Study to Evaluate an Influenza Vaccine Candidate | NCT00540228 | Trialant
NCT00540228
Sponsor
GlaxoSmithKline
Status
Completed
Last Update Posted
Jun 14, 2019Actual
Enrollment
1,006Actual
Phase
Phase 2
Conditions
Influenza
Interventions
Influenza Vaccine GSK1247446A - 4 different formulations
Fluarixâ„¢
Countries
France
Germany
Spain
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT00540228
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
110794
Secondary IDs
ID
Type
Description
Link
2007-003776-18
EudraCT Number
Brief Title
Study to Evaluate an Influenza Vaccine Candidate
Official Title
Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Influenza Vaccine GSK1247446A With Various Formulations in Subjects Aged 18-64 Years
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Jun 2019
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 5, 2007Actual
Primary Completion Date
May 8, 2008Actual
Completion Date
May 8, 2008Actual
First Submitted Date
Oct 4, 2007
First Submission Date that Met QC Criteria
Oct 4, 2007
First Posted Date
Oct 5, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 14, 2013
Results First Submitted that Met QC Criteria
Mar 14, 2013
Results First Posted Date
Apr 30, 2013Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
May 8, 2009
Certification/Extension First Submitted that Passed QC Review
Sep 25, 2009
Certification/Extension First Posted Date
Sep 28, 2009Estimated
Last Update Submitted Date
Jun 13, 2019
Last Update Posted Date
Jun 14, 2019Actual
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 18-64 years.
Detailed Description
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Conditions Module
Conditions
Influenza
Keywords
Influenza
Influenza Vaccine
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
1,006Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
GSK1247446A 1 Group
Experimental
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Biological: Influenza Vaccine GSK1247446A - 4 different formulations
GSK1247446A 2 Group
Experimental
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Biological: Influenza Vaccine GSK1247446A - 4 different formulations
GSK1247446A 3 Group
Experimental
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Biological: Influenza Vaccine GSK1247446A - 4 different formulations
GSK1247446A 4 Group
Experimental
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Biological: Influenza Vaccine GSK1247446A - 4 different formulations
Fluarix Group
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Influenza Vaccine GSK1247446A - 4 different formulations
Biological
Single dose, Intramuscular injection
GSK1247446A 1 Group
GSK1247446A 2 Group
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA). The seropositivity cut-off assay was 1:10. The results for Day 0 and Day 21 are the primary efficacy variables.
At Days 0, 21 and 180
Secondary Outcomes
Measure
Description
Time Frame
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Only subjects who the investigator believes that they can and will comply with the requirements of the protocol .
A male or female between, and including, 18 - 64 years of age at the time of vaccination.
Written informed consent obtained from the subject.
Healthy subjects as established by medical history and clinical 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 have a negative pregnancy test, practice adequate contraception for 30 days prior to vaccination, 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 preceding the first dose of study vaccine, or planned use during the study period.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose
Administration of a vaccine not foreseen by the study protocol from 30 days before vaccination, up to 21 days after vaccination.
History of hypersensitivity to a previous dose of influenza vaccine.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s)
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Confirmed influenza infection within a year preceding the study start.
Administration of an influenza vaccine within a year preceding the study start.
Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
Pregnant or lactating female.
Concurrent participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product
Acute disease at the time of enrolment.
History of chronic alcohol consumption and/or drug abuse.
Female planning to become pregnant or planning to discontinue contraceptive precautions.
Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
History of administration of experimental/licensed vaccine containing squalene and/or tocopherol within the last 12 months.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
64 Years
Standard Ages
Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
GSK Clinical Trials
GlaxoSmithKline
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
GSK Investigational Site
Caen
14052
France
GSK Investigational Site
References Module
Citations
Not provided
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
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
GSK1247446A 1 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
FG001
GSK1247446A 2 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
FG002
GSK1247446A 3 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
FG003
GSK1247446A 4 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
FG004
Fluarix Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG000200 subjects
FG001198 subjects
FG002204 subjects
FG003202 subjects
FG004202 subjects
COMPLETED
FG000197 subjects
FG001197 subjects
FG002204 subjects
FG003202 subjects
FG004
NOT COMPLETED
FG0003 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
GSK1247446A 1 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
BG001
GSK1247446A 2 Group
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
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
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA). The seropositivity cut-off assay was 1:10. The results for Day 0 and Day 21 are the primary efficacy variables.
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
Posted
Geometric Mean
95% Confidence Interval
titers
At Days 0, 21 and 180
ID
Title
Description
OG000
GSK1247446A 1 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Adverse Events Module
Frequency Threshold
5
Time Frame
SAE(s)reports were collected during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 21-day follow-up period (Days 0 to 20) after any vaccination.
Description
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
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
GSK1247446A 1 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Angina unstable
Cardiac disorders
Non-systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Ecchymosis
General disorders
Systematic Assessment
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
GSK Response Center
GlaxoSmithKline
866-435-7343
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D007251
Influenza, Human
Ancestor Terms
ID
Term
D012141
Respiratory Tract Infections
D007239
Infections
D009976
Orthomyxoviridae Infections
D012327
RNA Virus Infections
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
MeSH Terms
ID
Term
C510903
fluarix
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Single
Masking Description
Not provided
Who Masked
Participant
Active Comparator
Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Biological: Fluarixâ„¢
GSK1247446A 3 Group
GSK1247446A 4 Group
Fluarixâ„¢
Biological
Single dose, Intramuscular injection
Fluarix Group
At Days 21 and 180
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA).
At Days 21 and 180
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA).
At Days 0, 21 and 180
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
Titers are presented as geometric mean titers (GMTs). The 4 influenza strains assessed were A/Wisconsin (WISC), B/Malaysia (MALA), A/Brisbane (BRIS) and B/Florida (FLOR). The seropositivity cut-off assay was 1:28.
At Days 0 and 21
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
The mean was calculated for CD4 T-cells (per million CD4 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-γ), at least IL2 and at least TNF alpha (TNF-α).
At Days 0, 21 and 180
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
The mean was calculated for CD8 T-cells (per million CD8 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-γ), at least IL2 and at least TNF alpha (TNF-α).
At Days 0, 21 and 180
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal everyday activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site.
During the 7-day (Days 0-6) post vaccination period
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Assessed solicited general symptoms were arthralgia, fatigue, fever [oral temperature above (>) 38.0 degrees Celsius (°C)], headache, myalgia, nausea and shivering. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0°C. Related = symptom considered by the investigator to have a causal relationship to study vaccination.
During the 7-day (Days 0-6) post vaccination period
Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs).
MSCs were defined as conditions prompting emergency room visits or physician visits that were not related to common diseases or routine visits. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 = event which prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination
From Day 0 to Day 180
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (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 = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal activity Related = unsolicited AE assessed by the investigator as related to the vaccination.
During the 21-day (Days 0-20) post vaccination period
Number of Subjects With Serious Adverse Events (SAEs).
Serious adverse events (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.
From Day 0 to Day 180
Lagord
17140
France
GSK Investigational Site
Lille
59019
France
GSK Investigational Site
Paris
75679
France
GSK Investigational Site
Paris
75877
France
GSK Investigational Site
Toulouse
31300
France
GSK Investigational Site
Tübingen
Baden-Wurttemberg
72074
Germany
GSK Investigational Site
Würzburg
Bavaria
97070
Germany
GSK Investigational Site
Dresden
Saxony
01307
Germany
GSK Investigational Site
Freiberg
Saxony
09599
Germany
GSK Investigational Site
Schmiedeberg
Saxony
01762
Germany
GSK Investigational Site
Barcelona
08035
Spain
GSK Investigational Site
Barcelona
08036
Spain
GSK Investigational Site
Madrid
28035
Spain
GSK Investigational Site
Madrid
28040
Spain
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
202 subjects
0 subjects
0 subjects
FG0040 subjects
Lost to Follow-up
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
BG002
GSK1247446A 3 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
BG003
GSK1247446A 4 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
BG004
Fluarix Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
BG005
Total
Total of all reporting groups
200
BG001198
BG002204
BG003202
BG004202
BG0051006
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00040.5± 14.14
BG00140.3± 13.79
BG00239.7± 14.37
BG00339.7± 14.31
BG00440.1± 14.11
BG00540.1± 14.14
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000115
BG001116
BG002115
BG003140
BG004123
BG005609
Male
BG00085
BG00182
BG00289
BG00362
BG004
OG001
GSK1247446A 2 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG002
GSK1247446A 3 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG003
GSK1247446A 4 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG004
Fluarix Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG000189
OG001190
OG002192
OG003192
OG004187
Title
Denominators
Categories
SOLO, Day 0 [N=187;189;190;192;185]
Title
Measurements
OG00013.0(10.9 to 15.5)
OG00112.3(10.2 to 14.8)
OG00212.9(10.6 to 15.8)
OG00314.9(12.3 to 18.2)
OG00415.1(12.5 to 18.2)
SOLO, Day 21 [N=187;189;190;192;185]
Title
Measurements
OG000203.2(171.7 to 240.3)
OG001155.8(128.2 to 189.4)
OG002164.9(137.6 to 197.8)
OG003
SOLO, Day 180 [N=189;190;192;192;187]
Title
Measurements
OG00081.3(68.3 to 96.8)
OG00171.1(58.8 to 86.1)
OG00276.3(63.2 to 92.0)
OG003
WISC, Day 0 [N=187;189;190;192;185]
Title
Measurements
OG00029.4(23.8 to 36.4)
OG00130.0(24.3 to 37.2)
OG00229.9(24.5 to 36.5)
OG003
WISC, Day 21 [N=187;189;190;192;185]
Title
Measurements
OG000380.1(321.3 to 449.8)
OG001326.4(275.6 to 386.7)
OG002319.9(270.0 to 379.1)
OG003
WISC, Day 180 [N=189;190;192;192;187]
Title
Measurements
OG000174.3(145.6 to 208.8)
OG001149.5(125.3 to 178.3)
OG002164.0(138.0 to 195.0)
OG003
MALA, Day 0 [N=187;189;190;192;185]
Title
Measurements
OG00025.8(21.3 to 31.3)
OG00127.3(22.6 to 32.9)
OG00222.6(18.8 to 27.1)
OG003
MALA, Day 21 [N=187;189;190;192;185]
Title
Measurements
OG000225.8(195.3 to 261.1)
OG001246.1(210.9 to 287.2)
OG002195.5(165.1 to 231.4)
OG003
MALA, Day 180 [N=189;190;192;192;187]
Title
Measurements
OG000106.6(91.7 to 124.0)
OG001119.6(103.7 to 138.0)
OG00297.2(83.2 to 113.5)
OG003
Secondary
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA).
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
Posted
Number
subjects
At Days 21 and 180
ID
Title
Description
OG000
GSK1247446A 1 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG001
GSK1247446A 2 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG002
GSK1247446A 3 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG003
GSK1247446A 4 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG004
Fluarix Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG000189
OG001190
OG002192
OG003
Title
Denominators
Categories
SOLO, Day 21 [N=187;189;190;192;185]
Title
Measurements
OG000154
OG001141
OG002133
OG003
Secondary
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA).
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
Posted
Geometric Mean
95% Confidence Interval
fold increase
At Days 21 and 180
ID
Title
Description
OG000
GSK1247446A 1 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG001
GSK1247446A 2 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG002
GSK1247446A 3 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG003
GSK1247446A 4 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG004
Fluarix Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG000189
OG001190
OG002192
OG003
Title
Denominators
Categories
SOLO, Day 21 [N=187;189;190;192;185]
Title
Measurements
OG00015.6(12.7 to 19.2)
OG00112.7(10.2 to 15.8)
OG00212.8(10.1 to 16.1)
Secondary
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA).
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
Posted
Number
subjects
At Days 0, 21 and 180
ID
Title
Description
OG000
GSK1247446A 1 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG001
GSK1247446A 2 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG002
GSK1247446A 3 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG003
GSK1247446A 4 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG004
Fluarix Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG000189
OG001190
OG002192
OG003
Title
Denominators
Categories
SOLO, Day 0 [N=187;189;190;192;185]
Title
Measurements
OG00045
OG00146
OG00243
OG003
Secondary
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
Titers are presented as geometric mean titers (GMTs). The 4 influenza strains assessed were A/Wisconsin (WISC), B/Malaysia (MALA), A/Brisbane (BRIS) and B/Florida (FLOR). The seropositivity cut-off assay was 1:28.
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
Posted
Geometric Mean
95% Confidence Interval
titers
At Days 0 and 21
ID
Title
Description
OG000
GSK1247446A 1 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG001
GSK1247446A 2 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG002
GSK1247446A 3 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG003
GSK1247446A 4 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG004
Fluarix Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00047
OG00148
OG00244
OG003
Title
Denominators
Categories
WISC, Day 0 [N=43;47;44;43;42]
Title
Measurements
OG000134.3(94.6 to 190.8)
OG001136.3(101.4 to 183.1)
OG002160.8(111.0 to 232.9)
Secondary
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
The mean was calculated for CD4 T-cells (per million CD4 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-γ), at least IL2 and at least TNF alpha (TNF-α).
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
Posted
Mean
Standard Deviation
cells
At Days 0, 21 and 180
ID
Title
Description
OG000
GSK1247446A 1 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG001
GSK1247446A 2 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG002
GSK1247446A 3 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG003
GSK1247446A 4 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG004
Fluarix Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00046
OG00147
OG00243
OG003
Title
Denominators
Categories
All Doubles, Day 0 [N=45;47;43;47;39]
Title
Measurements
OG0002106.16± 1274.90
OG0012043.17± 894.18
OG0022252.44± 1726.88
OG003
Secondary
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
The mean was calculated for CD8 T-cells (per million CD8 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-γ), at least IL2 and at least TNF alpha (TNF-α).
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
Posted
Mean
Standard Deviation
cells
At Days 0, 21 and 180
ID
Title
Description
OG000
GSK1247446A 1 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG001
GSK1247446A 2 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG002
GSK1247446A 3 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG003
GSK1247446A 4 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG004
Fluarix Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00044
OG00146
OG00243
OG003
Title
Denominators
Categories
All Doubles, Day 0 [N=44;46;43;45;39]
Title
Measurements
OG00050.02± 113.85
OG001109.63± 405.09
OG00217.33± 33.12
OG003
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal everyday activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site.
The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects.
Posted
Number
subjects
During the 7-day (Days 0-6) post vaccination period
ID
Title
Description
OG000
GSK1247446A 1 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG001
GSK1247446A 2 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG002
GSK1247446A 3 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG003
GSK1247446A 4 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG004
Fluarix Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG000200
OG001198
OG002204
OG003
Title
Denominators
Categories
Any Ecchymosis
Title
Measurements
OG00011
OG0019
OG0028
OG003
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Assessed solicited general symptoms were arthralgia, fatigue, fever [oral temperature above (>) 38.0 degrees Celsius (°C)], headache, myalgia, nausea and shivering. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0°C. Related = symptom considered by the investigator to have a causal relationship to study vaccination.
The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects.
Posted
Number
subjects
During the 7-day (Days 0-6) post vaccination period
ID
Title
Description
OG000
GSK1247446A 1 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG001
GSK1247446A 2 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG002
GSK1247446A 3 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG003
GSK1247446A 4 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG004
Fluarix Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG000200
OG001198
OG002204
OG003
Title
Denominators
Categories
Any Arthralgia
Title
Measurements
OG00064
OG00151
OG00238
OG003
Secondary
Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs).
MSCs were defined as conditions prompting emergency room visits or physician visits that were not related to common diseases or routine visits. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 = event which prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination
The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects.
Posted
Number
subjects
From Day 0 to Day 180
ID
Title
Description
OG000
GSK1247446A 1 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG001
GSK1247446A 2 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG002
GSK1247446A 3 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG003
GSK1247446A 4 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG004
Fluarix Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG000200
OG001198
OG002204
OG003
Title
Denominators
Categories
Subjects with any MSCs
Title
Measurements
OG00070
OG00156
OG00253
OG003
Secondary
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (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 = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal activity Related = unsolicited AE assessed by the investigator as related to the vaccination.
The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects.
Posted
Number
subjects
During the 21-day (Days 0-20) post vaccination period
ID
Title
Description
OG000
GSK1247446A 1 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG001
GSK1247446A 2 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG002
GSK1247446A 3 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG003
GSK1247446A 4 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG004
Fluarix Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG000200
OG001198
OG002204
OG003
Title
Denominators
Categories
Subjects with any AE(s)
Title
Measurements
OG00085
OG00191
OG00270
OG003
Secondary
Number of Subjects With Serious Adverse Events (SAEs).
Serious adverse events (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.
The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects.
Posted
Number
subjects
From Day 0 to Day 180
ID
Title
Description
OG000
GSK1247446A 1 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG001
GSK1247446A 2 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG002
GSK1247446A 3 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG003
GSK1247446A 4 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
OG004
Fluarix Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG000200
OG001198
OG002204
OG003
Title
Denominators
Categories
Title
Measurements
OG0007
OG0013
OG0023
OG003
1
200
7
200
182
200
EG001
GSK1247446A 2 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
0
198
3
198
175
198
EG002
GSK1247446A 3 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
0
204
3
204
167
204
EG003
GSK1247446A 4 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
0
202
4
202
151
202
EG004
Fluarix Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
0
202
2
202
121
202
EG0000 affected200 at risk
EG0010 affected198 at risk
EG0020 affected204 at risk
EG0030 affected202 at risk
EG0041 affected202 at risk
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-systematic Assessment
EG0001 affected200 at risk
EG0010 affected198 at risk
EG0020 affected204 at risk
EG0030 affected202 at risk
EG0040 affected202 at risk
Cerebrovascular accident
Nervous system disorders
Non-systematic Assessment
EG0001 affected200 at risk
EG0010 affected198 at risk
EG0020 affected204 at risk
EG0030 affected202 at risk
EG0040 affected202 at risk
Cervical spinal stenosis
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
EG0001 affected200 at risk
EG0010 affected198 at risk
EG0020 affected204 at risk
EG0030 affected202 at risk
EG0040 affected202 at risk
Contusion
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected200 at risk
EG0010 affected198 at risk
EG0021 affected204 at risk
EG0030 affected202 at risk
EG0040 affected202 at risk
Dermatitis
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0000 affected200 at risk
EG0010 affected198 at risk
EG0020 affected204 at risk
EG0031 affected202 at risk
EG0040 affected202 at risk
Ectopic pregnancy
Pregnancy, puerperium and perinatal conditions
Non-systematic Assessment
EG0000 affected200 at risk
EG0011 affected198 at risk
EG0020 affected204 at risk
EG0030 affected202 at risk
EG0040 affected202 at risk
Gastritis
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected200 at risk
EG0010 affected198 at risk
EG0020 affected204 at risk
EG0031 affected202 at risk
EG0040 affected202 at risk
Haemorrhoids
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected200 at risk
EG0010 affected198 at risk
EG0021 affected204 at risk
EG0030 affected202 at risk
EG0040 affected202 at risk
Hand fracture
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected200 at risk
EG0011 affected198 at risk
EG0020 affected204 at risk
EG0030 affected202 at risk
EG0040 affected202 at risk
Hypersensitivity
Immune system disorders
Non-systematic Assessment
EG0001 affected200 at risk
EG0010 affected198 at risk
EG0020 affected204 at risk
EG0030 affected202 at risk
EG0040 affected202 at risk
Hypertension
Vascular disorders
Non-systematic Assessment
EG0000 affected200 at risk
EG0011 affected198 at risk
EG0020 affected204 at risk
EG0030 affected202 at risk
EG0040 affected202 at risk
Hypotension
Vascular disorders
Non-systematic Assessment
EG0001 affected200 at risk
EG0010 affected198 at risk
EG0020 affected204 at risk
EG0030 affected202 at risk
EG0040 affected202 at risk
Mania
Psychiatric disorders
Non-systematic Assessment
EG0000 affected200 at risk
EG0010 affected198 at risk
EG0020 affected204 at risk
EG0031 affected202 at risk
EG0040 affected202 at risk
Migraine
Nervous system disorders
Non-systematic Assessment
EG0000 affected200 at risk
EG0010 affected198 at risk
EG0021 affected204 at risk
EG0030 affected202 at risk
EG0040 affected202 at risk
Optic neuritis
Nervous system disorders
Non-systematic Assessment
EG0001 affected200 at risk
EG0010 affected198 at risk
EG0020 affected204 at risk
EG0030 affected202 at risk
EG0040 affected202 at risk
Palpitations
Cardiac disorders
Non-systematic Assessment
EG0000 affected200 at risk
EG0010 affected198 at risk
EG0020 affected204 at risk
EG0030 affected202 at risk
EG0041 affected202 at risk
Pancreatitis acute
Gastrointestinal disorders
Non-systematic Assessment
EG0001 affected200 at risk
EG0010 affected198 at risk
EG0020 affected204 at risk
EG0030 affected202 at risk
EG0040 affected202 at risk
Renal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-systematic Assessment
EG0000 affected200 at risk
EG0011 affected198 at risk
EG0020 affected204 at risk
EG0030 affected202 at risk
EG0040 affected202 at risk
Subcutaneous abscess
Infections and infestations
Non-systematic Assessment
EG0000 affected200 at risk
EG0010 affected198 at risk
EG0020 affected204 at risk
EG0031 affected202 at risk
EG0040 affected202 at risk
EG00011 affected200 at risk
EG0019 affected198 at risk
EG0028 affected204 at risk
EG00314 affected202 at risk
EG0047 affected202 at risk
Pain
General disorders
Systematic Assessment
EG000182 affected200 at risk
EG001175 affected198 at risk
EG002167 affected204 at risk
EG003151 affected202 at risk
EG004121 affected202 at risk
Redness
General disorders
Systematic Assessment
EG00075 affected200 at risk
EG00166 affected198 at risk
EG00253 affected204 at risk
EG00364 affected202 at risk
EG00449 affected202 at risk
Swelling
General disorders
Systematic Assessment
EG00069 affected200 at risk
EG00154 affected198 at risk
EG00249 affected204 at risk
EG00348 affected202 at risk
EG00427 affected202 at risk
Arthralgia
General disorders
Systematic Assessment
EG00064 affected200 at risk
EG00151 affected198 at risk
EG00238 affected204 at risk
EG00339 affected202 at risk
EG00425 affected202 at risk
Fatigue
General disorders
Systematic Assessment
EG000103 affected200 at risk
EG00190 affected198 at risk
EG00286 affected204 at risk
EG00378 affected202 at risk
EG00447 affected202 at risk
Fever >38°C
General disorders
Systematic Assessment
EG00027 affected200 at risk
EG00116 affected198 at risk
EG0028 affected204 at risk
EG0036 affected202 at risk
EG0043 affected202 at risk
Headache
General disorders
Systematic Assessment
EG00090 affected200 at risk
EG00177 affected198 at risk
EG00268 affected204 at risk
EG00366 affected202 at risk
EG00451 affected202 at risk
Myalgia
General disorders
Systematic Assessment
EG000102 affected200 at risk
EG00185 affected198 at risk
EG00274 affected204 at risk
EG00370 affected202 at risk
EG00449 affected202 at risk
Nausea
General disorders
Systematic Assessment
EG00025 affected200 at risk
EG00128 affected198 at risk
EG00212 affected204 at risk
EG00313 affected202 at risk
EG00411 affected202 at risk
Shivering
General disorders
Systematic Assessment
EG00074 affected200 at risk
EG00153 affected198 at risk
EG00240 affected204 at risk
EG00334 affected202 at risk
EG00412 affected202 at risk
Headache
Nervous system disorders
Non-systematic Assessment
EG00014 affected200 at risk
EG00112 affected198 at risk
EG00216 affected204 at risk
EG00319 affected202 at risk
EG00414 affected202 at risk
Rhinitis
Infections and infestations
Non-systematic Assessment
EG0005 affected200 at risk
EG0018 affected198 at risk
EG0026 affected204 at risk
EG0039 affected202 at risk
EG00413 affected202 at risk
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.