Trial Outcomes & Findings for Study to Evaluate the Immunogenicity and Safety of a Second Vaccination With the Adjuvanted Influenza Vaccine Candidate (NCT NCT00385840)

Last Updated: 2018-06-08

Results Overview

Assessed solicited local symptoms were ecchymosis, pain, redness and swelling. Any = Incidence of a particular solicited local symptom regardless of intensity grade. Grade 3 pain = Pain that prevented normal everyday activity. Grade 3 redness/swelling/ecchymosis = Redness/swelling/ecchymosis above 50 millimeters (mm).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

678 participants

Primary outcome timeframe

During the 7-day (Days 0-6) post-vaccination period

Results posted on

2018-06-08

Participant Flow

Participant milestones

Participant milestones
Measure	Fluarix Group Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK1247446A Group Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Study STARTED	133	545
Overall Study COMPLETED	129	531
Overall Study NOT COMPLETED	4	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Fluarix Group Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK1247446A Group Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Study Adverse Event	1	1
Overall Study Lost to Follow-up	3	13

Baseline Characteristics

Study to Evaluate the Immunogenicity and Safety of a Second Vaccination With the Adjuvanted Influenza Vaccine Candidate

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fluarix Group n=133 Participants Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK1247446A Group n=545 Participants Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Total n=678 Participants Total of all reporting groups
Age, Continuous	68.1 Years STANDARD_DEVIATION 5.78 • n=5 Participants	68.4 Years STANDARD_DEVIATION 5.95 • n=7 Participants	68.3 Years STANDARD_DEVIATION 5.91 • n=5 Participants
Sex: Female, Male Female	82 Participants n=5 Participants	284 Participants n=7 Participants	366 Participants n=5 Participants
Sex: Female, Male Male	51 Participants n=5 Participants	261 Participants n=7 Participants	312 Participants n=5 Participants

PRIMARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination period

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

Outcome measures

Outcome measures
Measure	Fluarix Group n=131 Participants Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK1247446A Group n=542 Participants Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms. Any Swelling	16 subjects	186 subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms. Any Ecchymosis	2 subjects	14 subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms. Grade 3 Ecchymosis	0 subjects	1 subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms. Any Pain	27 subjects	282 subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms. Grade 3 Pain	0 subjects	0 subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms. Any Redness	28 subjects	245 subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms. Grade 3 Redness	4 subjects	102 subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms. Grade 3 Swelling	2 subjects	56 subjects

PRIMARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination period

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

Assessed solicited general symptoms were arthralgia, fatigue, fever, headache, muscle aches and shivering. Any = Incidence of a particular solicited general symptom regardless of intensity grade or relationship with the study vaccination. Any Fever = Axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C). Grade 3 symptom = Symptom that prevented normal activity. Grade 3 fever = Axillary temperature \> 39.0°C. Related = Symptom considered by the investigator to have a causal relationship to study vaccination.

Outcome measures

Outcome measures
Measure	Fluarix Group n=131 Participants Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK1247446A Group n=542 Participants Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Any Arthralgia	10 subjects	96 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Arthralgia	0 subjects	3 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Arthralgia	7 subjects	78 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Any Fatigue	16 subjects	152 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Fatigue	0 subjects	5 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Fatigue	13 subjects	130 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Any Fever	1 subjects	35 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Fever	0 subjects	1 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Fever	0 subjects	29 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Any Headache	15 subjects	140 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Headache	0 subjects	1 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Headache	10 subjects	116 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Any Muscle aches	12 subjects	179 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Muscle aches	0 subjects	8 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Muscle aches	6 subjects	154 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Any Shivering	11 subjects	120 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Shivering	0 subjects	12 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Shivering	6 subjects	102 subjects

PRIMARY outcome

Timeframe: During the 30-day (Days 0-29) post vaccination period

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

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

Outcome measures

Outcome measures
Measure	Fluarix Group n=133 Participants Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK1247446A Group n=545 Participants Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). Any unsolicited AE(s)	31 subjects	121 subjects
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). Grade 3 unsolicited AE(s)	1 subjects	9 subjects
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). Related unsolicited AE(s)	4 subjects	34 subjects

PRIMARY outcome

Timeframe: During the entire study period (from Day 0 to Day 29)

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

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 SAE = Occurrence of any SAE regardless of intensity grade or relation to vaccination Related = SAE considered by the investigator to have a causal relationship to study vaccination.

Outcome measures

Outcome measures
Measure	Fluarix Group n=133 Participants Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK1247446A Group n=545 Participants Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With Any and Related Serious Adverse Events (SAEs). Any SAE(s)	1 subjects	2 subjects
Number of Subjects With Any and Related Serious Adverse Events (SAEs). Related SAE(s)	0 subjects	0 subjects

SECONDARY outcome

Timeframe: At Day 0 and Day 21

Population: The analysis was performed on the According-To-Protocol (ATP) cohort, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom results were available for antibodies against at least one study vaccine antigen component.

Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia. The seropositivity cut-off assay was 1:10.

Outcome measures

Outcome measures
Measure	Fluarix Group n=125 Participants Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK1247446A Group n=513 Participants Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. A/New Caledonia at Day 0	65.9 titers Interval 54.4 to 79.9	61.8 titers Interval 56.6 to 67.3
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. A/New Caledonia at Day 21	111.6 titers Interval 94.3 to 132.2	114.4 titers Interval 105.8 to 123.8
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. A/Wisconsin at Day 0	59.4 titers Interval 46.2 to 76.4	82.0 titers Interval 72.6 to 92.5
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. A/Wisconsin at Day 21	187.4 titers Interval 151.2 to 232.1	370.0 titers Interval 339.2 to 403.6
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. B/Malaysia at Day 0	100.2 titers Interval 83.1 to 120.7	112.1 titers Interval 101.7 to 123.6
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. B/Malaysia at Day 21	158.7 titers Interval 132.6 to 189.9	232.4 titers Interval 215.1 to 251.0

SECONDARY outcome

Timeframe: At Day 21

A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \<1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.

Outcome measures

Outcome measures
Measure	Fluarix Group n=125 Participants Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK1247446A Group n=513 Participants Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. A/New Caledonia	21 subjects	78 subjects
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. A/Wisconsin	52 subjects	271 subjects
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. B/Malaysia	10 subjects	99 subjects

SECONDARY outcome

Timeframe: At Day 0 and Day 21

A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.

Outcome measures

Outcome measures
Measure	Fluarix Group n=125 Participants Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK1247446A Group n=513 Participants Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. A/New Caledonia at Day 0	100 subjects	381 subjects
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. A/New Caledonia at Day 21	119 subjects	483 subjects
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. A/Wisconsin at Day 0	81 subjects	397 subjects
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. A/Wisconsin at Day 21	117 subjects	507 subjects
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. B/Malaysia at Day 0	111 subjects	442 subjects
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. B/Malaysia at Day 21	118 subjects	507 subjects

SECONDARY outcome

Timeframe: At Day 21

The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.

Outcome measures

Outcome measures
Measure	Fluarix Group n=125 Participants Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK1247446A Group n=513 Participants Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. A/New Caledonia	1.7 fold increase Interval 1.5 to 1.9	1.9 fold increase Interval 1.8 to 2.0
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. A/Wisconsin	3.2 fold increase Interval 2.6 to 3.8	4.5 fold increase Interval 4.1 to 5.0
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. B/Malaysia	1.6 fold increase Interval 1.4 to 1.7	2.1 fold increase Interval 1.9 to 2.2

Adverse Events

Fluarix Group

Serious events: 1 serious events

Other events: 66 other events

Deaths: 0 deaths

GSK1247446A Group

Serious events: 2 serious events

Other events: 434 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Fluarix Group n=133 participants at risk Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK1247446A Group n=545 participants at risk Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Hepatobiliary disorders Cholelithiasis	0.00% 0/133 • SAE(s): during the entire study period (Days 0-29); Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post vaccination period. For the systematically assessed other non-serious AEs, the number of participants at risk included those from Total Vaccinated cohort whose symptom sheet had been completed.	0.18% 1/545 • SAE(s): during the entire study period (Days 0-29); Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post vaccination period. For the systematically assessed other non-serious AEs, the number of participants at risk included those from Total Vaccinated cohort whose symptom sheet had been completed.
Gastrointestinal disorders Pancreatitis	0.00% 0/133 • SAE(s): during the entire study period (Days 0-29); Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post vaccination period. For the systematically assessed other non-serious AEs, the number of participants at risk included those from Total Vaccinated cohort whose symptom sheet had been completed.	0.18% 1/545 • SAE(s): during the entire study period (Days 0-29); Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post vaccination period. For the systematically assessed other non-serious AEs, the number of participants at risk included those from Total Vaccinated cohort whose symptom sheet had been completed.
Infections and infestations Pneumonia	0.75% 1/133 • SAE(s): during the entire study period (Days 0-29); Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post vaccination period. For the systematically assessed other non-serious AEs, the number of participants at risk included those from Total Vaccinated cohort whose symptom sheet had been completed.	0.00% 0/545 • SAE(s): during the entire study period (Days 0-29); Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post vaccination period. For the systematically assessed other non-serious AEs, the number of participants at risk included those from Total Vaccinated cohort whose symptom sheet had been completed.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.75% 1/133 • SAE(s): during the entire study period (Days 0-29); Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post vaccination period. For the systematically assessed other non-serious AEs, the number of participants at risk included those from Total Vaccinated cohort whose symptom sheet had been completed.	0.00% 0/545 • SAE(s): during the entire study period (Days 0-29); Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post vaccination period. For the systematically assessed other non-serious AEs, the number of participants at risk included those from Total Vaccinated cohort whose symptom sheet had been completed.
General disorders Sudden death	0.00% 0/133 • SAE(s): during the entire study period (Days 0-29); Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post vaccination period. For the systematically assessed other non-serious AEs, the number of participants at risk included those from Total Vaccinated cohort whose symptom sheet had been completed.	0.18% 1/545 • SAE(s): during the entire study period (Days 0-29); Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post vaccination period. For the systematically assessed other non-serious AEs, the number of participants at risk included those from Total Vaccinated cohort whose symptom sheet had been completed.

Other adverse events

Other adverse events
Measure	Fluarix Group n=133 participants at risk Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK1247446A Group n=545 participants at risk Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Infections and infestations Nasopharyngitis	9.8% 13/133 • SAE(s): during the entire study period (Days 0-29); Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post vaccination period. For the systematically assessed other non-serious AEs, the number of participants at risk included those from Total Vaccinated cohort whose symptom sheet had been completed.	6.1% 33/545 • SAE(s): during the entire study period (Days 0-29); Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post vaccination period. For the systematically assessed other non-serious AEs, the number of participants at risk included those from Total Vaccinated cohort whose symptom sheet had been completed.
General disorders Pain	20.6% 27/131 • SAE(s): during the entire study period (Days 0-29); Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post vaccination period. For the systematically assessed other non-serious AEs, the number of participants at risk included those from Total Vaccinated cohort whose symptom sheet had been completed.	52.0% 282/542 • SAE(s): during the entire study period (Days 0-29); Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post vaccination period. For the systematically assessed other non-serious AEs, the number of participants at risk included those from Total Vaccinated cohort whose symptom sheet had been completed.
General disorders Redness	21.4% 28/131 • SAE(s): during the entire study period (Days 0-29); Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post vaccination period. For the systematically assessed other non-serious AEs, the number of participants at risk included those from Total Vaccinated cohort whose symptom sheet had been completed.	45.2% 245/542 • SAE(s): during the entire study period (Days 0-29); Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post vaccination period. For the systematically assessed other non-serious AEs, the number of participants at risk included those from Total Vaccinated cohort whose symptom sheet had been completed.
General disorders Swelling	12.2% 16/131 • SAE(s): during the entire study period (Days 0-29); Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post vaccination period. For the systematically assessed other non-serious AEs, the number of participants at risk included those from Total Vaccinated cohort whose symptom sheet had been completed.	34.3% 186/542 • SAE(s): during the entire study period (Days 0-29); Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post vaccination period. For the systematically assessed other non-serious AEs, the number of participants at risk included those from Total Vaccinated cohort whose symptom sheet had been completed.
General disorders Arthralgia	7.6% 10/131 • SAE(s): during the entire study period (Days 0-29); Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post vaccination period. For the systematically assessed other non-serious AEs, the number of participants at risk included those from Total Vaccinated cohort whose symptom sheet had been completed.	17.7% 96/542 • SAE(s): during the entire study period (Days 0-29); Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post vaccination period. For the systematically assessed other non-serious AEs, the number of participants at risk included those from Total Vaccinated cohort whose symptom sheet had been completed.
General disorders Fatigue	12.2% 16/131 • SAE(s): during the entire study period (Days 0-29); Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post vaccination period. For the systematically assessed other non-serious AEs, the number of participants at risk included those from Total Vaccinated cohort whose symptom sheet had been completed.	28.0% 152/542 • SAE(s): during the entire study period (Days 0-29); Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post vaccination period. For the systematically assessed other non-serious AEs, the number of participants at risk included those from Total Vaccinated cohort whose symptom sheet had been completed.
General disorders Fever	0.76% 1/131 • SAE(s): during the entire study period (Days 0-29); Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post vaccination period. For the systematically assessed other non-serious AEs, the number of participants at risk included those from Total Vaccinated cohort whose symptom sheet had been completed.	6.5% 35/542 • SAE(s): during the entire study period (Days 0-29); Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post vaccination period. For the systematically assessed other non-serious AEs, the number of participants at risk included those from Total Vaccinated cohort whose symptom sheet had been completed.
General disorders Headache	11.5% 15/131 • SAE(s): during the entire study period (Days 0-29); Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post vaccination period. For the systematically assessed other non-serious AEs, the number of participants at risk included those from Total Vaccinated cohort whose symptom sheet had been completed.	25.8% 140/542 • SAE(s): during the entire study period (Days 0-29); Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post vaccination period. For the systematically assessed other non-serious AEs, the number of participants at risk included those from Total Vaccinated cohort whose symptom sheet had been completed.
General disorders Muscle aches	9.2% 12/131 • SAE(s): during the entire study period (Days 0-29); Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post vaccination period. For the systematically assessed other non-serious AEs, the number of participants at risk included those from Total Vaccinated cohort whose symptom sheet had been completed.	33.0% 179/542 • SAE(s): during the entire study period (Days 0-29); Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post vaccination period. For the systematically assessed other non-serious AEs, the number of participants at risk included those from Total Vaccinated cohort whose symptom sheet had been completed.
General disorders Shivering	8.4% 11/131 • SAE(s): during the entire study period (Days 0-29); Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post vaccination period. For the systematically assessed other non-serious AEs, the number of participants at risk included those from Total Vaccinated cohort whose symptom sheet had been completed.	22.1% 120/542 • SAE(s): during the entire study period (Days 0-29); Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AE(s): during the 30-day (Days 0-29) post vaccination period. For the systematically assessed other non-serious AEs, the number of participants at risk included those from Total Vaccinated cohort whose symptom sheet had been completed.

Additional Information

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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.
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