Evaluate Safety & Immunogenicity of GSK Bio's Influenza V... | NCT00529516

Label	Type	Description	Intervention Names
FluAS25 Group	Experimental	Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.	Biological: GSK Biologicals Influenza Vaccine GSK576389A
Fluarix ≥ 65 years age Group	Active Comparator	Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.	Biological: Fluarix
Fluarix 18-40 years age Group	Active Comparator	Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.	Biological: Fluarix

Name	Type	Description	Arm Group Labels	Other Names
Fluarix	Biological	Single dose, Intramuscular injection	Fluarix 18-40 years age Group Fluarix ≥ 65 years age Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)	Solicited local AEs assessed include ecchymosis, pain, redness and swelling. Any: any symptom regardless of intensity grade. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter.	During a 7-day follow-up period after vaccination
Duration of Solicited Local Adverse Events	Duration was expressed as the median number of days the symptom was experienced.	During a 7-day follow-up period after vaccination
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs)	Solicited general AEs assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any: any symptom regardless of intensity grade; any fever: oral temperature greater than or equal to 38 degrees Celsius (°C). Grade 3: symptoms that prevented normal activity ; Grade 3 fever: oral temperature greater than 40°C. Related: symptom assessed by the investigator as causally related to the study vaccination.	During a 7-day follow-up period after vaccination
Duration of Solicited General Adverse Events	Duration was expressed as the median number of days the symptom was experienced.	During a 7-day follow-up period after vaccination
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)	Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any: any AE regardless of intensity or relationship to vaccination. Grade 3: AE that prevented normal activity. Related: AE considered by the investigator to be causally related to the study vaccination.

Secondary Outcomes

Measure	Description	Time Frame
Number of Subjects With 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.	During the vaccination phase of the study (Day 0 to Day 20) and during the long term follow-up phase of the study (Day 21 to Day 179)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
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.
If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
Male or female subjects who participated in the 104888 study (NCT00377585) and were enrolled in the >= 65 years age group or in the 18-40 years age group .

Exclusion Criteria:

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 30 days after vaccination
Planned administration of an influenza vaccine other than the study vaccines during the entire study period
Any vaccination against influenza since January 2007
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
History of hypersensitivity to a previous dose of influenza vaccine
History of allergy or reactions likely to be exacerbated by any component of the vaccine(s)
Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination 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 dose of study vaccine or planned administration during the study period
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
Any medical conditions in which IM injections are contraindicated
Pregnant or lactating female, or planning to become pregnant or to discontinue contraceptive precautions.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Clearwater	Florida	33761	United States
GSK Investigational Site

Label	URL
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.	View source

ID	Type	URL	Comment
109821	Study Protocol	View IPD

ID	Title	Description
FG000	FluAS25 Group	Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
FG001

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)

Solicited local AEs assessed include ecchymosis, pain, redness and swelling. Any: any symptom regardless of intensity grade. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter.

The analysis was performed on the Total Vaccinated Cohort on subjects who completed the symptom sheet.

Posted

Number

Subjects

During a 7-day follow-up period after vaccination

ID	Title	Description
OG000	FluAS25 Group	Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
OG001	Fluarix ≥ 65 Years Age Group	Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
OG002	Fluarix 18-40 Years Age Group	Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.

Units	Counts
Participants	OG000472 OG001487 OG002288

Title

Denominators

Categories

Any Ecchymosis

Title	Measurements
	OG0007 OG0017 OG0022

Grade 3 Ecchymosis

Primary

Duration of Solicited Local Adverse Events

Duration was expressed as the median number of days the symptom was experienced.

The analysis was performed on the Total Vaccinated Cohort, on subjects that reported the specific symptom.

Posted

Median

Full Range

Days

During a 7-day follow-up period after vaccination

ID	Title	Description
OG000	FluAS25 Group	Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
OG001	Fluarix ≥ 65 Years Age Group	Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
OG002	Fluarix 18-40 Years Age Group	Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.

Primary

Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs)

Solicited general AEs assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any: any symptom regardless of intensity grade; any fever: oral temperature greater than or equal to 38 degrees Celsius (°C). Grade 3: symptoms that prevented normal activity ; Grade 3 fever: oral temperature greater than 40°C. Related: symptom assessed by the investigator as causally related to the study vaccination.

The analysis was performed on the Total Vaccinated Cohort on subjects who completed the symptom sheet.

Posted

Number

Subjects

During a 7-day follow-up period after vaccination

ID	Title	Description
OG000	FluAS25 Group	Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
OG001	Fluarix ≥ 65 Years Age Group	Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
OG002	Fluarix 18-40 Years Age Group

Primary

Duration of Solicited General Adverse Events

Duration was expressed as the median number of days the symptom was experienced.

The analysis was performed on the Total Vaccinated Cohort, on subjects that experienced the specific symptom.

Posted

Median

Full Range

Days

During a 7-day follow-up period after vaccination

ID	Title	Description
OG000	FluAS25 Group	Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
OG001	Fluarix ≥ 65 Years Age Group	Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
OG002	Fluarix 18-40 Years Age Group	Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.

Primary

Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)

Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any: any AE regardless of intensity or relationship to vaccination. Grade 3: AE that prevented normal activity. Related: AE considered by the investigator to be causally related to the study vaccination.

The analysis was performed on the Total Vaccinated Cohort which included all subjects with study vaccine administered.

Posted

Number

Subjects

During a 21-day follow-up period after vaccination

ID	Title	Description
OG000	FluAS25 Group	Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
OG001	Fluarix ≥ 65 Years Age Group	Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
OG002	Fluarix 18-40 Years Age Group

Secondary

Number of Subjects With 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.

The analysis was performed on the Total Vaccinated Cohort which included all subjects with study vaccine administered.

Posted

Number

Subjects

During the vaccination phase of the study (Day 0 to Day 20) and during the long term follow-up phase of the study (Day 21 to Day 179)

ID	Title	Description
OG000	FluAS25 Group	Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
OG001	Fluarix ≥ 65 Years Age Group	Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
OG002	Fluarix 18-40 Years Age Group	Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.

Secondary

Number of Subjects Reporting Any and Related Medically Significant Conditions (MSCs)

Medically significant conditions assessed include conditions prompting emergency room visits, hospitalizations or physician visits.

The analysis was performed on the Total Vaccinated Cohort which included all subjects with study vaccine administered.

Posted

Number

Subjects

During the vaccination phase of the study (Day 0 to Day 20) and during the long term follow-up phase of the study (Day 21 to Day 179)

ID	Title	Description
OG000	FluAS25 Group	Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
OG001	Fluarix ≥ 65 Years Age Group	Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
OG002	Fluarix 18-40 Years Age Group	Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.

Secondary

Serum Hemagglutination-inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains

Titers were expressed as Geometric Mean Titers. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.

The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity haemagglutination-inhibition (HI) which included all evaluable subjects who complied with the protocol up to the end of the active phase, for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Posted

Geometric Mean

95% Confidence Interval

Titer

At Days 0 and 21

ID	Title	Description
OG000	FluAS25 Group	Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
OG001	Fluarix ≥ 65 Years Age Group	Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
OG002	Fluarix 18-40 Years Age Group

Secondary

Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains

A seroconverted subject was defined as a subject who had either a pre-vaccination titer below1:10 and a post-vaccination titer greater than or equal to1:40 or a pre-vaccination titer greater than or equal to1:10 and at least a four-fold increase in post-vaccination titer. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.

Posted

Number

Subjects

At Day 21

ID	Title	Description
OG000	FluAS25 Group	Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
OG001	Fluarix ≥ 65 Years Age Group	Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.

Secondary

Seroconversion Factors for HI Antibodies Against Each of the Three Vaccine Strains

Seroconversion factor was defined as the fold increase in serum HI Geometric Mean Titers post-vaccination compared to Day 0.

Posted

Geometric Mean

95% Confidence Interval

Fold increase

At Day 21

ID	Title	Description
OG000	FluAS25 Group	Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
OG001	Fluarix ≥ 65 Years Age Group	Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
OG002	Fluarix 18-40 Years Age Group

Secondary

Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains

A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to1:40 that is usually accepted as indicating protection. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.

Posted

Number

Subjects

At Days 0 and 21

ID	Title	Description
OG000	FluAS25 Group	Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
OG001	Fluarix ≥ 65 Years Age Group	Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
OG002	Fluarix 18-40 Years Age Group

Secondary

Number of Cluster of Differentiation 4 (CD4) T-cells (Per Million CD4 T-cells) Producing at Least 2 Different Immune Markers

Results are presented as the geometric mean number of immune response marker-positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).

The analysis was performed on the ATP cohort of immunogenicity Cell-Mediated Immunity (CMI) which included a subset of subjects from the ATP Cohort for immunogenicity HI. This included subjects for whom data for immune response marker-positive CD4 result was available 21 days after vaccination.

Posted

Geometric Mean

Standard Deviation

Cells per million

At Day 0 and 21

ID	Title	Description
OG000	FluAS25 Group	Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
OG001	Fluarix ≥ 65 Years Age Group	Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.

Secondary

Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least CD40L and Another Immune Marker

Results are presented as the geometric mean number of CD40L-positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Other immune markers assessed include interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).

Posted

Geometric Mean

Standard Deviation

Cells per million

At Day 0 and 21

ID	Title	Description
OG000	FluAS25 Group	Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
OG001	Fluarix ≥ 65 Years Age Group	Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
OG002	Fluarix 18-40 Years Age Group

Secondary

Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least IFN-γ and Another Immune Marker

Results are presented as the geometric mean number of IFN-γ -positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNF-α).

Posted

Geometric Mean

Standard Deviation

Cells per million

At Day 0 and 21

ID	Title	Description
OG000	FluAS25 Group	Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
OG001	Fluarix ≥ 65 Years Age Group	Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
OG002	Fluarix 18-40 Years Age Group

Secondary

Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least IL-2 and Another Immune Marker

Results are presented as the geometric mean number of IFN-γ -positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).

Posted

Geometric Mean

Standard Deviation

Cells per million

At Day 0 and 21

ID	Title	Description
OG000	FluAS25 Group	Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
OG001	Fluarix ≥ 65 Years Age Group	Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
OG002	Fluarix 18-40 Years Age Group

Secondary

Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least TNF-α and Another Immune Marker

Posted

Geometric Mean

Standard Deviation

Cells per million

At Day 0 and 21

ID	Title	Description
OG000	FluAS25 Group	Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
OG001	Fluarix ≥ 65 Years Age Group	Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
OG002	Fluarix 18-40 Years Age Group

Secondary

Number of Cluster of Differentiation 8 (CD8) T-cells (Per Million CD8 T-cells) Expressing at Least 2 Different Immune Markers

Results are presented as the geometric mean number of immune response marker-positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).

Posted

Geometric Mean

Standard Deviation

Cells per million

At Day 0 and 21

ID	Title	Description
OG000	FluAS25 Group	Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
OG001	Fluarix ≥ 65 Years Age Group	Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.

Secondary

Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least CD40L and Another Immune Marker

Results are presented as the geometric mean number of CD40L-positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Other immune markers assessed include interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).

Posted

Geometric Mean

Standard Deviation

Cells per million

At Day 0 and 21

ID	Title	Description
OG000	FluAS25 Group	Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
OG001	Fluarix ≥ 65 Years Age Group	Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
OG002	Fluarix 18-40 Years Age Group

Secondary

Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least IFN-γ and Another Immune Marker

Results are presented as the geometric mean number of IFN-γ -positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNF-α).

Posted

Geometric Mean

Standard Deviation

Cells per million

At Day 0 and 21

ID	Title	Description
OG000	FluAS25 Group	Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
OG001	Fluarix ≥ 65 Years Age Group	Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
OG002	Fluarix 18-40 Years Age Group

Secondary

Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least IL-2 and Another Immune Marker

Results are presented as the geometric mean number of IFN-γ -positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).

Posted

Geometric Mean

Standard Deviation

Cells per million

At Day 0 and 21

ID	Title	Description
OG000	FluAS25 Group	Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
OG001	Fluarix ≥ 65 Years Age Group	Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
OG002	Fluarix 18-40 Years Age Group

Secondary

Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least TNF-α and Another Immune Marker

Posted

Geometric Mean

Standard Deviation

Cells per million

At Day 0 and 21

ID	Title	Description
OG000	FluAS25 Group	Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
OG001	Fluarix ≥ 65 Years Age Group	Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
OG002	Fluarix 18-40 Years Age Group

Serious Adverse Events

Term	Organ System	Assessment Type	Notes	Statistical Information
Ankle fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	Reported during the active phase of the study (Day 0 - 20)	EG0000 affected475 at risk EG0010 affected488 at risk EG0021 affected289 at risk
Chest pain	General disorders	Non-systematic Assessment	Reported during the active phase of the study (Day 0 - 20)	EG0000 affected475 at risk EG0011 affected488 at risk EG0020 affected289 at risk
Hip fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	Reported during the active phase of the study (Day 0 - 20)	EG0000 affected475 at risk EG0011 affected488 at risk EG0020 affected289 at risk
Injection site pain	General disorders	Non-systematic Assessment	Reported during the active phase of the study (Day 0 - 20)	EG0001 affected475 at risk EG0010 affected488 at risk EG0020 affected289 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	Reported during the active phase of the study (Day 0 - 20)	EG0000 affected475 at risk EG0011 affected488 at risk EG0020 affected289 at risk
Ulna fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	Reported during the active phase of the study (Day 0 - 20)	EG0001 affected475 at risk EG0010 affected488 at risk EG0020 affected289 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment		EG0001 affected475 at risk EG0012 affected488 at risk EG0020 affected289 at risk
Atrial fibrillation	Cardiac disorders	Non-systematic Assessment		EG0000 affected475 at risk EG0012 affected488 at risk EG0020 affected289 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment		EG0001 affected475 at risk EG0011 affected488 at risk EG0020 affected289 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment		EG0002 affected475 at risk EG0010 affected488 at risk EG0020 affected289 at risk
Coronary artery disease	Cardiac disorders	Non-systematic Assessment		EG0001 affected475 at risk EG0011 affected488 at risk EG0020 affected289 at risk
Inguinal hernia	Gastrointestinal disorders	Non-systematic Assessment		EG0000 affected475 at risk EG0012 affected488 at risk EG0020 affected289 at risk
Meniscus lesion	Injury, poisoning and procedural complications	Non-systematic Assessment		EG0000 affected475 at risk EG0011 affected488 at risk EG0021 affected289 at risk
Pneumonia	Infections and infestations	Non-systematic Assessment		EG0000 affected475 at risk EG0012 affected488 at risk EG0020 affected289 at risk
Radius fracture	Injury, poisoning and procedural complications	Non-systematic Assessment		EG0002 affected475 at risk EG0010 affected488 at risk EG0020 affected289 at risk
Abdominal hernia	Gastrointestinal disorders	Non-systematic Assessment		EG0000 affected475 at risk EG0011 affected488 at risk EG0020 affected289 at risk
Abdominal pain	Gastrointestinal disorders	Non-systematic Assessment		EG0000 affected475 at risk EG0010 affected488 at risk EG0021 affected289 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	Non-systematic Assessment		EG0000 affected475 at risk EG0010 affected488 at risk EG0021 affected289 at risk
Alcohol withdrawal syndrome	Psychiatric disorders	Non-systematic Assessment		EG0001 affected475 at risk EG0010 affected488 at risk EG0020 affected289 at risk
Angina unstable	Cardiac disorders	Non-systematic Assessment		EG0001 affected475 at risk EG0010 affected488 at risk EG0020 affected289 at risk
Arthritis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment		EG0001 affected475 at risk EG0010 affected488 at risk EG0020 affected289 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment		EG0000 affected475 at risk EG0011 affected488 at risk EG0020 affected289 at risk
Bronchitis	Infections and infestations	Non-systematic Assessment		EG0001 affected475 at risk EG0010 affected488 at risk EG0020 affected289 at risk
Cardiac failure	Cardiac disorders	Non-systematic Assessment		EG0000 affected475 at risk EG0011 affected488 at risk EG0020 affected289 at risk
Carotid artery stenosis	Nervous system disorders	Non-systematic Assessment		EG0001 affected475 at risk EG0010 affected488 at risk EG0020 affected289 at risk
Cellulitis	Infections and infestations	Non-systematic Assessment		EG0001 affected475 at risk EG0010 affected488 at risk EG0020 affected289 at risk
Cholecystitis infective	Infections and infestations	Non-systematic Assessment		EG0001 affected475 at risk EG0010 affected488 at risk EG0020 affected289 at risk
Contusion	Injury, poisoning and procedural complications	Non-systematic Assessment		EG0000 affected475 at risk EG0011 affected488 at risk EG0020 affected289 at risk
Coronary artery stenosis	Cardiac disorders	Non-systematic Assessment		EG0000 affected475 at risk EG0011 affected488 at risk EG0020 affected289 at risk
Cystitis	Infections and infestations	Non-systematic Assessment		EG0000 affected475 at risk EG0011 affected488 at risk EG0020 affected289 at risk
Deep vein thrombosis	Vascular disorders	Non-systematic Assessment		EG0001 affected475 at risk EG0010 affected488 at risk EG0020 affected289 at risk
Diverticulitis	Infections and infestations	Non-systematic Assessment		EG0001 affected475 at risk EG0010 affected488 at risk EG0020 affected289 at risk
Diverticulum	Gastrointestinal disorders	Non-systematic Assessment		EG0000 affected475 at risk EG0011 affected488 at risk EG0020 affected289 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment		EG0000 affected475 at risk EG0011 affected488 at risk EG0020 affected289 at risk
Enterovesical fistula	Gastrointestinal disorders	Non-systematic Assessment		EG0000 affected475 at risk EG0011 affected488 at risk EG0020 affected289 at risk
Erysipelas	Infections and infestations	Non-systematic Assessment		EG0001 affected475 at risk EG0010 affected488 at risk EG0020 affected289 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment		EG0000 affected475 at risk EG0011 affected488 at risk EG0020 affected289 at risk
Hydronephrosis	Renal and urinary disorders	Non-systematic Assessment		EG0000 affected475 at risk EG0011 affected488 at risk EG0020 affected289 at risk
Hypothyroidism	Endocrine disorders	Non-systematic Assessment		EG0001 affected475 at risk EG0010 affected488 at risk EG0020 affected289 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	Non-systematic Assessment		EG0000 affected475 at risk EG0011 affected488 at risk EG0020 affected289 at risk
Joint dislocation	Injury, poisoning and procedural complications	Non-systematic Assessment		EG0000 affected475 at risk EG0011 affected488 at risk EG0020 affected289 at risk
Large intestine perforation	Gastrointestinal disorders	Non-systematic Assessment		EG0001 affected475 at risk EG0010 affected488 at risk EG0020 affected289 at risk
Lung carcinoma cell type unspecified stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment		EG0001 affected475 at risk EG0010 affected488 at risk EG0020 affected289 at risk
Mitral valve incompetence	Cardiac disorders	Non-systematic Assessment		EG0000 affected475 at risk EG0011 affected488 at risk EG0020 affected289 at risk
Multiple fractures	Injury, poisoning and procedural complications	Non-systematic Assessment		EG0001 affected475 at risk EG0010 affected488 at risk EG0020 affected289 at risk
Multiple injuries	Injury, poisoning and procedural complications	Non-systematic Assessment		EG0000 affected475 at risk EG0011 affected488 at risk EG0020 affected289 at risk
Non-cardiac chest pain	General disorders	Non-systematic Assessment		EG0001 affected475 at risk EG0010 affected488 at risk EG0020 affected289 at risk
Oesophageal ulcer	Gastrointestinal disorders	Non-systematic Assessment		EG0001 affected475 at risk EG0010 affected488 at risk EG0020 affected289 at risk
Osteomyelitis	Infections and infestations	Non-systematic Assessment		EG0001 affected475 at risk EG0010 affected488 at risk EG0020 affected289 at risk
Pelvi-ureteric obstruction	Renal and urinary disorders	Non-systematic Assessment		EG0000 affected475 at risk EG0011 affected488 at risk EG0020 affected289 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment		EG0000 affected475 at risk EG0011 affected488 at risk EG0020 affected289 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment		EG0000 affected475 at risk EG0011 affected488 at risk EG0020 affected289 at risk
Precursor b-lymphoblastic lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment		EG0000 affected475 at risk EG0011 affected488 at risk EG0020 affected289 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment		EG0000 affected475 at risk EG0011 affected488 at risk EG0020 affected289 at risk
Sick sinus syndrome	Cardiac disorders	Non-systematic Assessment		EG0001 affected475 at risk EG0010 affected488 at risk EG0020 affected289 at risk
Spinal fusion surgery	Surgical and medical procedures	Non-systematic Assessment		EG0001 affected475 at risk EG0010 affected488 at risk EG0020 affected289 at risk
Staphylococcal infection	Infections and infestations	Non-systematic Assessment		EG0001 affected475 at risk EG0010 affected488 at risk EG0020 affected289 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	Non-systematic Assessment		EG0000 affected475 at risk EG0011 affected488 at risk EG0020 affected289 at risk
Ventricular tachycardia	Cardiac disorders	Non-systematic Assessment		EG0000 affected475 at risk EG0011 affected488 at risk EG0020 affected289 at risk
Vertigo	Ear and labyrinth disorders	Non-systematic Assessment		EG0000 affected475 at risk EG0011 affected488 at risk EG0020 affected289 at risk

Term	Organ System	Assessment Type	Statistical Information
Pain at the injection site	General disorders	Systematic Assessment	EG000271 affected475 at risk EG00176 affected488 at risk EG002170 affected289 at risk
Redness at the injection site	General disorders	Systematic Assessment	EG000111 affected475 at risk EG00114 affected488 at risk EG00216 affected289 at risk
Swelling at the injection site	General disorders	Systematic Assessment	EG00044 affected475 at risk EG0018 affected488 at risk EG0027 affected289 at risk
Arthralgia	General disorders	Systematic Assessment	EG00080 affected475 at risk EG00134 affected488 at risk EG00223 affected289 at risk
Fatigue	General disorders	Systematic Assessment	EG000131 affected475 at risk EG00146 affected488 at risk EG00271 affected289 at risk
Headache	General disorders	Systematic Assessment	EG000102 affected475 at risk EG00149 affected488 at risk EG00254 affected289 at risk
Myalgia	General disorders	Systematic Assessment	EG000132 affected475 at risk EG00151 affected488 at risk EG00270 affected289 at risk
Nausea	General disorders	Systematic Assessment	EG00035 affected475 at risk EG00123 affected488 at risk EG00217 affected289 at risk
Shivering	General disorders	Systematic Assessment	EG00095 affected475 at risk EG00131 affected488 at risk EG00231 affected289 at risk

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D012140	Respiratory Tract Diseases

ID	Title	Description
BG000	FluAS25 Group	Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
BG001	Fluarix ≥ 65 Years Age Group	Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
BG002	Fluarix 18-40 Years Age Group	Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	FluAS25 Group	Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.	23	475	346	475
EG001	Fluarix ≥ 65 Years Age Group	Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.	27	488	162	488
EG002	Fluarix 18-40 Years Age Group	Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.	4	289	200	289