Trial Outcomes & Findings for Immunogenicity and Safety Study of Different Formulations of GlaxoSmithKline (GSK) Biologicals H7N1 Influenza Vaccine Administered to Adults 65 Years of Age and Older (NCT NCT01949090)

NCT ID: NCT01949090

Last Updated: 2017-11-17

Results Overview

Seroconversion was defined as: For initially seronegative subjects \[antibody titer below (\<) 10 post-vaccination\], antibody titer greater than or equal to (≥) 40 after vaccination; For initially seropositive subjects (antibody titer ≥ 10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/mallard/Netherlands/12/2000 NIBRG-63 (H7N1) (Flu A/mallard/NL/12/2000 H7N1).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

363 participants

Primary outcome timeframe

At Day 42

Results posted on

2017-11-17

Participant Flow

Out of 363 subjects enrolled in the study, 3 subjects did not receive any vaccination.

Participant milestones

Participant milestones
Measure	GSK2789869A F1 Group Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F2 Group Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F3 Group Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F4 Group Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Placebo Group Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Overall Study STARTED	60	60	60	60	120
Overall Study COMPLETED	56	58	58	59	116
Overall Study NOT COMPLETED	4	2	2	1	4

Reasons for withdrawal

Reasons for withdrawal
Measure	GSK2789869A F1 Group Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F2 Group Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F3 Group Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F4 Group Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Placebo Group Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Overall Study Serious Adverse Event	0	1	2	0	1
Overall Study Withdrawal by Subject	2	0	0	0	1
Overall Study Protocol non-compliance	0	0	0	0	1
Overall Study Lost to Follow-up	2	1	0	1	1

Baseline Characteristics

Immunogenicity and Safety Study of Different Formulations of GlaxoSmithKline (GSK) Biologicals H7N1 Influenza Vaccine Administered to Adults 65 Years of Age and Older

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK2789869A F1 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F2 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F3 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F4 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Placebo Group n=120 Participants Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Total n=360 Participants Total of all reporting groups
Age, Continuous	72.9 Years STANDARD_DEVIATION 6.0 • n=5 Participants	73.9 Years STANDARD_DEVIATION 6.3 • n=7 Participants	73.6 Years STANDARD_DEVIATION 6.5 • n=5 Participants	73.4 Years STANDARD_DEVIATION 5.3 • n=4 Participants	73.0 Years STANDARD_DEVIATION 5.2 • n=21 Participants	73.30 Years STANDARD_DEVIATION 5.75 • n=8 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	37 Participants n=7 Participants	30 Participants n=5 Participants	36 Participants n=4 Participants	76 Participants n=21 Participants	214 Participants n=8 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	23 Participants n=7 Participants	30 Participants n=5 Participants	24 Participants n=4 Participants	44 Participants n=21 Participants	146 Participants n=8 Participants
Race/Ethnicity, Customized Geographic Ancestry · African Heritage/African American	4 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	14 Participants n=8 Participants
Race/Ethnicity, Customized Geographic Ancestry · Asian - East Asian Heritage	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=8 Participants
Race/Ethnicity, Customized Geographic Ancestry · Asian - South East Asian Heritage	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants
Race/Ethnicity, Customized Geographic Ancestry · White - Arabic/North African Heritage	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants
Race/Ethnicity, Customized Geographic Ancestry · White - Caucasian/European Heritage	56 Participants n=5 Participants	59 Participants n=7 Participants	52 Participants n=5 Participants	57 Participants n=4 Participants	116 Participants n=21 Participants	340 Participants n=8 Participants
Race/Ethnicity, Customized Geographic Ancestry · Other	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants

PRIMARY outcome

Timeframe: At Day 42

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects for whom data concerning immunogenicity outcome measure were available. This primary outcome measure was centered on the groups that received GSK2789869A vaccine.

Outcome measures

Outcome measures
Measure	GSK2789869A F1 Group n=56 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F2 Group n=56 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F3 Group n=55 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F4 Group n=53 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Placebo Group n=112 Participants Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of thee non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain	39 Participants	45 Participants	42 Participants	46 Participants	0 Participants

PRIMARY outcome

Timeframe: At Day 42

Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom data concerning immunogenicity outcome measure were available. This primary outcome measure was centered on the groups that received GSK2789869A vaccine.

A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection.

Outcome measures

Outcome measures
Measure	GSK2789869A F1 Group n=56 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F2 Group n=56 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F3 Group n=55 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F4 Group n=53 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Placebo Group n=112 Participants Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of thee non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain	39 Participants	49 Participants	43 Participants	47 Participants	1 Participants

PRIMARY outcome

Timeframe: At Day 42

Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom data concerning immunogenicity outcome measure were available. This primary outcome was centered on the groups that received GSK2789869A vaccine.

GMFR, also known as seroconversion factor (SCR) or mean geometric increase (MGI), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer for the vaccine virus.

Outcome measures

Outcome measures
Measure	GSK2789869A F1 Group n=56 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F2 Group n=56 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F3 Group n=55 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F4 Group n=53 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Placebo Group n=112 Participants Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of thee non-dominant arm at Day 0 and of the dominant arm at Day 21.
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain	11.0 Fold increase Interval 7.3 to 16.5	18.9 Fold increase Interval 14.0 to 25.4	16.0 Fold increase Interval 10.8 to 23.7	18.2 Fold increase Interval 12.6 to 26.3	1.0 Fold increase Interval 1.0 to 1.1

PRIMARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Population: The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest; prevented normal activities as assessed by inability to attend/do work or school. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

Outcome measures

Outcome measures
Measure	GSK2789869A F1 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F2 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F3 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F4 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Placebo Group n=120 Participants Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of thee non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 1	27 Participants	34 Participants	16 Participants	29 Participants	7 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 1	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 1	0 Participants	3 Participants	1 Participants	4 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 1	1 Participants	1 Participants	3 Participants	2 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 2	27 Participants	24 Participants	17 Participants	25 Participants	3 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 2	0 Participants	0 Participants	2 Participants	0 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 2	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 2	1 Participants	2 Participants	2 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Across doses	38 Participants	39 Participants	25 Participants	38 Participants	8 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Across doses	0 Participants	1 Participants	2 Participants	1 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Across doses	1 Participants	4 Participants	1 Participants	4 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Across doses	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Across doses	2 Participants	2 Participants	4 Participants	2 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Across doses	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Population: The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.

Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (symptoms included nausea, vomiting, diarrhoea and/or abdominal pain), headache, joint pain at other location, muscle aches, shivering, sweating and fever \[defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = general symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever = temperature \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

Outcome measures

Outcome measures
Measure	GSK2789869A F1 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F2 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F3 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F4 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Placebo Group n=120 Participants Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of thee non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Dose 1	7 Participants	14 Participants	10 Participants	8 Participants	22 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Dose 1	1 Participants	2 Participants	0 Participants	0 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Dose 1	5 Participants	8 Participants	7 Participants	4 Participants	13 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever, Dose 1	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever, Dose 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever, Dose 1	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Gastrointestinal, Dose 1	5 Participants	10 Participants	5 Participants	6 Participants	12 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastrointestinal, Dose 1	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Gastrointestinal, Dose 1	3 Participants	4 Participants	4 Participants	4 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Dose 1	9 Participants	13 Participants	9 Participants	9 Participants	19 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Dose 1	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose 1	7 Participants	6 Participants	6 Participants	4 Participants	10 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Joint pain, Dose 1	9 Participants	3 Participants	5 Participants	6 Participants	14 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Joint pain, Dose 1	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Joint pain, Dose 1	6 Participants	1 Participants	3 Participants	3 Participants	10 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Muscle aches, Dose 1	10 Participants	13 Participants	5 Participants	11 Participants	17 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Muscle aches, Dose 1	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Muscle aches, Dose 1	9 Participants	11 Participants	3 Participants	8 Participants	12 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Dose 1	3 Participants	1 Participants	3 Participants	1 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Dose 1	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Dose 1	3 Participants	0 Participants	1 Participants	0 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Sweating, Dose 1	1 Participants	2 Participants	3 Participants	3 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Sweating, Dose 1	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Sweating, Dose 1	1 Participants	2 Participants	0 Participants	1 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Dose 2	7 Participants	11 Participants	7 Participants	6 Participants	12 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Dose 2	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Dose 2	6 Participants	7 Participants	5 Participants	5 Participants	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever, Dose 2	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever, Dose 2	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever, Dose 2	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Gastrointestinal, Dose 2	7 Participants	3 Participants	6 Participants	3 Participants	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastrointestinal, Dose 2	0 Participants	0 Participants	2 Participants	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Gastrointestinal, Dose 2	3 Participants	2 Participants	3 Participants	1 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Dose 2	8 Participants	10 Participants	9 Participants	6 Participants	9 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Dose 2	0 Participants	2 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose 2	6 Participants	4 Participants	8 Participants	5 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Joint pain, Dose 2	4 Participants	10 Participants	5 Participants	5 Participants	10 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Joint pain, Dose 2	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Joint pain, Dose 2	3 Participants	5 Participants	4 Participants	4 Participants	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Muscle aches, Dose 2	10 Participants	12 Participants	8 Participants	11 Participants	11 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Muscle aches, Dose 2	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Muscle aches, Dose 2	10 Participants	9 Participants	7 Participants	9 Participants	8 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Dose 2	3 Participants	5 Participants	1 Participants	2 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Joint pain, Across doses	0 Participants	1 Participants	1 Participants	0 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Joint pain, Across doses	8 Participants	6 Participants	7 Participants	5 Participants	12 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Dose 2	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Dose 2	3 Participants	2 Participants	1 Participants	0 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Sweating, Dose 2	2 Participants	4 Participants	4 Participants	2 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Sweating, Dose 2	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Sweating, Dose 2	2 Participants	3 Participants	3 Participants	1 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Across doses	11 Participants	19 Participants	13 Participants	11 Participants	28 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Across doses	1 Participants	3 Participants	1 Participants	0 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Across doses	8 Participants	13 Participants	10 Participants	8 Participants	17 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever, Across doses	1 Participants	1 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever, Across doses	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever, Across doses	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Gastrointestinal, Across doses	11 Participants	11 Participants	8 Participants	9 Participants	16 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastrointestinal, Across doses	1 Participants	1 Participants	2 Participants	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Gastrointestinal, Across doses	5 Participants	5 Participants	5 Participants	5 Participants	9 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Across doses	13 Participants	17 Participants	13 Participants	11 Participants	24 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Across doses	1 Participants	2 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Across doses	9 Participants	9 Participants	10 Participants	8 Participants	13 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Joint pain, Across doses	12 Participants	12 Participants	8 Participants	8 Participants	17 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Muscle aches, Across doses	14 Participants	21 Participants	10 Participants	16 Participants	20 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Muscle aches, Across doses	0 Participants	1 Participants	1 Participants	0 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Muscle aches, Across doses	13 Participants	17 Participants	9 Participants	13 Participants	16 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Across doses	4 Participants	5 Participants	3 Participants	3 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Across doses	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Across doses	4 Participants	2 Participants	2 Participants	0 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Sweating, Across doses	2 Participants	5 Participants	5 Participants	3 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Sweating, Across doses	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Sweating, Across doses	2 Participants	4 Participants	3 Participants	2 Participants	5 Participants

PRIMARY outcome

Timeframe: At Day 0

Population: The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.

Among analysed biochemical parameters were alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], basophils \[BAS\], creatinine \[CRE\], eosinophils \[EOS\], hematocrit \[HEM\], hemoglobin \[HgB\], lymphocytes \[LYM\], monocytes \[MON\], neutrophils \[NEU\], platelets \[PLA\], red blood cells \[RBC\] and white blood cells \[WBC\].

Outcome measures

Outcome measures
Measure	GSK2789869A F1 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F2 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F3 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F4 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Placebo Group n=120 Participants Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of thee non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values WBC- Above	1 Participants	2 Participants	1 Participants	0 Participants	4 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values HEM- Above	4 Participants	4 Participants	3 Participants	2 Participants	9 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values HgB- Below	1 Participants	0 Participants	2 Participants	3 Participants	1 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values HgB- Above	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values LYM- Below	1 Participants	0 Participants	0 Participants	2 Participants	2 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values LYM- Above	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values MON- Below	2 Participants	0 Participants	3 Participants	3 Participants	6 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values MON- Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values NEU- Below	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values NEU- Above	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values PLA- Below	0 Participants	0 Participants	1 Participants	0 Participants	4 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values PLA- Above	0 Participants	1 Participants	0 Participants	1 Participants	2 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values RBC- Below	0 Participants	1 Participants	2 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values RBC- Above	1 Participants	0 Participants	2 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values WBC- Below	1 Participants	0 Participants	0 Participants	0 Participants	3 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values ALT- Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values ALT- Above	1 Participants	4 Participants	0 Participants	1 Participants	5 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values AST- Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values AST- Above	1 Participants	2 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values BAS- Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values BAS- Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values CRE- Below	1 Participants	6 Participants	6 Participants	7 Participants	8 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values CRE- Above	1 Participants	5 Participants	4 Participants	1 Participants	9 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values EOS- Below	3 Participants	2 Participants	8 Participants	4 Participants	13 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values EOS- Above	1 Participants	0 Participants	0 Participants	3 Participants	4 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values HEM- Below	0 Participants	0 Participants	2 Participants	2 Participants	1 Participants

PRIMARY outcome

Timeframe: At Day 7

Population: The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available at Day 7.

Outcome measures

Outcome measures
Measure	GSK2789869A F1 Group n=59 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F2 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F3 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F4 Group n=59 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Placebo Group n=120 Participants Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of thee non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values RBC- Above	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values WBC- Below	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values WBC- Above	0 Participants	1 Participants	0 Participants	1 Participants	3 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values PLA- Below	0 Participants	0 Participants	1 Participants	1 Participants	5 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values PLA- Above	0 Participants	1 Participants	0 Participants	1 Participants	3 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values RBC- Below	1 Participants	0 Participants	2 Participants	1 Participants	1 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values ALT- Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values MON- Below	2 Participants	0 Participants	3 Participants	7 Participants	6 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values MON- Above	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values NEU- Below	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values NEU- Above	0 Participants	0 Participants	1 Participants	0 Participants	3 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values ALT- Above	1 Participants	3 Participants	1 Participants	1 Participants	2 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values AST- Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values AST- Above	1 Participants	2 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values BAS- Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values BAS- Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values CRE- Below	2 Participants	5 Participants	5 Participants	6 Participants	5 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values CRE- Above	2 Participants	5 Participants	3 Participants	0 Participants	8 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values EOS- Below	3 Participants	2 Participants	7 Participants	5 Participants	10 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values EOS- Above	0 Participants	0 Participants	2 Participants	2 Participants	3 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values HEM- Below	2 Participants	1 Participants	2 Participants	1 Participants	2 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values HEM- Above	1 Participants	2 Participants	1 Participants	1 Participants	6 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values HgB- Below	2 Participants	1 Participants	4 Participants	2 Participants	2 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values HgB- Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values LYM- Below	3 Participants	0 Participants	1 Participants	1 Participants	2 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values LYM- Above	0 Participants	1 Participants	0 Participants	1 Participants	2 Participants

PRIMARY outcome

Timeframe: At Day 21

Population: The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available at Day 21.

Outcome measures

Outcome measures
Measure	GSK2789869A F1 Group n=59 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F2 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F3 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F4 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Placebo Group n=119 Participants Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of thee non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values ALT- Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values ALT- Above	2 Participants	4 Participants	1 Participants	3 Participants	3 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values AST- Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values AST- Above	1 Participants	3 Participants	0 Participants	0 Participants	3 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values BAS- Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values BAS- Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values CRE- Below	0 Participants	6 Participants	5 Participants	6 Participants	7 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values CRE- Above	4 Participants	4 Participants	3 Participants	1 Participants	9 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values EOS- Below	2 Participants	2 Participants	7 Participants	7 Participants	8 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values EOS- Above	1 Participants	0 Participants	1 Participants	2 Participants	4 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values HEM- Below	0 Participants	1 Participants	3 Participants	5 Participants	2 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values HEM- Above	0 Participants	2 Participants	2 Participants	2 Participants	4 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values HgB- Below	1 Participants	1 Participants	3 Participants	4 Participants	4 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values HgB- Above	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values LYM- Below	1 Participants	0 Participants	0 Participants	1 Participants	3 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values LYM- Above	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values MON- Below	4 Participants	5 Participants	3 Participants	4 Participants	10 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values MON- Above	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values NEU- Below	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values NEU- Above	0 Participants	1 Participants	1 Participants	0 Participants	2 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values PLA- Below	0 Participants	0 Participants	1 Participants	1 Participants	5 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values PLA- Above	0 Participants	1 Participants	0 Participants	1 Participants	3 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values RBC- Below	0 Participants	0 Participants	3 Participants	1 Participants	3 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values RBC- Above	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values WBC- Below	1 Participants	1 Participants	0 Participants	0 Participants	2 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values WBC- Above	1 Participants	2 Participants	1 Participants	0 Participants	2 Participants

PRIMARY outcome

Timeframe: At Day 28

Population: The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available at Day 28.

Outcome measures

Outcome measures
Measure	GSK2789869A F1 Group n=59 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F2 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F3 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F4 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Placebo Group n=118 Participants Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of thee non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values ALT- Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values ALT-Above	1 Participants	2 Participants	1 Participants	0 Participants	3 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values AST- Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values AST- Above	1 Participants	1 Participants	1 Participants	0 Participants	2 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values BAS- Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values BAS- Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values CRE- Below	0 Participants	4 Participants	3 Participants	4 Participants	2 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values CRE- Above	2 Participants	2 Participants	3 Participants	2 Participants	8 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values EOS- Below	2 Participants	6 Participants	5 Participants	3 Participants	9 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values EOS- Above	2 Participants	1 Participants	1 Participants	2 Participants	2 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values HEM- Below	1 Participants	2 Participants	3 Participants	4 Participants	3 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values HEM- Above	2 Participants	0 Participants	1 Participants	0 Participants	2 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values HgB- Below	2 Participants	2 Participants	4 Participants	4 Participants	4 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values HgB- Above	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values LYM- Below	2 Participants	0 Participants	0 Participants	1 Participants	3 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values LYM- Above	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values MON- Below	3 Participants	2 Participants	5 Participants	3 Participants	8 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values MON- Above	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values NEU- Below	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values NEU- Above	0 Participants	2 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values PLA- Below	0 Participants	0 Participants	1 Participants	1 Participants	4 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values PLA- Above	0 Participants	1 Participants	0 Participants	3 Participants	3 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values RBC- Below	0 Participants	0 Participants	3 Participants	2 Participants	3 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values RBC- Above	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values WBC- Below	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values WBC- Above	1 Participants	2 Participants	1 Participants	3 Participants	1 Participants

PRIMARY outcome

Timeframe: At Day 42

Population: The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available at Day 42.

Outcome measures

Outcome measures
Measure	GSK2789869A F1 Group n=59 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F2 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F3 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F4 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Placebo Group n=118 Participants Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of thee non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values LYM- Below	1 Participants	1 Participants	0 Participants	0 Participants	4 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values LYM- Above	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values MON- Below	2 Participants	10 Participants	5 Participants	8 Participants	18 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values MON- Above	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values NEU- Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values NEU- Above	1 Participants	0 Participants	1 Participants	1 Participants	3 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values HEM- Above	1 Participants	1 Participants	3 Participants	1 Participants	2 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values HgB- Below	1 Participants	1 Participants	5 Participants	3 Participants	3 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values HgB- Above	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values ALT- Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values ALT- Above	1 Participants	4 Participants	1 Participants	0 Participants	6 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values AST- Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values AST- Above	1 Participants	1 Participants	1 Participants	0 Participants	2 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values BAS- Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values BAS- Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values CRE- Below	0 Participants	7 Participants	3 Participants	3 Participants	7 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values CRE- Above	3 Participants	4 Participants	5 Participants	3 Participants	8 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values EOS- Below	3 Participants	6 Participants	9 Participants	3 Participants	10 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values EOS- Above	1 Participants	0 Participants	1 Participants	2 Participants	3 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values HEM- Below	1 Participants	1 Participants	3 Participants	4 Participants	3 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values PLA- Below	0 Participants	0 Participants	1 Participants	2 Participants	5 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values PLA- Above	0 Participants	1 Participants	0 Participants	2 Participants	3 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values RBC- Below	0 Participants	0 Participants	1 Participants	2 Participants	1 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values RBC- Above	1 Participants	0 Participants	2 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values WBC- Below	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants
Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values WBC- Above	2 Participants	1 Participants	1 Participants	1 Participants	2 Participants

PRIMARY outcome

Timeframe: From Day 0 up to Day 42

Population: The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.

MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.

Outcome measures

Outcome measures
Measure	GSK2789869A F1 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F2 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F3 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F4 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Placebo Group n=120 Participants Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of thee non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Subjects With Any Medically-attended Adverse Events (MAEs)	2 Participants	10 Participants	7 Participants	3 Participants	16 Participants

PRIMARY outcome

Timeframe: From Day 0 up to Day 42

Population: The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.

Any pIMD was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.

Outcome measures

Outcome measures
Measure	GSK2789869A F1 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F2 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F3 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F4 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Placebo Group n=120 Participants Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of thee non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From Day 0 up to Day 42

Population: The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.

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.

Outcome measures

Outcome measures
Measure	GSK2789869A F1 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F2 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F3 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F4 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Placebo Group n=120 Participants Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of thee non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Subjects With Any Unsolicited Adverse Events (AEs)	17 Participants	18 Participants	21 Participants	17 Participants	35 Participants

PRIMARY outcome

Timeframe: From Day 0 up to Day 42

Population: The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.

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	GSK2789869A F1 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F2 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F3 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F4 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Placebo Group n=120 Participants Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of thee non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Subjects With Serious Adverse Events (SAEs)	0 Participants	3 Participants	1 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: At Days 0, 21, 42 and Months 6 and 12

Population: The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 0, 21, and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Months 6 and 12 data were obtained from the ATP cohorts for immunogenicity at Months 6 and 12 respectively.

Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/mallard/NL/12/2000 (H7N1).

Outcome measures

Outcome measures
Measure	GSK2789869A F1 Group n=56 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F2 Group n=57 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F3 Group n=55 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F4 Group n=53 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Placebo Group n=114 Participants Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of thee non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) Flu A/mallard/NL/12/2000 (H7N1), Day 0	0 Participants	4 Participants	3 Participants	1 Participants	3 Participants
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) Flu A/mallard/NL/12/2000 (H7N1), Day 21	16 Participants	18 Participants	25 Participants	23 Participants	4 Participants
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) Flu A/mallard/NL/12/2000 (H7N1), Day 42	47 Participants	56 Participants	50 Participants	48 Participants	7 Participants
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) Flu A/mallard/NL/12/2000 (H7N1), Month 6	25 Participants	37 Participants	35 Participants	38 Participants	4 Participants
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) Flu A/mallard/NL/12/2000 (H7N1), Month 12	4 Participants	7 Participants	9 Participants	10 Participants	1 Participants

SECONDARY outcome

Timeframe: At Days 0, 21, 42 and Months 6 and 12

Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/mallard/NL/12/2000 (H7N1).

Outcome measures

Outcome measures
Measure	GSK2789869A F1 Group n=56 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F2 Group n=57 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F3 Group n=55 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F4 Group n=53 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Placebo Group n=114 Participants Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of thee non-dominant arm at Day 0 and of the dominant arm at Day 21.
Titers for Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) Flu A/mallard/NL/12/2000 (H7N1), Day 0	5.0 Titers Interval 5.0 to 5.0	5.6 Titers Interval 5.0 to 6.4	5.4 Titers Interval 4.9 to 5.8	5.1 Titers Interval 4.9 to 5.4	5.2 Titers Interval 5.0 to 5.5
Titers for Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) Flu A/mallard/NL/12/2000 (H7N1), Day 21	8.2 Titers Interval 6.5 to 10.2	8.9 Titers Interval 7.0 to 11.3	11.1 Titers Interval 8.6 to 14.5	10.6 Titers Interval 8.2 to 13.5	5.3 Titers Interval 5.0 to 5.6
Titers for Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) Flu A/mallard/NL/12/2000 (H7N1), Day 42	55.0 Titers Interval 36.7 to 82.5	104.8 Titers Interval 80.3 to 136.7	85.5 Titers Interval 58.0 to 126.1	97.0 Titers Interval 67.5 to 139.4	5.4 Titers Interval 5.1 to 5.8
Titers for Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) Flu A/mallard/NL/12/2000 (H7N1), Month 6	10.7 Titers Interval 8.4 to 13.7	16.1 Titers Interval 12.6 to 20.5	17.1 Titers Interval 12.9 to 22.6	17.5 Titers Interval 13.7 to 22.2	5.2 Titers Interval 5.0 to 5.5
Titers for Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) Flu A/mallard/NL/12/2000 (H7N1), Month 12	5.7 Titers Interval 5.0 to 6.4	5.9 Titers Interval 5.2 to 6.8	6.6 Titers Interval 5.6 to 7.9	7.2 Titers Interval 5.7 to 8.9	5.0 Titers Interval 5.0 to 5.1

SECONDARY outcome

Timeframe: At Days 0, 21 and 42 and at Months 6 and 12

Seroprotection (SPR) was defined as the proportion of subjects with H7N1 reciprocal HI titers equal to or above (≥) 1:40 against the tested vaccine virus. The flu strain assessed was Flu A/mallard/NL/12/2000 (H7N1).

Outcome measures

Outcome measures
Measure	GSK2789869A F1 Group n=56 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F2 Group n=57 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F3 Group n=55 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F4 Group n=53 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Placebo Group n=114 Participants Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of thee non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-homologous (H7N1) Flu A/mallard/NL/12/2000 (H7N1), Day 0	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-homologous (H7N1) Flu A/mallard/NL/12/2000 (H7N1), Day 21	7 Participants	6 Participants	9 Participants	8 Participants	1 Participants
Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-homologous (H7N1) Flu A/mallard/NL/12/2000 (H7N1), Day 42	39 Participants	49 Participants	43 Participants	47 Participants	1 Participants
Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-homologous (H7N1) Flu A/mallard/NL/12/2000 (H7N1), Month 6	10 Participants	17 Participants	17 Participants	14 Participants	0 Participants
Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-homologous (H7N1) Flu A/mallard/NL/12/2000 (H7N1), Month 12	2 Participants	1 Participants	1 Participants	3 Participants	0 Participants

SECONDARY outcome

Timeframe: At Days 21 and 42 and at Months 6 and 12

SCR was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer \< 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post-vaccination reciprocal titer against the vaccine virus. The flu strain assessed was Flu A/mallard/NL/12/2000 (H7N1).

Outcome measures

Outcome measures
Measure	GSK2789869A F1 Group n=56 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F2 Group n=55 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F3 Group n=55 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F4 Group n=52 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Placebo Group n=113 Participants Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of thee non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-homologous (H7N1) Flu A/mallard/NL/12/2000 (H7N1), Day 21	7 Participants	4 Participants	9 Participants	8 Participants	0 Participants
Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-homologous (H7N1) Flu A/mallard/NL/12/2000 (H7N1), Day 42	39 Participants	45 Participants	42 Participants	46 Participants	0 Participants
Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-homologous (H7N1) Flu A/mallard/NL/12/2000 (H7N1), Month 6	10 Participants	15 Participants	15 Participants	14 Participants	0 Participants
Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-homologous (H7N1) Flu A/mallard/NL/12/2000 (H7N1), Month 12	2 Participants	1 Participants	1 Participants	3 Participants	0 Participants

SECONDARY outcome

Timeframe: At Days 21 and 42 and at Months 6 and 12

GMFR, also known as seroconversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The flu strain assessed was Flu A/mallard/NL/12/2000 (H7N1).

Outcome measures

Outcome measures
Measure	GSK2789869A F1 Group n=56 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F2 Group n=55 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F3 Group n=55 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F4 Group n=52 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Placebo Group n=113 Participants Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of thee non-dominant arm at Day 0 and of the dominant arm at Day 21.
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) Flu A/mallard/NL/12/2000 (H7N1), Day 21	1.6 Fold increase Interval 1.3 to 2.0	1.6 Fold increase Interval 1.3 to 1.9	2.1 Fold increase Interval 1.6 to 2.7	2.1 Fold increase Interval 1.6 to 2.6	1.0 Fold increase Interval 1.0 to 1.0
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) Flu A/mallard/NL/12/2000 (H7N1), Day 42	11.0 Fold increase Interval 7.3 to 16.5	18.9 Fold increase Interval 14.0 to 25.4	16.0 Fold increase Interval 10.8 to 23.7	18.2 Fold increase Interval 12.6 to 26.3	1.0 Fold increase Interval 1.0 to 1.1
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) Flu A/mallard/NL/12/2000 (H7N1), Month 6	2.1 Fold increase Interval 1.7 to 2.7	3.0 Fold increase Interval 2.3 to 3.8	3.2 Fold increase Interval 2.4 to 4.2	3.4 Fold increase Interval 2.7 to 4.4	1.0 Fold increase Interval 1.0 to 1.1
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) Flu A/mallard/NL/12/2000 (H7N1), Month 12	1.1 Fold increase Interval 1.0 to 1.3	1.1 Fold increase Interval 0.9 to 1.3	1.3 Fold increase Interval 1.1 to 1.5	1.4 Fold increase Interval 1.1 to 1.8	1.0 Fold increase Interval 0.9 to 1.0

SECONDARY outcome

Timeframe: At Days 0, 21 and 42 and at Months 6 and 12

Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/Shanghai/2/2013 (H7N9).

Outcome measures

Outcome measures
Measure	GSK2789869A F1 Group n=28 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F2 Group n=28 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F3 Group n=29 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F4 Group n=25 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Placebo Group n=30 Participants Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of thee non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) Flu A/Shanghai/2/2013 (H7N9), Day 0	0 Participants	1 Participants	1 Participants	2 Participants	1 Participants
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) Flu A/Shanghai/2/2013 (H7N9), Day 21	6 Participants	13 Participants	12 Participants	9 Participants	1 Participants
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) Flu A/Shanghai/2/2013 (H7N9), Day 42	24 Participants	27 Participants	24 Participants	24 Participants	1 Participants
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) Flu A/Shanghai/2/2013 (H7N9), Month 6	10 Participants	19 Participants	18 Participants	14 Participants	0 Participants
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) Flu A/Shanghai/2/2013 (H7N9), Month 12	2 Participants	11 Participants	11 Participants	4 Participants	1 Participants

SECONDARY outcome

Timeframe: At Days 0, 21 and 42 and at Months 6 and 12

Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/Shanghai/2/2013 (H7N9).

Outcome measures

Outcome measures
Measure	GSK2789869A F1 Group n=28 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F2 Group n=28 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F3 Group n=29 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F4 Group n=25 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Placebo Group n=30 Participants Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of thee non-dominant arm at Day 0 and of the dominant arm at Day 21.
Titers for Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) Flu A/Shanghai/2/2013 (H7N9), Day 0	5.0 Titers Interval 5.0 to 5.0	5.3 Titers Interval 4.7 to 6.1	5.2 Titers Interval 4.8 to 5.8	5.8 Titers Interval 4.7 to 7.1	5.2 Titers Interval 4.8 to 5.8
Titers for Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) Flu A/Shanghai/2/2013 (H7N9), Day 21	7.6 Titers Interval 5.4 to 10.7	12.5 Titers Interval 8.2 to 18.9	10.0 Titers Interval 7.1 to 13.9	10.9 Titers Interval 6.8 to 17.4	5.2 Titers Interval 4.8 to 5.8
Titers for Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) Flu A/Shanghai/2/2013 (H7N9), Day 42	64.3 Titers Interval 36.6 to 113.2	201.3 Titers Interval 142.6 to 284.1	96.4 Titers Interval 51.6 to 179.9	179.9 Titers Interval 103.1 to 314.0	5.2 Titers Interval 4.8 to 5.8
Titers for Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) Flu A/Shanghai/2/2013 (H7N9), Month 6	8.6 Titers Interval 6.4 to 11.6	14.1 Titers Interval 10.4 to 19.1	14.7 Titers Interval 10.3 to 20.9	12.6 Titers Interval 8.9 to 17.7	5.0 Titers Interval 5.0 to 5.0
Titers for Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) Flu A/Shanghai/2/2013 (H7N9), Month 12	5.6 Titers Interval 4.8 to 6.6	8.4 Titers Interval 6.3 to 11.1	9.0 Titers Interval 6.5 to 12.3	7.0 Titers Interval 4.7 to 10.4	5.4 Titers Interval 4.6 to 6.2

SECONDARY outcome

Timeframe: At Days 0, 21 and 42 and at Months 6 and 12

Seroprotection (SPR) was defined as the proportion of subjects with H7N9 reciprocal HI titers equal to or above (≥) 1:40 against the tested vaccine virus. The flu strain assessed was Flu A/Shanghai/2/2013 (H7N9).

Outcome measures

Outcome measures
Measure	GSK2789869A F1 Group n=28 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F2 Group n=28 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F3 Group n=29 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F4 Group n=25 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Placebo Group n=30 Participants Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of thee non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-heterologous (H7N9) Flu A/Shanghai/2/2013 (H7N9), Day 0	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-heterologous (H7N9) Flu A/Shanghai/2/2013 (H7N9), Day 21	2 Participants	9 Participants	4 Participants	6 Participants	0 Participants
Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-heterologous (H7N9) Flu A/Shanghai/2/2013 (H7N9), Day 42	22 Participants	26 Participants	23 Participants	23 Participants	0 Participants
Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-heterologous (H7N9) Flu A/Shanghai/2/2013 (H7N9), Month 6	2 Participants	5 Participants	6 Participants	3 Participants	0 Participants
Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-heterologous (H7N9) Flu A/Shanghai/2/2013 (H7N9), Month 12	0 Participants	3 Participants	2 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: At Days 21 and 42 and at Months 6 and 12

Outcome measures

Outcome measures
Measure	GSK2789869A F1 Group n=27 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F2 Group n=28 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F3 Group n=29 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F4 Group n=24 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Placebo Group n=30 Participants Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of thee non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-heterologous (H7N9) Flu A/Shanghai/2/2013 (H7N9), Day 21	2 Participants	8 Participants	3 Participants	4 Participants	0 Participants
Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-heterologous (H7N9) Flu A/Shanghai/2/2013 (H7N9), Day 42	22 Participants	26 Participants	23 Participants	22 Participants	0 Participants
Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-heterologous (H7N9) Flu A/Shanghai/2/2013 (H7N9), Month 6	2 Participants	5 Participants	6 Participants	2 Participants	0 Participants
Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-heterologous (H7N9) Flu A/Shanghai/2/2013 (H7N9), Month 12	0 Participants	3 Participants	2 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: At Days 21 and 42 and at Months 6 and 12

Outcome measures

Outcome measures
Measure	GSK2789869A F1 Group n=27 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F2 Group n=28 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F3 Group n=29 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F4 Group n=24 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Placebo Group n=30 Participants Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of thee non-dominant arm at Day 0 and of the dominant arm at Day 21.
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) Flu A/Shanghai/2/2013 (H7N9), Day 21	1.5 Fold increase Interval 1.1 to 2.2	2.3 Fold increase Interval 1.6 to 3.5	1.9 Fold increase Interval 1.4 to 2.6	1.7 Fold increase Interval 1.1 to 2.5	1.0 Fold increase Interval 1.0 to 1.0
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) Flu A/Shanghai/2/2013 (H7N9), Day 42	14.1 Fold increase Interval 8.1 to 24.6	37.7 Fold increase Interval 25.8 to 54.9	18.4 Fold increase Interval 9.8 to 34.4	28.7 Fold increase Interval 15.6 to 52.7	1.0 Fold increase Interval 1.0 to 1.0
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) Flu A/Shanghai/2/2013 (H7N9), Month 6	1.8 Fold increase Interval 1.3 to 2.4	2.6 Fold increase Interval 1.9 to 3.6	2.8 Fold increase Interval 2.0 to 4.0	2.0 Fold increase Interval 1.3 to 3.2	1.0 Fold increase Interval 0.9 to 1.1
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9) Flu A/Shanghai/2/2013 (H7N9), Month 12	1.1 Fold increase Interval 1.0 to 1.3	1.6 Fold increase Interval 1.2 to 2.1	1.7 Fold increase Interval 1.2 to 2.3	1.2 Fold increase Interval 0.7 to 1.9	1.0 Fold increase Interval 0.8 to 1.2

SECONDARY outcome

Timeframe: At Days 0, 21 and 42 and Month 6

Population: The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 0, 21, and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Month 6 data was obtained from the ATP cohort for immunogenicity at Month 6.

Seropositivity cut-off values assessed were equal to or above (≥) 1:28 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/mallard/NL/12/2000 (H7N1).

Outcome measures

Outcome measures
Measure	GSK2789869A F1 Group n=28 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F2 Group n=29 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F3 Group n=29 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F4 Group n=25 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Placebo Group n=30 Participants Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of thee non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) Flu A/mallard/NL/12/2000 (H7N1), Day 0	2 Participants	7 Participants	3 Participants	2 Participants	3 Participants
Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) Flu A/mallard/NL/12/2000 (H7N1), Day 21	9 Participants	13 Participants	9 Participants	12 Participants	2 Participants
Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) Flu A/mallard/NL/12/2000 (H7N1), Day 42	26 Participants	27 Participants	24 Participants	24 Participants	2 Participants
Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1) Flu A/mallard/NL/12/2000 (H7N1), Month 6	22 Participants	27 Participants	23 Participants	20 Participants	3 Participants

SECONDARY outcome

Timeframe: At Days 0, 21 and 42 and at Month 6

Population: The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 0, 21, and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Month 6 data was obtained from the ATP cohort for immunogenicity at Month 6.

Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/mallard/NL/12/2000. The reference seropositivity cut-off value was ≥ 1:28.

Outcome measures

Outcome measures
Measure	GSK2789869A F1 Group n=28 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F2 Group n=29 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F3 Group n=29 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F4 Group n=25 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Placebo Group n=30 Participants Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of thee non-dominant arm at Day 0 and of the dominant arm at Day 21.
Titers for Serum Neutralizing Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) Flu A/mallard/NL/12/2000 (H7N1), Day 0	14.7 Titers Interval 13.7 to 15.8	16.8 Titers Interval 14.8 to 18.9	15.0 Titers Interval 13.9 to 16.3	14.8 Titers Interval 13.7 to 16.0	15.0 Titers Interval 13.9 to 16.2
Titers for Serum Neutralizing Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) Flu A/mallard/NL/12/2000 (H7N1), Day 21	17.5 Titers Interval 15.4 to 19.9	21.2 Titers Interval 17.5 to 25.6	18.2 Titers Interval 15.5 to 21.5	21.9 Titers Interval 17.6 to 27.2	14.7 Titers Interval 13.7 to 15.7
Titers for Serum Neutralizing Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) Flu A/mallard/NL/12/2000 (H7N1), Day 42	46.2 Titers Interval 34.2 to 62.5	71.4 Titers Interval 56.8 to 89.7	51.3 Titers Interval 38.1 to 69.1	74.7 Titers Interval 54.2 to 102.9	14.7 Titers Interval 13.7 to 15.7
Titers for Serum Neutralizing Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1) Flu A/mallard/NL/12/2000 (H7N1), Month 6	26.7 Titers Interval 22.7 to 31.5	38.5 Titers Interval 32.1 to 46.3	33.5 Titers Interval 27.0 to 41.7	39.4 Titers Interval 31.6 to 49.3	15.0 Titers Interval 13.9 to 16.3

SECONDARY outcome

Timeframe: At Days 21 and 42 and at Month 6

Population: The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 21 and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Month 6 data was obtained from the ATP cohort for immunogenicity at Month 6.

Vaccine response was defined as: For initially seronegative subjects antibody titer ≥ 1:56 at post-vaccination\]; For initially seropositive subjects antibody titer at post-vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/mallard/NL/12/2000 (H7N1).

Outcome measures

Outcome measures
Measure	GSK2789869A F1 Group n=28 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F2 Group n=29 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F3 Group n=29 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F4 Group n=25 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Placebo Group n=30 Participants Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of thee non-dominant arm at Day 0 and of the dominant arm at Day 21.
Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain Flu A/mallard/NL/12/2000 (H7N1), Day 21	0 Participants	0 Participants	1 Participants	3 Participants	0 Participants
Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain Flu A/mallard/NL/12/2000 (H7N1), Day 42	13 Participants	22 Participants	17 Participants	19 Participants	0 Participants
Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain Flu A/mallard/NL/12/2000 (H7N1), Month 6	4 Participants	9 Participants	10 Participants	13 Participants	0 Participants

SECONDARY outcome

Timeframe: At Days 0, 21 and 42 and at Month 6

Population: The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 0, 21 and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Month 6 data was obtained from the ATP cohort for immunogenicity at Month 6.

Seropositivity cut-off values assessed were equal to or above (≥) 1:28 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/Anhui/1/2013 (H7N9).

Outcome measures

Outcome measures
Measure	GSK2789869A F1 Group n=28 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F2 Group n=29 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F3 Group n=29 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F4 Group n=25 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Placebo Group n=30 Participants Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of thee non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) Flu A/Anhui/1/2013 (H7N9), Day 0	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants
Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) Flu A/Anhui/1/2013 (H7N9), Day 21	3 Participants	12 Participants	7 Participants	12 Participants	0 Participants
Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) Flu A/Anhui/1/2013 (H7N9), Day 42	25 Participants	27 Participants	23 Participants	24 Participants	0 Participants
Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9) Flu A/Anhui/1/2013 (H7N9), Month 6	16 Participants	23 Participants	22 Participants	20 Participants	1 Participants

SECONDARY outcome

Timeframe: At Days 0, 21 and 42 and at Month 6

Population: The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 0, 21, and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Month 6 data was obtained from the ATP cohort for immunogenicity at Month 6.

Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/Anhui/1/2013. The reference seropositivity cut-off value was ≥ 1:28.

Outcome measures

Outcome measures
Measure	GSK2789869A F1 Group n=28 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F2 Group n=29 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F3 Group n=29 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F4 Group n=25 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Placebo Group n=30 Participants Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of thee non-dominant arm at Day 0 and of the dominant arm at Day 21.
Titers for Antibodies Against Flu A/Anhui/1/2013 Strain of Influenza Disease Vaccine-homologous (H7N9) Flu A/Anhui/1/2013 (H7N9), Day 0	14.0 Titers Interval 14.0 to 14.0	14.4 Titers Interval 13.6 to 15.1	14.0 Titers Interval 14.0 to 14.0	14.8 Titers Interval 13.7 to 16.0	14.0 Titers Interval 14.0 to 14.0
Titers for Antibodies Against Flu A/Anhui/1/2013 Strain of Influenza Disease Vaccine-homologous (H7N9) Flu A/Anhui/1/2013 (H7N9), Day 21	15.1 Titers Interval 13.9 to 16.4	20.1 Titers Interval 16.8 to 24.0	16.5 Titers Interval 14.8 to 18.6	21.3 Titers Interval 17.3 to 26.1	14.0 Titers Interval 14.0 to 14.0
Titers for Antibodies Against Flu A/Anhui/1/2013 Strain of Influenza Disease Vaccine-homologous (H7N9) Flu A/Anhui/1/2013 (H7N9), Day 42	44.0 Titers Interval 32.4 to 59.7	79.1 Titers Interval 60.5 to 103.3	53.8 Titers Interval 37.8 to 76.6	85.6 Titers Interval 60.9 to 120.5	14.0 Titers Interval 14.0 to 14.0
Titers for Antibodies Against Flu A/Anhui/1/2013 Strain of Influenza Disease Vaccine-homologous (H7N9) Flu A/Anhui/1/2013 (H7N9), Month 6	24.8 Titers Interval 19.6 to 31.4	34.2 Titers Interval 27.3 to 42.8	36.1 Titers Interval 27.6 to 47.3	35.9 Titers Interval 28.9 to 44.7	14.3 Titers Interval 13.7 to 15.1

SECONDARY outcome

Timeframe: At Days 21 and 42 and at Month 6

Outcome measures

Outcome measures
Measure	GSK2789869A F1 Group n=28 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F2 Group n=29 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F3 Group n=29 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F4 Group n=25 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Placebo Group n=30 Participants Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of thee non-dominant arm at Day 0 and of the dominant arm at Day 21.
Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the Flu A/Anhui/1/2013 (H7N9) Virus Strain Flu A/Anhui/1/2013 (H7N9), Day 21	0 Participants	2 Participants	0 Participants	3 Participants	0 Participants
Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the Flu A/Anhui/1/2013 (H7N9) Virus Strain Flu A/Anhui/1/2013 (H7N9), Day 42	13 Participants	23 Participants	18 Participants	18 Participants	0 Participants
Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the Flu A/Anhui/1/2013 (H7N9) Virus Strain Flu A/Anhui/1/2013 (H7N9), Month 6	6 Participants	12 Participants	13 Participants	11 Participants	0 Participants

SECONDARY outcome

Timeframe: From Day 42 up to Month 12

Population: The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.

Outcome measures

Outcome measures
Measure	GSK2789869A F1 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F2 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F3 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F4 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Placebo Group n=120 Participants Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of thee non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Subjects With Any Medically-attended Adverse Events (MAEs)	23 Participants	24 Participants	26 Participants	21 Participants	43 Participants

SECONDARY outcome

Timeframe: From Day 42 up to Month 12

Population: The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.

An pIMD was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.

Outcome measures

Outcome measures
Measure	GSK2789869A F1 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F2 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F3 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F4 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Placebo Group n=120 Participants Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of thee non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: During the 21-day (From Day 0 to Day 20) post-vaccination period after each dose

Population: The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.

Outcome measures

Outcome measures
Measure	GSK2789869A F1 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F2 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F3 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F4 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Placebo Group n=120 Participants Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of thee non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Subjects With Any Unsolicited Adverse Events (AEs)	18 Participants	17 Participants	22 Participants	17 Participants	38 Participants

SECONDARY outcome

Timeframe: During the entire study period (From Day 0 up to Month 12)

Population: The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.

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	GSK2789869A F1 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F2 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F3 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F4 Group n=60 Participants Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Placebo Group n=120 Participants Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of thee non-dominant arm at Day 0 and of the dominant arm at Day 21.
Number of Subjects With Serious Adverse Events (SAEs)	3 Participants	10 Participants	7 Participants	7 Participants	13 Participants

Adverse Events

GSK2789869A F1 Group

Serious events: 3 serious events

Other events: 46 other events

Deaths: 0 deaths

GSK2789869A F2 Group

Serious events: 10 serious events

Other events: 48 other events

Deaths: 1 deaths

GSK2789869A F3 Group

Serious events: 7 serious events

Other events: 30 other events

Deaths: 2 deaths

GSK2789869A F4 Group

Serious events: 7 serious events

Other events: 44 other events

Deaths: 0 deaths

Placebo Group

Serious events: 13 serious events

Other events: 47 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	GSK2789869A F1 Group n=60 participants at risk Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F2 Group n=60 participants at risk Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F3 Group n=60 participants at risk Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F4 Group n=60 participants at risk Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Placebo Group n=120 participants at risk Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Blood and lymphatic system disorders Anaemia	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.83% 1/120 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
Blood and lymphatic system disorders Leukocytosis	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.83% 1/120 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
Cardiac disorders Angina pectoris	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	3.3% 2/60 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/120 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
Cardiac disorders Angina unstable	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	1.7% 1/60 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/120 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
Cardiac disorders Arrhythmia	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	1.7% 1/60 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/120 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
Cardiac disorders Atrial fibrillation	1.7% 1/60 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	1.7% 1/60 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	1.7% 2/120 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
Cardiac disorders Atrioventricular block complete	1.7% 1/60 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	1.7% 1/60 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/120 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
Cardiac disorders Bradycardia	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	1.7% 1/60 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	1.7% 1/60 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.83% 1/120 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
Cardiac disorders Cardiac failure congestive	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	1.7% 1/60 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	1.7% 2/120 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
Cardiac disorders Coronary artery disease	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	3.3% 2/60 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.83% 1/120 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
Cardiac disorders Coronary artery stenosis	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	1.7% 1/60 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/120 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
Cardiac disorders Supraventricular tachycardia	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.83% 1/120 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
Gastrointestinal disorders Haemorrhoids	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.83% 1/120 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
Gastrointestinal disorders Large intestine polyp	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.83% 1/120 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
Gastrointestinal disorders Vomiting	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	1.7% 1/60 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/120 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
General disorders Chest pain	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.83% 1/120 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
General disorders Gait disturbance	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.83% 1/120 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
Hepatobiliary disorders Cholangitis	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.83% 1/120 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
Infections and infestations Bronchitis	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	1.7% 1/60 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/120 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
Infections and infestations Cellulitis	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	1.7% 1/60 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/120 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
Infections and infestations Escherichia bacteraemia	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.83% 1/120 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
Infections and infestations Gastroenteritis	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.83% 1/120 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
Infections and infestations Klebsiella bacteraemia	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.83% 1/120 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
Infections and infestations Lobar pneumonia	1.7% 1/60 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/120 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
Infections and infestations Pneumonia	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	1.7% 1/60 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.83% 1/120 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
Infections and infestations Sepsis	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	1.7% 1/60 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/120 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
Infections and infestations Urinary tract infection	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.83% 1/120 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
Injury, poisoning and procedural complications Concussion	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.83% 1/120 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
Injury, poisoning and procedural complications Contusion	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.83% 1/120 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
Injury, poisoning and procedural complications Hip fracture	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	1.7% 1/60 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/120 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
Injury, poisoning and procedural complications Post procedural complication	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	1.7% 1/60 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/120 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
Injury, poisoning and procedural complications Spinal compression fracture	1.7% 1/60 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	1.7% 1/60 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/120 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.83% 1/120 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
Musculoskeletal and connective tissue disorders Fracture nonunion	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	1.7% 1/60 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/120 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	1.7% 1/60 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	1.7% 1/60 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/120 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	1.7% 1/60 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/120 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	3.3% 2/60 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/120 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	1.7% 1/60 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/120 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	1.7% 1/60 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/120 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.83% 1/120 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
Nervous system disorders Seizure	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	1.7% 1/60 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	1.7% 1/60 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/120 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
Nervous system disorders Syncope	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	1.7% 1/60 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/120 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
Psychiatric disorders Mental status changes	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	1.7% 1/60 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/120 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
Renal and urinary disorders Acute kidney injury	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	1.7% 1/60 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/120 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	1.7% 1/60 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/120 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	1.7% 1/60 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/120 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	1.7% 1/60 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/120 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
Respiratory, thoracic and mediastinal disorders Pneumothorax spontaneous	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.83% 1/120 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
Vascular disorders Aortic aneurysm	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.83% 1/120 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
Vascular disorders Deep vein thrombosis	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	1.7% 1/60 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/120 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
Vascular disorders Hypertension	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.83% 1/120 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).

Other adverse events

Other adverse events
Measure	GSK2789869A F1 Group n=60 participants at risk Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 1 (F1), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F2 Group n=60 participants at risk Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 2 (F2), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F3 Group n=60 participants at risk Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 3 (F3), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	GSK2789869A F4 Group n=60 participants at risk Healthy male and female adults, 65 years of age and older, who received two doses of GSK2789869A H7N1 vaccine Formulation 4 (F4), administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.	Placebo Group n=120 participants at risk Healthy male and female adults, 65 years of age and older, who received two doses of Placebo, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Infections and infestations Upper respiratory tract infection	3.3% 2/60 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	5.0% 3/60 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	5.0% 3/60 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	1.7% 1/60 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	5.0% 6/120 • Number of events 7 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	3.3% 2/60 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	3.3% 2/60 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	1.7% 1/60 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	5.0% 3/60 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	1.7% 2/120 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
General disorders Injection site pruritus	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	1.7% 1/60 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	5.0% 3/60 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/120 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
Nervous system disorders Dizziness	0.00% 0/60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	1.7% 1/60 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	3.3% 2/60 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	5.0% 3/60 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/120 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
General disorders Pain	63.3% 38/60 • Number of events 54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	65.0% 39/60 • Number of events 58 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	41.7% 25/60 • Number of events 33 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	63.3% 38/60 • Number of events 54 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	7.5% 9/120 • Number of events 11 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
General disorders Redness	1.7% 1/60 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	6.7% 4/60 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	1.7% 1/60 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	6.7% 4/60 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.83% 1/120 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
General disorders Swelling	3.3% 2/60 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	3.3% 2/60 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	6.7% 4/60 • Number of events 5 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	3.3% 2/60 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	0.00% 0/120 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
General disorders Fatigue	18.3% 11/60 • Number of events 14 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	31.7% 19/60 • Number of events 25 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	21.7% 13/60 • Number of events 17 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	18.3% 11/60 • Number of events 15 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	23.3% 28/120 • Number of events 35 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
General disorders Gastrointestinal	18.3% 11/60 • Number of events 12 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	18.3% 11/60 • Number of events 13 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	13.3% 8/60 • Number of events 11 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	15.0% 9/60 • Number of events 9 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	13.3% 16/120 • Number of events 18 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
General disorders Headache	21.7% 13/60 • Number of events 18 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	28.3% 17/60 • Number of events 26 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	21.7% 13/60 • Number of events 20 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	18.3% 11/60 • Number of events 15 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	20.0% 24/120 • Number of events 31 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
General disorders Joint pain	20.0% 12/60 • Number of events 13 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	21.7% 13/60 • Number of events 15 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	13.3% 8/60 • Number of events 10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	15.0% 9/60 • Number of events 13 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	14.2% 17/120 • Number of events 25 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
General disorders Muscle aches	23.3% 14/60 • Number of events 20 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	35.0% 21/60 • Number of events 25 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	16.7% 10/60 • Number of events 13 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	26.7% 16/60 • Number of events 22 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	17.5% 21/120 • Number of events 30 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
General disorders Shivering (Chills)	6.7% 4/60 • Number of events 6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	8.3% 5/60 • Number of events 6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	6.7% 4/60 • Number of events 5 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	5.0% 3/60 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	5.8% 7/120 • Number of events 8 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).
General disorders Sweating	3.3% 2/60 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	8.3% 5/60 • Number of events 6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	8.3% 5/60 • Number of events 7 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	5.0% 3/60 • Number of events 5 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).	5.8% 7/120 • Number of events 8 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 21-day (Days 0-20) post-vaccination period after each dose; SAEs: during the entire study period (from Day 0 up to Month 12).

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