Trial Outcomes & Findings for Study to Evaluate the Safety and Immunogenicity of a Pandemic Influenza Vaccine in Adults Aged 18 Years and Above (NCT NCT00319098)

NCT ID: NCT00319098

Last Updated: 2018-07-23

Results Overview

Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of symptom regardless of intensity grade. Grade 3 Pain = pain that prevented normal everyday activities Grade 3 ecchymosis/induration/redness/swelling = redness/swelling spreading beyond (\>) 50 millimeters (mm) in diameter

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

5075 participants

Primary outcome timeframe

During a 7 day follow-up period after each dose of vaccine and overall.

Results posted on

2018-07-23

Participant Flow

Out of the 5075 subjects enrolled in this study, 4 subjects did not receive any study vaccine and were hence excluded from study start.

Participant milestones

Participant milestones
Measure	GSK1562902A Group Male and female subjects aged 18 or over received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm. The group was further stratified by age for analyses.	Fluarix+Placebo Group Male and female subjects aged 18 or over received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm. The group was further stratified by age for analyses.
Overall Study STARTED	3802	1269
Overall Study COMPLETED	3667	1237
Overall Study NOT COMPLETED	135	32

Reasons for withdrawal

Reasons for withdrawal
Measure	GSK1562902A Group Male and female subjects aged 18 or over received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm. The group was further stratified by age for analyses.	Fluarix+Placebo Group Male and female subjects aged 18 or over received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm. The group was further stratified by age for analyses.
Overall Study Serious adverse event	3	0
Overall Study Adverse Event	20	1
Overall Study Withdrawal by Subject	37	8
Overall Study Migrated/moved from study area	2	1
Overall Study Lost to Follow-up	37	13
Overall Study Others	33	8
Overall Study Protocol Violation	3	1

Baseline Characteristics

Study to Evaluate the Safety and Immunogenicity of a Pandemic Influenza Vaccine in Adults Aged 18 Years and Above

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK1562902A 18-60 YOA Group n=3397 Participants Male and female subjects 18-60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.	GSK1562902A >60 YOA Group n=405 Participants Male and female subjects over (\>) 60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.	Fluarix+Placebo 18-60 YOA Group n=1136 Participants Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.	Fluarix+Placebo >60 YOA Group n=133 Participants Male and female subjects over (\>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.	Total n=5071 Participants Total of all reporting groups
Age, Continuous	34.8 Years STANDARD_DEVIATION 12.24 • n=5 Participants	67.3 Years STANDARD_DEVIATION 6.01 • n=7 Participants	35.4 Years STANDARD_DEVIATION 12.51 • n=5 Participants	66.6 Years STANDARD_DEVIATION 5.20 • n=4 Participants	38.36 Years STANDARD_DEVIATION 15.40 • n=21 Participants
Sex: Female, Male Female	2018 Participants n=5 Participants	187 Participants n=7 Participants	691 Participants n=5 Participants	56 Participants n=4 Participants	2952 Participants n=21 Participants
Sex: Female, Male Male	1379 Participants n=5 Participants	218 Participants n=7 Participants	445 Participants n=5 Participants	77 Participants n=4 Participants	2119 Participants n=21 Participants

PRIMARY outcome

Timeframe: During a 7 day follow-up period after each dose of vaccine and overall.

Population: The analysis was performed on the Total Vaccinated cohort (TVc) which included all vaccinated subjects for whom data were available and with the symptom sheet filled in.

Outcome measures

Outcome measures
Measure	GSK1562902A 18-60 YOA Group n=3343 Participants Male and female subjects 18-60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.	GSK1562902A >60 YOA Group n=403 Participants Male and female subjects over (\>) 60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.	Fluarix+Placebo 18-60 YOA Group n=1123 Participants Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.	Fluarix+Placebo >60 YOA Group n=133 Participants Male and female subjects over (\>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
Number of Subjects With Solicited Local Symptoms Grade 3 Swelling, Across [N=3343;1123;133]	189 Participants	22 Participants	12 Participants	1 Participants
Number of Subjects With Solicited Local Symptoms Any Redness, Across [N=3343;403;1123;133]	1277 Participants	165 Participants	312 Participants	38 Participants
Number of Subjects With Solicited Local Symptoms Any Ecchymosis, Dose 1 [N=3342;403;1123;133]	212 Participants	16 Participants	39 Participants	3 Participants
Number of Subjects With Solicited Local Symptoms Grade 3 Ecchymosis, Dose 1[N=3342;403;1123;133]	8 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms Any Induration, Dose 1[N=3342;403;1123;133]	876 Participants	73 Participants	199 Participants	17 Participants
Number of Subjects With Solicited Local Symptoms Grade 3 Induration, Dose 1[N=3342;403;1123;133]	96 Participants	6 Participants	10 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms Any Pain, Dose 1[N=3342;403;1123;133]	2926 Participants	233 Participants	724 Participants	36 Participants
Number of Subjects With Solicited Local Symptoms Grade 3 Pain, Dose 1[N=3342;403;1123;133]	169 Participants	3 Participants	6 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms Any Redness, Dose 1[N=3342;403;1123;133]	910 Participants	112 Participants	281 Participants	34 Participants
Number of Subjects With Solicited Local Symptoms Grade 3 Redness, Dose 1[N=3342;403;1123;133]	128 Participants	12 Participants	17 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms Any Swelling, Dose 1[N=3342;403;1123;133]	812 Participants	88 Participants	176 Participants	15 Participants
Number of Subjects With Solicited Local Symptoms Grade 3 Swelling, Dose 1[N=3342;403;1123;133]	134 Participants	12 Participants	12 Participants	1 Participants
Number of Subjects With Solicited Local Symptoms Any Ecchymosis, Dose 2 [N=3247;395;1102;132]	144 Participants	16 Participants	31 Participants	3 Participants
Number of Subjects With Solicited Local Symptoms Grade 3 Ecchymosis, Dose 2 [N=3247;395;1102;132]	3 Participants	1 Participants	1 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms Any Induration, Dose 2 [N=3247;395;1102;132]	734 Participants	75 Participants	41 Participants	5 Participants
Number of Subjects With Solicited Local Symptoms Grade 3 Induration, Dose 2 [N=3247;395;1102;132]	81 Participants	7 Participants	0 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms Any Pain, Dose 2 [N=3247;395;1102;132]	2451 Participants	199 Participants	173 Participants	8 Participants
Number of Subjects With Solicited Local Symptoms Grade 3 Pain, Dose 2 [N=3247;395;1102;132]	77 Participants	1 Participants	2 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms Any Redness, Dose 2 [N=3247;395;1102;132]	819 Participants	105 Participants	93 Participants	16 Participants
Number of Subjects With Solicited Local Symptoms Grade 3 Redness, Dose 2 [N=3247;395;1102;132]	168 Participants	25 Participants	1 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms Any Swelling, Dose 2 [N=3247;395;1102.132]	719 Participants	89 Participants	42 Participants	4 Participants
Number of Subjects With Solicited Local Symptoms Grade 3 Swelling, Dose 2 [N=3247;395;1102;132]	96 Participants	11 Participants	0 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms Any Ecchymosis, Across [N=3343;403;1123;133]	320 Participants	29 Participants	65 Participants	5 Participants
Number of Subjects With Solicited Local Symptoms Grade 3 Ecchymosis, Across [N=3343;403;1123;133]	11 Participants	2 Participants	1 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms Any Induration, Across [N=3343;403;1123;133]	1150 Participants	108 Participants	215 Participants	19 Participants
Number of Subjects With Solicited Local Symptoms Grade 3 Induration, Across [N=3343;403;1123;133]	148 Participants	12 Participants	10 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms Any Pain, Across [N=3343;403;1123;133]	3037 Participants	271 Participants	748 Participants	39 Participants
Number of Subjects With Solicited Local Symptoms Grade 3 Pain, Across [N=3343;403;1123;133]	221 Participants	4 Participants	8 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms Grade 3 Redness, Across [N=3343;403;1123;133]	250 Participants	36 Participants	17 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms Any Swelling, Across [N=3343;1123;133]	1107 Participants	133 Participants	196 Participants	17 Participants

PRIMARY outcome

Timeframe: During the 7-day (Days 0-6) after Dose 1

Population: The analysis was performed on the TVc which included all vaccinated subjects for whom data were available and with the symptom sheet filled in.

Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], headache, myalgia, shivering, sweating. Any = occurrence of symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 Fever = fever higher than (\>) 39.0 °C. Related = symptom considered by the investigator to be casually related with the study vaccination.

Outcome measures

Outcome measures
Measure	GSK1562902A 18-60 YOA Group n=3341 Participants Male and female subjects 18-60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.	GSK1562902A >60 YOA Group n=403 Participants Male and female subjects over (\>) 60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.	Fluarix+Placebo 18-60 YOA Group n=1123 Participants Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.	Fluarix+Placebo >60 YOA Group n=133 Participants Male and female subjects over (\>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
Number of Subjects With Solicited General Symptoms (Dose 1) Any Arthralgia, Dose 1	625 Participants	57 Participants	100 Participants	13 Participants
Number of Subjects With Solicited General Symptoms (Dose 1) Grade 3 Arthralgia, Dose 1	47 Participants	1 Participants	3 Participants	1 Participants
Number of Subjects With Solicited General Symptoms (Dose 1) Related Arthralgia, Dose 1	583 Participants	46 Participants	86 Participants	11 Participants
Number of Subjects With Solicited General Symptoms (Dose 1) Any Fatigue, Dose 1	1384 Participants	80 Participants	284 Participants	20 Participants
Number of Subjects With Solicited General Symptoms (Dose 1) Grade 3 Fatigue, Dose 1	90 Participants	3 Participants	4 Participants	2 Participants
Number of Subjects With Solicited General Symptoms (Dose 1) Related Fatigue, Dose 1	1220 Participants	67 Participants	235 Participants	15 Participants
Number of Subjects With Solicited General Symptoms (Dose 1) Any Fever, Dose 1	270 Participants	10 Participants	24 Participants	6 Participants
Number of Subjects With Solicited General Symptoms (Dose 1) Grade 3 Fever, Dose 1	7 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Solicited General Symptoms (Dose 1) Related Fever, Dose 1	243 Participants	8 Participants	20 Participants	5 Participants
Number of Subjects With Solicited General Symptoms (Dose 1) Any Headache, Dose 1	1159 Participants	79 Participants	275 Participants	18 Participants
Number of Subjects With Solicited General Symptoms (Dose 1) Grade 3 Headache, Dose 1	60 Participants	1 Participants	6 Participants	2 Participants
Number of Subjects With Solicited General Symptoms (Dose 1) Related Headache, Dose 1	960 Participants	63 Participants	203 Participants	15 Participants
Number of Subjects With Solicited General Symptoms (Dose 1) Any Myalgia, Dose 1	1336 Participants	93 Participants	239 Participants	12 Participants
Number of Subjects With Solicited General Symptoms (Dose 1) Grade 3 Myalgia, Dose 1	77 Participants	1 Participants	5 Participants	2 Participants
Number of Subjects With Solicited General Symptoms (Dose 1) Related Myalgia, Dose 1	1249 Participants	80 Participants	220 Participants	11 Participants
Number of Subjects With Solicited General Symptoms (Dose 1) Any Shivering, Dose 1	482 Participants	14 Participants	67 Participants	3 Participants
Number of Subjects With Solicited General Symptoms (Dose 1) Grade 3 Shivering, Dose 1	34 Participants	0 Participants	2 Participants	0 Participants
Number of Subjects With Solicited General Symptoms (Dose 1) Related Shivering, Dose 1	448 Participants	11 Participants	55 Participants	3 Participants
Number of Subjects With Solicited General Symptoms (Dose 1) Any Sweating, Dose 1	481 Participants	38 Participants	95 Participants	17 Participants
Number of Subjects With Solicited General Symptoms (Dose 1) Grade 3 Sweating, Dose 1	17 Participants	3 Participants	1 Participants	1 Participants
Number of Subjects With Solicited General Symptoms (Dose 1) Related Sweating, Dose 1	415 Participants	31 Participants	71 Participants	15 Participants

PRIMARY outcome

Timeframe: During the 7-day (Days 0-6) after Dose 2

Population: The analysis was performed on the TVc which included all vaccinated subjects for whom data were available and with the symptom sheet filled in.

Outcome measures

Outcome measures
Measure	GSK1562902A 18-60 YOA Group n=3246 Participants Male and female subjects 18-60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.	GSK1562902A >60 YOA Group n=395 Participants Male and female subjects over (\>) 60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.	Fluarix+Placebo 18-60 YOA Group n=1102 Participants Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.	Fluarix+Placebo >60 YOA Group n=132 Participants Male and female subjects over (\>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
Number of Subjects With Solicited General Symptoms (Dose 2) Any Arthralgia, Dose 2	513 Participants	47 Participants	41 Participants	6 Participants
Number of Subjects With Solicited General Symptoms (Dose 2) Grade 3 Arthralgia, Dose 2	46 Participants	3 Participants	2 Participants	0 Participants
Number of Subjects With Solicited General Symptoms (Dose 2) Related Arthralgia, Dose 2	493 Participants	39 Participants	34 Participants	4 Participants
Number of Subjects With Solicited General Symptoms (Dose 2) Any Fatigue, Dose 2	1108 Participants	77 Participants	148 Participants	14 Participants
Number of Subjects With Solicited General Symptoms (Dose 2) Grade 3 Fatigue, Dose 2	81 Participants	2 Participants	5 Participants	1 Participants
Number of Subjects With Solicited General Symptoms (Dose 2) Related Fatigue, Dose 2	1014 Participants	66 Participants	119 Participants	12 Participants
Number of Subjects With Solicited General Symptoms (Dose 2) Any Fever, Dose 2	278 Participants	16 Participants	15 Participants	5 Participants
Number of Subjects With Solicited General Symptoms (Dose 2) Grade 3 Fever, Dose 2	10 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Solicited General Symptoms (Dose 2) Related Fever, Dose 2	266 Participants	14 Participants	10 Participants	4 Participants
Number of Subjects With Solicited General Symptoms (Dose 2) Any Headache, Dose 2	934 Participants	69 Participants	155 Participants	8 Participants
Number of Subjects With Solicited General Symptoms (Dose 2) Grade 3 Headache, Dose 2	59 Participants	2 Participants	8 Participants	0 Participants
Number of Subjects With Solicited General Symptoms (Dose 2) Related Headache, Dose 2	800 Participants	56 Participants	111 Participants	8 Participants
Number of Subjects With Solicited General Symptoms (Dose 2) Any Myalgia, Dose 2	1044 Participants	72 Participants	67 Participants	10 Participants
Number of Subjects With Solicited General Symptoms (Dose 2) Grade 3 Myalgia, Dose 2	61 Participants	4 Participants	5 Participants	0 Participants
Number of Subjects With Solicited General Symptoms (Dose 2) Related Myalgia, Dose 2	999 Participants	65 Participants	53 Participants	7 Participants
Number of Subjects With Solicited General Symptoms (Dose 2) Any Shivering, Dose 2	390 Participants	15 Participants	24 Participants	5 Participants
Number of Subjects With Solicited General Symptoms (Dose 2) Grade 3 Shivering, Dose 2	29 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Solicited General Symptoms (Dose 2) Related Shivering, Dose 2	378 Participants	13 Participants	19 Participants	5 Participants
Number of Subjects With Solicited General Symptoms (Dose 2) Any Sweating, Dose 2	442 Participants	41 Participants	59 Participants	13 Participants
Number of Subjects With Solicited General Symptoms (Dose 2) Grade 3 Sweating, Dose 2	32 Participants	7 Participants	2 Participants	1 Participants
Number of Subjects With Solicited General Symptoms (Dose 2) Related Sweating, Dose 2	397 Participants	33 Participants	42 Participants	9 Participants

PRIMARY outcome

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

Population: The analysis was performed on the TVc which included all vaccinated subjects for whom data were available and with the symptom sheet filled in.

Outcome measures

Outcome measures
Measure	GSK1562902A 18-60 YOA Group n=3342 Participants Male and female subjects 18-60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.	GSK1562902A >60 YOA Group n=403 Participants Male and female subjects over (\>) 60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.	Fluarix+Placebo 18-60 YOA Group n=1123 Participants Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.	Fluarix+Placebo >60 YOA Group n=133 Participants Male and female subjects over (\>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
Number of Subjects With Solicited General Symptoms (Across Doses) Related Sweating, Across	649 Participants	53 Participants	102 Participants	16 Participants
Number of Subjects With Solicited General Symptoms (Across Doses) Any Arthralgia, Across	874 Participants	82 Participants	130 Participants	15 Participants
Number of Subjects With Solicited General Symptoms (Across Doses) Grade 3 Arthralgia, Across	87 Participants	4 Participants	4 Participants	1 Participants
Number of Subjects With Solicited General Symptoms (Across Doses) Related Arthralgia, Across	829 Participants	67 Participants	112 Participants	13 Participants
Number of Subjects With Solicited General Symptoms (Across Doses) Any Fatigue, Across	1736 Participants	117 Participants	346 Participants	24 Participants
Number of Subjects With Solicited General Symptoms (Across Doses) Grade 3 Fatigue, Across	155 Participants	4 Participants	8 Participants	3 Participants
Number of Subjects With Solicited General Symptoms (Across Doses) Related Fatigue, Across	1576 Participants	100 Participants	289 Participants	17 Participants
Number of Subjects With Solicited General Symptoms (Across Doses) Any Fever, Across	466 Participants	24 Participants	38 Participants	9 Participants
Number of Subjects With Solicited General Symptoms (Across Doses) Grade 3 Fever, Across	16 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Solicited General Symptoms (Across Doses) Related Fever, Across	432 Participants	20 Participants	29 Participants	7 Participants
Number of Subjects With Solicited General Symptoms (Across Doses) Any Headache, Across	1566 Participants	114 Participants	350 Participants	19 Participants
Number of Subjects With Solicited General Symptoms (Across Doses) Grade 3 Headache, Across	112 Participants	3 Participants	14 Participants	2 Participants
Number of Subjects With Solicited General Symptoms (Across Doses) Related Headache, Across	1347 Participants	94 Participants	266 Participants	16 Participants
Number of Subjects With Solicited General Symptoms (Across Doses) Any Myalgia, Across	1670 Participants	124 Participants	276 Participants	18 Participants
Number of Subjects With Solicited General Symptoms (Across Doses) Grade 3 Myalgia, Across	125 Participants	5 Participants	9 Participants	2 Participants
Number of Subjects With Solicited General Symptoms (Across Doses) Related Myalgia, Across	1593 Participants	107 Participants	249 Participants	14 Participants
Number of Subjects With Solicited General Symptoms (Across Doses) Any Shivering, Across	711 Participants	26 Participants	86 Participants	5 Participants
Number of Subjects With Solicited General Symptoms (Across Doses) Grade 3 Shivering, Across	56 Participants	1 Participants	2 Participants	0 Participants
Number of Subjects With Solicited General Symptoms (Across Doses) Related Shivering, Across	675 Participants	21 Participants	71 Participants	5 Participants
Number of Subjects With Solicited General Symptoms (Across Doses) Any Sweating, Across	727 Participants	64 Participants	134 Participants	19 Participants
Number of Subjects With Solicited General Symptoms (Across Doses) Grade 3 Sweating, Across	47 Participants	9 Participants	3 Participants	2 Participants

PRIMARY outcome

Timeframe: During the 21st Day (Days 0-20) post Dose 1

Population: The analysis was performed on the TVc which included all vaccinated subjects for whom data were available and with the symptom sheet filled in at Day 51.

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. Related symptoms were not available.

Outcome measures

Outcome measures
Measure	GSK1562902A 18-60 YOA Group n=3397 Participants Male and female subjects 18-60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.	GSK1562902A >60 YOA Group n=405 Participants Male and female subjects over (\>) 60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.	Fluarix+Placebo 18-60 YOA Group n=1136 Participants Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.	Fluarix+Placebo >60 YOA Group n=133 Participants Male and female subjects over (\>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
Number of Subjects With Unsolicited Adverse Events (AEs) Any AEs	917 Participants	74 Participants	244 Participants	19 Participants
Number of Subjects With Unsolicited Adverse Events (AEs) Grade 3 AEs	95 Participants	5 Participants	22 Participants	1 Participants

PRIMARY outcome

Timeframe: During the 30 Day (Days 0-29) post Dose 2

Population: The analysis was performed on the TVc which included all subjects who had received the second dose and for whom data were available.

Outcome measures

Outcome measures
Measure	GSK1562902A 18-60 YOA Group n=3267 Participants Male and female subjects 18-60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.	GSK1562902A >60 YOA Group n=396 Participants Male and female subjects over (\>) 60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.	Fluarix+Placebo 18-60 YOA Group n=1111 Participants Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.	Fluarix+Placebo >60 YOA Group n=133 Participants Male and female subjects over (\>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
Number of Subjects With AEs Any AEs	644 Participants	75 Participants	180 Participants	23 Participants
Number of Subjects With AEs Grade 3 AEs	65 Participants	9 Participants	28 Participants	3 Participants

PRIMARY outcome

Timeframe: From Day 0 to Day 180

Population: The analysis was performed on the Vaccinated Cohort (Extended follow-up) which included all vaccinated subjects for whom data were available at Day 180.

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Outcome measures
Measure	GSK1562902A 18-60 YOA Group n=3253 Participants Male and female subjects 18-60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.	GSK1562902A >60 YOA Group n=390 Participants Male and female subjects over (\>) 60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.	Fluarix+Placebo 18-60 YOA Group n=1102 Participants Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.	Fluarix+Placebo >60 YOA Group n=129 Participants Male and female subjects over (\>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
Number of Subjects With Serious Adverse Events (SAEs)	27 Participants	15 Participants	10 Participants	5 Participants

PRIMARY outcome

Timeframe: From Day 0 to Day 180

Population: The analysis was performed on the Vaccinated Cohort (Extended follow-up) which included all vaccinated subjects for whom data were available at Day 180.

NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.

Outcome measures

Outcome measures
Measure	GSK1562902A 18-60 YOA Group n=3253 Participants Male and female subjects 18-60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.	GSK1562902A >60 YOA Group n=390 Participants Male and female subjects over (\>) 60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.	Fluarix+Placebo 18-60 YOA Group n=1102 Participants Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.	Fluarix+Placebo >60 YOA Group n=129 Participants Male and female subjects over (\>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
Number of Subjects With New Onset Chronic Diseases (NOCDs)	9 Participants	7 Participants	3 Participants	0 Participants

PRIMARY outcome

Timeframe: From Day 0 to Day 51

Population: The analysis was performed on the TVc which included all vaccinated subjects for whom data were available at Day 51.

MSCs prompting emergency room or physician visits that were not related to common diseases or routine visits. Common diseases included upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.

Outcome measures

Outcome measures
Measure	GSK1562902A 18-60 YOA Group n=3397 Participants Male and female subjects 18-60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.	GSK1562902A >60 YOA Group n=405 Participants Male and female subjects over (\>) 60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.	Fluarix+Placebo 18-60 YOA Group n=1136 Participants Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.	Fluarix+Placebo >60 YOA Group n=133 Participants Male and female subjects over (\>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
Number of Subjects With Medically Significant Conditions (MSCs)	60 Participants	10 Participants	11 Participants	3 Participants

SECONDARY outcome

Timeframe: At Day 0 (PRE), 21 and 42

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects of the immunogenicity subset for whom data concerning immunogenicity endpoint measures were available. This includes subjects for whom assay results were available after vaccination.

Anti-HA antibody titers were expressed as Geometric Mean Tiyers (GMTs).

Outcome measures

Outcome measures
Measure	GSK1562902A 18-60 YOA Group n=269 Participants Male and female subjects 18-60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.	GSK1562902A >60 YOA Group n=146 Participants Male and female subjects over (\>) 60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.	Fluarix+Placebo 18-60 YOA Group n=97 Participants Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.	Fluarix+Placebo >60 YOA Group n=50 Participants Male and female subjects over (\>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
Anti- Haemagglutinin Antibody (Anti-HA) Titers Against Avian Influenza A Subtype H5N1 anti-HA, Pre [N=269;146;96;50]	5.0 Titers Interval 5.0 to 5.0	5.0 Titers Interval 5.0 to 5.0	5.0 Titers Interval 5.0 to 5.0	5.0 Titers Interval 5.0 to 5.0
Anti- Haemagglutinin Antibody (Anti-HA) Titers Against Avian Influenza A Subtype H5N1 anti-HA, Day 21 [N=269;145;97;49]	31.8 Titers Interval 25.7 to 39.4	43.8 Titers Interval 33.3 to 57.5	6.0 Titers Interval 5.1 to 7.0	7.5 Titers Interval 5.5 to 10.4
Anti- Haemagglutinin Antibody (Anti-HA) Titers Against Avian Influenza A Subtype H5N1 anti-HA, Day 42 [N=268;140;96;50]	307.0 Titers Interval 258.4 to 364.8	187.0 Titers Interval 148.8 to 235.1	5.6 Titers Interval 4.9 to 6.3	7.5 Titers Interval 5.5 to 10.2

SECONDARY outcome

Timeframe: At Day 21 and Day 42

Seroconversion rate for Haemagglutinin antibody response was defined as the number of vaccinees who had either a pre-vaccination titer lower than (\<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a fourfold increase in post-vaccination titer. Seroconversion rate for Neutralising antibody response was defined as the percentage of vaccinees with a minimum 4-fold increase in titer at post-vaccination.

Outcome measures

Outcome measures
Measure	GSK1562902A 18-60 YOA Group n=269 Participants Male and female subjects 18-60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.	GSK1562902A >60 YOA Group n=146 Participants Male and female subjects over (\>) 60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.	Fluarix+Placebo 18-60 YOA Group n=96 Participants Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.	Fluarix+Placebo >60 YOA Group n=50 Participants Male and female subjects over (\>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
Number of Seroconverted Subjects Against H5N1 anti-HA, Day 21 [N=269;145;96;49]	147 Participants	89 Participants	5 Participants	5 Participants
Number of Seroconverted Subjects Against H5N1 anti-HA, Day 42 [N=268;140;96;50]	245 Participants	128 Participants	3 Participants	6 Participants

SECONDARY outcome

Timeframe: At Day 21 and Day 42

Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to day 0.

Outcome measures

Outcome measures
Measure	GSK1562902A 18-60 YOA Group n=269 Participants Male and female subjects 18-60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.	GSK1562902A >60 YOA Group n=145 Participants Male and female subjects over (\>) 60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.	Fluarix+Placebo 18-60 YOA Group n=96 Participants Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.	Fluarix+Placebo >60 YOA Group n=50 Participants Male and female subjects over (\>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam Influenza Strain A/Vietnam, Day 21 [N=268;140;96;50]	61.4 Titer fold increase Interval 51.7 to 73.0	37.4 Titer fold increase Interval 29.8 to 47.0	1.1 Titer fold increase Interval 1.0 to 1.3	1.5 Titer fold increase Interval 1.1 to 2.0
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam Influenza Strain A/Vietnam, Day 21 [N=269;145;96;49]	6.4 Titer fold increase Interval 5.1 to 7.9	8.8 Titer fold increase Interval 6.7 to 11.5	1.2 Titer fold increase Interval 1.0 to 1.4	1.5 Titer fold increase Interval 1.1 to 2.1

SECONDARY outcome

Timeframe: At Day 0 (PRE), Day 21 and Day 42

Seroprotection rate was defined as the number of vaccinees with a serum HI titer ≥1:40 that usually is accepted as indicating protection.

Outcome measures

Outcome measures
Measure	GSK1562902A 18-60 YOA Group n=269 Participants Male and female subjects 18-60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.	GSK1562902A >60 YOA Group n=146 Participants Male and female subjects over (\>) 60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.	Fluarix+Placebo 18-60 YOA Group n=97 Participants Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.	Fluarix+Placebo >60 YOA Group n=50 Participants Male and female subjects over (\>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
Number of Seroprotected Subjects Against A/Vietnam Influenza Strain A/Vietnam, PRE [N=269;146;96;50]	0 Participants	0 Participants	0 Participants	0 Participants
Number of Seroprotected Subjects Against A/Vietnam Influenza Strain A/Vietnam, Day 21 [N=269;145;97;49]	147 Participants	89 Participants	5 Participants	5 Participants
Number of Seroprotected Subjects Against A/Vietnam Influenza Strain A/Vietnam, Day 42 [N=268;140;96;50]	245 Participants	128 Participants	3 Participants	6 Participants

Adverse Events

GSK1562902A 18-60 YOA Group

Serious events: 27 serious events

Other events: 3189 other events

Deaths: 0 deaths

GSK1562902A >60 YOA Group

Serious events: 15 serious events

Other events: 338 other events

Deaths: 0 deaths

Fluarix+Placebo 18-60 YOA Group

Serious events: 10 serious events

Other events: 938 other events

Deaths: 0 deaths

Fluarix+Placebo >60 YOA Group

Serious events: 5 serious events

Other events: 83 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	GSK1562902A 18-60 YOA Group n=3397 participants at risk Male and female subjects 18-60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.	GSK1562902A >60 YOA Group n=405 participants at risk Male and female subjects over (\>) 60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.	Fluarix+Placebo 18-60 YOA Group n=1136 participants at risk Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.	Fluarix+Placebo >60 YOA Group n=133 participants at risk Male and female subjects over (\>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
General disorders Ecchymosis	9.4% 320/3397 • Solicited local and general symptoms during the 7 days post-vaccination, Unsolicited AEs during the 21 post Dose 1 and 30 days post Dose 2; SAEs from Day 0 to Day 180. During the given time frame for unsolicited AEs, no symptom reached nor surpassed the 5% threshold.	7.2% 29/405 • Solicited local and general symptoms during the 7 days post-vaccination, Unsolicited AEs during the 21 post Dose 1 and 30 days post Dose 2; SAEs from Day 0 to Day 180. During the given time frame for unsolicited AEs, no symptom reached nor surpassed the 5% threshold.	5.7% 65/1136 • Solicited local and general symptoms during the 7 days post-vaccination, Unsolicited AEs during the 21 post Dose 1 and 30 days post Dose 2; SAEs from Day 0 to Day 180. During the given time frame for unsolicited AEs, no symptom reached nor surpassed the 5% threshold.	3.8% 5/133 • Solicited local and general symptoms during the 7 days post-vaccination, Unsolicited AEs during the 21 post Dose 1 and 30 days post Dose 2; SAEs from Day 0 to Day 180. During the given time frame for unsolicited AEs, no symptom reached nor surpassed the 5% threshold.
General disorders Induration	33.9% 1150/3397 • Solicited local and general symptoms during the 7 days post-vaccination, Unsolicited AEs during the 21 post Dose 1 and 30 days post Dose 2; SAEs from Day 0 to Day 180. During the given time frame for unsolicited AEs, no symptom reached nor surpassed the 5% threshold.	26.7% 108/405 • Solicited local and general symptoms during the 7 days post-vaccination, Unsolicited AEs during the 21 post Dose 1 and 30 days post Dose 2; SAEs from Day 0 to Day 180. During the given time frame for unsolicited AEs, no symptom reached nor surpassed the 5% threshold.	18.9% 215/1136 • Solicited local and general symptoms during the 7 days post-vaccination, Unsolicited AEs during the 21 post Dose 1 and 30 days post Dose 2; SAEs from Day 0 to Day 180. During the given time frame for unsolicited AEs, no symptom reached nor surpassed the 5% threshold.	14.3% 19/133 • Solicited local and general symptoms during the 7 days post-vaccination, Unsolicited AEs during the 21 post Dose 1 and 30 days post Dose 2; SAEs from Day 0 to Day 180. During the given time frame for unsolicited AEs, no symptom reached nor surpassed the 5% threshold.
General disorders Pain	89.4% 3037/3397 • Solicited local and general symptoms during the 7 days post-vaccination, Unsolicited AEs during the 21 post Dose 1 and 30 days post Dose 2; SAEs from Day 0 to Day 180. During the given time frame for unsolicited AEs, no symptom reached nor surpassed the 5% threshold.	66.9% 271/405 • Solicited local and general symptoms during the 7 days post-vaccination, Unsolicited AEs during the 21 post Dose 1 and 30 days post Dose 2; SAEs from Day 0 to Day 180. During the given time frame for unsolicited AEs, no symptom reached nor surpassed the 5% threshold.	65.8% 748/1136 • Solicited local and general symptoms during the 7 days post-vaccination, Unsolicited AEs during the 21 post Dose 1 and 30 days post Dose 2; SAEs from Day 0 to Day 180. During the given time frame for unsolicited AEs, no symptom reached nor surpassed the 5% threshold.	29.3% 39/133 • Solicited local and general symptoms during the 7 days post-vaccination, Unsolicited AEs during the 21 post Dose 1 and 30 days post Dose 2; SAEs from Day 0 to Day 180. During the given time frame for unsolicited AEs, no symptom reached nor surpassed the 5% threshold.
General disorders Redness	37.6% 1277/3397 • Solicited local and general symptoms during the 7 days post-vaccination, Unsolicited AEs during the 21 post Dose 1 and 30 days post Dose 2; SAEs from Day 0 to Day 180. During the given time frame for unsolicited AEs, no symptom reached nor surpassed the 5% threshold.	40.7% 165/405 • Solicited local and general symptoms during the 7 days post-vaccination, Unsolicited AEs during the 21 post Dose 1 and 30 days post Dose 2; SAEs from Day 0 to Day 180. During the given time frame for unsolicited AEs, no symptom reached nor surpassed the 5% threshold.	27.5% 312/1136 • Solicited local and general symptoms during the 7 days post-vaccination, Unsolicited AEs during the 21 post Dose 1 and 30 days post Dose 2; SAEs from Day 0 to Day 180. During the given time frame for unsolicited AEs, no symptom reached nor surpassed the 5% threshold.	28.6% 38/133 • Solicited local and general symptoms during the 7 days post-vaccination, Unsolicited AEs during the 21 post Dose 1 and 30 days post Dose 2; SAEs from Day 0 to Day 180. During the given time frame for unsolicited AEs, no symptom reached nor surpassed the 5% threshold.
General disorders Swelling	32.6% 1107/3397 • Solicited local and general symptoms during the 7 days post-vaccination, Unsolicited AEs during the 21 post Dose 1 and 30 days post Dose 2; SAEs from Day 0 to Day 180. During the given time frame for unsolicited AEs, no symptom reached nor surpassed the 5% threshold.	32.8% 133/405 • Solicited local and general symptoms during the 7 days post-vaccination, Unsolicited AEs during the 21 post Dose 1 and 30 days post Dose 2; SAEs from Day 0 to Day 180. During the given time frame for unsolicited AEs, no symptom reached nor surpassed the 5% threshold.	17.3% 196/1136 • Solicited local and general symptoms during the 7 days post-vaccination, Unsolicited AEs during the 21 post Dose 1 and 30 days post Dose 2; SAEs from Day 0 to Day 180. During the given time frame for unsolicited AEs, no symptom reached nor surpassed the 5% threshold.	12.8% 17/133 • Solicited local and general symptoms during the 7 days post-vaccination, Unsolicited AEs during the 21 post Dose 1 and 30 days post Dose 2; SAEs from Day 0 to Day 180. During the given time frame for unsolicited AEs, no symptom reached nor surpassed the 5% threshold.
General disorders Arthralgia	25.7% 874/3397 • Solicited local and general symptoms during the 7 days post-vaccination, Unsolicited AEs during the 21 post Dose 1 and 30 days post Dose 2; SAEs from Day 0 to Day 180. During the given time frame for unsolicited AEs, no symptom reached nor surpassed the 5% threshold.	20.2% 82/405 • Solicited local and general symptoms during the 7 days post-vaccination, Unsolicited AEs during the 21 post Dose 1 and 30 days post Dose 2; SAEs from Day 0 to Day 180. During the given time frame for unsolicited AEs, no symptom reached nor surpassed the 5% threshold.	11.4% 130/1136 • Solicited local and general symptoms during the 7 days post-vaccination, Unsolicited AEs during the 21 post Dose 1 and 30 days post Dose 2; SAEs from Day 0 to Day 180. During the given time frame for unsolicited AEs, no symptom reached nor surpassed the 5% threshold.	11.3% 15/133 • Solicited local and general symptoms during the 7 days post-vaccination, Unsolicited AEs during the 21 post Dose 1 and 30 days post Dose 2; SAEs from Day 0 to Day 180. During the given time frame for unsolicited AEs, no symptom reached nor surpassed the 5% threshold.
General disorders Fatigue	51.1% 1736/3397 • Solicited local and general symptoms during the 7 days post-vaccination, Unsolicited AEs during the 21 post Dose 1 and 30 days post Dose 2; SAEs from Day 0 to Day 180. During the given time frame for unsolicited AEs, no symptom reached nor surpassed the 5% threshold.	28.9% 117/405 • Solicited local and general symptoms during the 7 days post-vaccination, Unsolicited AEs during the 21 post Dose 1 and 30 days post Dose 2; SAEs from Day 0 to Day 180. During the given time frame for unsolicited AEs, no symptom reached nor surpassed the 5% threshold.	30.5% 346/1136 • Solicited local and general symptoms during the 7 days post-vaccination, Unsolicited AEs during the 21 post Dose 1 and 30 days post Dose 2; SAEs from Day 0 to Day 180. During the given time frame for unsolicited AEs, no symptom reached nor surpassed the 5% threshold.	18.0% 24/133 • Solicited local and general symptoms during the 7 days post-vaccination, Unsolicited AEs during the 21 post Dose 1 and 30 days post Dose 2; SAEs from Day 0 to Day 180. During the given time frame for unsolicited AEs, no symptom reached nor surpassed the 5% threshold.
General disorders Fever	13.7% 466/3397 • Solicited local and general symptoms during the 7 days post-vaccination, Unsolicited AEs during the 21 post Dose 1 and 30 days post Dose 2; SAEs from Day 0 to Day 180. During the given time frame for unsolicited AEs, no symptom reached nor surpassed the 5% threshold.	5.9% 24/405 • Solicited local and general symptoms during the 7 days post-vaccination, Unsolicited AEs during the 21 post Dose 1 and 30 days post Dose 2; SAEs from Day 0 to Day 180. During the given time frame for unsolicited AEs, no symptom reached nor surpassed the 5% threshold.	3.3% 38/1136 • Solicited local and general symptoms during the 7 days post-vaccination, Unsolicited AEs during the 21 post Dose 1 and 30 days post Dose 2; SAEs from Day 0 to Day 180. During the given time frame for unsolicited AEs, no symptom reached nor surpassed the 5% threshold.	6.8% 9/133 • Solicited local and general symptoms during the 7 days post-vaccination, Unsolicited AEs during the 21 post Dose 1 and 30 days post Dose 2; SAEs from Day 0 to Day 180. During the given time frame for unsolicited AEs, no symptom reached nor surpassed the 5% threshold.
General disorders Headache	46.1% 1566/3397 • Solicited local and general symptoms during the 7 days post-vaccination, Unsolicited AEs during the 21 post Dose 1 and 30 days post Dose 2; SAEs from Day 0 to Day 180. During the given time frame for unsolicited AEs, no symptom reached nor surpassed the 5% threshold.	28.1% 114/405 • Solicited local and general symptoms during the 7 days post-vaccination, Unsolicited AEs during the 21 post Dose 1 and 30 days post Dose 2; SAEs from Day 0 to Day 180. During the given time frame for unsolicited AEs, no symptom reached nor surpassed the 5% threshold.	30.8% 350/1136 • Solicited local and general symptoms during the 7 days post-vaccination, Unsolicited AEs during the 21 post Dose 1 and 30 days post Dose 2; SAEs from Day 0 to Day 180. During the given time frame for unsolicited AEs, no symptom reached nor surpassed the 5% threshold.	14.3% 19/133 • Solicited local and general symptoms during the 7 days post-vaccination, Unsolicited AEs during the 21 post Dose 1 and 30 days post Dose 2; SAEs from Day 0 to Day 180. During the given time frame for unsolicited AEs, no symptom reached nor surpassed the 5% threshold.
General disorders Myalgia	49.2% 1670/3397 • Solicited local and general symptoms during the 7 days post-vaccination, Unsolicited AEs during the 21 post Dose 1 and 30 days post Dose 2; SAEs from Day 0 to Day 180. During the given time frame for unsolicited AEs, no symptom reached nor surpassed the 5% threshold.	30.6% 124/405 • Solicited local and general symptoms during the 7 days post-vaccination, Unsolicited AEs during the 21 post Dose 1 and 30 days post Dose 2; SAEs from Day 0 to Day 180. During the given time frame for unsolicited AEs, no symptom reached nor surpassed the 5% threshold.	24.3% 276/1136 • Solicited local and general symptoms during the 7 days post-vaccination, Unsolicited AEs during the 21 post Dose 1 and 30 days post Dose 2; SAEs from Day 0 to Day 180. During the given time frame for unsolicited AEs, no symptom reached nor surpassed the 5% threshold.	13.5% 18/133 • Solicited local and general symptoms during the 7 days post-vaccination, Unsolicited AEs during the 21 post Dose 1 and 30 days post Dose 2; SAEs from Day 0 to Day 180. During the given time frame for unsolicited AEs, no symptom reached nor surpassed the 5% threshold.
General disorders Shivering	20.9% 711/3397 • Solicited local and general symptoms during the 7 days post-vaccination, Unsolicited AEs during the 21 post Dose 1 and 30 days post Dose 2; SAEs from Day 0 to Day 180. During the given time frame for unsolicited AEs, no symptom reached nor surpassed the 5% threshold.	6.4% 26/405 • Solicited local and general symptoms during the 7 days post-vaccination, Unsolicited AEs during the 21 post Dose 1 and 30 days post Dose 2; SAEs from Day 0 to Day 180. During the given time frame for unsolicited AEs, no symptom reached nor surpassed the 5% threshold.	7.6% 86/1136 • Solicited local and general symptoms during the 7 days post-vaccination, Unsolicited AEs during the 21 post Dose 1 and 30 days post Dose 2; SAEs from Day 0 to Day 180. During the given time frame for unsolicited AEs, no symptom reached nor surpassed the 5% threshold.	3.8% 5/133 • Solicited local and general symptoms during the 7 days post-vaccination, Unsolicited AEs during the 21 post Dose 1 and 30 days post Dose 2; SAEs from Day 0 to Day 180. During the given time frame for unsolicited AEs, no symptom reached nor surpassed the 5% threshold.
General disorders Sweating	21.4% 727/3397 • Solicited local and general symptoms during the 7 days post-vaccination, Unsolicited AEs during the 21 post Dose 1 and 30 days post Dose 2; SAEs from Day 0 to Day 180. During the given time frame for unsolicited AEs, no symptom reached nor surpassed the 5% threshold.	15.8% 64/405 • Solicited local and general symptoms during the 7 days post-vaccination, Unsolicited AEs during the 21 post Dose 1 and 30 days post Dose 2; SAEs from Day 0 to Day 180. During the given time frame for unsolicited AEs, no symptom reached nor surpassed the 5% threshold.	11.8% 134/1136 • Solicited local and general symptoms during the 7 days post-vaccination, Unsolicited AEs during the 21 post Dose 1 and 30 days post Dose 2; SAEs from Day 0 to Day 180. During the given time frame for unsolicited AEs, no symptom reached nor surpassed the 5% threshold.	14.3% 19/133 • Solicited local and general symptoms during the 7 days post-vaccination, Unsolicited AEs during the 21 post Dose 1 and 30 days post Dose 2; SAEs from Day 0 to Day 180. During the given time frame for unsolicited AEs, no symptom reached nor surpassed the 5% threshold.

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