Trial Outcomes & Findings for Study to Evaluate the Immunogenicity and Safety of 2 Formulations of GlaxoSmithKline (GSK) Biologicals' GSK1247446A Low Dose Influenza Vaccine Candidate (NCT NCT00374842)

Last Updated: 2018-06-08

Results Overview

Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), B/Malaysia (B/MAL) strains. Titers were presented as geometric mean titers (GMTs) calculated on subjects with available results, and expressed in haemagglutination-inhibition unit (HIU), e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen. The seropositivity cut-off value of the assay was 10 HIU.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

300 participants

Primary outcome timeframe

At Day 0 and at Day 21.

Results posted on

2018-06-08

Participant Flow

A total of 300 subjects were enrolled in the study. Study duration was of approximately 1 month (30 days) for all subjects.

Participant milestones

Participant milestones
Measure	GSK1247446A Formulation 1 Group Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK1247446A Formulation 2 Group Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix Group Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Study STARTED	100	100	100
Overall Study COMPLETED	100	100	100
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Evaluate the Immunogenicity and Safety of 2 Formulations of GlaxoSmithKline (GSK) Biologicals' GSK1247446A Low Dose Influenza Vaccine Candidate

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK1247446A Formulation 1 Group n=100 Participants Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK1247446A Formulation 2 Group n=100 Participants Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix Group n=100 Participants Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Total n=300 Participants Total of all reporting groups
Age, Continuous	37.3 Years STANDARD_DEVIATION 13.94 • n=5 Participants	35.0 Years STANDARD_DEVIATION 13.26 • n=7 Participants	37.7 Years STANDARD_DEVIATION 13.75 • n=5 Participants	36.7 Years STANDARD_DEVIATION 13.65 • n=4 Participants
Sex: Female, Male Female	65 Participants n=5 Participants	60 Participants n=7 Participants	57 Participants n=5 Participants	182 Participants n=4 Participants
Sex: Female, Male Male	35 Participants n=5 Participants	40 Participants n=7 Participants	43 Participants n=5 Participants	118 Participants n=4 Participants

PRIMARY outcome

Timeframe: At Day 0 and at Day 21.

Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.

Outcome measures

Outcome measures
Measure	GSK1247446A Formulation 1 Group n=99 Participants Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm	GSK1247446A Formulation 2 Group n=99 Participants Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix Group n=98 Participants Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Titers of Serum Haemagglutination-inhibition (HI) Antibodies Against Each of the 3 Influenza Strains Assessed. A/CAL, Day 0	31.9 HIU Interval 23.5 to 43.4	36.1 HIU Interval 26.9 to 48.5	26.1 HIU Interval 20.5 to 33.2
Titers of Serum Haemagglutination-inhibition (HI) Antibodies Against Each of the 3 Influenza Strains Assessed. A/CAL, Day 21	475.4 HIU Interval 352.2 to 641.6	399.0 HIU Interval 294.7 to 540.2	380.6 HIU Interval 274.2 to 528.4
Titers of Serum Haemagglutination-inhibition (HI) Antibodies Against Each of the 3 Influenza Strains Assessed. A/WIS, Day 0	16.8 HIU Interval 13.1 to 21.5	19.9 HIU Interval 15.2 to 25.9	14.7 HIU Interval 11.6 to 18.6
Titers of Serum Haemagglutination-inhibition (HI) Antibodies Against Each of the 3 Influenza Strains Assessed. A/WIS, Day 21	276.2 HIU Interval 223.5 to 341.3	241.9 HIU Interval 192.9 to 303.4	172.3 HIU Interval 136.4 to 217.6
Titers of Serum Haemagglutination-inhibition (HI) Antibodies Against Each of the 3 Influenza Strains Assessed. B/MAL, Day 0	20.4 HIU Interval 15.9 to 26.1	22.2 HIU Interval 17.6 to 27.9	26.5 HIU Interval 20.9 to 33.6
Titers of Serum Haemagglutination-inhibition (HI) Antibodies Against Each of the 3 Influenza Strains Assessed. B/MAL, Day 21	268.6 HIU Interval 221.3 to 326.0	301.5 HIU Interval 246.1 to 369.4	219.2 HIU Interval 171.4 to 280.2

PRIMARY outcome

Timeframe: At Day 0 and at Day 21.

A seroprotected subject was a subject whose antibody titer against each of the influenza strains assessed (A/New Caledonia (A/CAL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL) strains) was equal to or higher than (\>=) the assay seroprotection cut-off value of 40 haemagglutination-inhibition units (HIU) (e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen).

Outcome measures

Outcome measures
Measure	GSK1247446A Formulation 1 Group n=99 Participants Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm	GSK1247446A Formulation 2 Group n=99 Participants Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix Group n=98 Participants Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Seroprotected Subjects Against Each of the 3 Influenza Strains Assessed. A/CAL, Day 0	41 Subject	55 Subject	35 Subject
Number of Seroprotected Subjects Against Each of the 3 Influenza Strains Assessed. A/CAL, Day 21	95 Subject	97 Subject	93 Subject
Number of Seroprotected Subjects Against Each of the 3 Influenza Strains Assessed. A/WIS, Day 0	32 Subject	37 Subject	25 Subject
Number of Seroprotected Subjects Against Each of the 3 Influenza Strains Assessed. A/WIS, Day 21	97 Subject	97 Subject	93 Subject
Number of Seroprotected Subjects Against Each of the 3 Influenza Strains Assessed. B/MAL, Day 0	31 Subject	39 Subject	44 Subject
Number of Seroprotected Subjects Against Each of the 3 Influenza Strains Assessed. B/MAL, Day 21	97 Subject	98 Subject	94 Subject

PRIMARY outcome

Timeframe: At Day 21.

Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), and B/Malaysia (B/MAL) strains. A seroconverted subject was a subject who had either a pre-vaccination serum HI antibody titer lower than 10 haemagglutination-inhibition units (HIU) (e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen) and a post-vaccination titer higher than or equal to 40 HIU, or a pre-vaccination titer \>= 10 and at least a four-fold increase in post- vaccination titer.

Outcome measures

Outcome measures
Measure	GSK1247446A Formulation 1 Group n=99 Participants Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm	GSK1247446A Formulation 2 Group n=99 Participants Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix Group n=98 Participants Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Seroconverted Subjects Against Each of the 3 Influenza Strains Assessed A/CAL, Day 21	69 Subject	64 Subject	66 Subject
Number of Seroconverted Subjects Against Each of the 3 Influenza Strains Assessed A/WIS, Day 21	88 Subject	79 Subject	73 Subject
Number of Seroconverted Subjects Against Each of the 3 Influenza Strains Assessed B/MAL, Day 21	76 Subject	82 Subject	65 Subject

PRIMARY outcome

Timeframe: At Day 21.

Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), and B/Malaysia (B/MAL) strains. The seroconversion factor (SCF) was defined as a ratio, as the fold increase in serum haemagglutination-inhibition geometric mean titers (GMTs) post-vaccination compared to Day 0 (with GMTs in the above calculation expressed in haemagglutination-inhibition units (HIU) \[e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenza antigen\]).

Outcome measures

Outcome measures
Measure	GSK1247446A Formulation 1 Group n=99 Participants Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm	GSK1247446A Formulation 2 Group n=99 Participants Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix Group n=98 Participants Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Seroconversion Factor Against Each of the 3 Influenza Strains Assessed. A/CAL, Day 21	14.9 Fold increase Interval 10.4 to 21.3	11.0 Fold increase Interval 7.7 to 15.9	14.6 Fold increase Interval 9.9 to 21.6
Seroconversion Factor Against Each of the 3 Influenza Strains Assessed. A/WIS, Day 21	16.5 Fold increase Interval 13.0 to 20.9	12.2 Fold increase Interval 9.2 to 16.1	11.7 Fold increase Interval 8.8 to 15.6
Seroconversion Factor Against Each of the 3 Influenza Strains Assessed. B/MAL, Day 21	13.2 Fold increase Interval 10.0 to 17.4	13.6 Fold increase Interval 10.2 to 18.0	8.3 Fold increase Interval 6.2 to 11.0

SECONDARY outcome

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

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

Assessed solicited local symptoms were ecchymosis, pain, redness and swelling the site of injection. Any = occurrence of a solicited local symptom regardless of intensity grade. Grade 3 pain = Pain which prevented normal activity. Grade 3 ecchymosis/redness/swelling = ecchymosis/redness/swelling at injection site with a diameter larger than (\>) 50 millimeters (mm). All solicited local symptoms assessed were considered by the investigator as causally related to the study vaccination.

Outcome measures

Outcome measures
Measure	GSK1247446A Formulation 1 Group n=100 Participants Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm	GSK1247446A Formulation 2 Group n=100 Participants Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix Group n=100 Participants Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ 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 ecchymosis	6 Subject	11 Subject	6 Subject
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 ecchymosis (> 50 mm)	0 Subject	0 Subject	0 Subject
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any pain	92 Subject	89 Subject	64 Subject
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 pain	10 Subject	0 Subject	0 Subject
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any redness	24 Subject	12 Subject	15 Subject
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 redness (> 50 mm)	6 Subject	2 Subject	1 Subject
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any swelling	28 Subject	17 Subject	7 Subject
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 swelling (> 50 mm)	7 Subject	4 Subject	2 Subject

SECONDARY outcome

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

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

Assessed solicited general symptoms were arthralgia, fatigue, fever (axillary temperature higher than or equal to (\>=) 37.5 degrees Celsius (°C)), headache, muscle aches, and shivering. Any = Occurrence of a particular symptom regardless of intensity or relationship to vaccination. Grade 3 symptom = Symptom which prevented normal activity. Related = Symptom assessed by the investigator as causally related to the study vaccination. Grade 3 fever = axillary temperature higher than 39.0°C.

Outcome measures

Outcome measures
Measure	GSK1247446A Formulation 1 Group n=100 Participants Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm	GSK1247446A Formulation 2 Group n=100 Participants Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix Group n=100 Participants Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ 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	32 Subject	14 Subject	7 Subject
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 arthralgia	3 Subject	1 Subject	0 Subject
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related arthralgia	32 Subject	13 Subject	5 Subject
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any fatigue	60 Subject	42 Subject	28 Subject
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 fatigue	6 Subject	2 Subject	1 Subject
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related fatigue	59 Subject	39 Subject	26 Subject
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Axillary fever (>= 37.5°C)	30 Subject	12 Subject	2 Subject
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 axillary fever (> 39.0°C)	2 Subject	0 Subject	0 Subject
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related axillary fever (>= 37.5°C)	30 Subject	12 Subject	2 Subject
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any headache	51 Subject	40 Subject	29 Subject
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 headache	9 Subject	6 Subject	3 Subject
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related headache	50 Subject	35 Subject	23 Subject
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any muscle aches	48 Subject	30 Subject	12 Subject
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 muscle aches	4 Subject	2 Subject	0 Subject
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related muscle aches	47 Subject	29 Subject	11 Subject
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any shivering	33 Subject	13 Subject	5 Subject
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 shivering	2 Subject	2 Subject	0 Subject
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related shivering	33 Subject	13 Subject	5 Subject

SECONDARY outcome

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

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

An unsolicited AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. Any AE = any occurrence of an AE, regardless of intensity or relationship to study vaccination. Grade 3 = an event that prevented normal activity. Related = event assessed by the investigator as causally related to the study vaccination.

Outcome measures

Outcome measures
Measure	GSK1247446A Formulation 1 Group n=100 Participants Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm	GSK1247446A Formulation 2 Group n=100 Participants Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix Group n=100 Participants Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ 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) Subject(s) with any unsolicited AE(s)	55 Subject	47 Subject	35 Subject
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Subject(s) with Grade 3 unsolicited AE(s)	11 Subject	5 Subject	6 Subject
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Subject(s) with related unsolicited AE(s)	33 Subject	22 Subject	16 Subject

SECONDARY outcome

Timeframe: From study start to study end, from Day 0 to Day 30

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 = any occurrence of an SAE, regardless of relationship to study vaccination. A related SAE = an SAE assessed by the investigator as causally related to the study vaccination.

Outcome measures

Outcome measures
Measure	GSK1247446A Formulation 1 Group n=100 Participants Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm	GSK1247446A Formulation 2 Group n=100 Participants Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix Group n=100 Participants Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With Any and Related Serious Adverse Events (SAEs) Subject(s) with any SAE(s)	1 Subject	0 Subject	0 Subject
Number of Subjects With Any and Related Serious Adverse Events (SAEs) Subject(s) with related SAE(s)	0 Subject	0 Subject	0 Subject

Adverse Events

GSK1247446A Formulation 1 Group

Serious events: 1 serious events

Other events: 98 other events

Deaths: 0 deaths

GSK1247446A Formulation 2 Group

Serious events: 0 serious events

Other events: 95 other events

Deaths: 0 deaths

Fluarix Group

Serious events: 0 serious events

Other events: 81 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	GSK1247446A Formulation 1 Group n=100 participants at risk Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK1247446A Formulation 2 Group n=100 participants at risk Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix Group n=100 participants at risk Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
Injury, poisoning and procedural complications Post procedural nausea	1.0% 1/100 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 30-day (Days 0-29) follow-up period after vaccination. Serious adverse events: From study start to study end (Days 0-30)	0.00% 0/100 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 30-day (Days 0-29) follow-up period after vaccination. Serious adverse events: From study start to study end (Days 0-30)	0.00% 0/100 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 30-day (Days 0-29) follow-up period after vaccination. Serious adverse events: From study start to study end (Days 0-30)

Other adverse events

Other adverse events
Measure	GSK1247446A Formulation 1 Group n=100 participants at risk Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	GSK1247446A Formulation 2 Group n=100 participants at risk Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix Group n=100 participants at risk Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
General disorders Ecchymosis	6.0% 6/100 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 30-day (Days 0-29) follow-up period after vaccination. Serious adverse events: From study start to study end (Days 0-30)	11.0% 11/100 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 30-day (Days 0-29) follow-up period after vaccination. Serious adverse events: From study start to study end (Days 0-30)	6.0% 6/100 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 30-day (Days 0-29) follow-up period after vaccination. Serious adverse events: From study start to study end (Days 0-30)
General disorders Pain	92.0% 92/100 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 30-day (Days 0-29) follow-up period after vaccination. Serious adverse events: From study start to study end (Days 0-30)	89.0% 89/100 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 30-day (Days 0-29) follow-up period after vaccination. Serious adverse events: From study start to study end (Days 0-30)	64.0% 64/100 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 30-day (Days 0-29) follow-up period after vaccination. Serious adverse events: From study start to study end (Days 0-30)
General disorders Redness	24.0% 24/100 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 30-day (Days 0-29) follow-up period after vaccination. Serious adverse events: From study start to study end (Days 0-30)	12.0% 12/100 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 30-day (Days 0-29) follow-up period after vaccination. Serious adverse events: From study start to study end (Days 0-30)	15.0% 15/100 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 30-day (Days 0-29) follow-up period after vaccination. Serious adverse events: From study start to study end (Days 0-30)
General disorders Swelling	28.0% 28/100 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 30-day (Days 0-29) follow-up period after vaccination. Serious adverse events: From study start to study end (Days 0-30)	17.0% 17/100 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 30-day (Days 0-29) follow-up period after vaccination. Serious adverse events: From study start to study end (Days 0-30)	7.0% 7/100 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 30-day (Days 0-29) follow-up period after vaccination. Serious adverse events: From study start to study end (Days 0-30)
General disorders Arthralgia	32.0% 32/100 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 30-day (Days 0-29) follow-up period after vaccination. Serious adverse events: From study start to study end (Days 0-30)	14.0% 14/100 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 30-day (Days 0-29) follow-up period after vaccination. Serious adverse events: From study start to study end (Days 0-30)	7.0% 7/100 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 30-day (Days 0-29) follow-up period after vaccination. Serious adverse events: From study start to study end (Days 0-30)
General disorders Fatigue	60.0% 60/100 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 30-day (Days 0-29) follow-up period after vaccination. Serious adverse events: From study start to study end (Days 0-30)	42.0% 42/100 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 30-day (Days 0-29) follow-up period after vaccination. Serious adverse events: From study start to study end (Days 0-30)	28.0% 28/100 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 30-day (Days 0-29) follow-up period after vaccination. Serious adverse events: From study start to study end (Days 0-30)
General disorders Headache	51.0% 51/100 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 30-day (Days 0-29) follow-up period after vaccination. Serious adverse events: From study start to study end (Days 0-30)	40.0% 40/100 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 30-day (Days 0-29) follow-up period after vaccination. Serious adverse events: From study start to study end (Days 0-30)	29.0% 29/100 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 30-day (Days 0-29) follow-up period after vaccination. Serious adverse events: From study start to study end (Days 0-30)
General disorders Muscle aches	48.0% 48/100 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 30-day (Days 0-29) follow-up period after vaccination. Serious adverse events: From study start to study end (Days 0-30)	30.0% 30/100 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 30-day (Days 0-29) follow-up period after vaccination. Serious adverse events: From study start to study end (Days 0-30)	12.0% 12/100 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 30-day (Days 0-29) follow-up period after vaccination. Serious adverse events: From study start to study end (Days 0-30)
General disorders Shivering	33.0% 33/100 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 30-day (Days 0-29) follow-up period after vaccination. Serious adverse events: From study start to study end (Days 0-30)	13.0% 13/100 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 30-day (Days 0-29) follow-up period after vaccination. Serious adverse events: From study start to study end (Days 0-30)	5.0% 5/100 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 30-day (Days 0-29) follow-up period after vaccination. Serious adverse events: From study start to study end (Days 0-30)
Blood and lymphatic system disorders Lymphadenopathy	5.0% 5/100 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 30-day (Days 0-29) follow-up period after vaccination. Serious adverse events: From study start to study end (Days 0-30)	2.0% 2/100 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 30-day (Days 0-29) follow-up period after vaccination. Serious adverse events: From study start to study end (Days 0-30)	0.00% 0/100 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 30-day (Days 0-29) follow-up period after vaccination. Serious adverse events: From study start to study end (Days 0-30)
Gastrointestinal disorders Nausea	7.0% 7/100 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 30-day (Days 0-29) follow-up period after vaccination. Serious adverse events: From study start to study end (Days 0-30)	3.0% 3/100 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 30-day (Days 0-29) follow-up period after vaccination. Serious adverse events: From study start to study end (Days 0-30)	2.0% 2/100 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 30-day (Days 0-29) follow-up period after vaccination. Serious adverse events: From study start to study end (Days 0-30)
Infections and infestations Nasopharyngitis	15.0% 15/100 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 30-day (Days 0-29) follow-up period after vaccination. Serious adverse events: From study start to study end (Days 0-30)	8.0% 8/100 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 30-day (Days 0-29) follow-up period after vaccination. Serious adverse events: From study start to study end (Days 0-30)	11.0% 11/100 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 30-day (Days 0-29) follow-up period after vaccination. Serious adverse events: From study start to study end (Days 0-30)
Nervous system disorders Headache	9.0% 9/100 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 30-day (Days 0-29) follow-up period after vaccination. Serious adverse events: From study start to study end (Days 0-30)	6.0% 6/100 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 30-day (Days 0-29) follow-up period after vaccination. Serious adverse events: From study start to study end (Days 0-30)	2.0% 2/100 • Solicited symptoms: within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 30-day (Days 0-29) follow-up period after vaccination. Serious adverse events: From study start to study end (Days 0-30)

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