Trial Outcomes & Findings for Study to Evaluate an Influenza Vaccine Candidate (NCT NCT00321373)

Last Updated: 2018-06-08

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

1220 participants

Primary outcome timeframe

At Days 0 and 21 post-vaccination

Results posted on

2018-06-08

Participant Flow

A total of 1220 subjects were enrolled in the study. Study duration was of approximately 6 months (180 days) for all subjects.

Participant milestones

Participant milestones
Measure	GSK1247446A-AS03 Group Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. 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 the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix Group Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Study STARTED	407	406	407
Overall Study COMPLETED	405	406	404
Overall Study NOT COMPLETED	2	0	3

Reasons for withdrawal

Reasons for withdrawal
Measure	GSK1247446A-AS03 Group Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix Group Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Study Adverse Event	0	1
Overall Study Lost to Follow-up	1	1
Overall Study Withdrawal by Subject	1	0
Overall Study Other	0	1

Baseline Characteristics

Study to Evaluate an Influenza Vaccine Candidate

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK1247446A-AS03 Group n=407 Participants Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK1247446A Group n=406 Participants Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix Group n=407 Participants Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Total n=1220 Participants Total of all reporting groups
Age, Continuous	64.0 Years STANDARD_DEVIATION 5.12 • n=5 Participants	64.1 Years STANDARD_DEVIATION 4.95 • n=7 Participants	64.2 Years STANDARD_DEVIATION 5.38 • n=5 Participants	64.1 Years STANDARD_DEVIATION 5.15 • n=4 Participants
Sex: Female, Male Female	209 Participants n=5 Participants	205 Participants n=7 Participants	208 Participants n=5 Participants	622 Participants n=4 Participants
Sex: Female, Male Male	198 Participants n=5 Participants	201 Participants n=7 Participants	199 Participants n=5 Participants	598 Participants n=4 Participants

PRIMARY outcome

Timeframe: At Days 0 and 21 post-vaccination

Population: The analysis was based on the ATP cohort for immunogenicity at Day 21 including subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination at this time point.

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

Outcome measures

Outcome measures
Measure	GSK1247446A-AS03 Group n=395 Participants Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK1247446A Group n=393 Participants Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix Group n=389 Participants Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. 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 Virus B/Malaysia, Day 0 [N=395,393,389]	17.8 titer Interval 16.0 to 19.7	16.0 titer Interval 14.4 to 17.8	15.6 titer Interval 14.0 to 17.4
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus A/New Caledonia, Day 0 [N=395,393,389]	13.4 titer Interval 12.3 to 14.8	13.9 titer Interval 12.6 to 15.3	14.2 titer Interval 13.0 to 15.6
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus A/New York, Day 0 [N=395,393,389]	10.8 titer Interval 9.9 to 11.8	11.9 titer Interval 10.7 to 13.1	11.5 titer Interval 10.5 to 12.7
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus A/New Caledonia, Day 21 [N=395,393,389]	168.0 titer Interval 148.5 to 190.1	97.7 titer Interval 85.7 to 111.3	202.4 titer Interval 177.4 to 230.9
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus A/New York, Day 21 [N=395,393,389]	179.8 titer Interval 159.3 to 202.9	70.4 titer Interval 61.3 to 80.7	104.3 titer Interval 91.5 to 118.9
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus B/Malaysia, Day 21 [N=394,390,389]	341.2 titer Interval 305.7 to 380.9	175.4 titer Interval 154.1 to 199.5	292.0 titer Interval 257.1 to 331.5

SECONDARY outcome

Timeframe: At Day 180 post-vaccination.

Population: The analysis was based on the ATP cohort for immunogenicity at Day 180 including subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination at this time point.

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

Outcome measures

Outcome measures
Measure	GSK1247446A-AS03 Group n=389 Participants Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK1247446A Group n=383 Participants Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix Group n=380 Participants Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. 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 Virus A/New Caledonia at Day180	64.3 titer Interval 57.6 to 71.8	54.3 titer Interval 48.3 to 61.0	84.4 titer Interval 74.8 to 95.3
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus A/New York at Day180	56.8 titer Interval 50.9 to 63.5	35.8 titer Interval 31.7 to 40.3	42.4 titer Interval 37.7 to 47.6
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus B/Malaysia at Day180	88.6 titer Interval 79.0 to 99.3	65.2 titer Interval 58.0 to 73.3	90.9 titer Interval 80.7 to 102.5

SECONDARY outcome

Timeframe: During the 7-day (Days 0-6) follow-up period after vaccination

Population: The analysis was based on the Total Vaccinated Cohort that included all vaccinated subjects with the symptom sheet completed.

Assessed solicited local symptoms were ecchymosis, pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 ecchymosis/redness/swelling = ecchymosis/redness/swelling spreading beyond 50 millimeters (mm) of injection site.

Outcome measures

Outcome measures
Measure	GSK1247446A-AS03 Group n=405 Participants Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK1247446A Group n=404 Participants Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix Group n=406 Participants Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. 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 Pain	246 Subjects	32 Subjects	86 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms. Grade 3 Pain	12 Subjects	0 Subjects	1 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms. Any Ecchymosis	28 Subjects	20 Subjects	19 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms. Ecchymosis > 50mm	1 Subjects	0 Subjects	1 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms. Any Redness	95 Subjects	50 Subjects	65 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms. Redness > 50mm	22 Subjects	1 Subjects	6 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms. Any Swelling	84 Subjects	8 Subjects	50 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms. Swelling > 50mm	19 Subjects	0 Subjects	4 Subjects

SECONDARY outcome

Timeframe: During the 7-day (Days 0-6) follow up period after vaccination

Population: The analysis was based on the Total vaccinated Cohort which included all vaccinated subjects with the symptom sheet completed.

Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as oral temperature equal to or above 37.5 degrees Celsius (°C)\], headache, muscle aches, shivering. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

Outcome measures

Outcome measures
Measure	GSK1247446A-AS03 Group n=405 Participants Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK1247446A Group n=404 Participants Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix Group n=406 Participants Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. 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	80 Subjects	17 Subjects	21 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Arthralgia	6 Subjects	0 Subjects	1 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Arthralgia	73 Subjects	14 Subjects	18 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Any Fatigue	149 Subjects	42 Subjects	47 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Fatigue	6 Subjects	1 Subjects	0 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Fatigue	148 Subjects	36 Subjects	42 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Fever (oral) ≥37.5°C	21 Subjects	4 Subjects	2 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Fever (oral) ≥39.0°C	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Fever	21 Subjects	2 Subjects	1 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Any Headache	104 Subjects	51 Subjects	53 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Headache	5 Subjects	0 Subjects	1 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Headache	100 Subjects	45 Subjects	46 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Any Muscle aches	129 Subjects	31 Subjects	38 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Muscle aches	6 Subjects	0 Subjects	0 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Muscle aches	125 Subjects	28 Subjects	36 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Any Shivering	95 Subjects	19 Subjects	26 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Shivering	10 Subjects	1 Subjects	1 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Shivering	94 Subjects	17 Subjects	22 Subjects

SECONDARY outcome

Timeframe: During the 30-day (Days 0-29) follow-up period after vaccination

Population: The analysis was based on the Total Vaccinated Cohort which included all vaccinated subjects.

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

Outcome measures

Outcome measures
Measure	GSK1247446A-AS03 Group n=407 Participants Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK1247446A Group n=406 Participants Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix Group n=407 Participants Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With Unsolicited Adverse Events (AEs). Subjects with any AEs	114 Subjects	82 Subjects	95 Subjects
Number of Subjects With Unsolicited Adverse Events (AEs). Subjects with Grade 3 AEs	13 Subjects	11 Subjects	16 Subjects
Number of Subjects With Unsolicited Adverse Events (AEs). Subjects with related AEs	43 Subjects	19 Subjects	19 Subjects

SECONDARY outcome

Timeframe: During the entire study period (Day 0 to Day 180)

Population: The analysis was based 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 or result in disability/incapacity. Any = occurrence of any SAE regardless of intensity grade or relation to vaccination. Related = SAE assessed by the investigator as related to the vaccination.

Outcome measures

Outcome measures
Measure	GSK1247446A-AS03 Group n=407 Participants Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK1247446A Group n=406 Participants Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix Group n=407 Participants Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. 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) Subjects with any SAE(s)	8 Subjects	13 Subjects	13 Subjects
Number of Subjects With Any and Related Serious Adverse Events (SAEs) Subjects with related SAE(s)	2 Subjects	1 Subjects	0 Subjects

Adverse Events

GSK1247446A-AS03 Group

Serious events: 8 serious events

Other events: 302 other events

Deaths: 0 deaths

GSK1247446A Group

Serious events: 13 serious events

Other events: 143 other events

Deaths: 0 deaths

Fluarix Group

Serious events: 13 serious events

Other events: 181 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	GSK1247446A-AS03 Group n=407 participants at risk Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK1247446A Group n=406 participants at risk Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix Group n=407 participants at risk Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
General disorders Arthralgia	19.7% 80/407 • SAEs were collected during the entire study (Days 0-180). AEs were collected during the 30-day (Days 0-29) post-vaccination period. Solicited local/general symptoms were collected during the 7-day (Days 0-6) post-vaccination period. Non-serious AEs included solicited symptoms that were assessed on a subset of the Total Vaccinated Cohort, comprised of subjects who had symptom sheets completed.	4.2% 17/406 • SAEs were collected during the entire study (Days 0-180). AEs were collected during the 30-day (Days 0-29) post-vaccination period. Solicited local/general symptoms were collected during the 7-day (Days 0-6) post-vaccination period. Non-serious AEs included solicited symptoms that were assessed on a subset of the Total Vaccinated Cohort, comprised of subjects who had symptom sheets completed.	5.2% 21/407 • SAEs were collected during the entire study (Days 0-180). AEs were collected during the 30-day (Days 0-29) post-vaccination period. Solicited local/general symptoms were collected during the 7-day (Days 0-6) post-vaccination period. Non-serious AEs included solicited symptoms that were assessed on a subset of the Total Vaccinated Cohort, comprised of subjects who had symptom sheets completed.
General disorders Fatigue	36.6% 149/407 • SAEs were collected during the entire study (Days 0-180). AEs were collected during the 30-day (Days 0-29) post-vaccination period. Solicited local/general symptoms were collected during the 7-day (Days 0-6) post-vaccination period. Non-serious AEs included solicited symptoms that were assessed on a subset of the Total Vaccinated Cohort, comprised of subjects who had symptom sheets completed.	10.3% 42/406 • SAEs were collected during the entire study (Days 0-180). AEs were collected during the 30-day (Days 0-29) post-vaccination period. Solicited local/general symptoms were collected during the 7-day (Days 0-6) post-vaccination period. Non-serious AEs included solicited symptoms that were assessed on a subset of the Total Vaccinated Cohort, comprised of subjects who had symptom sheets completed.	11.5% 47/407 • SAEs were collected during the entire study (Days 0-180). AEs were collected during the 30-day (Days 0-29) post-vaccination period. Solicited local/general symptoms were collected during the 7-day (Days 0-6) post-vaccination period. Non-serious AEs included solicited symptoms that were assessed on a subset of the Total Vaccinated Cohort, comprised of subjects who had symptom sheets completed.
General disorders Fever	5.2% 21/407 • SAEs were collected during the entire study (Days 0-180). AEs were collected during the 30-day (Days 0-29) post-vaccination period. Solicited local/general symptoms were collected during the 7-day (Days 0-6) post-vaccination period. Non-serious AEs included solicited symptoms that were assessed on a subset of the Total Vaccinated Cohort, comprised of subjects who had symptom sheets completed.	0.99% 4/406 • SAEs were collected during the entire study (Days 0-180). AEs were collected during the 30-day (Days 0-29) post-vaccination period. Solicited local/general symptoms were collected during the 7-day (Days 0-6) post-vaccination period. Non-serious AEs included solicited symptoms that were assessed on a subset of the Total Vaccinated Cohort, comprised of subjects who had symptom sheets completed.	0.49% 2/407 • SAEs were collected during the entire study (Days 0-180). AEs were collected during the 30-day (Days 0-29) post-vaccination period. Solicited local/general symptoms were collected during the 7-day (Days 0-6) post-vaccination period. Non-serious AEs included solicited symptoms that were assessed on a subset of the Total Vaccinated Cohort, comprised of subjects who had symptom sheets completed.
General disorders Headache	25.6% 104/407 • SAEs were collected during the entire study (Days 0-180). AEs were collected during the 30-day (Days 0-29) post-vaccination period. Solicited local/general symptoms were collected during the 7-day (Days 0-6) post-vaccination period. Non-serious AEs included solicited symptoms that were assessed on a subset of the Total Vaccinated Cohort, comprised of subjects who had symptom sheets completed.	12.6% 51/406 • SAEs were collected during the entire study (Days 0-180). AEs were collected during the 30-day (Days 0-29) post-vaccination period. Solicited local/general symptoms were collected during the 7-day (Days 0-6) post-vaccination period. Non-serious AEs included solicited symptoms that were assessed on a subset of the Total Vaccinated Cohort, comprised of subjects who had symptom sheets completed.	13.0% 53/407 • SAEs were collected during the entire study (Days 0-180). AEs were collected during the 30-day (Days 0-29) post-vaccination period. Solicited local/general symptoms were collected during the 7-day (Days 0-6) post-vaccination period. Non-serious AEs included solicited symptoms that were assessed on a subset of the Total Vaccinated Cohort, comprised of subjects who had symptom sheets completed.
General disorders Muscle aches	31.7% 129/407 • SAEs were collected during the entire study (Days 0-180). AEs were collected during the 30-day (Days 0-29) post-vaccination period. Solicited local/general symptoms were collected during the 7-day (Days 0-6) post-vaccination period. Non-serious AEs included solicited symptoms that were assessed on a subset of the Total Vaccinated Cohort, comprised of subjects who had symptom sheets completed.	7.6% 31/406 • SAEs were collected during the entire study (Days 0-180). AEs were collected during the 30-day (Days 0-29) post-vaccination period. Solicited local/general symptoms were collected during the 7-day (Days 0-6) post-vaccination period. Non-serious AEs included solicited symptoms that were assessed on a subset of the Total Vaccinated Cohort, comprised of subjects who had symptom sheets completed.	9.3% 38/407 • SAEs were collected during the entire study (Days 0-180). AEs were collected during the 30-day (Days 0-29) post-vaccination period. Solicited local/general symptoms were collected during the 7-day (Days 0-6) post-vaccination period. Non-serious AEs included solicited symptoms that were assessed on a subset of the Total Vaccinated Cohort, comprised of subjects who had symptom sheets completed.
General disorders Shivering	23.3% 95/407 • SAEs were collected during the entire study (Days 0-180). AEs were collected during the 30-day (Days 0-29) post-vaccination period. Solicited local/general symptoms were collected during the 7-day (Days 0-6) post-vaccination period. Non-serious AEs included solicited symptoms that were assessed on a subset of the Total Vaccinated Cohort, comprised of subjects who had symptom sheets completed.	4.7% 19/406 • SAEs were collected during the entire study (Days 0-180). AEs were collected during the 30-day (Days 0-29) post-vaccination period. Solicited local/general symptoms were collected during the 7-day (Days 0-6) post-vaccination period. Non-serious AEs included solicited symptoms that were assessed on a subset of the Total Vaccinated Cohort, comprised of subjects who had symptom sheets completed.	6.4% 26/407 • SAEs were collected during the entire study (Days 0-180). AEs were collected during the 30-day (Days 0-29) post-vaccination period. Solicited local/general symptoms were collected during the 7-day (Days 0-6) post-vaccination period. Non-serious AEs included solicited symptoms that were assessed on a subset of the Total Vaccinated Cohort, comprised of subjects who had symptom sheets completed.
General disorders Ecchymosis	6.9% 28/407 • SAEs were collected during the entire study (Days 0-180). AEs were collected during the 30-day (Days 0-29) post-vaccination period. Solicited local/general symptoms were collected during the 7-day (Days 0-6) post-vaccination period. Non-serious AEs included solicited symptoms that were assessed on a subset of the Total Vaccinated Cohort, comprised of subjects who had symptom sheets completed.	4.9% 20/406 • SAEs were collected during the entire study (Days 0-180). AEs were collected during the 30-day (Days 0-29) post-vaccination period. Solicited local/general symptoms were collected during the 7-day (Days 0-6) post-vaccination period. Non-serious AEs included solicited symptoms that were assessed on a subset of the Total Vaccinated Cohort, comprised of subjects who had symptom sheets completed.	4.7% 19/407 • SAEs were collected during the entire study (Days 0-180). AEs were collected during the 30-day (Days 0-29) post-vaccination period. Solicited local/general symptoms were collected during the 7-day (Days 0-6) post-vaccination period. Non-serious AEs included solicited symptoms that were assessed on a subset of the Total Vaccinated Cohort, comprised of subjects who had symptom sheets completed.
General disorders Pain	60.4% 246/407 • SAEs were collected during the entire study (Days 0-180). AEs were collected during the 30-day (Days 0-29) post-vaccination period. Solicited local/general symptoms were collected during the 7-day (Days 0-6) post-vaccination period. Non-serious AEs included solicited symptoms that were assessed on a subset of the Total Vaccinated Cohort, comprised of subjects who had symptom sheets completed.	7.9% 32/406 • SAEs were collected during the entire study (Days 0-180). AEs were collected during the 30-day (Days 0-29) post-vaccination period. Solicited local/general symptoms were collected during the 7-day (Days 0-6) post-vaccination period. Non-serious AEs included solicited symptoms that were assessed on a subset of the Total Vaccinated Cohort, comprised of subjects who had symptom sheets completed.	21.1% 86/407 • SAEs were collected during the entire study (Days 0-180). AEs were collected during the 30-day (Days 0-29) post-vaccination period. Solicited local/general symptoms were collected during the 7-day (Days 0-6) post-vaccination period. Non-serious AEs included solicited symptoms that were assessed on a subset of the Total Vaccinated Cohort, comprised of subjects who had symptom sheets completed.
General disorders Redness	23.3% 95/407 • SAEs were collected during the entire study (Days 0-180). AEs were collected during the 30-day (Days 0-29) post-vaccination period. Solicited local/general symptoms were collected during the 7-day (Days 0-6) post-vaccination period. Non-serious AEs included solicited symptoms that were assessed on a subset of the Total Vaccinated Cohort, comprised of subjects who had symptom sheets completed.	12.3% 50/406 • SAEs were collected during the entire study (Days 0-180). AEs were collected during the 30-day (Days 0-29) post-vaccination period. Solicited local/general symptoms were collected during the 7-day (Days 0-6) post-vaccination period. Non-serious AEs included solicited symptoms that were assessed on a subset of the Total Vaccinated Cohort, comprised of subjects who had symptom sheets completed.	16.0% 65/407 • SAEs were collected during the entire study (Days 0-180). AEs were collected during the 30-day (Days 0-29) post-vaccination period. Solicited local/general symptoms were collected during the 7-day (Days 0-6) post-vaccination period. Non-serious AEs included solicited symptoms that were assessed on a subset of the Total Vaccinated Cohort, comprised of subjects who had symptom sheets completed.
General disorders Swelling	20.6% 84/407 • SAEs were collected during the entire study (Days 0-180). AEs were collected during the 30-day (Days 0-29) post-vaccination period. Solicited local/general symptoms were collected during the 7-day (Days 0-6) post-vaccination period. Non-serious AEs included solicited symptoms that were assessed on a subset of the Total Vaccinated Cohort, comprised of subjects who had symptom sheets completed.	2.0% 8/406 • SAEs were collected during the entire study (Days 0-180). AEs were collected during the 30-day (Days 0-29) post-vaccination period. Solicited local/general symptoms were collected during the 7-day (Days 0-6) post-vaccination period. Non-serious AEs included solicited symptoms that were assessed on a subset of the Total Vaccinated Cohort, comprised of subjects who had symptom sheets completed.	12.3% 50/407 • SAEs were collected during the entire study (Days 0-180). AEs were collected during the 30-day (Days 0-29) post-vaccination period. Solicited local/general symptoms were collected during the 7-day (Days 0-6) post-vaccination period. Non-serious AEs included solicited symptoms that were assessed on a subset of the Total Vaccinated Cohort, comprised of subjects who had symptom sheets completed.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

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

Restriction type: OTHER