Trial Outcomes & Findings for Evaluation of Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2186877A in Adults 65 Years and Older (NCT NCT00760617)

NCT ID: NCT00760617

Last Updated: 2018-08-17

Results Overview

Grade 3 ecchymosis, redness and swelling was greater than or equal to 100 millimeter (mm) i.e. ≥ 100 mm and grade 3 pain was considerable pain at rest, that prevented normal everyday activities. Any was occurrence of any local symptom regardless of their intensity grade.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 526 participants
• Primary outcome timeframe: Day 0-6
• Results posted on: 2018-08-17

Participant Flow

Participant milestones

Measure	New Generation Influenza Vaccine GSK2186877A Group Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group Subjects aged ≥65 years received 1 dose of Fluarix vaccine	Fluarix Young Group Subjects aged 18-40 years received 1 dose of Fluarix vaccine
Overall Study STARTED	266	144	116
Overall Study COMPLETED	261	142	111
Overall Study NOT COMPLETED	5	2	5

Reasons for withdrawal

Measure	New Generation Influenza Vaccine GSK2186877A Group Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group Subjects aged ≥65 years received 1 dose of Fluarix vaccine	Fluarix Young Group Subjects aged 18-40 years received 1 dose of Fluarix vaccine
Overall Study Adverse Event	5	2	0
Overall Study Lost to Follow-up	0	0	5

Baseline Characteristics

Evaluation of Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2186877A in Adults 65 Years and Older

Baseline characteristics by cohort

Measure	New Generation Influenza Vaccine GSK2186877A Group n=266 Participants Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group n=144 Participants Subjects aged ≥65 years received 1 dose of Fluarix vaccine	Fluarix Young Group n=116 Participants Subjects aged 18-40 years received 1 dose of Fluarix vaccine	Total n=526 Participants Total of all reporting groups
Age, Continuous	73.5 Years STANDARD_DEVIATION 5.27 • n=5 Participants	73.8 Years STANDARD_DEVIATION 5.54 • n=7 Participants	28.2 Years STANDARD_DEVIATION 6.34 • n=5 Participants	63.59 Years STANDARD_DEVIATION 19.65 • n=4 Participants
Sex: Female, Male Female	143 Participants n=5 Participants	68 Participants n=7 Participants	53 Participants n=5 Participants	264 Participants n=4 Participants
Sex: Female, Male Male	123 Participants n=5 Participants	76 Participants n=7 Participants	63 Participants n=5 Participants	262 Participants n=4 Participants

PRIMARY outcome

Timeframe: Day 0-6

Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.

Grade 3 ecchymosis, redness and swelling was greater than or equal to 100 millimeter (mm) i.e. ≥ 100 mm and grade 3 pain was considerable pain at rest, that prevented normal everyday activities. Any was occurrence of any local symptom regardless of their intensity grade.

Outcome measures

Measure	New Generation Influenza Vaccine GSK2186877A Group n=265 Participants Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group n=144 Participants Subjects aged ≥65 years received 1 dose of Fluarix vaccine	Fluarix Young Group n=115 Participants Subjects aged 18-40 years received 1 dose of Fluarix vaccine
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Any ecchymosis	2 Participants	2 Participants	1 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Grade 3 ecchymosis	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Any pain	108 Participants	18 Participants	61 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Grade 3 pain	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Any redness	43 Participants	5 Participants	3 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Grade 3 redness	1 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Any swelling	20 Participants	7 Participants	1 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Grade 3 swelling	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 0-6

Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.

Duration was defined as number of days with any grade of local symptoms and grade for quantifiable symptoms: ecchymosis, redness and swelling was greater than (>) 20mm.

Outcome measures

Measure	New Generation Influenza Vaccine GSK2186877A Group n=108 Participants Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group n=18 Participants Subjects aged ≥65 years received 1 dose of Fluarix vaccine	Fluarix Young Group n=61 Participants Subjects aged 18-40 years received 1 dose of Fluarix vaccine
Duration of Solicited Local AEs Redness	2.0 Days Interval 1.0 to 7.0	2.0 Days Interval 2.0 to 3.0	2.0 Days Interval 1.0 to 2.0
Duration of Solicited Local AEs Ecchymosis	6.0 Days Interval 6.0 to 6.0	4.0 Days Interval 2.0 to 6.0	7.0 Days Interval 7.0 to 7.0
Duration of Solicited Local AEs Pain	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 7.0
Duration of Solicited Local AEs Swelling	2.0 Days Interval 1.0 to 7.0	3.0 Days Interval 1.0 to 5.0	2.0 Days Interval 2.0 to 2.0

PRIMARY outcome

Timeframe: Day 0-6

Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.

Any fever was defined as oral temperature ≥38.0 degree centigrade (°C), grade 3 fever was oral temperature >40.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relationship to vaccination, grade 3 was defined as a general symptom that prevented normal activity and related was a general symptom assessed by the investigator as causally related to the study vaccination.

Outcome measures

Measure	New Generation Influenza Vaccine GSK2186877A Group n=265 Participants Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group n=144 Participants Subjects aged ≥65 years received 1 dose of Fluarix vaccine	Fluarix Young Group n=115 Participants Subjects aged 18-40 years received 1 dose of Fluarix vaccine
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Related arthralgia	20 Participants	5 Participants	7 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Any myalgia	42 Participants	8 Participants	16 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Grade 3 fever	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Related fever	4 Participants	1 Participants	3 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Any arthralgia	30 Participants	6 Participants	10 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Grade 3 arthralgia	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Any fatigue	51 Participants	11 Participants	27 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Grade 3 fatigue	1 Participants	0 Participants	2 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Related fatigue	39 Participants	10 Participants	19 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Any gastrointestinal symptoms	24 Participants	5 Participants	9 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Grade 3 gastrointestinal symptoms	0 Participants	0 Participants	2 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Related gastrointestinal symptoms	13 Participants	4 Participants	2 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Any headache	39 Participants	7 Participants	30 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Grade 3 headache	1 Participants	0 Participants	4 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Related headache	24 Participants	4 Participants	17 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Grade 3 myalgia	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Related myalgia	31 Participants	6 Participants	12 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Any shivering	37 Participants	6 Participants	10 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Grade 3 shivering	0 Participants	0 Participants	1 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Related shivering	29 Participants	4 Participants	7 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Any fever	5 Participants	1 Participants	5 Participants

PRIMARY outcome

Timeframe: Day 0-6

Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.

Duration was defined as number of days with any grade of general symptoms.

Outcome measures

Measure	New Generation Influenza Vaccine GSK2186877A Group n=51 Participants Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group n=11 Participants Subjects aged ≥65 years received 1 dose of Fluarix vaccine	Fluarix Young Group n=30 Participants Subjects aged 18-40 years received 1 dose of Fluarix vaccine
Duration of Solicited General AEs Arthralgia	2.0 Days Interval 1.0 to 5.0	1.5 Days Interval 1.0 to 3.0	3.0 Days Interval 1.0 to 5.0
Duration of Solicited General AEs Fatigue	2.0 Days Interval 1.0 to 7.0	2.0 Days Interval 1.0 to 5.0	2.0 Days Interval 1.0 to 5.0
Duration of Solicited General AEs Gastrointestinal symptoms	1.0 Days Interval 1.0 to 7.0	2.0 Days Interval 1.0 to 6.0	1.0 Days Interval 1.0 to 3.0
Duration of Solicited General AEs Headache	1.0 Days Interval 1.0 to 7.0	1.0 Days Interval 1.0 to 3.0	1.5 Days Interval 1.0 to 4.0
Duration of Solicited General AEs Myalgia	2.0 Days Interval 1.0 to 4.0	2.0 Days Interval 2.0 to 5.0	2.0 Days Interval 1.0 to 6.0
Duration of Solicited General AEs Shivering	1.0 Days Interval 1.0 to 6.0	2.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.0
Duration of Solicited General AEs Fever	1.0 Days Interval 1.0 to 7.0	1.0 Days Interval 1.0 to 1.0	1.0 Days Interval 1.0 to 1.0

PRIMARY outcome

Timeframe: Day 0-20

Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.

Unsolicited adverse event (AE) covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade, grade 3 was unsolicited symptom that prevented normal activity and related was event assessed by the investigator as possibly related to the study vaccination.

Outcome measures

Measure	New Generation Influenza Vaccine GSK2186877A Group n=266 Participants Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group n=144 Participants Subjects aged ≥65 years received 1 dose of Fluarix vaccine	Fluarix Young Group n=116 Participants Subjects aged 18-40 years received 1 dose of Fluarix vaccine
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs Any AE(s)	49 Participants	20 Participants	18 Participants
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs Grade 3 AE(s)	6 Participants	1 Participants	4 Participants
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs Related AE(s)	1 Participants	2 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 0-20

Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.

For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as symptom that prevented normal activity and related was general symptom assessed by the investigator as possibly related to the study vaccination.

Outcome measures

Measure	New Generation Influenza Vaccine GSK2186877A Group n=266 Participants Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group n=144 Participants Subjects aged ≥65 years received 1 dose of Fluarix vaccine	Fluarix Young Group n=116 Participants Subjects aged 18-40 years received 1 dose of Fluarix vaccine
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 0 to 20 Grade 3 AE(s)	4 Participants	1 Participants	1 Participants
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 0 to 20 Any AE(s)	20 Participants	8 Participants	9 Participants
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 0 to 20 Related AE(s)	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 21-179

Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.

For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as symptom that prevented normal activity and related was general symptom assessed by the investigator as possibly related to the study vaccination.

Outcome measures

Measure	New Generation Influenza Vaccine GSK2186877A Group n=266 Participants Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group n=144 Participants Subjects aged ≥65 years received 1 dose of Fluarix vaccine	Fluarix Young Group n=116 Participants Subjects aged 18-40 years received 1 dose of Fluarix vaccine
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 21 to 179 Any AE(s)	103 Participants	48 Participants	33 Participants
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 21 to 179 Grade 3 AE(s)	26 Participants	8 Participants	9 Participants
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 21 to 179 Related AE(s)	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 0-179

Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.

AESI for safety monitoring are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoiimune etiology. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as symptom that prevented normal activity and related was general symptom assessed by the investigator as possibly related to the study vaccination.

Outcome measures

Measure	New Generation Influenza Vaccine GSK2186877A Group n=266 Participants Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group n=144 Participants Subjects aged ≥65 years received 1 dose of Fluarix vaccine	Fluarix Young Group n=116 Participants Subjects aged 18-40 years received 1 dose of Fluarix vaccine
Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Disease (AID) Any AE(s)	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Disease (AID) Grade 3 AE(s)	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Disease (AID) Related AE(s)	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 0-20

Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was event assessed by the investigator as causally related to the study vaccination.

Outcome measures

Measure	New Generation Influenza Vaccine GSK2186877A Group n=266 Participants Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group n=144 Participants Subjects aged ≥65 years received 1 dose of Fluarix vaccine	Fluarix Young Group n=116 Participants Subjects aged 18-40 years received 1 dose of Fluarix vaccine
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 0 to Day 20 Any SAE(s)	4 Participants	2 Participants	1 Participants
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 0 to Day 20 Related SAE(s)	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 21-179

Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was event assessed by the investigator as causally related to the study vaccination.

Outcome measures

Measure	New Generation Influenza Vaccine GSK2186877A Group n=266 Participants Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group n=144 Participants Subjects aged ≥65 years received 1 dose of Fluarix vaccine	Fluarix Young Group n=116 Participants Subjects aged 18-40 years received 1 dose of Fluarix vaccine
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 21 to Day 179 Any SAE(s)	19 Participants	7 Participants	2 Participants
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 21 to Day 179 Related SAE(s)	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 180 to Day 209

Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was event assessed by the investigator as causally related to the study vaccination.

Outcome measures

Measure	New Generation Influenza Vaccine GSK2186877A Group n=266 Participants Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group n=144 Participants Subjects aged ≥65 years received 1 dose of Fluarix vaccine	Fluarix Young Group n=116 Participants Subjects aged 18-40 years received 1 dose of Fluarix vaccine
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 180 to Day 209 Any SAE(s)	0 Participants	3 Participants	0 Participants
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 180 to Day 209 Related SAE(s)	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At Day 0 and 21

Population: Analysis was performed on According-to-Protocol (ATP) immunogenicity cohort for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.

Antibody titers were expressed as Geometric mean titres (GMTs) with separate vaccine strains. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.

Outcome measures

Measure	New Generation Influenza Vaccine GSK2186877A Group n=253 Participants Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group n=142 Participants Subjects aged ≥65 years received 1 dose of Fluarix vaccine	Fluarix Young Group n=108 Participants Subjects aged 18-40 years received 1 dose of Fluarix vaccine
Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21 A/Brisbane vaccine strain at Day 0	27.9 titer Interval 24.7 to 31.6	22.9 titer Interval 19.6 to 26.7	43.2 titer Interval 33.9 to 54.9
Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21 A/Brisbane vaccine strain at Day 21	74.6 titer Interval 66.7 to 83.3	57.5 titer Interval 49.5 to 66.8	164.7 titer Interval 133.9 to 202.5
Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21 A/Uruguay vaccine strain at Day 0	28.1 titer Interval 24.3 to 32.6	22.8 titer Interval 19.0 to 27.4	28.9 titer Interval 22.9 to 36.5
Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21 A/Uruguay vaccine strain at Day 21	243.9 titer Interval 213.5 to 278.7	134.8 titer Interval 107.9 to 168.4	171.1 titer Interval 141.0 to 207.7
Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21 B/Brisbane vaccine strain at Day 0	126.5 titer Interval 111.5 to 143.5	159.9 titer Interval 136.1 to 188.0	192.7 titer Interval 150.6 to 246.7
Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21 B/Brisbane vaccine strain at Day 21	519.0 titer Interval 467.1 to 576.6	402.5 titer Interval 344.2 to 470.6	711.5 titer Interval 611.2 to 828.2

SECONDARY outcome

Timeframe: Day 180

Population: Analysis was performed on According-to-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at day 180.

Antibody titers were expressed as GMTs with separate vaccine strains. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.

Outcome measures

Measure	New Generation Influenza Vaccine GSK2186877A Group n=241 Participants Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group n=130 Participants Subjects aged ≥65 years received 1 dose of Fluarix vaccine	Fluarix Young Group n=103 Participants Subjects aged 18-40 years received 1 dose of Fluarix vaccine
HI Antibody Titers at Day 180 A/Brisbane vaccine strain	34.9 titers Interval 30.9 to 39.4	27.7 titers Interval 23.9 to 32.0	99.5 titers Interval 79.8 to 124.0
HI Antibody Titers at Day 180 A/Uruguay vaccine strain	90.1 titers Interval 77.0 to 105.4	69.9 titers Interval 55.8 to 87.6	86.1 titers Interval 68.2 to 108.7
HI Antibody Titers at Day 180 B/Brisbane vaccine strain	278.7 titers Interval 248.4 to 312.6	255.7 titers Interval 218.9 to 298.7	463.3 titers Interval 384.0 to 558.9

SECONDARY outcome

Timeframe: At Day 0 and 21

Population: Analysis was performed on According-to-Protocol (ATP) immunogenicity cohort for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.

Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.

Outcome measures

Measure	New Generation Influenza Vaccine GSK2186877A Group n=253 Participants Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group n=142 Participants Subjects aged ≥65 years received 1 dose of Fluarix vaccine	Fluarix Young Group n=108 Participants Subjects aged 18-40 years received 1 dose of Fluarix vaccine
The Number of Subjects Seropositive to HI Antibodies at Day 0 and 21 A/Brisbane vaccine strain at Day 0	226 Participants	125 Participants	97 Participants
The Number of Subjects Seropositive to HI Antibodies at Day 0 and 21 A/Brisbane vaccine strain at Day 21	251 Participants	141 Participants	108 Participants
The Number of Subjects Seropositive to HI Antibodies at Day 0 and 21 A/Uruguay vaccine strain at Day 0	212 Participants	116 Participants	90 Participants
The Number of Subjects Seropositive to HI Antibodies at Day 0 and 21 A/Uruguay vaccine strain at Day 21	253 Participants	140 Participants	108 Participants
The Number of Subjects Seropositive to HI Antibodies at Day 0 and 21 B/Brisbane vaccine strain at Day 0	253 Participants	142 Participants	108 Participants
The Number of Subjects Seropositive to HI Antibodies at Day 0 and 21 B/Brisbane vaccine strain at Day 21	253 Participants	142 Participants	108 Participants

SECONDARY outcome

Timeframe: Day 180

Population: Analysis was performed on According-to-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at day 180.

Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.

Outcome measures

Measure	New Generation Influenza Vaccine GSK2186877A Group n=241 Participants Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group n=130 Participants Subjects aged ≥65 years received 1 dose of Fluarix vaccine	Fluarix Young Group n=103 Participants Subjects aged 18-40 years received 1 dose of Fluarix vaccine
The Number of Subjects Seropositive to HI Antibodies at Day 180 B/Brisbane vaccine strain	241 Participants	130 Participants	103 Participants
The Number of Subjects Seropositive to HI Antibodies at Day 180 A/Brisbane vaccine strain	226 Participants	123 Participants	102 Participants
The Number of Subjects Seropositive to HI Antibodies at Day 180 A/Uruguay vaccine strain	235 Participants	125 Participants	99 Participants

SECONDARY outcome

Timeframe: Day 21

Population: Analysis was performed on According-to-Protocol (ATP) immunogenicity cohort for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.

Seroconversion was defined as the percentage of vaccinees who had either a pre-vaccination titre less than (<) 1:10 and a post-vaccination titre ≥1:40 or a pre-vaccination titre ≥1:10 and at least a 4-fold increase in post-vaccination titre. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.

Outcome measures

Measure	New Generation Influenza Vaccine GSK2186877A Group n=253 Participants Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group n=142 Participants Subjects aged ≥65 years received 1 dose of Fluarix vaccine	Fluarix Young Group n=108 Participants Subjects aged 18-40 years received 1 dose of Fluarix vaccine
The Number of Subjects Seroconverted to HI Antibodies at Day 21 A/Brisbane vaccine strain	77 Participants	46 Participants	48 Participants
The Number of Subjects Seroconverted to HI Antibodies at Day 21 A/Uruguay vaccine strain	209 Participants	97 Participants	67 Participants
The Number of Subjects Seroconverted to HI Antibodies at Day 21 B/Brisbane vaccine strain	130 Participants	47 Participants	50 Participants

SECONDARY outcome

Timeframe: Day 180

Population: Analysis was performed on According-to-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at day 180.

Seroconversion was defined as the percentage of vaccinees who had either a pre-vaccination titre <1:10 and a post-vaccination titre ≥1:40 or a pre-vaccination titre ≥1:10 and at least a 4-fold increase in post-vaccination titre. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.

Outcome measures

Measure	New Generation Influenza Vaccine GSK2186877A Group n=241 Participants Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group n=130 Participants Subjects aged ≥65 years received 1 dose of Fluarix vaccine	Fluarix Young Group n=103 Participants Subjects aged 18-40 years received 1 dose of Fluarix vaccine
The Number of Subjects Seroconverted to HI Antibodies at Day 180 A/Brisbane vaccine strain	15 Participants	11 Participants	31 Participants
The Number of Subjects Seroconverted to HI Antibodies at Day 180 A/Uruguay vaccine strain	99 Participants	47 Participants	37 Participants
The Number of Subjects Seroconverted to HI Antibodies at Day 180 B/Brisbane vaccine strain	64 Participants	19 Participants	36 Participants

SECONDARY outcome

Timeframe: Day 21

Population: Analysis was performed on According-to-Protocol (ATP) immunogenicity cohort for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.

SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.

Outcome measures

Measure	New Generation Influenza Vaccine GSK2186877A Group n=253 Participants Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group n=142 Participants Subjects aged ≥65 years received 1 dose of Fluarix vaccine	Fluarix Young Group n=108 Participants Subjects aged 18-40 years received 1 dose of Fluarix vaccine
HI Antibody Seroconversion Factor (SCF) at Day 21 A/Brisbane vaccine strain	2.7 fold increase Interval 2.4 to 3.0	2.5 fold increase Interval 2.1 to 2.9	3.8 fold increase Interval 3.0 to 4.9
HI Antibody Seroconversion Factor (SCF) at Day 21 A/Uruguay vaccine strain	8.7 fold increase Interval 7.5 to 9.9	5.9 fold increase Interval 4.9 to 7.2	5.9 fold increase Interval 4.8 to 7.3
HI Antibody Seroconversion Factor (SCF) at Day 21 B/Brisbane vaccine strain	4.1 fold increase Interval 3.6 to 4.6	2.5 fold increase Interval 2.2 to 2.9	3.7 fold increase Interval 3.0 to 4.5

SECONDARY outcome

Timeframe: Day 180

Population: Analysis was performed on According-to-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at day 180.

SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.

Outcome measures

Measure	New Generation Influenza Vaccine GSK2186877A Group n=241 Participants Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group n=130 Participants Subjects aged ≥65 years received 1 dose of Fluarix vaccine	Fluarix Young Group n=103 Participants Subjects aged 18-40 years received 1 dose of Fluarix vaccine
HI Antibody SCF at Day 180 A/Brisbane vaccine strain	1.3 fold increase Interval 1.1 to 1.4	1.2 fold increase Interval 1.1 to 1.4	2.4 fold increase Interval 1.9 to 2.9
HI Antibody SCF at Day 180 A/Uruguay vaccine strain	3.4 fold increase Interval 3.0 to 3.8	2.9 fold increase Interval 2.4 to 3.6	3.1 fold increase Interval 2.5 to 3.9
HI Antibody SCF at Day 180 B/Brisbane vaccine strain	2.2 fold increase Interval 2.0 to 2.4	1.7 fold increase Interval 1.5 to 1.9	2.7 fold increase Interval 2.3 to 3.2

SECONDARY outcome

Timeframe: At Day 0 and 21

Population: Analysis was performed on According-to-Protocol (ATP) immunogenicity cohort for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.

Seroprotection was defined as the percentage of vaccinees with a serum HI titre ≥1:40 that usually is accepted as indicating protection. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.

Outcome measures

Measure	New Generation Influenza Vaccine GSK2186877A Group n=253 Participants Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group n=142 Participants Subjects aged ≥65 years received 1 dose of Fluarix vaccine	Fluarix Young Group n=108 Participants Subjects aged 18-40 years received 1 dose of Fluarix vaccine
The Number of Subjects Seroprotected to HI Antibodies at Day 0 and Day 21 A/Brisbane vaccine strain at Day 0	124 Participants	55 Participants	68 Participants
The Number of Subjects Seroprotected to HI Antibodies at Day 0 and Day 21 A/Brisbane vaccine strain at Day 21	222 Participants	108 Participants	101 Participants
The Number of Subjects Seroprotected to HI Antibodies at Day 0 and Day 21 A/Uruguay vaccine strain at Day 0	121 Participants	58 Participants	53 Participants
The Number of Subjects Seroprotected to HI Antibodies at Day 0 and Day 21 A/Uruguay vaccine strain at Day 21	248 Participants	123 Participants	104 Participants
The Number of Subjects Seroprotected to HI Antibodies at Day 0 and Day 21 B/Brisbane vaccine strain at Day 0	236 Participants	136 Participants	101 Participants
The Number of Subjects Seroprotected to HI Antibodies at Day 0 and Day 21 B/Brisbane vaccine strain at Day 21	253 Participants	141 Participants	108 Participants

SECONDARY outcome

Timeframe: Day 180

Population: Analysis was performed on According-to-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at day 180.

Seroprotection was defined as the percentage of vaccinees with a serum HI titre ≥1:40 that usually is accepted as indicating protection. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.

Outcome measures

Measure	New Generation Influenza Vaccine GSK2186877A Group n=241 Participants Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group n=130 Participants Subjects aged ≥65 years received 1 dose of Fluarix vaccine	Fluarix Young Group n=103 Participants Subjects aged 18-40 years received 1 dose of Fluarix vaccine
The Number of Subjects Seroprotected to HI Antibodies at Day 180 A/Brisbane vaccine strain	143 Participants	65 Participants	89 Participants
The Number of Subjects Seroprotected to HI Antibodies at Day 180 A/Uruguay vaccine strain	193 Participants	94 Participants	87 Participants
The Number of Subjects Seroprotected to HI Antibodies at Day 180 B/Brisbane vaccine strain	241 Participants	129 Participants	103 Participants

SECONDARY outcome

Timeframe: At Day 0 and 21

Population: Analysis was performed on According-to-Protocol (ATP) immunogenicity cohort for cell mediated immunity (CMI) which included subjects for whom data concerning immunogenicity CMI outcome measures were available at day 21.

The markers assessed were CD4-ALL DOUBLES, CD40 Ligand (CD40L), interleukin 2 (IL-2), tumour necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ) and vaccine strains tested included A/Brisbane, A/Uruguay and B/Brisbane antigens.

Outcome measures

Measure	New Generation Influenza Vaccine GSK2186877A Group n=66 Participants Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group n=34 Participants Subjects aged ≥65 years received 1 dose of Fluarix vaccine	Fluarix Young Group n=22 Participants Subjects aged 18-40 years received 1 dose of Fluarix vaccine
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 B/Brisbane [CD4-CD40L] Day 21	1230.63 cells per million CD4 T-cells Standard Deviation 731.08	850.96 cells per million CD4 T-cells Standard Deviation 901.02	1275.70 cells per million CD4 T-cells Standard Deviation 508.40
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 A/Brisbane [CD4-IFN-γ] Day 0	430.40 cells per million CD4 T-cells Standard Deviation 373.24	338.29 cells per million CD4 T-cells Standard Deviation 613.41	777.72 cells per million CD4 T-cells Standard Deviation 837.25
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 A/Brisbane [CD4-IFN-γ] Day 21	839.94 cells per million CD4 T-cells Standard Deviation 536.38	481.04 cells per million CD4 T-cells Standard Deviation 976.79	985.11 cells per million CD4 T-cells Standard Deviation 713.98
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 A/Uruguay [CD4-IFN-γ] Day 0	282.79 cells per million CD4 T-cells Standard Deviation 321.42	301.64 cells per million CD4 T-cells Standard Deviation 426.04	501.13 cells per million CD4 T-cells Standard Deviation 482.16
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 A/Uruguay [CD4-IFN-γ] Day 21	628.36 cells per million CD4 T-cells Standard Deviation 400.49	399.84 cells per million CD4 T-cells Standard Deviation 387.97	638.93 cells per million CD4 T-cells Standard Deviation 418.36
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 B/Brisbane [CD4-IFN-γ] Day 0	447.23 cells per million CD4 T-cells Standard Deviation 708.32	299.25 cells per million CD4 T-cells Standard Deviation 441.05	681.49 cells per million CD4 T-cells Standard Deviation 413.65
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 B/Brisbane [CD4-IFN-γ] Day 21	800.89 cells per million CD4 T-cells Standard Deviation 648.91	478.15 cells per million CD4 T-cells Standard Deviation 851.02	934.53 cells per million CD4 T-cells Standard Deviation 471.32
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 A/Brisbane [CD4-IL2] Day 0	645.57 cells per million CD4 T-cells Standard Deviation 445.17	542.90 cells per million CD4 T-cells Standard Deviation 700.45	1033.28 cells per million CD4 T-cells Standard Deviation 884.01
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 A/Brisbane [CD4-IL2] Day 21	1176.29 cells per million CD4 T-cells Standard Deviation 568.05	816.63 cells per million CD4 T-cells Standard Deviation 1114.87	1259.69 cells per million CD4 T-cells Standard Deviation 691.36
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 A/Uruguay [CD4-IL2] Day 0	385.93 cells per million CD4 T-cells Standard Deviation 375.33	392.63 cells per million CD4 T-cells Standard Deviation 488.21	599.02 cells per million CD4 T-cells Standard Deviation 523.72
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 B/Brisbane [CD4-CD40L] Day 0	775.18 cells per million CD4 T-cells Standard Deviation 754.90	630.27 cells per million CD4 T-cells Standard Deviation 630.81	959.42 cells per million CD4 T-cells Standard Deviation 465.42
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 B/Brisbane [CD4-TNF-α] Day 0	646.27 cells per million CD4 T-cells Standard Deviation 718.92	558.87 cells per million CD4 T-cells Standard Deviation 591.29	818.77 cells per million CD4 T-cells Standard Deviation 441.82
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 A/Brisbane [CD4-CD40L] Day 0	694.63 cells per million CD4 T-cells Standard Deviation 452.67	616.27 cells per million CD4 T-cells Standard Deviation 682.26	1127.82 cells per million CD4 T-cells Standard Deviation 946.50
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 A/Brisbane [CD4-CD40L] Day 21	1305.74 cells per million CD4 T-cells Standard Deviation 622.93	855.81 cells per million CD4 T-cells Standard Deviation 974.19	1379.47 cells per million CD4 T-cells Standard Deviation 735.06
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 A/Uruguay [CD4-CD40L] Day 0	392.35 cells per million CD4 T-cells Standard Deviation 368.33	361.18 cells per million CD4 T-cells Standard Deviation 498.91	646.92 cells per million CD4 T-cells Standard Deviation 542.81
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 A/Uruguay [CD4-CD40L] Day 21	803.34 cells per million CD4 T-cells Standard Deviation 459.33	543.41 cells per million CD4 T-cells Standard Deviation 463.96	816.08 cells per million CD4 T-cells Standard Deviation 447.79
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 A/Brisbane [CD4-ALL DOUBLES] Day 0	751.28 cells per million CD4 T-cells Standard Deviation 492.55	682.47 cells per million CD4 T-cells Standard Deviation 759.31	1179.17 cells per million CD4 T-cells Standard Deviation 1031.92
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 A/Brisbane [CD4-ALL DOUBLES] Day 21	1431.41 cells per million CD4 T-cells Standard Deviation 679.60	972.14 cells per million CD4 T-cells Standard Deviation 1204.18	1513.30 cells per million CD4 T-cells Standard Deviation 798.38
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 A/Uruguay [CD4-ALL DOUBLES] Day 0	451.86 cells per million CD4 T-cells Standard Deviation 419.39	444.42 cells per million CD4 T-cells Standard Deviation 578.82	743.45 cells per million CD4 T-cells Standard Deviation 552.48
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 A/Uruguay [CD4-ALL DOUBLES] Day 21	912.85 cells per million CD4 T-cells Standard Deviation 496.53	592.66 cells per million CD4 T-cells Standard Deviation 518.19	912.28 cells per million CD4 T-cells Standard Deviation 476.16
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 B/Brisbane [CD4-ALL DOUBLES] Day 0	828.74 cells per million CD4 T-cells Standard Deviation 840.19	679.28 cells per million CD4 T-cells Standard Deviation 702.37	1045.61 cells per million CD4 T-cells Standard Deviation 510.95
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 B/Brisbane [CD4-ALL DOUBLES] Day 21	1361.30 cells per million CD4 T-cells Standard Deviation 799.10	935.28 cells per million CD4 T-cells Standard Deviation 1130.22	1403.64 cells per million CD4 T-cells Standard Deviation 580.53
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 A/Uruguay [CD4-IL2] Day 21	745.33 cells per million CD4 T-cells Standard Deviation 428.75	505.78 cells per million CD4 T-cells Standard Deviation 459.04	745.61 cells per million CD4 T-cells Standard Deviation 444.27
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 B/Brisbane [CD4-IL2] Day 0	711.32 cells per million CD4 T-cells Standard Deviation 760.06	547.71 cells per million CD4 T-cells Standard Deviation 646.50	852.51 cells per million CD4 T-cells Standard Deviation 479.69
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 B/Brisbane [CD4-IL2] Day 21	1112.52 cells per million CD4 T-cells Standard Deviation 725.72	778.12 cells per million CD4 T-cells Standard Deviation 1034.69	1156.73 cells per million CD4 T-cells Standard Deviation 494.36
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 A/Brisbane [CD4-TNF-α] Day 0	606.82 cells per million CD4 T-cells Standard Deviation 442.61	610.09 cells per million CD4 T-cells Standard Deviation 669.96	900.67 cells per million CD4 T-cells Standard Deviation 914.33
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 A/Brisbane [CD4-TNF-α] Day 21	1057.44 cells per million CD4 T-cells Standard Deviation 568.35	749.70 cells per million CD4 T-cells Standard Deviation 1068.11	1096.74 cells per million CD4 T-cells Standard Deviation 689.90
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 A/Uruguay [CD4-TNF-α] Day 0	405.12 cells per million CD4 T-cells Standard Deviation 403.06	414.27 cells per million CD4 T-cells Standard Deviation 508.57	575.28 cells per million CD4 T-cells Standard Deviation 509.48
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 A/Uruguay [CD4-TNF-α] Day 21	740.68 cells per million CD4 T-cells Standard Deviation 448.67	449.51 cells per million CD4 T-cells Standard Deviation 463.77	685.63 cells per million CD4 T-cells Standard Deviation 429.55
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 B/Brisbane [CD4-TNF-α] Day 21	1021.43 cells per million CD4 T-cells Standard Deviation 690.24	715.45 cells per million CD4 T-cells Standard Deviation 973.99	1023.28 cells per million CD4 T-cells Standard Deviation 475.97

Adverse Events

New Generation Influenza Vaccine GSK2186877A Group

Serious events: 19 serious events

Other events: 160 other events

Deaths: 0 deaths

Fluarix Elderly Group

Serious events: 7 serious events

Other events: 39 other events

Deaths: 0 deaths

Fluarix Young Group

Serious events: 2 serious events

Other events: 80 other events

Deaths: 0 deaths

Serious adverse events

Measure	New Generation Influenza Vaccine GSK2186877A Group n=266 participants at risk Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group n=144 participants at risk Subjects aged ≥65 years received 1 dose of Fluarix vaccine	Fluarix Young Group n=116 participants at risk Subjects aged 18-40 years received 1 dose of Fluarix vaccine
Cardiac disorders Cardiac failure	0.38% 1/266 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/116 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Central nervous system lymphoma	0.38% 1/266 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/116 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Injury, poisoning and procedural complications Concussion	0.38% 1/266 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/116 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Injury, poisoning and procedural complications Facial bones fracture	0.38% 1/266 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/116 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Nervous system disorders Locked-in syndrome	0.38% 1/266 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/116 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Musculoskeletal and connective tissue disorders Osteoarthritis	1.1% 3/266 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/116 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Infections and infestations Pneumonia	0.75% 2/266 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/116 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Infections and infestations Postoperative wound infection	0.38% 1/266 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/116 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Renal and urinary disorders Renal failure acute	0.38% 1/266 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/116 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Injury, poisoning and procedural complications Skin laceration	0.38% 1/266 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/116 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Reproductive system and breast disorders Testicular torsion	0.00% 0/266 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.86% 1/116 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Nervous system disorders Transient ischaemic attack	0.00% 0/266 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.69% 1/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/116 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Nervous system disorders Cerebrovascular accident	1.1% 3/266 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/116 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Cardiac disorders Angina pectoris	0.75% 2/266 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/116 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Cardiac disorders Myocardial infarction	0.38% 1/266 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.69% 1/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/116 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/266 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.86% 1/116 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Nervous system disorders Anoxic encephalopathy	0.00% 0/266 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.69% 1/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/116 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Cardiac disorders Arrhythmia	0.00% 0/266 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.69% 1/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/116 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Cardiac disorders Atrial fibrillation	0.00% 0/266 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.69% 1/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/116 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Cardiac disorders Atrioventricular block	0.38% 1/266 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/116 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/266 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.69% 1/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/116 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Injury, poisoning and procedural complications Cartilage injury	0.38% 1/266 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/116 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Hepatobiliary disorders Cholecystitis chronic	0.38% 1/266 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/116 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Injury, poisoning and procedural complications Contusion	0.38% 1/266 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/116 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Nervous system disorders Convulsion	0.00% 0/266 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.69% 1/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/116 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Cardiac disorders Coronary artery disease	0.38% 1/266 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/116 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Reproductive system and breast disorders Epididymitis	0.38% 1/266 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/116 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Infections and infestations Gastroenteritis norovirus	0.38% 1/266 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/116 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Eye disorders Glaucoma	0.00% 0/266 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.69% 1/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/116 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Vascular disorders Hypertension	0.38% 1/266 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/116 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/266 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.86% 1/116 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Injury, poisoning and procedural complications Incisional hernia	0.38% 1/266 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/116 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Gastrointestinal disorders Large intestine perforation	0.38% 1/266 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/116 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Vascular disorders Peripheral arterial occlusive disease	0.38% 1/266 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/116 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.38% 1/266 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/116 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Infections and infestations Sepsis	0.38% 1/266 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/116 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Nervous system disorders Subarachnoid haemorrhage	0.38% 1/266 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/116 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/266 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.69% 1/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/116 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Renal and urinary disorders Urinary retention	0.38% 1/266 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/116 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Infections and infestations Urinary tract infection	0.38% 1/266 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/116 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Injury, poisoning and procedural complications Wound	0.00% 0/266 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.69% 1/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/116 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Renal and urinary disorders Dysuria	0.00% 0/266 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.69% 1/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/116 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Nervous system disorders Embolic cerebral infarction	0.00% 0/266 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.69% 1/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/116 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/266 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.69% 1/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/116 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.

Other adverse events

Measure	New Generation Influenza Vaccine GSK2186877A Group n=266 participants at risk Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group n=144 participants at risk Subjects aged ≥65 years received 1 dose of Fluarix vaccine	Fluarix Young Group n=116 participants at risk Subjects aged 18-40 years received 1 dose of Fluarix vaccine
General disorders Pain	40.8% 108/265 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	12.5% 18/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	53.0% 61/115 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
General disorders Redness	16.2% 43/265 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	3.5% 5/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	2.6% 3/115 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
General disorders Swelling	7.5% 20/265 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	4.9% 7/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.87% 1/115 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
General disorders Arthralgia	11.3% 30/265 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	4.2% 6/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	8.7% 10/115 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
General disorders Fatigue	19.2% 51/265 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	7.6% 11/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	23.5% 27/115 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
General disorders Gastrointestinal symptoms	9.1% 24/265 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	3.5% 5/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	7.8% 9/115 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
General disorders Headache	14.7% 39/265 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	4.9% 7/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	26.1% 30/115 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
General disorders Myalgia	15.8% 42/265 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	5.6% 8/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	13.9% 16/115 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
General disorders Shivering	14.0% 37/265 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	4.2% 6/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	8.7% 10/115 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Infections and infestations Nasopharyngitis	4.1% 11/266 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	2.8% 4/144 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	6.9% 8/116 • Serious adverse events were assessed during Day 0-20, Day 21-179 and Day 180-209. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 and 21 day post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.

Additional Information

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GlaxoSmithKline

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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