Trial Outcomes & Findings for Evaluate Safety & Immunogenicity of GSK Bio's Influenza Vaccine GSK576389A After Repeated Vaccination in Elderly Adults (NCT NCT00529516)

Last Updated: 2018-06-08

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1252 participants

Primary outcome timeframe

During a 7-day follow-up period after vaccination

Results posted on

2018-06-08

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.	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.
Overall Study STARTED	475	488	289
Overall Study COMPLETED	472	486	288
Overall Study NOT COMPLETED	3	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	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.
Overall Study Adverse Event	2	1	0
Overall Study Withdrawal by Subject	1	1	0
Overall Study Lost to Follow-up	0	0	1

Baseline Characteristics

Evaluate Safety & Immunogenicity of GSK Bio's Influenza Vaccine GSK576389A After Repeated Vaccination in Elderly Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FluAS25 Group n=475 Participants 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.	Fluarix ≥ 65 Years Age Group n=488 Participants 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.	Fluarix 18-40 Years Age Group n=289 Participants 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.	Total n=1252 Participants Total of all reporting groups
Age, Continuous	73.8 Years STANDARD_DEVIATION 5.50 • n=5 Participants	73.7 Years STANDARD_DEVIATION 5.80 • n=7 Participants	30.9 Years STANDARD_DEVIATION 6.64 • n=5 Participants	63.86 Years STANDARD_DEVIATION 19.00 • n=4 Participants
Sex: Female, Male Female	248 Participants n=5 Participants	253 Participants n=7 Participants	167 Participants n=5 Participants	668 Participants n=4 Participants
Sex: Female, Male Male	227 Participants n=5 Participants	235 Participants n=7 Participants	122 Participants n=5 Participants	584 Participants n=4 Participants

PRIMARY outcome

Timeframe: During a 7-day follow-up period after vaccination

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

Outcome measures

Outcome measures
Measure	FluAS25 Group n=472 Participants 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.	Fluarix ≥ 65 Years Age Group n=487 Participants 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.	Fluarix 18-40 Years Age Group n=288 Participants 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.
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Any Ecchymosis	7 Subjects	7 Subjects	2 Subjects
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Grade 3 Ecchymosis	0 Subjects	0 Subjects	0 Subjects
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Any Pain	271 Subjects	76 Subjects	170 Subjects
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Grade 3 Pain	2 Subjects	0 Subjects	0 Subjects
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Any Redness	111 Subjects	14 Subjects	16 Subjects
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Grade 3 Redness	12 Subjects	0 Subjects	0 Subjects
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Any Swelling	44 Subjects	8 Subjects	7 Subjects
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Grade 3 Swelling	1 Subjects	0 Subjects	0 Subjects

PRIMARY outcome

Timeframe: During a 7-day follow-up period after vaccination

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

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

Outcome measures

Outcome measures
Measure	FluAS25 Group n=271 Participants 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.	Fluarix ≥ 65 Years Age Group n=76 Participants 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.	Fluarix 18-40 Years Age Group n=170 Participants 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.
Duration of Solicited Local Adverse Events Ecchymosis (N= 7; 7; 2)	3.0 Days Interval 1.0 to 7.0	2.0 Days Interval 1.0 to 5.0	4.5 Days Interval 4.0 to 5.0
Duration of Solicited Local Adverse Events Pain (N= 271; 76; 170)	2.0 Days Interval 1.0 to 7.0	2.0 Days Interval 1.0 to 7.0	2.0 Days Interval 1.0 to 5.0
Duration of Solicited Local Adverse Events Redness (N= 111; 14; 16)	3.0 Days Interval 1.0 to 7.0	2.0 Days Interval 1.0 to 7.0	1.5 Days Interval 1.0 to 3.0
Duration of Solicited Local Adverse Events Swelling (N= 44; 8; 5)	3.0 Days Interval 1.0 to 7.0	1.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 4.0

PRIMARY outcome

Timeframe: During a 7-day follow-up period after vaccination

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

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.

Outcome measures

Outcome measures
Measure	FluAS25 Group n=472 Participants 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.	Fluarix ≥ 65 Years Age Group n=487 Participants 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.	Fluarix 18-40 Years Age Group n=288 Participants 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.
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) Any Arthralgia	80 Subjects	34 Subjects	23 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) Grade 3 Arthralgia	2 Subjects	0 Subjects	1 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) Related Arthralgia	65 Subjects	20 Subjects	22 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) Any Fatigue	131 Subjects	46 Subjects	71 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) Grade 3 Fatigue	4 Subjects	0 Subjects	1 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) Related Fatigue	109 Subjects	29 Subjects	54 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) Any Headache	102 Subjects	49 Subjects	54 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) Grade 3 Headache	4 Subjects	1 Subjects	1 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) Related Headache	87 Subjects	37 Subjects	39 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) Any Myalgia	132 Subjects	51 Subjects	70 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) Grade 3 Myalgia	4 Subjects	0 Subjects	1 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) Related Myalgia	116 Subjects	38 Subjects	64 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) Any Nausea	35 Subjects	23 Subjects	17 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) Grade 3 Nausea	2 Subjects	0 Subjects	0 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) Related Nausea	29 Subjects	15 Subjects	13 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) Any Shivering	95 Subjects	31 Subjects	31 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) Grade 3 Shivering	5 Subjects	0 Subjects	0 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) Related Shivering	88 Subjects	24 Subjects	28 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) Any Fever	17 Subjects	0 Subjects	1 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) Grade 3 Fever	0 Subjects	0 Subjects	0 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) Related Fever	15 Subjects	0 Subjects	1 Subjects

PRIMARY outcome

Timeframe: During a 7-day follow-up period after vaccination

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

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

Outcome measures

Outcome measures
Measure	FluAS25 Group n=132 Participants 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.	Fluarix ≥ 65 Years Age Group n=51 Participants 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.	Fluarix 18-40 Years Age Group n=70 Participants 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.
Duration of Solicited General Adverse Events Arthralgia (N= 80; 34; 23)	2.0 Days Interval 1.0 to 7.0	3.0 Days Interval 1.0 to 7.0	2.0 Days Interval 1.0 to 6.0
Duration of Solicited General Adverse Events Fatigue (N= 131; 46; 71)	2.0 Days Interval 1.0 to 7.0	2.0 Days Interval 1.0 to 7.0	2.0 Days Interval 1.0 to 7.0
Duration of Solicited General Adverse Events Headache (N= 102; 49; 54)	1.0 Days Interval 1.0 to 7.0	1.0 Days Interval 1.0 to 7.0	2.0 Days Interval 1.0 to 6.0
Duration of Solicited General Adverse Events Myalgia (N= 132; 51; 70)	2.0 Days Interval 1.0 to 7.0	2.0 Days Interval 1.0 to 6.0	2.0 Days Interval 1.0 to 6.0
Duration of Solicited General Adverse Events Nausea (N= 35; 23; 17)	1.0 Days Interval 1.0 to 4.0	1.0 Days Interval 1.0 to 7.0	2.0 Days Interval 1.0 to 4.0
Duration of Solicited General Adverse Events Shivering (N= 95; 31; 31)	1.0 Days Interval 1.0 to 5.0	2.0 Days Interval 1.0 to 7.0	1.0 Days Interval 1.0 to 6.0
Duration of Solicited General Adverse Events Fever (N= 17; 0; 1)	1.0 Days Interval 1.0 to 2.0	NA Days No Fever was experienced by any of the subjects in this arm.	1.0 Days Interval 1.0 to 1.0

PRIMARY outcome

Timeframe: During a 21-day follow-up period after vaccination

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

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.

Outcome measures

Outcome measures
Measure	FluAS25 Group n=475 Participants 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.	Fluarix ≥ 65 Years Age Group n=488 Participants 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.	Fluarix 18-40 Years Age Group n=289 Participants 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.
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Any AEs	82 Subjects	68 Subjects	62 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Grade 3 AEs	7 Subjects	5 Subjects	5 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Related AEs	19 Subjects	6 Subjects	11 Subjects

SECONDARY outcome

Timeframe: 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)

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

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.

Outcome measures

Outcome measures
Measure	FluAS25 Group n=475 Participants 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.	Fluarix ≥ 65 Years Age Group n=488 Participants 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.	Fluarix 18-40 Years Age Group n=289 Participants 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.
Number of Subjects With Any and Related Serious Adverse Events (SAEs) Any SAEs - Vaccination Phase	2 Subjects	3 Subjects	1 Subjects
Number of Subjects With Any and Related Serious Adverse Events (SAEs) Related SAEs - Vaccination Phase	1 Subjects	0 Subjects	0 Subjects
Number of Subjects With Any and Related Serious Adverse Events (SAEs) Any SAEs - Long Term Follow-up Phase	21 Subjects	24 Subjects	3 Subjects
Number of Subjects With Any and Related Serious Adverse Events (SAEs) Related SAEs - Long Term Follow-up Phase	0 Subjects	0 Subjects	0 Subjects

SECONDARY outcome

Timeframe: 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)

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

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

Outcome measures

Outcome measures
Measure	FluAS25 Group n=475 Participants 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.	Fluarix ≥ 65 Years Age Group n=488 Participants 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.	Fluarix 18-40 Years Age Group n=289 Participants 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.
Number of Subjects Reporting Any and Related Medically Significant Conditions (MSCs) Any MSCs - Vaccination Phase	22 Subjects	25 Subjects	11 Subjects
Number of Subjects Reporting Any and Related Medically Significant Conditions (MSCs) Grade 3 MSCs - Vaccination Phase	3 Subjects	3 Subjects	2 Subjects
Number of Subjects Reporting Any and Related Medically Significant Conditions (MSCs) Related MSCs - Vaccination Phase	1 Subjects	1 Subjects	1 Subjects
Number of Subjects Reporting Any and Related Medically Significant Conditions (MSCs) Any MSCs - Long Term Follow-up Phase	112 Subjects	137 Subjects	71 Subjects
Number of Subjects Reporting Any and Related Medically Significant Conditions (MSCs) Grade 3 MSCs - Long Term Follow-up Phase	23 Subjects	29 Subjects	20 Subjects
Number of Subjects Reporting Any and Related Medically Significant Conditions (MSCs) Related MSCs - Long Term Follow-up Phase	0 Subjects	0 Subjects	1 Subjects

SECONDARY outcome

Timeframe: At Days 0 and 21

Population: 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.

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

Outcome measures

Outcome measures
Measure	FluAS25 Group n=447 Participants 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.	Fluarix ≥ 65 Years Age Group n=461 Participants 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.	Fluarix 18-40 Years Age Group n=271 Participants 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.
Serum Hemagglutination-inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains A/Solomon Islands [Day 0] (N= 445; 461; 270)	10.5 Titer Interval 9.6 to 11.5	10.8 Titer Interval 9.9 to 11.9	48.9 Titer Interval 39.9 to 59.9
Serum Hemagglutination-inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains A/Solomon Islands [Day 21] (N= 447; 461; 271)	103.5 Titer Interval 92.4 to 115.8	53.7 Titer Interval 47.6 to 60.7	143.4 Titer Interval 125.8 to 163.6
Serum Hemagglutination-inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains A/Wisconsin [Day 0] (N= 445; 461; 270)	110.0 Titer Interval 97.7 to 123.9	79.5 Titer Interval 70.5 to 89.7	112.5 Titer Interval 98.1 to 129.0
Serum Hemagglutination-inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains A/Wisconsin [Day 21] (N= 447; 461; 271)	430.6 Titer Interval 394.0 to 470.6	217.9 Titer Interval 196.3 to 241.8	251.2 Titer Interval 226.4 to 278.8
Serum Hemagglutination-inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains B/Malaysia [Day 0] (N= 445; 461; 270)	95.8 Titer Interval 86.8 to 105.7	82.5 Titer Interval 75.2 to 90.6	110.5 Titer Interval 95.9 to 127.2
Serum Hemagglutination-inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains B/Malaysia [Day 21] (N= 447; 461; 271)	202.2 Titer Interval 187.1 to 218.5	152.3 Titer Interval 140.0 to 165.6	209.2 Titer Interval 188.9 to 231.7

SECONDARY outcome

Timeframe: At Day 21

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.

Outcome measures

Outcome measures
Measure	FluAS25 Group n=445 Participants 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.	Fluarix ≥ 65 Years Age Group n=461 Participants 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.	Fluarix 18-40 Years Age Group n=270 Participants 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.
Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains A/Solomon Islands	320 Subjects	238 Subjects	94 Subjects
Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains A/Wisconsin	226 Subjects	156 Subjects	66 Subjects
Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains B/Malaysia	82 Subjects	66 Subjects	46 Subjects

SECONDARY outcome

Timeframe: At Day 21

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

Outcome measures

Outcome measures
Measure	FluAS25 Group n=445 Participants 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.	Fluarix ≥ 65 Years Age Group n=461 Participants 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.	Fluarix 18-40 Years Age Group n=270 Participants 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.
Seroconversion Factors for HI Antibodies Against Each of the Three Vaccine Strains A/Wisconsin	3.9 Fold increase Interval 3.5 to 4.3	2.7 Fold increase Interval 2.5 to 3.0	2.2 Fold increase Interval 2.0 to 2.5
Seroconversion Factors for HI Antibodies Against Each of the Three Vaccine Strains A/Solomon Islands	9.8 Fold increase Interval 8.7 to 11.1	5.0 Fold increase Interval 4.4 to 5.5	2.9 Fold increase Interval 2.5 to 3.4
Seroconversion Factors for HI Antibodies Against Each of the Three Vaccine Strains B/Malaysia	2.1 Fold increase Interval 2.0 to 2.3	1.8 Fold increase Interval 1.7 to 2.0	1.9 Fold increase Interval 1.7 to 2.1

SECONDARY outcome

Timeframe: At Days 0 and 21

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.

Outcome measures

Outcome measures
Measure	FluAS25 Group n=447 Participants 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.	Fluarix ≥ 65 Years Age Group n=461 Participants 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.	Fluarix 18-40 Years Age Group n=271 Participants 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.
Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains A/Solomon Islands [Day 0] (N= 445; 461; 270)	71 Subjects	73 Subjects	164 Subjects
Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains A/Solomon Islands [Day 21] (N= 447; 461; 271)	381 Subjects	306 Subjects	255 Subjects
Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains A/Wisconsin [Day 0] (N= 445; 461; 270)	381 Subjects	362 Subjects	235 Subjects
Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains A/Wisconsin [Day 21] (N= 447; 461; 271)	445 Subjects	442 Subjects	270 Subjects
Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains B/Malaysia [Day 0] (N= 445; 461; 270)	392 Subjects	399 Subjects	236 Subjects
Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains B/Malaysia [Day 21] (N= 447; 461; 271)	445 Subjects	443 Subjects	268 Subjects

SECONDARY outcome

Timeframe: At Day 0 and 21

Population: 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.

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).

Outcome measures

Outcome measures
Measure	FluAS25 Group n=65 Participants 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.	Fluarix ≥ 65 Years Age Group n=63 Participants 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.	Fluarix 18-40 Years Age Group n=40 Participants 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.
Number of Cluster of Differentiation 4 (CD4) T-cells (Per Million CD4 T-cells) Producing at Least 2 Different Immune Markers Day 0 (N= 62; 60; 39)	830.72 Cells per million Standard Deviation 889.90	674.91 Cells per million Standard Deviation 567.07	1276.25 Cells per million Standard Deviation 701.42
Number of Cluster of Differentiation 4 (CD4) T-cells (Per Million CD4 T-cells) Producing at Least 2 Different Immune Markers Day 21 (N= 65; 63; 40)	2013.28 Cells per million Standard Deviation 1388.55	1010.22 Cells per million Standard Deviation 1069.96	1607.66 Cells per million Standard Deviation 839.45

SECONDARY outcome

Timeframe: At Day 0 and 21

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).

Outcome measures

Outcome measures
Measure	FluAS25 Group n=65 Participants 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.	Fluarix ≥ 65 Years Age Group n=63 Participants 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.	Fluarix 18-40 Years Age Group n=40 Participants 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.
Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least CD40L and Another Immune Marker Day 0 (N= 62; 60; 39)	822.37 Cells per million Standard Deviation 875.39	660.01 Cells per million Standard Deviation 560.95	1260.65 Cells per million Standard Deviation 681.46
Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least CD40L and Another Immune Marker Day 21 (N= 65; 63; 40)	1961.18 Cells per million Standard Deviation 1337.11	981.82 Cells per million Standard Deviation 1056.18	1556.00 Cells per million Standard Deviation 830.54

SECONDARY outcome

Timeframe: At Day 0 and 21

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).

Outcome measures

Outcome measures
Measure	FluAS25 Group n=65 Participants 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.	Fluarix ≥ 65 Years Age Group n=63 Participants 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.	Fluarix 18-40 Years Age Group n=40 Participants 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.
Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least IFN-γ and Another Immune Marker Day 0 (N= 62; 60; 39)	513.25 Cells per million Standard Deviation 586.78	371.64 Cells per million Standard Deviation 397.45	753.45 Cells per million Standard Deviation 556.25
Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least IFN-γ and Another Immune Marker Day 21 (N= 65; 63; 40)	1081.11 Cells per million Standard Deviation 966.36	574.28 Cells per million Standard Deviation 685.03	870.84 Cells per million Standard Deviation 589.37

SECONDARY outcome

Timeframe: At Day 0 and 21

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).

Outcome measures

Outcome measures
Measure	FluAS25 Group n=65 Participants 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.	Fluarix ≥ 65 Years Age Group n=63 Participants 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.	Fluarix 18-40 Years Age Group n=40 Participants 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.
Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least IL-2 and Another Immune Marker Day 0 (N= 62; 60; 39)	769.96 Cells per million Standard Deviation 809.58	634.57 Cells per million Standard Deviation 518.17	1030.23 Cells per million Standard Deviation 585.91
Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least IL-2 and Another Immune Marker Day 21 (N= 65; 63; 40)	1644.34 Cells per million Standard Deviation 1110.14	856.60 Cells per million Standard Deviation 855.82	1288.54 Cells per million Standard Deviation 664.82

SECONDARY outcome

Timeframe: At Day 0 and 21

Outcome measures

Outcome measures
Measure	FluAS25 Group n=65 Participants 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.	Fluarix ≥ 65 Years Age Group n=63 Participants 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.	Fluarix 18-40 Years Age Group n=40 Participants 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.
Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least TNF-α and Another Immune Marker Day 0 (N= 62; 60; 39)	586.39 Cells per million Standard Deviation 698.83	409.05 Cells per million Standard Deviation 415.62	746.02 Cells per million Standard Deviation 551.82
Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least TNF-α and Another Immune Marker Day 21 (N= 65; 63; 40)	1189.34 Cells per million Standard Deviation 945.05	608.51 Cells per million Standard Deviation 700.32	921.15 Cells per million Standard Deviation 549.61

SECONDARY outcome

Timeframe: At Day 0 and 21

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).

Outcome measures

Outcome measures
Measure	FluAS25 Group n=64 Participants 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.	Fluarix ≥ 65 Years Age Group n=62 Participants 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.	Fluarix 18-40 Years Age Group n=40 Participants 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.
Number of Cluster of Differentiation 8 (CD8) T-cells (Per Million CD8 T-cells) Expressing at Least 2 Different Immune Markers Day 0 (N= 55; 54; 39)	8.25 Cells per million Standard Deviation 166.35	6.82 Cells per million Standard Deviation 123.10	3.56 Cells per million Standard Deviation 247.08
Number of Cluster of Differentiation 8 (CD8) T-cells (Per Million CD8 T-cells) Expressing at Least 2 Different Immune Markers Day 21 (N= 64; 62; 40)	16.75 Cells per million Standard Deviation 168.54	6.51 Cells per million Standard Deviation 112.42	3.48 Cells per million Standard Deviation 79.78

SECONDARY outcome

Timeframe: At Day 0 and 21

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).

Outcome measures

Outcome measures
Measure	FluAS25 Group n=64 Participants 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.	Fluarix ≥ 65 Years Age Group n=62 Participants 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.	Fluarix 18-40 Years Age Group n=40 Participants 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.
Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least CD40L and Another Immune Marker Day 0 (N= 55; 54; 39)	6.19 Cells per million Standard Deviation 120.88	4.33 Cells per million Standard Deviation 134.18	2.12 Cells per million Standard Deviation 220.32
Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least CD40L and Another Immune Marker Day 21 (N= 64; 62; 40)	8.09 Cells per million Standard Deviation 123.89	5.79 Cells per million Standard Deviation 85.20	3.64 Cells per million Standard Deviation 71.55

SECONDARY outcome

Timeframe: At Day 0 and 21

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).

Outcome measures

Outcome measures
Measure	FluAS25 Group n=64 Participants 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.	Fluarix ≥ 65 Years Age Group n=62 Participants 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.	Fluarix 18-40 Years Age Group n=40 Participants 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.
Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least IFN-γ and Another Immune Marker Day 0 (N= 55; 54; 39)	2.77 Cells per million Standard Deviation 69.92	2.64 Cells per million Standard Deviation 50.62	1.58 Cells per million Standard Deviation 32.08
Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least IFN-γ and Another Immune Marker Day 21 (N= 64; 62; 40)	3.09 Cells per million Standard Deviation 97.36	2.82 Cells per million Standard Deviation 56.06	2.17 Cells per million Standard Deviation 28.97

SECONDARY outcome

Timeframe: At Day 0 and 21

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).

Outcome measures

Outcome measures
Measure	FluAS25 Group n=64 Participants 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.	Fluarix ≥ 65 Years Age Group n=62 Participants 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.	Fluarix 18-40 Years Age Group n=40 Participants 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.
Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least IL-2 and Another Immune Marker Day 0 (N= 55; 54; 39)	6.82 Cells per million Standard Deviation 135.79	8.43 Cells per million Standard Deviation 119.70	3.21 Cells per million Standard Deviation 249.46
Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least IL-2 and Another Immune Marker Day 21 (N= 64; 62; 40)	12.70 Cells per million Standard Deviation 159.08	5.64 Cells per million Standard Deviation 101.15	3.20 Cells per million Standard Deviation 55.75

SECONDARY outcome

Timeframe: At Day 0 and 21

Outcome measures

Outcome measures
Measure	FluAS25 Group n=64 Participants 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.	Fluarix ≥ 65 Years Age Group n=62 Participants 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.	Fluarix 18-40 Years Age Group n=40 Participants 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.
Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least TNF-α and Another Immune Marker Day 0 (N= 55; 54; 39)	3.05 Cells per million Standard Deviation 72.38	2.48 Cells per million Standard Deviation 42.55	3.13 Cells per million Standard Deviation 44.03
Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least TNF-α and Another Immune Marker Day 21 (N= 64; 62; 40)	5.67 Cells per million Standard Deviation 89.23	3.54 Cells per million Standard Deviation 69.71	2.73 Cells per million Standard Deviation 40.30

Adverse Events

FluAS25 Group

Serious events: 23 serious events

Other events: 346 other events

Deaths: 0 deaths

Fluarix ≥ 65 Years Age Group

Serious events: 27 serious events

Other events: 162 other events

Deaths: 0 deaths

Fluarix 18-40 Years Age Group

Serious events: 4 serious events

Other events: 200 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	FluAS25 Group n=475 participants at risk 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.	Fluarix ≥ 65 Years Age Group n=488 participants at risk 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.	Fluarix 18-40 Years Age Group n=289 participants at risk 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.
General disorders Pain at the injection site	57.1% 271/475 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic method are reported during the active phase (Day 0 - 20) and during the long term follow-up phase (Day 21 - 179) of the study. Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.	15.6% 76/488 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic method are reported during the active phase (Day 0 - 20) and during the long term follow-up phase (Day 21 - 179) of the study. Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.	58.8% 170/289 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic method are reported during the active phase (Day 0 - 20) and during the long term follow-up phase (Day 21 - 179) of the study. Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
General disorders Redness at the injection site	23.4% 111/475 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic method are reported during the active phase (Day 0 - 20) and during the long term follow-up phase (Day 21 - 179) of the study. Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.	2.9% 14/488 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic method are reported during the active phase (Day 0 - 20) and during the long term follow-up phase (Day 21 - 179) of the study. Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.	5.5% 16/289 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic method are reported during the active phase (Day 0 - 20) and during the long term follow-up phase (Day 21 - 179) of the study. Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
General disorders Swelling at the injection site	9.3% 44/475 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic method are reported during the active phase (Day 0 - 20) and during the long term follow-up phase (Day 21 - 179) of the study. Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.	1.6% 8/488 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic method are reported during the active phase (Day 0 - 20) and during the long term follow-up phase (Day 21 - 179) of the study. Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.	2.4% 7/289 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic method are reported during the active phase (Day 0 - 20) and during the long term follow-up phase (Day 21 - 179) of the study. Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
General disorders Arthralgia	16.8% 80/475 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic method are reported during the active phase (Day 0 - 20) and during the long term follow-up phase (Day 21 - 179) of the study. Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.	7.0% 34/488 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic method are reported during the active phase (Day 0 - 20) and during the long term follow-up phase (Day 21 - 179) of the study. Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.	8.0% 23/289 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic method are reported during the active phase (Day 0 - 20) and during the long term follow-up phase (Day 21 - 179) of the study. Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
General disorders Fatigue	27.6% 131/475 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic method are reported during the active phase (Day 0 - 20) and during the long term follow-up phase (Day 21 - 179) of the study. Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.	9.4% 46/488 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic method are reported during the active phase (Day 0 - 20) and during the long term follow-up phase (Day 21 - 179) of the study. Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.	24.6% 71/289 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic method are reported during the active phase (Day 0 - 20) and during the long term follow-up phase (Day 21 - 179) of the study. Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
General disorders Headache	21.5% 102/475 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic method are reported during the active phase (Day 0 - 20) and during the long term follow-up phase (Day 21 - 179) of the study. Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.	10.0% 49/488 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic method are reported during the active phase (Day 0 - 20) and during the long term follow-up phase (Day 21 - 179) of the study. Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.	18.7% 54/289 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic method are reported during the active phase (Day 0 - 20) and during the long term follow-up phase (Day 21 - 179) of the study. Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
General disorders Myalgia	27.8% 132/475 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic method are reported during the active phase (Day 0 - 20) and during the long term follow-up phase (Day 21 - 179) of the study. Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.	10.5% 51/488 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic method are reported during the active phase (Day 0 - 20) and during the long term follow-up phase (Day 21 - 179) of the study. Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.	24.2% 70/289 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic method are reported during the active phase (Day 0 - 20) and during the long term follow-up phase (Day 21 - 179) of the study. Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
General disorders Nausea	7.4% 35/475 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic method are reported during the active phase (Day 0 - 20) and during the long term follow-up phase (Day 21 - 179) of the study. Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.	4.7% 23/488 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic method are reported during the active phase (Day 0 - 20) and during the long term follow-up phase (Day 21 - 179) of the study. Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.	5.9% 17/289 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic method are reported during the active phase (Day 0 - 20) and during the long term follow-up phase (Day 21 - 179) of the study. Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
General disorders Shivering	20.0% 95/475 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic method are reported during the active phase (Day 0 - 20) and during the long term follow-up phase (Day 21 - 179) of the study. Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.	6.4% 31/488 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic method are reported during the active phase (Day 0 - 20) and during the long term follow-up phase (Day 21 - 179) of the study. Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.	10.7% 31/289 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic method are reported during the active phase (Day 0 - 20) and during the long term follow-up phase (Day 21 - 179) of the study. Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER