2.2 to 2.8)
OG0042.3(2.1 to 2.6)
OG0053.2(2.8 to 3.7)
OG0062.7(2.3 to 3.1)
OG0072.8(2.4 to 3.2)
OG0082.3(2.0 to 2.6)
OG00912.0(9.7 to 15.0)
2.0
(1.8 to 2.3)
OG0042.4(2.1 to 2.7)
OG0053.1(2.7 to 3.6)
OG0062.1(1.8 to 2.4)
OG0072.5(2.2 to 2.9)
OG0081.6(1.4 to 1.8)
OG0094.0(3.2 to 5.0)
1.4
(1.3 to 1.6)
OG0041.4(1.3 to 1.6)
OG0051.8(1.6 to 2.0)
OG0061.5(1.4 to 1.7)
OG0071.6(1.4 to 1.8)
OG0081.5(1.3 to 1.7)
OG0095.6(4.5 to 7.0)
158
OG004169
OG005172
OG006153
OG007163
OG008132
OG009182
139
OG004131
OG005139
OG006130
OG007134
OG008132
OG009122
190
OG004192
OG005191
OG006187
OG007185
OG008179
OG009197
148
OG004156
OG005149
OG006139
OG007145
OG008144
OG00977
187
OG004186
OG005192
OG006182
OG007184
OG008183
OG009195
164
OG004170
OG005179
OG006166
OG007160
OG008156
OG009158
168
OG004166
OG005176
OG006158
OG007162
OG008162
OG009144
494.63
± 883.53
OG004483.24± 481.37
OG005808.90± 858.38
OG006655.32± 616.75
OG007797.68± 5271.86
OG008536.24± 578.48
OG0091027.23± 838.01
309.67
± 517.11
OG004538.87± 691.59
OG005702.79± 3741.48
OG006457.98± 321.69
OG007594.26± 598.83
OG008427.71± 745.78
OG009821.78± 646.48
1015.18
± 1044.87
OG0041051.06± 1024.97
OG0051998.33± 2730.32
OG0061234.37± 830.47
OG0071302.34± 3490.03
OG008922.62± 1170.30
OG0091455.68± 870.69
250.48
± 375.23
OG004490.56± 546.12
OG005259.15± 278.35
OG006403.06± 482.16
OG007442.39± 315.27
OG008301.23± 584.68
OG0091098.75± 909.18
817.57
± 675.70
OG0041019.48± 698.91
OG0051255.53± 941.27
OG0061153.76± 699.26
OG0071057.60± 4968.52
OG008781.66± 880.46
OG0091707.62± 1591.31
141.26
± 500.24
OG004192.02± 314.38
OG005167.87± 296.47
OG006153.91± 311.96
OG007165.48± 281.57
OG008150.60± 512.37
OG009504.55± 441.35
471.56
± 881.73
OG004391.29± 474.16
OG005510.16± 871.38
OG006599.32± 592.08
OG007697.39± 5282.26
OG008406.14± 571.70
OG009967.83± 848.55
284.63
± 522.58
OG004511.21± 679.89
OG005587.17± 1872.24
OG006418.98± 333.83
OG007568.96± 559.46
OG008322.37± 713.98
OG009742.80± 659.21
940.53
± 1065.84
OG004977.44± 970.75
OG0051763.75± 1858.49
OG0061162.09± 715.63
OG0071156.07± 3501.25
OG008798.75± 1155.23
OG0091383.25± 871.98
219.83
± 386.13
OG004479.21± 550.01
OG005256.73± 280.28
OG006383.93± 466.87
OG007431.32± 319.06
OG008342.65± 589.08
OG0091076.46± 903.85
754.45
± 694.91
OG004975.92± 710.25
OG0051160.31± 959.34
OG0061039.13± 699.33
OG007957.22± 5023.06
OG008707.72± 874.64
OG0091614.08± 1617.78
235.01
± 355.44
OG004171.07± 194.84
OG005137.02± 189.76
OG006203.95± 254.48
OG007184.52± 211.26
OG008198.86± 422.78
OG009380.34± 384.07
426.15
± 660.07
OG004379.49± 361.80
OG005543.09± 681.65
OG006467.66± 450.93
OG007576.14± 4664.15
OG008442.66± 449.36
OG009755.12± 645.89
295.56
± 424.20
OG004243.93± 321.57
OG005495.18± 3550.69
OG006305.13± 248.40
OG007310.45± 276.10
OG008272.34± 453.35
OG009589.57± 493.89
606.43
± 745.80
OG004651.21± 651.51
OG0051293.10± 2390.91
OG006718.87± 619.16
OG007691.57± 2944.57
OG008548.91± 732.46
OG009976.96± 643.43
302.23
± 249.59
OG004248.66± 236.24
OG005237.57± 200.43
OG006277.94± 372.05
OG007210.23± 266.19
OG008256.03± 440.55
OG009874.82± 729.66
509.84
± 520.06
OG004611.65± 527.80
OG005852.80± 715.28
OG006745.46± 575.21
OG007709.84± 4385.83
OG008523.15± 697.47
OG0091306.18± 1346.37
150.59
± 407.63
OG004152.22± 284.11
OG005157.54± 255.06
OG006161.81± 293.16
OG007170.79± 253.02
OG008122.12± 451.59
OG009356.84± 313.43
415.13
± 691.39
OG004409.73± 365.35
OG005677.81± 689.59
OG006529.19± 520.65
OG007678.22± 4760.15
OG008461.05± 498.00
OG009813.73± 693.31
251.35
± 445.04
OG004388.89± 560.47
OG005532.86± 708.29
OG006393.79± 295.93
OG007470.64± 443.13
OG008343.41± 607.93
OG009589.89± 469.14
762.07
± 766.05
OG004792.75± 828.41
OG0051425.03± 1236.35
OG006908.72± 680.48
OG0071041.76± 2883.12
OG008733.36± 900.95
OG0091061.62± 635.42
190.27
± 322.46
OG004411.11± 457.99
OG005269.03± 243.51
OG006360.78± 420.71
OG007333.95± 309.81
OG008221.19± 537.35
OG009871.60± 724.64
692.82
± 570.55
OG004876.95± 569.97
OG0051038.01± 765.73
OG006949.33± 588.11
OG007872.00± 4655.93
OG008695.83± 757.57
OG0091348.21± 1359.92
124.70
± 306.20
OG004143.44± 199.20
OG005112.41± 169.39
OG006100.38± 185.42
OG007111.07± 179.39
OG008104.10± 311.25
OG009234.98± 234.23
279.64
± 553.81
OG004296.79± 289.33
OG005336.45± 541.95
OG006325.65± 410.44
OG007449.86± 3979.03
OG008273.66± 355.95
OG009490.23± 532.90
342.30
± 455.39
OG004404.64± 410.30
OG005600.83± 3581.08
OG006303.13± 263.25
OG007420.75± 422.38
OG008327.09± 552.26
OG009667.60± 450.65
623.21
± 728.42
OG004702.41± 635.67
OG0051293.59± 2431.45
OG006802.15± 591.12
OG007884.71± 2654.95
OG008575.97± 723.76
OG009995.86± 630.33
118.04
± 257.63
OG004241.23± 332.43
OG005117.51± 175.00
OG006152.19± 297.33
OG007193.88± 141.46
OG008126.64± 402.92
OG009605.04± 641.27
312.72
± 391.89
OG004518.35± 419.60
OG005580.98± 579.68
OG006547.64± 464.44
OG007540.54± 3022.19
OG008285.50± 526.85
OG009805.41± 1133.76
463.85
± 832.67
OG004728.09± 640.63
OG005676.69± 785.39
OG006670.60± 881.04
OG007566.79± 522.16
OG008638.11± 929.43
OG0091366.02± 966.33
416.48
± 442.15
OG004774.07± 452.40
OG005423.03± 839.74
OG006582.68± 429.62
OG007588.22± 334.48
OG008742.01± 481.80
OG0091304.54± 1096.30
361.05
± 490.66
OG004425.72± 346.49
OG005471.70± 566.40
OG006353.82± 432.84
OG007234.90± 304.83
OG008690.69± 642.61
OG009999.02± 831.24
439.97
± 825.94
OG004680.00± 607.45
OG005683.28± 761.14
OG006623.11± 800.89
OG007554.83± 502.42
OG008625.97± 924.73
OG0091268.21± 889.54
394.05
± 415.93
OG004743.85± 425.01
OG005414.76± 732.26
OG006592.52± 424.79
OG007537.41± 351.86
OG008679.16± 486.34
OG0091260.62± 1067.54
280.73
± 402.63
OG004261.43± 263.15
OG005338.11± 488.06
OG006271.38± 373.04
OG007136.97± 262.56
OG008445.44± 577.53
OG009867.78± 658.04
372.77
± 618.70
OG004399.91± 481.00
OG005325.70± 547.57
OG006523.69± 683.65
OG007374.66± 407.51
OG008467.74± 807.28
OG009971.26± 783.42
253.06
± 234.64
OG004411.84± 384.77
OG005240.48± 567.12
OG006361.94± 357.95
OG007360.90± 250.90
OG008458.80± 456.80
OG0091073.05± 935.35
304.00
± 404.11
OG004368.31± 348.92
OG005400.05± 505.26
OG006304.33± 467.47
OG007175.36± 258.68
OG008691.47± 597.60
OG009859.06± 642.57
480.46
± 667.59
OG004603.02± 608.61
OG005551.29± 712.29
OG006489.69± 841.98
OG007339.94± 440.33
OG008700.87± 861.25
OG0091011.95± 565.94
315.90
± 393.50
OG004672.69± 432.34
OG005373.28± 680.43
OG006518.17± 374.93
OG007345.05± 300.46
OG008612.61± 455.63
OG0091119.01± 801.11
200.30
± 422.18
OG004263.40± 301.07
OG005350.38± 473.03
OG006254.19± 373.61
OG007228.89± 247.41
OG008533.13± 517.19
OG009730.49± 549.49
395.86
± 758.84
OG004599.10± 496.66
OG005512.38± 740.10
OG006601.79± 703.08
OG007561.14± 451.82
OG008521.03± 873.58
OG0091187.70± 734.12
149.41
± 359.72
OG004476.90± 332.91
OG005160.26± 542.67
OG006360.57± 367.88
OG007385.22± 227.19
OG008505.39± 393.49
OG009798.97± 716.33
5.14
± 87.63
OG0044.87± 92.78
OG0054.71± 49.37
OG0069.62± 50.39
OG0074.76± 132.76
OG0086.33± 91.54
OG0092.34± 132.36
3.93
± 124.78
OG0046.67± 112.61
OG0055.53± 169.17
OG0068.19± 95.91
OG0076.73± 108.10
OG0088.22± 153.57
OG0099.16± 63.84
4.15
± 66.82
OG0047.73± 139.86
OG00512.49± 189.06
OG00616.86± 219.38
OG0074.99± 168.28
OG00839.03± 123.00
OG0092.00± 57.24
10.85
± 215.20
OG0046.74± 63.87
OG0052.48± 44.95
OG00626.27± 218.28
OG00723.57± 184.06
OG00816.83± 232.88
OG00911.02± 175.35
8.09
± 302.34
OG00431.02± 243.07
OG00522.20± 183.56
OG00660.96± 415.86
OG00713.39± 193.75
OG00824.91± 153.61
OG00916.20± 225.18
2.31
± 25.28
OG0042.75± 106.31
OG0051.47± 26.08
OG0062.39± 55.56
OG0072.94± 67.71
OG00810.48± 95.48
OG0092.70± 77.94
2.20
± 47.58
OG0043.22± 72.42
OG0052.21± 42.86
OG0063.36± 55.81
OG0073.45± 82.08
OG0082.30± 53.40
OG0092.97± 43.37
1.82
± 70.40
OG0042.78± 66.95
OG0051.47± 26.82
OG0063.10± 43.93
OG0072.08± 53.94
OG0084.55± 93.16
OG0092.96± 99.03
3.00
± 45.24
OG0045.72± 90.85
OG0055.01± 88.79
OG0065.58± 98.17
OG0075.17± 34.65
OG0087.27± 43.58
OG0092.04± 35.04
2.82
± 87.95
OG0042.84± 47.37
OG0051.66± 34.20
OG0063.29± 76.69
OG0075.21± 59.00
OG0085.52± 168.72
OG0093.98± 95.04
4.45
± 142.55
OG0049.13± 183.09
OG0055.64± 138.31
OG0068.97± 271.08
OG0074.47± 183.70
OG0083.43± 72.64
OG0099.50± 127.97
3.99
± 62.89
OG0044.69± 90.75
OG0051.89± 57.50
OG0063.04± 89.37
OG0076.83± 63.62
OG0088.68± 98.54
OG0094.59± 65.86
2.18
± 51.19
OG0043.96± 75.52
OG0052.03± 23.00
OG0065.60± 50.57
OG0073.18± 106.55
OG0083.25± 64.56
OG0091.59± 141.41
2.46
± 120.14
OG0045.23± 75.71
OG0052.51± 168.10
OG0064.70± 53.61
OG0074.05± 52.57
OG0087.23± 129.33
OG0097.26± 64.60
3.52
± 66.86
OG0046.18± 125.90
OG00510.28± 119.10
OG00612.07± 140.10
OG0074.02± 92.71
OG0086.94± 109.72
OG0092.21± 47.90
6.09
± 157.93
OG00410.28± 61.17
OG0051.69± 19.96
OG00617.27± 129.27
OG00717.76± 137.26
OG0089.94± 190.65
OG0099.07± 168.50
5.42
± 269.73
OG00414.05± 224.41
OG0059.75± 159.06
OG00623.95± 323.71
OG00718.53± 162.45
OG00821.99± 122.96
OG00912.44± 163.33
3.03
± 42.10
OG0041.20± 13.14
OG0052.12± 30.13
OG0063.28± 81.61
OG0072.96± 40.40
OG0084.00± 42.26
OG0092.67± 38.98
3.97
± 61.17
OG0041.98± 40.41
OG0054.86± 57.41
OG0064.36± 36.32
OG0075.57± 83.12
OG0087.30± 69.21
OG0092.17± 44.90
3.13
± 61.75
OG0042.11± 71.74
OG0054.05± 62.37
OG0065.41± 65.29
OG0076.43± 82.32
OG0083.75± 71.92
OG0092.00± 23.96
3.05
± 40.35
OG0042.97± 61.70
OG0054.41± 109.49
OG00610.92± 109.83
OG0076.18± 125.87
OG00814.11± 81.52
OG0092.69± 51.22
9.50
± 106.18
OG0042.13± 22.15
OG0052.66± 49.28
OG00612.10± 182.42
OG00717.14± 88.20
OG0086.41± 108.44
OG0092.17± 64.13
4.83
± 129.69
OG0047.60± 27.90
OG0058.49± 137.21
OG00617.98± 127.27
OG0075.19± 81.07
OG0087.95± 75.16
OG00912.46± 96.16
2.59
± 42.20
OG0042.58± 39.14
OG0052.28± 45.26
OG0062.18± 33.72
OG0075.63± 58.18
OG0083.94± 52.44
OG0094.33± 81.83
5.85
± 65.60
OG0042.68± 61.45
OG0053.78± 51.36
OG0065.33± 36.95
OG0076.03± 110.26
OG0084.35± 64.50
OG0091.91± 131.67
3.70
± 67.70
OG0048.64± 86.13
OG0059.54± 187.33
OG0065.96± 128.54
OG00710.06± 78.63
OG0083.93± 93.43
OG0093.41± 64.37
3.47
± 65.17
OG0045.60± 66.01
OG00512.32± 188.66
OG00611.29± 211.80
OG0078.52± 135.47
OG00816.28± 142.20
OG0092.52± 46.95
8.77
± 177.85
OG0046.77± 50.82
OG0052.67± 37.22
OG00626.25± 172.19
OG00723.27± 109.52
OG00814.97± 169.37
OG0099.07± 123.64
9.21
± 224.57
OG00415.20± 160.37
OG0059.02± 96.93
OG00627.84± 355.89
OG00715.64± 126.07
OG00819.42± 124.13
OG0098.57± 151.66
16.14
± 132.83
OG00420.72± 412.35
OG00521.73± 368.70
OG00621.00± 327.24
OG00711.95± 384.28
OG00810.44± 226.57
OG0093.13± 186.12
9.61
± 157.68
OG00425.48± 138.45
OG0059.18± 143.21
OG00612.73± 460.97
OG0074.71± 115.31
OG0086.47± 83.62
OG0097.96± 132.07
3.18
± 74.24
OG0043.97± 69.10
OG0051.93± 31.31
OG0062.70± 59.56
OG0074.89± 86.67
OG0088.74± 100.11
OG0093.94± 40.79
15.32
± 145.70
OG0049.60± 232.78
OG0058.57± 321.14
OG00613.90± 118.80
OG0076.00± 315.87
OG0086.46± 135.88
OG0093.43± 66.51
7.48
± 92.38
OG0048.46± 105.02
OG0056.10± 113.43
OG0063.77± 59.02
OG0072.75± 73.05
OG0083.63± 81.37
OG0093.78± 95.38
3.89
± 53.23
OG0041.90± 35.38
OG0053.12± 47.02
OG0063.07± 31.51
OG0073.11± 45.39
OG0082.36± 55.08
OG0092.65± 79.58
2.89
± 43.98
OG0042.50± 53.46
OG0052.53± 46.46
OG0062.39± 154.17
OG0073.67± 78.90
OG0081.97± 157.41
OG0092.72± 125.70
6.19
± 170.54
OG00410.24± 49.87
OG0054.96± 55.70
OG0068.54± 430.43
OG0072.56± 40.61
OG0084.12± 49.87
OG0095.33± 182.33
3.36
± 44.53
OG0043.76± 68.56
OG0051.89± 25.49
OG0064.31± 70.92
OG0074.89± 86.67
OG0084.93± 111.36
OG0097.15± 75.19
42.75
± 112.35
OG00419.37± 415.28
OG00532.48± 357.67
OG00615.96± 296.44
OG00711.89± 385.26
OG00810.37± 212.91
OG0094.04± 153.21
7.47
± 77.13
OG00411.50± 130.60
OG00511.62± 176.05
OG0063.86± 81.13
OG0075.99± 110.92
OG0084.38± 95.85
OG0096.11± 91.97
3.60
± 37.07
OG0041.62± 76.42
OG0051.53± 21.24
OG0062.44± 28.80
OG0072.73± 44.50
OG0082.54± 79.84
OG0093.39± 69.30
6.69
± 85.85
OG0046.67± 210.64
OG0053.26± 108.02
OG0069.09± 213.44
OG0074.86± 78.63
OG0086.81± 139.38
OG0093.52± 125.46
3.84
± 93.04
OG0046.11± 48.41
OG0055.46± 88.95
OG0065.07± 415.90
OG0073.63± 81.27
OG0084.69± 42.36
OG0094.58± 132.21
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
84
OG00491
OG005119
OG00693
OG007106
OG00832
OG00993
0
OG0041
OG0052
OG0060
OG0071
OG0080
OG0090
12
OG00433
OG00536
OG00618
OG00734
OG0085
OG0092
1
OG0041
OG0052
OG0060
OG0072
OG0080
OG0090
13
OG00418
OG00523
OG00611
OG00725
OG0085
OG0092
0
OG0041
OG0051
OG0060
OG0071
OG0080
OG0090
2.0
(1.0 to 6.0)
OG0042.0(1.0 to 7.0)
OG0052.0(1.0 to 6.0)
OG0062.0(1.0 to 7.0)
OG0072.0(1.0 to 7.0)
OG0082.0(1.0 to 7.0)
OG0092.0(1.0 to 7.0)
3.0
(1.0 to 7.0)
OG0042.0(1.0 to 7.0)
OG0053.0(1.0 to 7.0)
OG0062.0(1.0 to 5.0)
OG0073.0(1.0 to 6.0)
OG0082.0(1.0 to 4.0)
OG0091.0(1.0 to 1.0)
1.0
(1.0 to 6.0)
OG0042.0(1.0 to 7.0)
OG0053.0(1.0 to 7.0)
OG0062.0(1.0 to 4.0)
OG0072.0(1.0 to 7.0)
OG0081.0(1.0 to 6.0)
OG0091.5(1.0 to 2.0)
1
OG0040
OG0052
OG0060
OG0071
OG0080
OG0090
10
OG00416
OG00528
OG00620
OG00725
OG0089
OG0099
35
OG00446
OG00555
OG00638
OG00763
OG00824
OG00941
0
OG0040
OG0051
OG0060
OG0071
OG0080
OG0092
20
OG00435
OG00538
OG00625
OG00735
OG00816
OG00930
35
OG00439
OG00555
OG00636
OG00748
OG00823
OG00945
0
OG0040
OG0054
OG0060
OG0071
OG0080
OG0090
18
OG00424
OG00527
OG00615
OG00727
OG00820
OG00930
30
OG00447
OG00566
OG00646
OG00756
OG00819
OG00940
1
OG0041
OG0053
OG0060
OG0072
OG0080
OG0091
24
OG00436
OG00546
OG00634
OG00744
OG00815
OG00933
10
OG00413
OG00518
OG0068
OG00714
OG0086
OG00913
0
OG0040
OG0051
OG0060
OG0071
OG0080
OG0090
5
OG0048
OG0059
OG0064
OG00710
OG0084
OG00911
26
OG00418
OG00543
OG00617
OG00731
OG0088
OG00921
0
OG0040
OG0054
OG0060
OG0072
OG0080
OG0091
21
OG0047
OG00527
OG00612
OG00721
OG0086
OG00916
2
OG0042
OG0056
OG0063
OG0076
OG0080
OG0091
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
2
OG0041
OG0055
OG0063
OG0074
OG0080
OG0091
1.0
(1.0 to 7.0)
OG0042.0(1.0 to 6.0)
OG0052.0(1.0 to 6.0)
OG0062.0(1.0 to 7.0)
OG0072.0(1.0 to 7.0)
OG0082.0(1.0 to 7.0)
OG0092.0(1.0 to 7.0)
1.0
(1.0 to 7.0)
OG0041.0(1.0 to 6.0)
OG0052.0(1.0 to 5.0)
OG0061.5(1.0 to 6.0)
OG0071.0(1.0 to 7.0)
OG0081.0(1.0 to 6.0)
OG0092.0(1.0 to 7.0)
2.0
(1.0 to 6.0)
OG0042.0(1.0 to 6.0)
OG0052.0(1.0 to 7.0)
OG0062.0(1.0 to 7.0)
OG0072.0(1.0 to 7.0)
OG0082.0(1.0 to 7.0)
OG0092.0(1.0 to 7.0)
1.0
(1.0 to 4.0)
OG0041.0(1.0 to 5.0)
OG0051.5(1.0 to 5.0)
OG0061.0(1.0 to 5.0)
OG0071.0(1.0 to 7.0)
OG0081.5(1.0 to 3.0)
OG0091.0(1.0 to 6.0)
1.0
(1.0 to 6.0)
OG0041.0(1.0 to 5.0)
OG0051.0(1.0 to 5.0)
OG0061.0(1.0 to 7.0)
OG0071.0(1.0 to 7.0)
OG0082.5(1.0 to 7.0)
OG0091.0(1.0 to 6.0)
1.5
(1.0 to 2.0)
OG0041.0(1.0 to 1.0)
OG0051.0(1.0 to 4.0)
OG0061.0(1.0 to 2.0)
OG0071.0(1.0 to 2.0)
OG008NA(NA to NA)None of the subjects in this group reported any fever.