Influenza
Conditions
Keywords
Fluarix, Influenza Infection, GSK Biologicals' influenza vaccine GSK576389A
Brief summary
This observer blind study is designed to compare the immune response of GSK Biologicals' influenza vaccine GSK576389A when administered using various presentations in adults aged 65 years and older. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed description
The study contains 6 parallel groups, stratified by two age groups: 65-74 years and ≥ 75 years and by two influenza vaccination histories: no influenza vaccination in the last 3 seasons and at least one influenza vaccination in the last 3 seasons.
Interventions
BIOLOGICALGSK Bio's influenza vaccine GSK576389A [NH 2006/07 season]
Single dose, intramuscular injection, GSK Bio's influenza vaccine GSK576389A formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
BIOLOGICALGSK Bio's influenza vaccine GSK576389A [NH 2007/08 season]
Single dose, intramuscular injection, GSK Bio's influenza vaccine GSK576389A formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
BIOLOGICALFluarix [NH 2006/07 season]
Single dose, intramuscular injection, Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
BIOLOGICALFluarix [NH 2007/08 season]
Single dose, intramuscular injection, Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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 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 before entering into the study.
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 up to Visit 2 after vaccination. * Planned administration of an influenza vaccine other than the study vaccines during the entire study period. * Vaccination against influenza since January 2007 (including the Northern Hemisphere NH 2006/2007 or NH 2007/08 influenza vaccine). * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). * History of hypersensivity to a previous dose of influenza vaccine. * History of allergy or reactions likely to be exacerbated by any component of the vaccine(s) * Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation or pre-existing laboratory screening tests. * Acute disease at the time of enrolment. * 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 intramuscular injections are contraindicated.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Haemagglutination Inhibition (HI) Antibody Titers for the H1N1 Vaccine Strain | At Days 0 and 21 | Antibody titers were expressed as Geometric mean titers (GMTs). The H1N1 vaccine strains included A/New Caledonia and A/Solomon Islands antigens. A/New Caledonia vaccine strain was administered to both groups receiving the adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season. A/Solomon Islands vaccine strain was administered to both groups receiving the adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | 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/New Caledonia (for all groups receiving vaccine formulations for the Northern Hemisphere \[NH\] 2006/2007 influenza season) or A/Solomon Islands (for all groups receiving vaccine formulations for the NH 2007/2008 influenza season), A/Wisconsin and B/Malaysia antigens. |
| 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/New Caledonia (for all groups receiving vaccine formulations for the Northern Hemisphere \[NH\] 2006/2007 influenza season) or A/Solomon Islands (for all groups receiving vaccine formulations for the NH 2007/2008 influenza season), A/Wisconsin and B/Malaysia antigens. |
| The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | At Days 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/New Caledonia (for all groups receiving vaccine formulations for the Northern Hemisphere \[NH\] 2006/2007 influenza season) or A/Solomon Islands (for all groups receiving vaccine formulations for the NH 2007/2008 influenza season), A/Wisconsin and B/Malaysia antigens. |
| Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | During a 7-day follow-up period (Day 0-6) after vaccination | Grade 3 ecchymosis, redness and swelling was greater than 100 millimeter (mm) i.e. \>100mm 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. |
| Duration of Solicited Local AEs | During a 7-day follow-up period (Day 0-6) after vaccination | Duration was defined as number of days with any grade of local symptoms. |
| HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations | At Days 0 and 21 | Antibody titers were expressed as GMTs. The vaccine strains included A/New Caledonia or A/Solomon Islands, A/Wisconsin and B/Malaysia antigens. A/New Caledonia vaccine strain was administered to all groups receiving the Northern Hemisphere 2006/2007 influenza season vaccine formulations. A/Solomon Islands vaccine strain was administered to all groups receiving the Northern Hemisphere 2007/2008 influenza season vaccine formulations. A/Wisconsin and B/Malaysia vaccine strains were administered to all groups. |
| Duration of Solicited General AEs | During a 7-day follow-up period (Day 0-6) after vaccination | Duration was defined as number of days with any grade of general symptoms. |
| Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs | During a 21-day follow-up period (Day 0-20) after vaccination | 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. |
| Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs) | During a 21-day follow-up period (Day 0-20) after vaccination | MSCs were defined as an AEs with a medically-attended visit (MAE) i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. Any MSC was defined as at least one MSC experienced. Grade 3 was a MSC that prevented normal activities and related was defined as a MSC assessed by the investigator to be causally related to the study vaccination. |
| Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | During a 21-day follow-up period (Day 0-20) after vaccination | 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. |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | During a 7-day follow-up period (Day 0-6) after vaccination | Any temperature was defined as oral temperature greater than or equal to 38.0 degree centigrade i.e ≥38.0°C, grade 3 temperature was oral temperature ≥39.0°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. |
Countries
Denmark, Estonia, Norway
Participant flow
Pre-assignment details
Two subjects enrolled in this study were not vaccinated and as such not accounted for under Started.
Participants by arm
| Arm | Count |
|---|---|
| GSK576389A- 2006/2007 Season - 1 Container Group Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container. | 269 |
| GSK576389A - 2006/2007 Season - 2 Containers Group Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers. | 266 |
| Fluarix 2006/2007 Season Group Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season. | 264 |
| GSK576389A - 2007/2008 Season - 1 Container Group Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container. | 264 |
| GSK576389A - 2007/2008 Season - 2 Containers Group Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers. | 268 |
| Fluarix 2007/2008 Season Group Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season. | 263 |
| Total | 1,594 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 | 0 | 1 | 1 |
| Overall Study | Lost to Follow-up | 1 | 1 | 1 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | GSK576389A- 2006/2007 Season - 1 Container Group | GSK576389A - 2006/2007 Season - 2 Containers Group | Fluarix 2006/2007 Season Group | GSK576389A - 2007/2008 Season - 1 Container Group | GSK576389A - 2007/2008 Season - 2 Containers Group | Fluarix 2007/2008 Season Group | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 73.2 Years STANDARD_DEVIATION 5.56 | 73.0 Years STANDARD_DEVIATION 5.16 | 72.8 Years STANDARD_DEVIATION 5.06 | 73.3 Years STANDARD_DEVIATION 5.86 | 73.2 Years STANDARD_DEVIATION 5.72 | 73.0 Years STANDARD_DEVIATION 5.2 | 73.08 Years STANDARD_DEVIATION 5.43 |
| Sex: Female, Male Female | 151 Participants | 149 Participants | 150 Participants | 145 Participants | 152 Participants | 153 Participants | 900 Participants |
| Sex: Female, Male Male | 118 Participants | 117 Participants | 114 Participants | 119 Participants | 116 Participants | 110 Participants | 694 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 233 / 269 | 224 / 266 | 145 / 264 | 224 / 264 | 219 / 268 | 138 / 263 |
| serious Total, serious adverse events | 2 / 269 | 0 / 266 | 0 / 264 | 2 / 264 | 0 / 268 | 1 / 263 |
Outcome results
Primary
Haemagglutination Inhibition (HI) Antibody Titers for the H1N1 Vaccine Strain
Antibody titers were expressed as Geometric mean titers (GMTs). The H1N1 vaccine strains included A/New Caledonia and A/Solomon Islands antigens. A/New Caledonia vaccine strain was administered to both groups receiving the adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season. A/Solomon Islands vaccine strain was administered to both groups receiving the adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season.
Time frame: At Days 0 and 21
Population: The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity were available. This primary outcome was assessed only on those groups receiving any of the GSK Bio's influenza vaccine GSK576389A formulations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK576389A- 2006/2007 Season - 1 Container Group | Haemagglutination Inhibition (HI) Antibody Titers for the H1N1 Vaccine Strain | A/New Caledonia at Day 0 (N=259;259;0;0;0;0) | 37.9 titer |
| GSK576389A- 2006/2007 Season - 1 Container Group | Haemagglutination Inhibition (HI) Antibody Titers for the H1N1 Vaccine Strain | A/New Caledonia at Day 21 (N=259;259;0;0;0;0) | 130.8 titer |
| GSK576389A- 2006/2007 Season - 1 Container Group | Haemagglutination Inhibition (HI) Antibody Titers for the H1N1 Vaccine Strain | A/Solomon Islands at Day 0 (N=0;0;0;258;263;0) | NA titer |
| GSK576389A- 2006/2007 Season - 1 Container Group | Haemagglutination Inhibition (HI) Antibody Titers for the H1N1 Vaccine Strain | A/Solomon Islands at Day 21 (N=0;0;0;258;263;0) | NA titer |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Haemagglutination Inhibition (HI) Antibody Titers for the H1N1 Vaccine Strain | A/New Caledonia at Day 21 (N=259;259;0;0;0;0) | 138.5 titer |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Haemagglutination Inhibition (HI) Antibody Titers for the H1N1 Vaccine Strain | A/Solomon Islands at Day 0 (N=0;0;0;258;263;0) | NA titer |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Haemagglutination Inhibition (HI) Antibody Titers for the H1N1 Vaccine Strain | A/Solomon Islands at Day 21 (N=0;0;0;258;263;0) | NA titer |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Haemagglutination Inhibition (HI) Antibody Titers for the H1N1 Vaccine Strain | A/New Caledonia at Day 0 (N=259;259;0;0;0;0) | 40.1 titer |
| GSK576389A - 2007/2008 Season - 1 Container Group | Haemagglutination Inhibition (HI) Antibody Titers for the H1N1 Vaccine Strain | A/Solomon Islands at Day 0 (N=0;0;0;258;263;0) | 9.4 titer |
| GSK576389A - 2007/2008 Season - 1 Container Group | Haemagglutination Inhibition (HI) Antibody Titers for the H1N1 Vaccine Strain | A/New Caledonia at Day 21 (N=259;259;0;0;0;0) | NA titer |
| GSK576389A - 2007/2008 Season - 1 Container Group | Haemagglutination Inhibition (HI) Antibody Titers for the H1N1 Vaccine Strain | A/Solomon Islands at Day 21 (N=0;0;0;258;263;0) | 82.0 titer |
| GSK576389A - 2007/2008 Season - 1 Container Group | Haemagglutination Inhibition (HI) Antibody Titers for the H1N1 Vaccine Strain | A/New Caledonia at Day 0 (N=259;259;0;0;0;0) | NA titer |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Haemagglutination Inhibition (HI) Antibody Titers for the H1N1 Vaccine Strain | A/Solomon Islands at Day 21 (N=0;0;0;258;263;0) | 88.6 titer |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Haemagglutination Inhibition (HI) Antibody Titers for the H1N1 Vaccine Strain | A/New Caledonia at Day 21 (N=259;259;0;0;0;0) | NA titer |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Haemagglutination Inhibition (HI) Antibody Titers for the H1N1 Vaccine Strain | A/New Caledonia at Day 0 (N=259;259;0;0;0;0) | NA titer |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Haemagglutination Inhibition (HI) Antibody Titers for the H1N1 Vaccine Strain | A/Solomon Islands at Day 0 (N=0;0;0;258;263;0) | 9.0 titer |
Secondary
Duration of Solicited General AEs
Duration was defined as number of days with any grade of general symptoms.
Time frame: During a 7-day follow-up period (Day 0-6) after vaccination
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK576389A- 2006/2007 Season - 1 Container Group | Duration of Solicited General AEs | Arthralgia (N=58;36;19;39;30;20) | 2.0 Days |
| GSK576389A- 2006/2007 Season - 1 Container Group | Duration of Solicited General AEs | Nausea (N=22;25;14;26;18;10) | 1.0 Days |
| GSK576389A- 2006/2007 Season - 1 Container Group | Duration of Solicited General AEs | Fatigue (N=89;90;39;83;82;33) | 2.0 Days |
| GSK576389A- 2006/2007 Season - 1 Container Group | Duration of Solicited General AEs | Temperature (N=4;4;1;7;9;0) | 1.0 Days |
| GSK576389A- 2006/2007 Season - 1 Container Group | Duration of Solicited General AEs | Headache (N=76;67;26;62;58;27) | 1.0 Days |
| GSK576389A- 2006/2007 Season - 1 Container Group | Duration of Solicited General AEs | Shivering (N=46;25;6;45;25;6) | 1.0 Days |
| GSK576389A- 2006/2007 Season - 1 Container Group | Duration of Solicited General AEs | Myalgia (N=85;63;25;75;77;29) | 2.0 Days |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Duration of Solicited General AEs | Fatigue (N=89;90;39;83;82;33) | 2.0 Days |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Duration of Solicited General AEs | Myalgia (N=85;63;25;75;77;29) | 2.0 Days |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Duration of Solicited General AEs | Headache (N=76;67;26;62;58;27) | 2.0 Days |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Duration of Solicited General AEs | Nausea (N=22;25;14;26;18;10) | 1.0 Days |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Duration of Solicited General AEs | Arthralgia (N=58;36;19;39;30;20) | 1.5 Days |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Duration of Solicited General AEs | Temperature (N=4;4;1;7;9;0) | 1.0 Days |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Duration of Solicited General AEs | Shivering (N=46;25;6;45;25;6) | 1.0 Days |
| Fluarix 2006/2007 Season Group | Duration of Solicited General AEs | Headache (N=76;67;26;62;58;27) | 1.5 Days |
| Fluarix 2006/2007 Season Group | Duration of Solicited General AEs | Fatigue (N=89;90;39;83;82;33) | 2.0 Days |
| Fluarix 2006/2007 Season Group | Duration of Solicited General AEs | Arthralgia (N=58;36;19;39;30;20) | 2.0 Days |
| Fluarix 2006/2007 Season Group | Duration of Solicited General AEs | Nausea (N=22;25;14;26;18;10) | 1.0 Days |
| Fluarix 2006/2007 Season Group | Duration of Solicited General AEs | Shivering (N=46;25;6;45;25;6) | 1.0 Days |
| Fluarix 2006/2007 Season Group | Duration of Solicited General AEs | Myalgia (N=85;63;25;75;77;29) | 2.0 Days |
| Fluarix 2006/2007 Season Group | Duration of Solicited General AEs | Temperature (N=4;4;1;7;9;0) | 3.0 Days |
| GSK576389A - 2007/2008 Season - 1 Container Group | Duration of Solicited General AEs | Myalgia (N=85;63;25;75;77;29) | 2.0 Days |
| GSK576389A - 2007/2008 Season - 1 Container Group | Duration of Solicited General AEs | Arthralgia (N=58;36;19;39;30;20) | 2.0 Days |
| GSK576389A - 2007/2008 Season - 1 Container Group | Duration of Solicited General AEs | Fatigue (N=89;90;39;83;82;33) | 2.0 Days |
| GSK576389A - 2007/2008 Season - 1 Container Group | Duration of Solicited General AEs | Headache (N=76;67;26;62;58;27) | 1.0 Days |
| GSK576389A - 2007/2008 Season - 1 Container Group | Duration of Solicited General AEs | Nausea (N=22;25;14;26;18;10) | 1.0 Days |
| GSK576389A - 2007/2008 Season - 1 Container Group | Duration of Solicited General AEs | Shivering (N=46;25;6;45;25;6) | 1.0 Days |
| GSK576389A - 2007/2008 Season - 1 Container Group | Duration of Solicited General AEs | Temperature (N=4;4;1;7;9;0) | 1.0 Days |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Duration of Solicited General AEs | Headache (N=76;67;26;62;58;27) | 1.0 Days |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Duration of Solicited General AEs | Fatigue (N=89;90;39;83;82;33) | 1.0 Days |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Duration of Solicited General AEs | Temperature (N=4;4;1;7;9;0) | 1.0 Days |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Duration of Solicited General AEs | Arthralgia (N=58;36;19;39;30;20) | 2.0 Days |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Duration of Solicited General AEs | Shivering (N=46;25;6;45;25;6) | 1.0 Days |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Duration of Solicited General AEs | Myalgia (N=85;63;25;75;77;29) | 2.0 Days |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Duration of Solicited General AEs | Nausea (N=22;25;14;26;18;10) | 1.0 Days |
| Fluarix 2007/2008 Season Group | Duration of Solicited General AEs | Temperature (N=4;4;1;7;9;0) | NA Days |
| Fluarix 2007/2008 Season Group | Duration of Solicited General AEs | Nausea (N=22;25;14;26;18;10) | 1.5 Days |
| Fluarix 2007/2008 Season Group | Duration of Solicited General AEs | Headache (N=76;67;26;62;58;27) | 2.0 Days |
| Fluarix 2007/2008 Season Group | Duration of Solicited General AEs | Fatigue (N=89;90;39;83;82;33) | 2.0 Days |
| Fluarix 2007/2008 Season Group | Duration of Solicited General AEs | Shivering (N=46;25;6;45;25;6) | 1.0 Days |
| Fluarix 2007/2008 Season Group | Duration of Solicited General AEs | Arthralgia (N=58;36;19;39;30;20) | 3.0 Days |
| Fluarix 2007/2008 Season Group | Duration of Solicited General AEs | Myalgia (N=85;63;25;75;77;29) | 2.0 Days |
Secondary
Duration of Solicited Local AEs
Duration was defined as number of days with any grade of local symptoms.
Time frame: During a 7-day follow-up period (Day 0-6) after vaccination
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK576389A- 2006/2007 Season - 1 Container Group | Duration of Solicited Local AEs | Ecchymosis (N=4;4;5;7;7;10) | 3.0 Days |
| GSK576389A- 2006/2007 Season - 1 Container Group | Duration of Solicited Local AEs | Pain (N=165;146;47;148;144;37) | 2.0 Days |
| GSK576389A- 2006/2007 Season - 1 Container Group | Duration of Solicited Local AEs | Redness (N=113;131;58;108;120;50) | 3.0 Days |
| GSK576389A- 2006/2007 Season - 1 Container Group | Duration of Solicited Local AEs | Swelling (N=52;53;12;53;49;18) | 3.0 Days |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Duration of Solicited Local AEs | Redness (N=113;131;58;108;120;50) | 3.0 Days |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Duration of Solicited Local AEs | Pain (N=165;146;47;148;144;37) | 2.0 Days |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Duration of Solicited Local AEs | Ecchymosis (N=4;4;5;7;7;10) | 4.0 Days |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Duration of Solicited Local AEs | Swelling (N=52;53;12;53;49;18) | 3.0 Days |
| Fluarix 2006/2007 Season Group | Duration of Solicited Local AEs | Swelling (N=52;53;12;53;49;18) | 2.0 Days |
| Fluarix 2006/2007 Season Group | Duration of Solicited Local AEs | Redness (N=113;131;58;108;120;50) | 3.0 Days |
| Fluarix 2006/2007 Season Group | Duration of Solicited Local AEs | Pain (N=165;146;47;148;144;37) | 2.0 Days |
| Fluarix 2006/2007 Season Group | Duration of Solicited Local AEs | Ecchymosis (N=4;4;5;7;7;10) | 6.0 Days |
| GSK576389A - 2007/2008 Season - 1 Container Group | Duration of Solicited Local AEs | Ecchymosis (N=4;4;5;7;7;10) | 6.0 Days |
| GSK576389A - 2007/2008 Season - 1 Container Group | Duration of Solicited Local AEs | Swelling (N=52;53;12;53;49;18) | 2.0 Days |
| GSK576389A - 2007/2008 Season - 1 Container Group | Duration of Solicited Local AEs | Pain (N=165;146;47;148;144;37) | 3.0 Days |
| GSK576389A - 2007/2008 Season - 1 Container Group | Duration of Solicited Local AEs | Redness (N=113;131;58;108;120;50) | 3.0 Days |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Duration of Solicited Local AEs | Redness (N=113;131;58;108;120;50) | 4.0 Days |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Duration of Solicited Local AEs | Swelling (N=52;53;12;53;49;18) | 3.0 Days |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Duration of Solicited Local AEs | Pain (N=165;146;47;148;144;37) | 3.0 Days |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Duration of Solicited Local AEs | Ecchymosis (N=4;4;5;7;7;10) | 3.0 Days |
| Fluarix 2007/2008 Season Group | Duration of Solicited Local AEs | Pain (N=165;146;47;148;144;37) | 2.0 Days |
| Fluarix 2007/2008 Season Group | Duration of Solicited Local AEs | Redness (N=113;131;58;108;120;50) | 2.0 Days |
| Fluarix 2007/2008 Season Group | Duration of Solicited Local AEs | Swelling (N=52;53;12;53;49;18) | 2.0 Days |
| Fluarix 2007/2008 Season Group | Duration of Solicited Local AEs | Ecchymosis (N=4;4;5;7;7;10) | 6.0 Days |
Secondary
HI Antibody Seroconversion Factors
Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/New Caledonia (for all groups receiving vaccine formulations for the Northern Hemisphere \[NH\] 2006/2007 influenza season) or A/Solomon Islands (for all groups receiving vaccine formulations for the NH 2007/2008 influenza season), A/Wisconsin and B/Malaysia antigens.
Time frame: At Day 21
Population: The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK576389A- 2006/2007 Season - 1 Container Group | HI Antibody Seroconversion Factors | A/New Caledonia strain (N=259;259;255;0;0;0) | 3.5 fold increase |
| GSK576389A- 2006/2007 Season - 1 Container Group | HI Antibody Seroconversion Factors | A/Solomon Islands strain (N=0;0;0;258;263;257) | NA fold increase |
| GSK576389A- 2006/2007 Season - 1 Container Group | HI Antibody Seroconversion Factors | A/Wisconsin strain (N=259;259;255;258;263;257) | 8.0 fold increase |
| GSK576389A- 2006/2007 Season - 1 Container Group | HI Antibody Seroconversion Factors | B/Malaysia strain (N=259;259;255;258;263;257) | 4.1 fold increase |
| GSK576389A - 2006/2007 Season - 2 Containers Group | HI Antibody Seroconversion Factors | A/Wisconsin strain (N=259;259;255;258;263;257) | 7.8 fold increase |
| GSK576389A - 2006/2007 Season - 2 Containers Group | HI Antibody Seroconversion Factors | A/Solomon Islands strain (N=0;0;0;258;263;257) | NA fold increase |
| GSK576389A - 2006/2007 Season - 2 Containers Group | HI Antibody Seroconversion Factors | A/New Caledonia strain (N=259;259;255;0;0;0) | 3.5 fold increase |
| GSK576389A - 2006/2007 Season - 2 Containers Group | HI Antibody Seroconversion Factors | B/Malaysia strain (N=259;259;255;258;263;257) | 3.6 fold increase |
| Fluarix 2006/2007 Season Group | HI Antibody Seroconversion Factors | B/Malaysia strain (N=259;259;255;258;263;257) | 3.2 fold increase |
| Fluarix 2006/2007 Season Group | HI Antibody Seroconversion Factors | A/Wisconsin strain (N=259;259;255;258;263;257) | 5.2 fold increase |
| Fluarix 2006/2007 Season Group | HI Antibody Seroconversion Factors | A/Solomon Islands strain (N=0;0;0;258;263;257) | NA fold increase |
| Fluarix 2006/2007 Season Group | HI Antibody Seroconversion Factors | A/New Caledonia strain (N=259;259;255;0;0;0) | 3.3 fold increase |
| GSK576389A - 2007/2008 Season - 1 Container Group | HI Antibody Seroconversion Factors | A/New Caledonia strain (N=259;259;255;0;0;0) | NA fold increase |
| GSK576389A - 2007/2008 Season - 1 Container Group | HI Antibody Seroconversion Factors | B/Malaysia strain (N=259;259;255;258;263;257) | 3.7 fold increase |
| GSK576389A - 2007/2008 Season - 1 Container Group | HI Antibody Seroconversion Factors | A/Solomon Islands strain (N=0;0;0;258;263;257) | 8.7 fold increase |
| GSK576389A - 2007/2008 Season - 1 Container Group | HI Antibody Seroconversion Factors | A/Wisconsin strain (N=259;259;255;258;263;257) | 7.0 fold increase |
| GSK576389A - 2007/2008 Season - 2 Containers Group | HI Antibody Seroconversion Factors | A/Wisconsin strain (N=259;259;255;258;263;257) | 7.0 fold increase |
| GSK576389A - 2007/2008 Season - 2 Containers Group | HI Antibody Seroconversion Factors | B/Malaysia strain (N=259;259;255;258;263;257) | 3.9 fold increase |
| GSK576389A - 2007/2008 Season - 2 Containers Group | HI Antibody Seroconversion Factors | A/Solomon Islands strain (N=0;0;0;258;263;257) | 9.9 fold increase |
| GSK576389A - 2007/2008 Season - 2 Containers Group | HI Antibody Seroconversion Factors | A/New Caledonia strain (N=259;259;255;0;0;0) | NA fold increase |
| Fluarix 2007/2008 Season Group | HI Antibody Seroconversion Factors | A/Solomon Islands strain (N=0;0;0;258;263;257) | 7.2 fold increase |
| Fluarix 2007/2008 Season Group | HI Antibody Seroconversion Factors | A/Wisconsin strain (N=259;259;255;258;263;257) | 4.2 fold increase |
| Fluarix 2007/2008 Season Group | HI Antibody Seroconversion Factors | B/Malaysia strain (N=259;259;255;258;263;257) | 3.3 fold increase |
| Fluarix 2007/2008 Season Group | HI Antibody Seroconversion Factors | A/New Caledonia strain (N=259;259;255;0;0;0) | NA fold increase |
Secondary
HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations
Antibody titers were expressed as GMTs. The vaccine strains included A/New Caledonia or A/Solomon Islands, A/Wisconsin and B/Malaysia antigens. A/New Caledonia vaccine strain was administered to all groups receiving the Northern Hemisphere 2006/2007 influenza season vaccine formulations. A/Solomon Islands vaccine strain was administered to all groups receiving the Northern Hemisphere 2007/2008 influenza season vaccine formulations. A/Wisconsin and B/Malaysia vaccine strains were administered to all groups.
Time frame: At Days 0 and 21
Population: The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK576389A- 2006/2007 Season - 1 Container Group | HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Solomon Islands at Day 0 (N=0;0;0;258;263;257) | NA titer |
| GSK576389A- 2006/2007 Season - 1 Container Group | HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations | A/New Caledonia at Day 21 (N=259;259;255;0;0;0) | 130.8 titer |
| GSK576389A- 2006/2007 Season - 1 Container Group | HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations | A/New Caledonia at Day 0 (N=259;259;255;0;0;0) | 37.9 titer |
| GSK576389A- 2006/2007 Season - 1 Container Group | HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Solomon Islands at Day 21 (N=0;0;0;258;263;257) | NA titer |
| GSK576389A- 2006/2007 Season - 1 Container Group | HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Wisconsin at Day 0 (N=259;259;255;258;263;257) | 47.7 titer |
| GSK576389A- 2006/2007 Season - 1 Container Group | HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Wisconsin at Day 21 (N=259;259;255;258;263;257) | 379.7 titer |
| GSK576389A- 2006/2007 Season - 1 Container Group | HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations | B/Malaysia at Day 0 (N=259;259;255;258;263;257) | 57.9 titer |
| GSK576389A- 2006/2007 Season - 1 Container Group | HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations | B/Malaysia at Day 21 (N=259;259;255;258;263;257) | 236.4 titer |
| GSK576389A - 2006/2007 Season - 2 Containers Group | HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Solomon Islands at Day 21 (N=0;0;0;258;263;257) | NA titer |
| GSK576389A - 2006/2007 Season - 2 Containers Group | HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations | B/Malaysia at Day 21 (N=259;259;255;258;263;257) | 213.8 titer |
| GSK576389A - 2006/2007 Season - 2 Containers Group | HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations | A/New Caledonia at Day 0 (N=259;259;255;0;0;0) | 40.1 titer |
| GSK576389A - 2006/2007 Season - 2 Containers Group | HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations | B/Malaysia at Day 0 (N=259;259;255;258;263;257) | 59.5 titer |
| GSK576389A - 2006/2007 Season - 2 Containers Group | HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Wisconsin at Day 21 (N=259;259;255;258;263;257) | 409.9 titer |
| GSK576389A - 2006/2007 Season - 2 Containers Group | HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Solomon Islands at Day 0 (N=0;0;0;258;263;257) | NA titer |
| GSK576389A - 2006/2007 Season - 2 Containers Group | HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations | A/New Caledonia at Day 21 (N=259;259;255;0;0;0) | 138.5 titer |
| GSK576389A - 2006/2007 Season - 2 Containers Group | HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Wisconsin at Day 0 (N=259;259;255;258;263;257) | 52.8 titer |
| Fluarix 2006/2007 Season Group | HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations | A/New Caledonia at Day 21 (N=259;259;255;0;0;0) | 114.7 titer |
| Fluarix 2006/2007 Season Group | HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Solomon Islands at Day 0 (N=0;0;0;258;263;257) | NA titer |
| Fluarix 2006/2007 Season Group | HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Solomon Islands at Day 21 (N=0;0;0;258;263;257) | NA titer |
| Fluarix 2006/2007 Season Group | HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations | B/Malaysia at Day 21 (N=259;259;255;258;263;257) | 193.2 titer |
| Fluarix 2006/2007 Season Group | HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Wisconsin at Day 0 (N=259;259;255;258;263;257) | 53.3 titer |
| Fluarix 2006/2007 Season Group | HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Wisconsin at Day 21 (N=259;259;255;258;263;257) | 275.5 titer |
| Fluarix 2006/2007 Season Group | HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations | B/Malaysia at Day 0 (N=259;259;255;258;263;257) | 59.6 titer |
| Fluarix 2006/2007 Season Group | HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations | A/New Caledonia at Day 0 (N=259;259;255;0;0;0) | 35.3 titer |
| GSK576389A - 2007/2008 Season - 1 Container Group | HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations | B/Malaysia at Day 0 (N=259;259;255;258;263;257) | 68.0 titer |
| GSK576389A - 2007/2008 Season - 1 Container Group | HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Wisconsin at Day 21 (N=259;259;255;258;263;257) | 399.9 titer |
| GSK576389A - 2007/2008 Season - 1 Container Group | HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Wisconsin at Day 0 (N=259;259;255;258;263;257) | 56.7 titer |
| GSK576389A - 2007/2008 Season - 1 Container Group | HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations | A/New Caledonia at Day 0 (N=259;259;255;0;0;0) | NA titer |
| GSK576389A - 2007/2008 Season - 1 Container Group | HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Solomon Islands at Day 0 (N=0;0;0;258;263;257) | 9.4 titer |
| GSK576389A - 2007/2008 Season - 1 Container Group | HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Solomon Islands at Day 21 (N=0;0;0;258;263;257) | 82.0 titer |
| GSK576389A - 2007/2008 Season - 1 Container Group | HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations | B/Malaysia at Day 21 (N=259;259;255;258;263;257) | 253.6 titer |
| GSK576389A - 2007/2008 Season - 1 Container Group | HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations | A/New Caledonia at Day 21 (N=259;259;255;0;0;0) | NA titer |
| GSK576389A - 2007/2008 Season - 2 Containers Group | HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations | B/Malaysia at Day 21 (N=259;259;255;258;263;257) | 201.9 titer |
| GSK576389A - 2007/2008 Season - 2 Containers Group | HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations | A/New Caledonia at Day 0 (N=259;259;255;0;0;0) | NA titer |
| GSK576389A - 2007/2008 Season - 2 Containers Group | HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Wisconsin at Day 0 (N=259;259;255;258;263;257) | 52.8 titer |
| GSK576389A - 2007/2008 Season - 2 Containers Group | HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Wisconsin at Day 21 (N=259;259;255;258;263;257) | 367.4 titer |
| GSK576389A - 2007/2008 Season - 2 Containers Group | HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations | B/Malaysia at Day 0 (N=259;259;255;258;263;257) | 51.6 titer |
| GSK576389A - 2007/2008 Season - 2 Containers Group | HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations | A/New Caledonia at Day 21 (N=259;259;255;0;0;0) | NA titer |
| GSK576389A - 2007/2008 Season - 2 Containers Group | HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Solomon Islands at Day 0 (N=0;0;0;258;263;257) | 9.0 titer |
| GSK576389A - 2007/2008 Season - 2 Containers Group | HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Solomon Islands at Day 21 (N=0;0;0;258;263;257) | 88.6 titer |
| Fluarix 2007/2008 Season Group | HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations | B/Malaysia at Day 21 (N=259;259;255;258;263;257) | 180.5 titer |
| Fluarix 2007/2008 Season Group | HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Wisconsin at Day 0 (N=259;259;255;258;263;257) | 42.8 titer |
| Fluarix 2007/2008 Season Group | HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Solomon Islands at Day 0 (N=0;0;0;258;263;257) | 8.5 titer |
| Fluarix 2007/2008 Season Group | HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Solomon Islands at Day 21 (N=0;0;0;258;263;257) | 61.0 titer |
| Fluarix 2007/2008 Season Group | HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Wisconsin at Day 21 (N=259;259;255;258;263;257) | 178.9 titer |
| Fluarix 2007/2008 Season Group | HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations | A/New Caledonia at Day 21 (N=259;259;255;0;0;0) | NA titer |
| Fluarix 2007/2008 Season Group | HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations | B/Malaysia at Day 0 (N=259;259;255;258;263;257) | 54.3 titer |
| Fluarix 2007/2008 Season Group | HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations | A/New Caledonia at Day 0 (N=259;259;255;0;0;0) | NA titer |
Secondary
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Grade 3 ecchymosis, redness and swelling was greater than 100 millimeter (mm) i.e. \>100mm 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.
Time frame: During a 7-day follow-up period (Day 0-6) after vaccination
Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK576389A- 2006/2007 Season - 1 Container Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any redness | 113 Subjects |
| GSK576389A- 2006/2007 Season - 1 Container Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 ecchymosis | 1 Subjects |
| GSK576389A- 2006/2007 Season - 1 Container Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 pain | 0 Subjects |
| GSK576389A- 2006/2007 Season - 1 Container Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any ecchymosis | 4 Subjects |
| GSK576389A- 2006/2007 Season - 1 Container Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 redness | 19 Subjects |
| GSK576389A- 2006/2007 Season - 1 Container Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any swelling | 52 Subjects |
| GSK576389A- 2006/2007 Season - 1 Container Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 swelling | 4 Subjects |
| GSK576389A- 2006/2007 Season - 1 Container Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any pain | 165 Subjects |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 redness | 27 Subjects |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any swelling | 53 Subjects |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 swelling | 6 Subjects |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 ecchymosis | 0 Subjects |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any pain | 146 Subjects |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 pain | 2 Subjects |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any ecchymosis | 4 Subjects |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any redness | 131 Subjects |
| Fluarix 2006/2007 Season Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any ecchymosis | 6 Subjects |
| Fluarix 2006/2007 Season Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 pain | 0 Subjects |
| Fluarix 2006/2007 Season Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 redness | 4 Subjects |
| Fluarix 2006/2007 Season Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any redness | 59 Subjects |
| Fluarix 2006/2007 Season Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 ecchymosis | 0 Subjects |
| Fluarix 2006/2007 Season Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 swelling | 0 Subjects |
| Fluarix 2006/2007 Season Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any swelling | 13 Subjects |
| Fluarix 2006/2007 Season Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any pain | 47 Subjects |
| GSK576389A - 2007/2008 Season - 1 Container Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any swelling | 53 Subjects |
| GSK576389A - 2007/2008 Season - 1 Container Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any ecchymosis | 7 Subjects |
| GSK576389A - 2007/2008 Season - 1 Container Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 swelling | 0 Subjects |
| GSK576389A - 2007/2008 Season - 1 Container Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 pain | 1 Subjects |
| GSK576389A - 2007/2008 Season - 1 Container Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any pain | 148 Subjects |
| GSK576389A - 2007/2008 Season - 1 Container Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 redness | 19 Subjects |
| GSK576389A - 2007/2008 Season - 1 Container Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 ecchymosis | 1 Subjects |
| GSK576389A - 2007/2008 Season - 1 Container Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any redness | 108 Subjects |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 redness | 24 Subjects |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any ecchymosis | 7 Subjects |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 ecchymosis | 0 Subjects |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any pain | 144 Subjects |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 pain | 3 Subjects |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any redness | 120 Subjects |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any swelling | 49 Subjects |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 swelling | 5 Subjects |
| Fluarix 2007/2008 Season Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 pain | 0 Subjects |
| Fluarix 2007/2008 Season Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 swelling | 0 Subjects |
| Fluarix 2007/2008 Season Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any swelling | 18 Subjects |
| Fluarix 2007/2008 Season Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any pain | 37 Subjects |
| Fluarix 2007/2008 Season Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any ecchymosis | 10 Subjects |
| Fluarix 2007/2008 Season Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 ecchymosis | 1 Subjects |
| Fluarix 2007/2008 Season Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 redness | 0 Subjects |
| Fluarix 2007/2008 Season Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any redness | 51 Subjects |
Secondary
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
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.
Time frame: During a 21-day follow-up period (Day 0-20) after vaccination
Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK576389A- 2006/2007 Season - 1 Container Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Any SAE(S) | 2 Subjects |
| GSK576389A- 2006/2007 Season - 1 Container Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Related SAE(s) | 0 Subjects |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Any SAE(S) | 0 Subjects |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Related SAE(s) | 0 Subjects |
| Fluarix 2006/2007 Season Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Any SAE(S) | 0 Subjects |
| Fluarix 2006/2007 Season Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Related SAE(s) | 0 Subjects |
| GSK576389A - 2007/2008 Season - 1 Container Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Any SAE(S) | 2 Subjects |
| GSK576389A - 2007/2008 Season - 1 Container Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Related SAE(s) | 0 Subjects |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Any SAE(S) | 0 Subjects |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Related SAE(s) | 0 Subjects |
| Fluarix 2007/2008 Season Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Any SAE(S) | 1 Subjects |
| Fluarix 2007/2008 Season Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Related SAE(s) | 0 Subjects |
Secondary
Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)
MSCs were defined as an AEs with a medically-attended visit (MAE) i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. Any MSC was defined as at least one MSC experienced. Grade 3 was a MSC that prevented normal activities and related was defined as a MSC assessed by the investigator to be causally related to the study vaccination.
Time frame: During a 21-day follow-up period (Day 0-20) after vaccination
Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK576389A- 2006/2007 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs) | Grade 3 MSC(s) | 0 Subjects |
| GSK576389A- 2006/2007 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs) | Any MSC(s) | 7 Subjects |
| GSK576389A- 2006/2007 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs) | Related MSC(s) | 1 Subjects |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs) | Grade 3 MSC(s) | 1 Subjects |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs) | Any MSC(s) | 4 Subjects |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs) | Related MSC(s) | 0 Subjects |
| Fluarix 2006/2007 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs) | Grade 3 MSC(s) | 0 Subjects |
| Fluarix 2006/2007 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs) | Any MSC(s) | 11 Subjects |
| Fluarix 2006/2007 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs) | Related MSC(s) | 1 Subjects |
| GSK576389A - 2007/2008 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs) | Grade 3 MSC(s) | 1 Subjects |
| GSK576389A - 2007/2008 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs) | Any MSC(s) | 5 Subjects |
| GSK576389A - 2007/2008 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs) | Related MSC(s) | 0 Subjects |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs) | Grade 3 MSC(s) | 1 Subjects |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs) | Any MSC(s) | 11 Subjects |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs) | Related MSC(s) | 4 Subjects |
| Fluarix 2007/2008 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs) | Any MSC(s) | 9 Subjects |
| Fluarix 2007/2008 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs) | Related MSC(s) | 2 Subjects |
| Fluarix 2007/2008 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs) | Grade 3 MSC(s) | 1 Subjects |
Secondary
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Any temperature was defined as oral temperature greater than or equal to 38.0 degree centigrade i.e ≥38.0°C, grade 3 temperature was oral temperature ≥39.0°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.
Time frame: During a 7-day follow-up period (Day 0-6) after vaccination
Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK576389A- 2006/2007 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any arthralgia | 58 Subjects |
| GSK576389A- 2006/2007 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 arthralgia | 3 Subjects |
| GSK576389A- 2006/2007 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related arthralgia | 57 Subjects |
| GSK576389A- 2006/2007 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any fatigue | 89 Subjects |
| GSK576389A- 2006/2007 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 fatigue | 4 Subjects |
| GSK576389A- 2006/2007 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related fatigue | 89 Subjects |
| GSK576389A- 2006/2007 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any headache | 76 Subjects |
| GSK576389A- 2006/2007 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 headache | 6 Subjects |
| GSK576389A- 2006/2007 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related headache | 73 Subjects |
| GSK576389A- 2006/2007 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any myalgia | 85 Subjects |
| GSK576389A- 2006/2007 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 myalgia | 1 Subjects |
| GSK576389A- 2006/2007 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related myalgia | 83 Subjects |
| GSK576389A- 2006/2007 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any nausea | 22 Subjects |
| GSK576389A- 2006/2007 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 nausea | 1 Subjects |
| GSK576389A- 2006/2007 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related nausea | 20 Subjects |
| GSK576389A- 2006/2007 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any shivering | 46 Subjects |
| GSK576389A- 2006/2007 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 shivering | 1 Subjects |
| GSK576389A- 2006/2007 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related shivering | 45 Subjects |
| GSK576389A- 2006/2007 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any temperature | 8 Subjects |
| GSK576389A- 2006/2007 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 temperature | 1 Subjects |
| GSK576389A- 2006/2007 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related temperature | 8 Subjects |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 myalgia | 0 Subjects |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 headache | 3 Subjects |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any fatigue | 90 Subjects |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 temperature | 1 Subjects |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any myalgia | 63 Subjects |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related headache | 64 Subjects |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any arthralgia | 36 Subjects |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related shivering | 25 Subjects |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 shivering | 0 Subjects |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any temperature | 6 Subjects |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related fatigue | 89 Subjects |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related arthralgia | 36 Subjects |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related temperature | 6 Subjects |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any shivering | 25 Subjects |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related nausea | 25 Subjects |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 arthralgia | 0 Subjects |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any headache | 67 Subjects |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 fatigue | 3 Subjects |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 nausea | 0 Subjects |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any nausea | 25 Subjects |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related myalgia | 63 Subjects |
| Fluarix 2006/2007 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any fatigue | 39 Subjects |
| Fluarix 2006/2007 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 fatigue | 0 Subjects |
| Fluarix 2006/2007 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related fatigue | 34 Subjects |
| Fluarix 2006/2007 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any temperature | 2 Subjects |
| Fluarix 2006/2007 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any headache | 26 Subjects |
| Fluarix 2006/2007 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 headache | 0 Subjects |
| Fluarix 2006/2007 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related headache | 23 Subjects |
| Fluarix 2006/2007 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any myalgia | 25 Subjects |
| Fluarix 2006/2007 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 myalgia | 1 Subjects |
| Fluarix 2006/2007 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 temperature | 0 Subjects |
| Fluarix 2006/2007 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related myalgia | 22 Subjects |
| Fluarix 2006/2007 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any nausea | 14 Subjects |
| Fluarix 2006/2007 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 nausea | 0 Subjects |
| Fluarix 2006/2007 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related nausea | 11 Subjects |
| Fluarix 2006/2007 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any shivering | 6 Subjects |
| Fluarix 2006/2007 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 shivering | 0 Subjects |
| Fluarix 2006/2007 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related temperature | 1 Subjects |
| Fluarix 2006/2007 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related shivering | 3 Subjects |
| Fluarix 2006/2007 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any arthralgia | 19 Subjects |
| Fluarix 2006/2007 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 arthralgia | 1 Subjects |
| Fluarix 2006/2007 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related arthralgia | 16 Subjects |
| GSK576389A - 2007/2008 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 fatigue | 4 Subjects |
| GSK576389A - 2007/2008 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related shivering | 44 Subjects |
| GSK576389A - 2007/2008 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 shivering | 3 Subjects |
| GSK576389A - 2007/2008 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related nausea | 24 Subjects |
| GSK576389A - 2007/2008 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 headache | 2 Subjects |
| GSK576389A - 2007/2008 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related arthralgia | 39 Subjects |
| GSK576389A - 2007/2008 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related fatigue | 81 Subjects |
| GSK576389A - 2007/2008 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 temperature | 1 Subjects |
| GSK576389A - 2007/2008 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any fatigue | 83 Subjects |
| GSK576389A - 2007/2008 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any shivering | 45 Subjects |
| GSK576389A - 2007/2008 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any temperature | 12 Subjects |
| GSK576389A - 2007/2008 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any myalgia | 75 Subjects |
| GSK576389A - 2007/2008 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related headache | 62 Subjects |
| GSK576389A - 2007/2008 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any nausea | 26 Subjects |
| GSK576389A - 2007/2008 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 myalgia | 0 Subjects |
| GSK576389A - 2007/2008 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related myalgia | 75 Subjects |
| GSK576389A - 2007/2008 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any headache | 62 Subjects |
| GSK576389A - 2007/2008 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any arthralgia | 39 Subjects |
| GSK576389A - 2007/2008 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 nausea | 1 Subjects |
| GSK576389A - 2007/2008 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 arthralgia | 1 Subjects |
| GSK576389A - 2007/2008 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related temperature | 12 Subjects |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any fatigue | 82 Subjects |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 myalgia | 2 Subjects |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 arthralgia | 1 Subjects |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related myalgia | 77 Subjects |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any headache | 58 Subjects |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any nausea | 18 Subjects |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 temperature | 1 Subjects |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 nausea | 0 Subjects |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related nausea | 18 Subjects |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related fatigue | 81 Subjects |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any shivering | 25 Subjects |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 shivering | 2 Subjects |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related arthralgia | 30 Subjects |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 fatigue | 1 Subjects |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any arthralgia | 30 Subjects |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related shivering | 25 Subjects |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related headache | 58 Subjects |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related temperature | 13 Subjects |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 headache | 1 Subjects |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any temperature | 13 Subjects |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any myalgia | 77 Subjects |
| Fluarix 2007/2008 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related fatigue | 32 Subjects |
| Fluarix 2007/2008 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 temperature | 0 Subjects |
| Fluarix 2007/2008 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 nausea | 1 Subjects |
| Fluarix 2007/2008 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related shivering | 6 Subjects |
| Fluarix 2007/2008 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any headache | 27 Subjects |
| Fluarix 2007/2008 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any arthralgia | 20 Subjects |
| Fluarix 2007/2008 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any temperature | 2 Subjects |
| Fluarix 2007/2008 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 headache | 0 Subjects |
| Fluarix 2007/2008 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 arthralgia | 1 Subjects |
| Fluarix 2007/2008 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any nausea | 10 Subjects |
| Fluarix 2007/2008 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 myalgia | 0 Subjects |
| Fluarix 2007/2008 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any shivering | 6 Subjects |
| Fluarix 2007/2008 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related temperature | 1 Subjects |
| Fluarix 2007/2008 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 fatigue | 0 Subjects |
| Fluarix 2007/2008 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related nausea | 9 Subjects |
| Fluarix 2007/2008 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any fatigue | 33 Subjects |
| Fluarix 2007/2008 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related headache | 23 Subjects |
| Fluarix 2007/2008 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 shivering | 0 Subjects |
| Fluarix 2007/2008 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any myalgia | 29 Subjects |
| Fluarix 2007/2008 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related myalgia | 28 Subjects |
| Fluarix 2007/2008 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related arthralgia | 19 Subjects |
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.
Time frame: During a 21-day follow-up period (Day 0-20) after vaccination
Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK576389A- 2006/2007 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs | Grade 3 AE(s) | 2 Subjects |
| GSK576389A- 2006/2007 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs | Any AE(s) | 43 Subjects |
| GSK576389A- 2006/2007 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs | Related AE(s) | 22 Subjects |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs | Grade 3 AE(s) | 1 Subjects |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs | Any AE(s) | 39 Subjects |
| GSK576389A - 2006/2007 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs | Related AE(s) | 21 Subjects |
| Fluarix 2006/2007 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs | Grade 3 AE(s) | 0 Subjects |
| Fluarix 2006/2007 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs | Any AE(s) | 36 Subjects |
| Fluarix 2006/2007 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs | Related AE(s) | 11 Subjects |
| GSK576389A - 2007/2008 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs | Grade 3 AE(s) | 3 Subjects |
| GSK576389A - 2007/2008 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs | Any AE(s) | 45 Subjects |
| GSK576389A - 2007/2008 Season - 1 Container Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs | Related AE(s) | 28 Subjects |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs | Grade 3 AE(s) | 2 Subjects |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs | Any AE(s) | 53 Subjects |
| GSK576389A - 2007/2008 Season - 2 Containers Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs | Related AE(s) | 30 Subjects |
| Fluarix 2007/2008 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs | Any AE(s) | 29 Subjects |
| Fluarix 2007/2008 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs | Related AE(s) | 12 Subjects |
| Fluarix 2007/2008 Season Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs | Grade 3 AE(s) | 1 Subjects |
Secondary
The Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations
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/New Caledonia (for all groups receiving vaccine formulations for the Northern Hemisphere \[NH\] 2006/2007 influenza season) or A/Solomon Islands (for all groups receiving vaccine formulations for the NH 2007/2008 influenza season), A/Wisconsin and B/Malaysia antigens.
Time frame: At Day 21
Population: The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK576389A- 2006/2007 Season - 1 Container Group | The Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/New Caledonia strain (N=259;259;255;0;0;0) | 104 Subjects |
| GSK576389A- 2006/2007 Season - 1 Container Group | The Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Solomon Islands strain (N=0;0;0;258;263;257) | NA Subjects |
| GSK576389A- 2006/2007 Season - 1 Container Group | The Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Wisconsin strain (N=259;259;255;258;263;257) | 177 Subjects |
| GSK576389A- 2006/2007 Season - 1 Container Group | The Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | B/Malaysia strain (N=259;259;255;258;263;257) | 110 Subjects |
| GSK576389A - 2006/2007 Season - 2 Containers Group | The Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Wisconsin strain (N=259;259;255;258;263;257) | 188 Subjects |
| GSK576389A - 2006/2007 Season - 2 Containers Group | The Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Solomon Islands strain (N=0;0;0;258;263;257) | NA Subjects |
| GSK576389A - 2006/2007 Season - 2 Containers Group | The Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/New Caledonia strain (N=259;259;255;0;0;0) | 95 Subjects |
| GSK576389A - 2006/2007 Season - 2 Containers Group | The Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | B/Malaysia strain (N=259;259;255;258;263;257) | 100 Subjects |
| Fluarix 2006/2007 Season Group | The Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | B/Malaysia strain (N=259;259;255;258;263;257) | 85 Subjects |
| Fluarix 2006/2007 Season Group | The Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Wisconsin strain (N=259;259;255;258;263;257) | 128 Subjects |
| Fluarix 2006/2007 Season Group | The Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Solomon Islands strain (N=0;0;0;258;263;257) | NA Subjects |
| Fluarix 2006/2007 Season Group | The Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/New Caledonia strain (N=259;259;255;0;0;0) | 78 Subjects |
| GSK576389A - 2007/2008 Season - 1 Container Group | The Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/New Caledonia strain (N=259;259;255;0;0;0) | NA Subjects |
| GSK576389A - 2007/2008 Season - 1 Container Group | The Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | B/Malaysia strain (N=259;259;255;258;263;257) | 108 Subjects |
| GSK576389A - 2007/2008 Season - 1 Container Group | The Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Solomon Islands strain (N=0;0;0;258;263;257) | 177 Subjects |
| GSK576389A - 2007/2008 Season - 1 Container Group | The Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Wisconsin strain (N=259;259;255;258;263;257) | 171 Subjects |
| GSK576389A - 2007/2008 Season - 2 Containers Group | The Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Wisconsin strain (N=259;259;255;258;263;257) | 173 Subjects |
| GSK576389A - 2007/2008 Season - 2 Containers Group | The Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | B/Malaysia strain (N=259;259;255;258;263;257) | 111 Subjects |
| GSK576389A - 2007/2008 Season - 2 Containers Group | The Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Solomon Islands strain (N=0;0;0;258;263;257) | 192 Subjects |
| GSK576389A - 2007/2008 Season - 2 Containers Group | The Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/New Caledonia strain (N=259;259;255;0;0;0) | NA Subjects |
| Fluarix 2007/2008 Season Group | The Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Solomon Islands strain (N=0;0;0;258;263;257) | 161 Subjects |
| Fluarix 2007/2008 Season Group | The Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Wisconsin strain (N=259;259;255;258;263;257) | 109 Subjects |
| Fluarix 2007/2008 Season Group | The Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | B/Malaysia strain (N=259;259;255;258;263;257) | 88 Subjects |
| Fluarix 2007/2008 Season Group | The Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/New Caledonia strain (N=259;259;255;0;0;0) | NA Subjects |
Secondary
The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations
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/New Caledonia (for all groups receiving vaccine formulations for the Northern Hemisphere \[NH\] 2006/2007 influenza season) or A/Solomon Islands (for all groups receiving vaccine formulations for the NH 2007/2008 influenza season), A/Wisconsin and B/Malaysia antigens.
Time frame: At Days 0 and 21
Population: The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK576389A- 2006/2007 Season - 1 Container Group | The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Solomon Islands at Day 0 (N=0;0;0;258;263;257) | NA Subjects |
| GSK576389A- 2006/2007 Season - 1 Container Group | The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/New Caledonia at Day 21 (N=259;259;255;0;0;0) | 252 Subjects |
| GSK576389A- 2006/2007 Season - 1 Container Group | The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/New Caledonia at Day 0 (N=259;259;255;0;0;0) | 160 Subjects |
| GSK576389A- 2006/2007 Season - 1 Container Group | The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Solomon Islands at Day 21 (N=0;0;0;258;263;257) | NA Subjects |
| GSK576389A- 2006/2007 Season - 1 Container Group | The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Wisconsin at Day 0 (N=259;259;255;258;263;257) | 169 Subjects |
| GSK576389A- 2006/2007 Season - 1 Container Group | The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Wisconsin at Day 21 (N=259;259;255;258;263;257) | 252 Subjects |
| GSK576389A- 2006/2007 Season - 1 Container Group | The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | B/Malaysia at Day 0 (N=259;259;255;258;263;257) | 194 Subjects |
| GSK576389A- 2006/2007 Season - 1 Container Group | The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | B/Malaysia at Day 21 (N=259;259;255;258;263;257) | 255 Subjects |
| GSK576389A - 2006/2007 Season - 2 Containers Group | The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Solomon Islands at Day 21 (N=0;0;0;258;263;257) | NA Subjects |
| GSK576389A - 2006/2007 Season - 2 Containers Group | The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | B/Malaysia at Day 21 (N=259;259;255;258;263;257) | 253 Subjects |
| GSK576389A - 2006/2007 Season - 2 Containers Group | The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/New Caledonia at Day 0 (N=259;259;255;0;0;0) | 163 Subjects |
| GSK576389A - 2006/2007 Season - 2 Containers Group | The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | B/Malaysia at Day 0 (N=259;259;255;258;263;257) | 188 Subjects |
| GSK576389A - 2006/2007 Season - 2 Containers Group | The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Wisconsin at Day 21 (N=259;259;255;258;263;257) | 257 Subjects |
| GSK576389A - 2006/2007 Season - 2 Containers Group | The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Solomon Islands at Day 0 (N=0;0;0;258;263;257) | NA Subjects |
| GSK576389A - 2006/2007 Season - 2 Containers Group | The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/New Caledonia at Day 21 (N=259;259;255;0;0;0) | 246 Subjects |
| GSK576389A - 2006/2007 Season - 2 Containers Group | The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Wisconsin at Day 0 (N=259;259;255;258;263;257) | 174 Subjects |
| Fluarix 2006/2007 Season Group | The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/New Caledonia at Day 21 (N=259;259;255;0;0;0) | 239 Subjects |
| Fluarix 2006/2007 Season Group | The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Solomon Islands at Day 0 (N=0;0;0;258;263;257) | NA Subjects |
| Fluarix 2006/2007 Season Group | The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Solomon Islands at Day 21 (N=0;0;0;258;263;257) | NA Subjects |
| Fluarix 2006/2007 Season Group | The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | B/Malaysia at Day 21 (N=259;259;255;258;263;257) | 249 Subjects |
| Fluarix 2006/2007 Season Group | The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Wisconsin at Day 0 (N=259;259;255;258;263;257) | 172 Subjects |
| Fluarix 2006/2007 Season Group | The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Wisconsin at Day 21 (N=259;259;255;258;263;257) | 249 Subjects |
| Fluarix 2006/2007 Season Group | The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | B/Malaysia at Day 0 (N=259;259;255;258;263;257) | 185 Subjects |
| Fluarix 2006/2007 Season Group | The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/New Caledonia at Day 0 (N=259;259;255;0;0;0) | 156 Subjects |
| GSK576389A - 2007/2008 Season - 1 Container Group | The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | B/Malaysia at Day 0 (N=259;259;255;258;263;257) | 200 Subjects |
| GSK576389A - 2007/2008 Season - 1 Container Group | The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Wisconsin at Day 21 (N=259;259;255;258;263;257) | 255 Subjects |
| GSK576389A - 2007/2008 Season - 1 Container Group | The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Wisconsin at Day 0 (N=259;259;255;258;263;257) | 180 Subjects |
| GSK576389A - 2007/2008 Season - 1 Container Group | The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/New Caledonia at Day 0 (N=259;259;255;0;0;0) | NA Subjects |
| GSK576389A - 2007/2008 Season - 1 Container Group | The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Solomon Islands at Day 0 (N=0;0;0;258;263;257) | 30 Subjects |
| GSK576389A - 2007/2008 Season - 1 Container Group | The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Solomon Islands at Day 21 (N=0;0;0;258;263;257) | 202 Subjects |
| GSK576389A - 2007/2008 Season - 1 Container Group | The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | B/Malaysia at Day 21 (N=259;259;255;258;263;257) | 257 Subjects |
| GSK576389A - 2007/2008 Season - 1 Container Group | The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/New Caledonia at Day 21 (N=259;259;255;0;0;0) | NA Subjects |
| GSK576389A - 2007/2008 Season - 2 Containers Group | The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | B/Malaysia at Day 21 (N=259;259;255;258;263;257) | 260 Subjects |
| GSK576389A - 2007/2008 Season - 2 Containers Group | The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/New Caledonia at Day 0 (N=259;259;255;0;0;0) | NA Subjects |
| GSK576389A - 2007/2008 Season - 2 Containers Group | The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Wisconsin at Day 0 (N=259;259;255;258;263;257) | 171 Subjects |
| GSK576389A - 2007/2008 Season - 2 Containers Group | The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Wisconsin at Day 21 (N=259;259;255;258;263;257) | 259 Subjects |
| GSK576389A - 2007/2008 Season - 2 Containers Group | The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | B/Malaysia at Day 0 (N=259;259;255;258;263;257) | 184 Subjects |
| GSK576389A - 2007/2008 Season - 2 Containers Group | The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/New Caledonia at Day 21 (N=259;259;255;0;0;0) | NA Subjects |
| GSK576389A - 2007/2008 Season - 2 Containers Group | The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Solomon Islands at Day 0 (N=0;0;0;258;263;257) | 26 Subjects |
| GSK576389A - 2007/2008 Season - 2 Containers Group | The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Solomon Islands at Day 21 (N=0;0;0;258;263;257) | 215 Subjects |
| Fluarix 2007/2008 Season Group | The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | B/Malaysia at Day 21 (N=259;259;255;258;263;257) | 246 Subjects |
| Fluarix 2007/2008 Season Group | The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Wisconsin at Day 0 (N=259;259;255;258;263;257) | 158 Subjects |
| Fluarix 2007/2008 Season Group | The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Solomon Islands at Day 0 (N=0;0;0;258;263;257) | 26 Subjects |
| Fluarix 2007/2008 Season Group | The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Solomon Islands at Day 21 (N=0;0;0;258;263;257) | 187 Subjects |
| Fluarix 2007/2008 Season Group | The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/Wisconsin at Day 21 (N=259;259;255;258;263;257) | 239 Subjects |
| Fluarix 2007/2008 Season Group | The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/New Caledonia at Day 21 (N=259;259;255;0;0;0) | NA Subjects |
| Fluarix 2007/2008 Season Group | The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | B/Malaysia at Day 0 (N=259;259;255;258;263;257) | 182 Subjects |
| Fluarix 2007/2008 Season Group | The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations | A/New Caledonia at Day 0 (N=259;259;255;0;0;0) | NA Subjects |