Trial Outcomes & Findings for Safety and Immunogenicity of H1N1 Vaccines in Adults Aged 18 Years and Older (NCT NCT00985088)

NCT ID: NCT00985088

Last Updated: 2017-12-12

Results Overview

A seropositive subject against the A/California/ virus strain was defined as a subject with H1N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (≥) the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 60 years (y) old and subjects older than (\>) 60 years.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 1343 participants
• Primary outcome timeframe: At Day 0
• Results posted on: 2017-12-12

Participant Flow

Out of 1343 subjects enrolled in the study, 3 subjects did not receive any vaccination.

Participant milestones

Measure	GSK2340274A F1_2D Group Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 1 (F1) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F2_2D Group Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F2_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F1_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F1_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_2D Group Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.	GSK2340273A F3_2D Group Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Overall Study STARTED	222	114	112	221	223	115	111	222
Overall Study COMPLETED	211	112	108	214	214	108	107	216
Overall Study NOT COMPLETED	11	2	4	7	9	7	4	6

Reasons for withdrawal

Measure	GSK2340274A F1_2D Group Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 1 (F1) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F2_2D Group Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F2_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F1_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F1_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_2D Group Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.	GSK2340273A F3_2D Group Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Overall Study Serious Adverse Event	1	1	0	0	0	0	0	1
Overall Study Adverse Event	0	0	1	0	0	0	0	0
Overall Study Withdrawal by Subject	4	0	0	1	3	2	1	2
Overall Study Migrated/moved from study area	0	0	1	0	0	0	0	1
Overall Study Lost to Follow-up	6	1	2	6	6	5	3	2

Baseline Characteristics

Safety and Immunogenicity of H1N1 Vaccines in Adults Aged 18 Years and Older

Baseline characteristics by cohort

Measure	GSK2340274A F1_2D Group n=222 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 1 (F1) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F2_2D Group n=114 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F2_1D Group n=112 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F1_1D Group n=221 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F1_1D Group n=223 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_2D Group n=115 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_1D Group n=111 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.	GSK2340273A F3_2D Group n=222 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	Total n=1340 Participants Total of all reporting groups
Age, Continuous	58.4 Years STANDARD_DEVIATION 17.37 • n=5 Participants	58.8 Years STANDARD_DEVIATION 18.69 • n=7 Participants	59.3 Years STANDARD_DEVIATION 17.71 • n=5 Participants	58.6 Years STANDARD_DEVIATION 17.91 • n=4 Participants	58.7 Years STANDARD_DEVIATION 17.59 • n=21 Participants	58.4 Years STANDARD_DEVIATION 17.96 • n=8 Participants	58.8 Years STANDARD_DEVIATION 17.55 • n=8 Participants	58.7 Years STANDARD_DEVIATION 18.16 • n=24 Participants	58.7 Years STANDARD_DEVIATION 17.8 • n=42 Participants
Sex: Female, Male Female	135 Participants n=5 Participants	69 Participants n=7 Participants	69 Participants n=5 Participants	138 Participants n=4 Participants	132 Participants n=21 Participants	70 Participants n=8 Participants	75 Participants n=8 Participants	128 Participants n=24 Participants	816 Participants n=42 Participants
Sex: Female, Male Male	87 Participants n=5 Participants	45 Participants n=7 Participants	43 Participants n=5 Participants	83 Participants n=4 Participants	91 Participants n=21 Participants	45 Participants n=8 Participants	36 Participants n=8 Participants	94 Participants n=24 Participants	524 Participants n=42 Participants
Race/Ethnicity, Customized Geographic ancestry · African heritage/ African American	14 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	14 Participants n=4 Participants	9 Participants n=21 Participants	8 Participants n=8 Participants	4 Participants n=8 Participants	12 Participants n=24 Participants	75 Participants n=42 Participants
Race/Ethnicity, Customized Geographic ancestry · American Indian or Alaskan Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	4 Participants n=42 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian - Central/South Asian heritage	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants	3 Participants n=24 Participants	9 Participants n=42 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian - East Asian heritage	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	2 Participants n=24 Participants	6 Participants n=42 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian - Japanese heritage	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	3 Participants n=42 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian - South East Asian heritage	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	2 Participants n=24 Participants	5 Participants n=42 Participants
Race/Ethnicity, Customized Geographic ancestry · Native Hawaiian or Other Pacific Islander	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	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants
Race/Ethnicity, Customized Geographic ancestry · White - Arabic/North African heritage	3 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=8 Participants	1 Participants n=8 Participants	1 Participants n=24 Participants	11 Participants n=42 Participants
Race/Ethnicity, Customized Geographic ancestry · White - Caucasian/European heritage	201 Participants n=5 Participants	102 Participants n=7 Participants	101 Participants n=5 Participants	192 Participants n=4 Participants	199 Participants n=21 Participants	98 Participants n=8 Participants	102 Participants n=8 Participants	196 Participants n=24 Participants	1191 Participants n=42 Participants
Race/Ethnicity, Customized Geographic ancestry · Other	3 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	9 Participants n=4 Participants	10 Participants n=21 Participants	2 Participants n=8 Participants	3 Participants n=8 Participants	5 Participants n=24 Participants	35 Participants n=42 Participants

PRIMARY outcome

Timeframe: At Day 0

Population: The analysis was performed only on subjects receiving F1 or F2 of GSK2340274A vaccine from the According-to-Protocol (ATP) cohort for immunogenicity, which included all subjects who received the vaccine/placebo doses on Days 0, 21 and for whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.

A seropositive subject against the A/California/ virus strain was defined as a subject with H1N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (≥) the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 60 years (y) old and subjects older than (>) 60 years.

Outcome measures

Measure	GSK2340274A F1 Group n=275 Participants Pooled group comprising the subjects from GSK2340274A F1\_2D Group and GSK2340274A F1\_1D Group.	GSK2340274A F2 Group n=138 Participants Pooled group comprising the subjects from GSK2340274A F2\_1D Group and GSK2340274A F2\_2D Group.	GSK2340274A F2_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F1_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F1_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_2D Group Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.	GSK2340273A F3_2D Group Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Number of Subjects Seropositive for Haemagglutination Inhibition (HI) Antibodies Against the A/California Virus Strain 18 - 60y	91 Participants	48 Participants	—	—	—	—	—	—
Number of Subjects Seropositive for Haemagglutination Inhibition (HI) Antibodies Against the A/California Virus Strain > 60y	168 Participants	75 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At Day 21

Population: The analysis was performed only on subjects receiving F1 or F2 of GSK2340274A vaccine from the ATP cohort for immunogenicity, which included all subjects who received the vaccine/placebo doses on both Days 0 and 21 and for whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.

A seropositive subject against the A/California/ virus strain was defined as a subject with H1N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (≥) the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 60 years (y) old and subjects > 60 years.

Outcome measures

Measure	GSK2340274A F1 Group n=275 Participants Pooled group comprising the subjects from GSK2340274A F1\_2D Group and GSK2340274A F1\_1D Group.	GSK2340274A F2 Group n=138 Participants Pooled group comprising the subjects from GSK2340274A F2\_1D Group and GSK2340274A F2\_2D Group.	GSK2340274A F2_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F1_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F1_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_2D Group Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.	GSK2340273A F3_2D Group Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Number of Subjects Seropositive for Haemagglutination Inhibition (HI) Antibodies Against the A/California Virus Strain 18 - 60y	163 Participants	83 Participants	—	—	—	—	—	—
Number of Subjects Seropositive for Haemagglutination Inhibition (HI) Antibodies Against the A/California Virus Strain > 60y	275 Participants	136 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At Day 0

Population: The analysis was performed only on subjects receiving F1 or F2 of GSK2340274A vaccine from the ATP cohort for immunogenicity, which included all subjects who received the vaccine/placebo doses on both Days 0 and 21 and for whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.

A seropositive subject against the A/California/ virus strain was defined as a subject with H1N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (≥) the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 64 years (y) old and subjects > 64 years.

Outcome measures

Measure	GSK2340274A F1 Group n=257 Participants Pooled group comprising the subjects from GSK2340274A F1\_2D Group and GSK2340274A F1\_1D Group.	GSK2340274A F2 Group n=128 Participants Pooled group comprising the subjects from GSK2340274A F2\_1D Group and GSK2340274A F2\_2D Group.	GSK2340274A F2_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F1_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F1_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_2D Group Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.	GSK2340273A F3_2D Group Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Number of Subjects Seropositive for (HI) Antibodies Against the A/California Virus Strain 18 - 64y	99 Participants	52 Participants	—	—	—	—	—	—
Number of Subjects Seropositive for (HI) Antibodies Against the A/California Virus Strain > 64y	160 Participants	71 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At Day 21

Population: The analysis was performed only on subjects receiving F1 or F2 of GSK2340274A vaccine from the ATP cohort for immunogenicity, which included all subjects who received the vaccine/placebo doses on both Days 0 and 21 and for whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.

A seropositive subject against the A/California/ virus strain was defined as a subject with H1N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (≥) the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 64 years (y) old and subjects > 64 years.

Outcome measures

Measure	GSK2340274A F1 Group n=257 Participants Pooled group comprising the subjects from GSK2340274A F1\_2D Group and GSK2340274A F1\_1D Group.	GSK2340274A F2 Group n=128 Participants Pooled group comprising the subjects from GSK2340274A F2\_1D Group and GSK2340274A F2\_2D Group.	GSK2340274A F2_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F1_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F1_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_2D Group Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.	GSK2340273A F3_2D Group Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Number of Subjects Seropositive for (HI) Antibodies Against the A/California Virus Strain 18 - 64y	181 Participants	93 Participants	—	—	—	—	—	—
Number of Subjects Seropositive for (HI) Antibodies Against the A/California Virus Strain > 64y	257 Participants	126 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At Day 21

Population: The analysis was performed only on subjects receiving F1 or F2 of GSK2340274A vaccine from the ATP cohort for immunogenicity, which included all subjects who received the vaccine/placebo doses on both Days 0 and 21 and for whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.

A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥ 1:40 and at least a 4-fold increase in pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) and results were tabulated for subjects between 18 and 60 years of age and older (>60y).

Outcome measures

Measure	GSK2340274A F1 Group n=275 Participants Pooled group comprising the subjects from GSK2340274A F1\_2D Group and GSK2340274A F1\_1D Group.	GSK2340274A F2 Group n=138 Participants Pooled group comprising the subjects from GSK2340274A F2\_1D Group and GSK2340274A F2\_2D Group.	GSK2340274A F2_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F1_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F1_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_2D Group Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.	GSK2340273A F3_2D Group Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Number of Seroconverted (SCR) Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California Virus Strain 18 - 60y	149 Participants	69 Participants	—	—	—	—	—	—
Number of Seroconverted (SCR) Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California Virus Strain > 60y	215 Participants	82 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At Day 21

Population: The analysis was performed only on subjects receiving F1 or F2 of GSK2340274A vaccine from the ATP cohort for immunogenicity, which included all subjects who received the vaccine/placebo doses on both Days 0 and 21 and for whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.

A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥ 1:40 and at least a 4-fold increase in pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) and results were tabulated for subjects between 18 and 64 years and older (>64y).

Outcome measures

Measure	GSK2340274A F1 Group n=257 Participants Pooled group comprising the subjects from GSK2340274A F1\_2D Group and GSK2340274A F1\_1D Group.	GSK2340274A F2 Group n=128 Participants Pooled group comprising the subjects from GSK2340274A F2\_1D Group and GSK2340274A F2\_2D Group.	GSK2340274A F2_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F1_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F1_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_2D Group Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.	GSK2340273A F3_2D Group Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Number of Seroconverted (SCR) Subjects for HI Antibodies Against A/California Strain > 64y	201 Participants	76 Participants	—	—	—	—	—	—
Number of Seroconverted (SCR) Subjects for HI Antibodies Against A/California Strain 18 - 64y	163 Participants	75 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At Day 0

Population: The analysis was performed only on subjects receiving F1 or F2 of GSK2340274A vaccine from the ATP cohort for immunogenicity, which included all subjects who received the vaccine/placebo doses on both Days 0 and 21 and for whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.

A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) and results were tabulated for subjects between 18 and 60 years and older (>60y).

Outcome measures

Measure	GSK2340274A F1 Group n=275 Participants Pooled group comprising the subjects from GSK2340274A F1\_2D Group and GSK2340274A F1\_1D Group.	GSK2340274A F2 Group n=138 Participants Pooled group comprising the subjects from GSK2340274A F2\_1D Group and GSK2340274A F2\_2D Group.	GSK2340274A F2_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F1_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F1_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_2D Group Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.	GSK2340273A F3_2D Group Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Virus Strain 18 - 60y	35 Participants	17 Participants	—	—	—	—	—	—
Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Virus Strain > 60y	35 Participants	22 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At Day 21

Population: The analysis was performed only on subjects receiving F1 or F2 of GSK2340274A vaccine from the ATP cohort for immunogenicity, which included all subjects who received the vaccine/placebo doses on both Days 0 and 21 and for whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.

A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The Flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18 and 60 years and older (>60y).

Outcome measures

Measure	GSK2340274A F1 Group n=275 Participants Pooled group comprising the subjects from GSK2340274A F1\_2D Group and GSK2340274A F1\_1D Group.	GSK2340274A F2 Group n=138 Participants Pooled group comprising the subjects from GSK2340274A F2\_1D Group and GSK2340274A F2\_2D Group.	GSK2340274A F2_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F1_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F1_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_2D Group Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.	GSK2340273A F3_2D Group Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Virus Strain 18 - 60y	160 Participants	78 Participants	—	—	—	—	—	—
Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Virus Strain > 60y	250 Participants	104 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At Day 0

Population: The analysis was performed only on subjects receiving F1 or F2 of GSK2340274A vaccine from the ATP cohort for immunogenicity, which included all subjects who received the vaccine/placebo doses on both Days 0 and 21 and for whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.

A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The Flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18 and 64 years and older (>64y).

Outcome measures

Measure	GSK2340274A F1 Group n=257 Participants Pooled group comprising the subjects from GSK2340274A F1\_2D Group and GSK2340274A F1\_1D Group.	GSK2340274A F2 Group n=128 Participants Pooled group comprising the subjects from GSK2340274A F2\_1D Group and GSK2340274A F2\_2D Group.	GSK2340274A F2_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F1_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F1_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_2D Group Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.	GSK2340273A F3_2D Group Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Strain 18 - 64y	36 Participants	19 Participants	—	—	—	—	—	—
Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Strain > 64y	34 Participants	20 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At Day 21

Population: The analysis was performed only on subjects receiving F1 or F2 of GSK2340274A vaccine from the ATP cohort for immunogenicity, which included all subjects who received the vaccine/placebo doses on both Days 0 and 21 and for whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.

A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The Flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18 and 64 years and older (>64y).

Outcome measures

Measure	GSK2340274A F1 Group n=257 Participants Pooled group comprising the subjects from GSK2340274A F1\_2D Group and GSK2340274A F1\_1D Group.	GSK2340274A F2 Group n=128 Participants Pooled group comprising the subjects from GSK2340274A F2\_1D Group and GSK2340274A F2\_2D Group.	GSK2340274A F2_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F1_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F1_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_2D Group Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.	GSK2340273A F3_2D Group Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Strain 18 - 64y	176 Participants	86 Participants	—	—	—	—	—	—
Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Strain > 64y	234 Participants	96 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At Day 21

Population: The analysis was performed only on subjects receiving F1 or F2 of GSK2340274A vaccine from the ATP cohort for immunogenicity, which included all subjects who received the vaccine/placebo doses on both Days 0 and 21 and for whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.

SCF was defined as the fold increase in serum HI geometric mean ratio (mean[log10(POST/PRE)]) vaccination compared to Day 21. The flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18 and 60 years of age and older (>60y).

Outcome measures

Measure	GSK2340274A F1 Group n=275 Participants Pooled group comprising the subjects from GSK2340274A F1\_2D Group and GSK2340274A F1\_1D Group.	GSK2340274A F2 Group n=138 Participants Pooled group comprising the subjects from GSK2340274A F2\_1D Group and GSK2340274A F2\_2D Group.	GSK2340274A F2_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F1_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F1_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_2D Group Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.	GSK2340273A F3_2D Group Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Seroconversion Factor (SCF) for Haemagglutination Inhibition (HI) Antibodies Against A/California Virus Strain 18 - 60y	30.1 Fold increase Interval 24.5 to 36.9	18.5 Fold increase Interval 13.8 to 24.6	—	—	—	—	—	—
Seroconversion Factor (SCF) for Haemagglutination Inhibition (HI) Antibodies Against A/California Virus Strain > 60y	10.8 Fold increase Interval 9.4 to 12.5	7.4 Fold increase Interval 6.0 to 9.2	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At Day 21

Population: The analysis was performed only on subjects receiving F1 or F2 of GSK2340274A vaccine from the ATP cohort for immunogenicity, which included all subjects who received the vaccine/placebo doses on both Days 0 and 21 and for whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.

SCF was defined as the fold increase in serum HI geometric mean ratio (mean[log10(POST/PRE)]) vaccination compared to Day 21. The flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18 and 64 years of age and older (>64y).

Outcome measures

Measure	GSK2340274A F1 Group n=257 Participants Pooled group comprising the subjects from GSK2340274A F1\_2D Group and GSK2340274A F1\_1D Group.	GSK2340274A F2 Group n=128 Participants Pooled group comprising the subjects from GSK2340274A F2\_1D Group and GSK2340274A F2\_2D Group.	GSK2340274A F2_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F1_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F1_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_2D Group Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.	GSK2340273A F3_2D Group Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Seroconversion Factor (SCF) for HI Antibodies Against A/California Strain 18 - 64y	29.2 Fold increase Interval 24.0 to 35.6	17.0 Fold increase Interval 13.0 to 22.3	—	—	—	—	—	—
Seroconversion Factor (SCF) for HI Antibodies Against A/California Strain > 64y	10.3 Fold increase Interval 8.9 to 11.9	7.3 Fold increase Interval 5.9 to 9.2	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At Days 0 and 21

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who received the vaccine/ placebo doses on both Days 0 and 21 and from whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.

A seropositive subject against the A/California/ virus strain was defined as a subject with H1N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (≥) the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 60 years (y) old and > 60 years and subjects between 18 and 64 years old and > 64 years, respectively.

Outcome measures

Measure	GSK2340274A F1 Group n=140 Participants Pooled group comprising the subjects from GSK2340274A F1\_2D Group and GSK2340274A F1\_1D Group.	GSK2340274A F2 Group n=70 Participants Pooled group comprising the subjects from GSK2340274A F2\_1D Group and GSK2340274A F2\_2D Group.	GSK2340274A F2_1D Group n=68 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F1_1D Group n=135 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F1_1D Group n=137 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_2D Group n=64 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_1D Group n=67 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.	GSK2340273A F3_2D Group n=136 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Number of Subjects Seropositive for HI Antibodies Against A/California Virus Strain A/California strain (18-60 y), Day 21	80 Participants	41 Participants	42 Participants	83 Participants	79 Participants	44 Participants	43 Participants	77 Participants
Number of Subjects Seropositive for HI Antibodies Against A/California Virus Strain A/California strain (>64 y), Day 21	128 Participants	63 Participants	63 Participants	129 Participants	120 Participants	56 Participants	58 Participants	115 Participants
Number of Subjects Seropositive for HI Antibodies Against A/California Virus Strain A/California strain (18-60 y), Day 0	47 Participants	25 Participants	23 Participants	44 Participants	52 Participants	21 Participants	22 Participants	37 Participants
Number of Subjects Seropositive for HI Antibodies Against A/California Virus Strain A/California strain (>60 y), Day 0	92 Participants	36 Participants	39 Participants	76 Participants	76 Participants	30 Participants	41 Participants	83 Participants
Number of Subjects Seropositive for HI Antibodies Against A/California Virus Strain A/California strain (>60 y), Day 21	140 Participants	68 Participants	68 Participants	135 Participants	129 Participants	58 Participants	62 Participants	124 Participants
Number of Subjects Seropositive for HI Antibodies Against A/California Virus Strain A/California strain (18-64 y), Day 0	55 Participants	28 Participants	24 Participants	44 Participants	57 Participants	23 Participants	25 Participants	40 Participants
Number of Subjects Seropositive for HI Antibodies Against A/California Virus Strain A/California strain (18-64 y), Day 21	92 Participants	46 Participants	47 Participants	89 Participants	88 Participants	46 Participants	47 Participants	86 Participants
Number of Subjects Seropositive for HI Antibodies Against A/California Virus Strain A/California strain (>64 y), Day 0	84 Participants	33 Participants	38 Participants	76 Participants	71 Participants	28 Participants	38 Participants	80 Participants

SECONDARY outcome

Timeframe: At Days 0 and 21

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who received the vaccine/ placebo doses on both Days 0 and 21 and from whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.

Antibody titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 60 years (y) old and > 60 years and subjects between 18 and 64 years old and > 64 years, respectively.

Outcome measures

Measure	GSK2340274A F1 Group n=140 Participants Pooled group comprising the subjects from GSK2340274A F1\_2D Group and GSK2340274A F1\_1D Group.	GSK2340274A F2 Group n=70 Participants Pooled group comprising the subjects from GSK2340274A F2\_1D Group and GSK2340274A F2\_2D Group.	GSK2340274A F2_1D Group n=68 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F1_1D Group n=135 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F1_1D Group n=137 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_2D Group n=64 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_1D Group n=67 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.	GSK2340273A F3_2D Group n=136 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Titers for HI Antibodies Against A/California Strain A/California strain (>60 y), Day 21	150.7 Titers Interval 124.1 to 183.1	84.1 Titers Interval 62.4 to 113.4	88.9 Titers Interval 66.5 to 118.9	118.5 Titers Interval 98.3 to 142.9	72.6 Titers Interval 57.3 to 92.0	47.0 Titers Interval 32.1 to 68.8	47.6 Titers Interval 35.0 to 64.9	47.3 Titers Interval 36.9 to 60.6
Titers for HI Antibodies Against A/California Strain A/California strain (18-64 y), Day 0	13.5 Titers Interval 10.8 to 16.8	14.5 Titers Interval 10.1 to 20.6	10.9 Titers Interval 8.3 to 14.3	12.1 Titers Interval 9.4 to 15.6	14.5 Titers Interval 11.5 to 18.2	11.2 Titers Interval 8.0 to 15.6	11.3 Titers Interval 8.4 to 15.3	10.8 Titers Interval 8.6 to 13.6
Titers for HI Antibodies Against A/California Strain A/California strain (18-64 y), Day 21	389.2 Titers Interval 310.9 to 487.3	265.2 Titers Interval 191.7 to 366.8	172.1 Titers Interval 126.3 to 234.5	359.6 Titers Interval 282.1 to 458.3	149.1 Titers Interval 114.7 to 193.8	183.1 Titers Interval 124.0 to 270.4	234.9 Titers Interval 164.4 to 335.7	96.6 Titers Interval 72.1 to 129.5
Titers for HI Antibodies Against A/California Strain A/California strain (>64 y), Day 0	13.0 Titers Interval 11.0 to 15.3	10.1 Titers Interval 8.1 to 12.6	13.9 Titers Interval 10.1 to 19.0	12.4 Titers Interval 10.3 to 14.9	12.1 Titers Interval 10.1 to 14.5	9.4 Titers Interval 7.3 to 12.1	12.2 Titers Interval 9.7 to 15.5	12.6 Titers Interval 10.6 to 14.9
Titers for HI Antibodies Against A/California Strain A/California strain (>64 y), Day 21	143.5 Titers Interval 117.5 to 175.4	83.0 Titers Interval 60.5 to 113.9	90.7 Titers Interval 66.7 to 123.3	118.8 Titers Interval 98.8 to 142.9	69.3 Titers Interval 54.3 to 88.3	42.2 Titers Interval 29.4 to 60.6	42.7 Titers Interval 31.5 to 57.8	46.0 Titers Interval 35.5 to 59.8
Titers for HI Antibodies Against A/California Strain A/California strain (18-60 y), Day 0	13.9 Titers Interval 10.9 to 17.7	14.9 Titers Interval 10.1 to 21.8	11.3 Titers Interval 8.5 to 14.9	12.9 Titers Interval 9.9 to 16.9	15.0 Titers Interval 11.7 to 19.2	10.6 Titers Interval 7.5 to 14.8	11.0 Titers Interval 8.0 to 15.1	11.0 Titers Interval 8.6 to 14.1
Titers for HI Antibodies Against A/California Strain A/California strain (18-60 y), Day 21	415.0 Titers Interval 328.6 to 524.0	299.1 Titers Interval 214.6 to 416.9	191.7 Titers Interval 139.5 to 263.5	391.0 Titers Interval 311.0 to 491.6	149.9 Titers Interval 114.0 to 197.2	167.6 Titers Interval 113.8 to 246.8	231.9 Titers Interval 158.4 to 339.6	100.3 Titers Interval 73.3 to 137.5
Titers for HI Antibodies Against A/California Strain A/California strain (>60 y), Day 0	12.8 Titers Interval 11.0 to 15.0	10.2 Titers Interval 8.2 to 12.6	13.4 Titers Interval 9.9 to 18.0	11.9 Titers Interval 10.0 to 14.2	11.9 Titers Interval 10.1 to 14.2	9.9 Titers Interval 7.7 to 12.7	12.4 Titers Interval 9.9 to 15.6	12.3 Titers Interval 10.5 to 14.5

SECONDARY outcome

Timeframe: At Day 21

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who received the vaccine/ placebo doses on both Days 0 and 21 and from whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.

A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥ 1:40 and at least a 4-fold increase in pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) and results were tabulated for subjects between 18-60 years of age and older (>60y) and for subjects between 18-64 years old and >64 years.

Outcome measures

Measure	GSK2340274A F1 Group n=140 Participants Pooled group comprising the subjects from GSK2340274A F1\_2D Group and GSK2340274A F1\_1D Group.	GSK2340274A F2 Group n=70 Participants Pooled group comprising the subjects from GSK2340274A F2\_1D Group and GSK2340274A F2\_2D Group.	GSK2340274A F2_1D Group n=68 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F1_1D Group n=135 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F1_1D Group n=137 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_2D Group n=64 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_1D Group n=67 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.	GSK2340273A F3_2D Group n=136 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Number of Seroconverted (SCR) Subjects for HI Antibodies Against A/California Virus Strain A/California strain, > 60y	109 Participants	45 Participants	37 Participants	106 Participants	69 Participants	24 Participants	27 Participants	52 Participants
Number of Seroconverted (SCR) Subjects for HI Antibodies Against A/California Virus Strain A/California strain, 18-64y	84 Participants	38 Participants	37 Participants	79 Participants	64 Participants	37 Participants	37 Participants	55 Participants
Number of Seroconverted (SCR) Subjects for HI Antibodies Against A/California Virus Strain A/California strain, > 64y	99 Participants	41 Participants	35 Participants	102 Participants	63 Participants	22 Participants	23 Participants	46 Participants
Number of Seroconverted (SCR) Subjects for HI Antibodies Against A/California Virus Strain A/California strain, 18-60y	74 Participants	34 Participants	35 Participants	75 Participants	58 Participants	35 Participants	33 Participants	49 Participants

SECONDARY outcome

Timeframe: At Days 0 and 21

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who received the vaccine/ placebo doses on both Days 0 and 21 and from whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.

A seroprotected subject was defined as a vaccinated subject with serum HI antibody titers ≥ 1:40. The Flu strain assessed was A/California/7/09 (H1N1)v-like) and results were tabulated for subjects between 18-60 years of age and older (>60y) and for subjects between 18-64 years old and >64 years.

Outcome measures

Measure	GSK2340274A F1 Group n=140 Participants Pooled group comprising the subjects from GSK2340274A F1\_2D Group and GSK2340274A F1\_1D Group.	GSK2340274A F2 Group n=70 Participants Pooled group comprising the subjects from GSK2340274A F2\_1D Group and GSK2340274A F2\_2D Group.	GSK2340274A F2_1D Group n=68 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F1_1D Group n=135 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F1_1D Group n=137 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_2D Group n=64 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_1D Group n=67 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.	GSK2340273A F3_2D Group n=136 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Number of Seroprotected (SPR) Subjects Against HI Antibodies for the A/California Virus Strain A/California strain (18-60y), Day 0	18 Participants	10 Participants	7 Participants	17 Participants	19 Participants	7 Participants	6 Participants	13 Participants
Number of Seroprotected (SPR) Subjects Against HI Antibodies for the A/California Virus Strain A/California strain (18-60y), Day 21	79 Participants	40 Participants	38 Participants	81 Participants	71 Participants	39 Participants	41 Participants	61 Participants
Number of Seroprotected (SPR) Subjects Against HI Antibodies for the A/California Virus Strain A/California strain (> 60y), Day 0	16 Participants	9 Participants	13 Participants	19 Participants	23 Participants	7 Participants	12 Participants	18 Participants
Number of Seroprotected (SPR) Subjects Against HI Antibodies for the A/California Virus Strain A/California strain (> 60y), Day 21	127 Participants	55 Participants	49 Participants	123 Participants	93 Participants	32 Participants	39 Participants	74 Participants
Number of Seroprotected (SPR) Subjects Against HI Antibodies for the A/California Virus Strain A/California strain (18-64y), Day 0	19 Participants	11 Participants	8 Participants	17 Participants	20 Participants	8 Participants	7 Participants	14 Participants
Number of Seroprotected (SPR) Subjects Against HI Antibodies for the A/California Virus Strain A/California strain (18-64y), Day 21	91 Participants	45 Participants	41 Participants	85 Participants	79 Participants	41 Participants	45 Participants	68 Participants
Number of Seroprotected (SPR) Subjects Against HI Antibodies for the A/California Virus Strain A/California strain (> 64y), Day 0	15 Participants	8 Participants	12 Participants	19 Participants	22 Participants	6 Participants	11 Participants	17 Participants
Number of Seroprotected (SPR) Subjects Against HI Antibodies for the A/California Virus Strain A/California strain (> 64y), Day 21	115 Participants	50 Participants	46 Participants	119 Participants	85 Participants	30 Participants	35 Participants	67 Participants

SECONDARY outcome

Timeframe: At Day 21

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who received the vaccine/ placebo doses on both Days 0 and 21 and from whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.

SCF was defined as the fold increase in serum HI geometric mean ratio (mean[log10(POST/PRE)]) vaccination compared to Day 21. The flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18-60 years of age and older (> 60y) and for subjects between 18-64 years old and > 64 years.

Outcome measures

Measure	GSK2340274A F1 Group n=140 Participants Pooled group comprising the subjects from GSK2340274A F1\_2D Group and GSK2340274A F1\_1D Group.	GSK2340274A F2 Group n=70 Participants Pooled group comprising the subjects from GSK2340274A F2\_1D Group and GSK2340274A F2\_2D Group.	GSK2340274A F2_1D Group n=68 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F1_1D Group n=135 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F1_1D Group n=137 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_2D Group n=64 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_1D Group n=67 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.	GSK2340273A F3_2D Group n=136 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Seroconversion Factor (SCF) for HI Antibodies Against A/California Virus Strain A/California strain, > 64y	11.1 Fold increase Interval 9.0 to 13.6	8.2 Fold increase Interval 6.0 to 11.4	6.5 Fold increase Interval 4.8 to 8.9	9.6 Fold increase Interval 7.9 to 11.6	5.7 Fold increase Interval 4.6 to 7.2	4.5 Fold increase Interval 3.1 to 6.4	3.5 Fold increase Interval 2.7 to 4.6	3.7 Fold increase Interval 2.9 to 4.6
Seroconversion Factor (SCF) for HI Antibodies Against A/California Virus Strain A/California strain, > 60y	11.8 Fold increase Interval 9.6 to 14.4	8.3 Fold increase Interval 6.0 to 11.3	6.7 Fold increase Interval 5.0 to 8.9	9.9 Fold increase Interval 8.1 to 12.1	6.1 Fold increase Interval 4.9 to 7.6	4.8 Fold increase Interval 3.3 to 6.8	3.8 Fold increase Interval 2.9 to 5.1	3.8 Fold increase Interval 3.1 to 4.8
Seroconversion Factor (SCF) for HI Antibodies Against A/California Virus Strain A/California strain, 18-64y	28.8 Fold increase Interval 22.0 to 37.9	18.3 Fold increase Interval 12.1 to 27.8	15.8 Fold increase Interval 11.0 to 22.7	29.6 Fold increase Interval 22.1 to 39.8	10.3 Fold increase Interval 7.7 to 13.8	16.4 Fold increase Interval 10.9 to 24.5	20.7 Fold increase Interval 13.0 to 33.0	8.9 Fold increase Interval 6.6 to 12.2
Seroconversion Factor (SCF) for HI Antibodies Against A/California Virus Strain A/California strain, 18-60y	29.9 Fold increase Interval 22.4 to 40.0	20.1 Fold increase Interval 13.0 to 31.2	17.0 Fold increase Interval 11.4 to 25.2	30.2 Fold increase Interval 22.4 to 40.7	10.0 Fold increase Interval 7.3 to 13.6	15.9 Fold increase Interval 10.4 to 24.2	21.1 Fold increase Interval 12.9 to 34.5	9.1 Fold increase Interval 6.6 to 12.7

SECONDARY outcome

Timeframe: At Days 0 and 42

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who received the vaccine/ placebo doses on both Days 0 and 21 and from whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.

A seropositive subject against the A/California/ virus strain was defined as a subject with H1N1 reciprocal HI antibody titers greater than or equal to (≥) the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 60 years (y) old and > 60 years and subjects between 18 and 64 years old and > 64 years, respectively.

Outcome measures

Measure	GSK2340274A F1 Group n=64 Participants Pooled group comprising the subjects from GSK2340274A F1\_2D Group and GSK2340274A F1\_1D Group.	GSK2340274A F2 Group n=69 Participants Pooled group comprising the subjects from GSK2340274A F2\_1D Group and GSK2340274A F2\_2D Group.	GSK2340274A F2_1D Group n=68 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F1_1D Group n=67 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F1_1D Group n=64 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_2D Group n=64 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_1D Group n=63 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.	GSK2340273A F3_2D Group n=69 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Number of Subjects Seropositive for HI Antibodies Against the A/California Virus Strain A/California strain (18-60 y), Day 0	24 Participants	24 Participants	21 Participants	23 Participants	26 Participants	20 Participants	22 Participants	15 Participants
Number of Subjects Seropositive for HI Antibodies Against the A/California Virus Strain A/California strain (18-60 y), Day 42	39 Participants	39 Participants	40 Participants	40 Participants	39 Participants	43 Participants	43 Participants	37 Participants
Number of Subjects Seropositive for HI Antibodies Against the A/California Virus Strain A/California strain (> 60 y), Day 0	39 Participants	36 Participants	39 Participants	42 Participants	33 Participants	31 Participants	40 Participants	44 Participants
Number of Subjects Seropositive for HI Antibodies Against the A/California Virus Strain A/California strain (> 60 y), Day 42	64 Participants	68 Participants	68 Participants	67 Participants	59 Participants	61 Participants	56 Participants	68 Participants
Number of Subjects Seropositive for HI Antibodies Against the A/California Virus Strain A/California strain (18-64 y), Day 0	25 Participants	27 Participants	22 Participants	23 Participants	28 Participants	22 Participants	25 Participants	16 Participants
Number of Subjects Seropositive for HI Antibodies Against the A/California Virus Strain A/California strain (18-64 y), Day 42	42 Participants	44 Participants	45 Participants	44 Participants	42 Participants	45 Participants	47 Participants	41 Participants
Number of Subjects Seropositive for HI Antibodies Against the A/California Virus Strain A/California strain (> 64 y), Day 42	61 Participants	63 Participants	63 Participants	63 Participants	56 Participants	59 Participants	52 Participants	64 Participants
Number of Subjects Seropositive for HI Antibodies Against the A/California Virus Strain A/California strain (> 64 y), Day 0	38 Participants	33 Participants	38 Participants	42 Participants	31 Participants	29 Participants	37 Participants	43 Participants

SECONDARY outcome

Timeframe: At Days 0 and 42

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who received the vaccine/ placebo doses on both Days 0 and 21 and from whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.

Antibody titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 60 years (y) old and > 60 years and subjects between 18 and 64 years old and > 64 years, respectively.

Outcome measures

Measure	GSK2340274A F1 Group n=64 Participants Pooled group comprising the subjects from GSK2340274A F1\_2D Group and GSK2340274A F1\_1D Group.	GSK2340274A F2 Group n=69 Participants Pooled group comprising the subjects from GSK2340274A F2\_1D Group and GSK2340274A F2\_2D Group.	GSK2340274A F2_1D Group n=68 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F1_1D Group n=67 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F1_1D Group n=64 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_2D Group n=64 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_1D Group n=63 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.	GSK2340273A F3_2D Group n=69 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Titers for HI Antibodies Against the A/California Virus Strain A/California strain (> 60 y), Day 0	11.2 Titers Interval 9.1 to 13.8	10.3 Titers Interval 8.3 to 12.8	13.4 Titers Interval 9.9 to 18.0	13.5 Titers Interval 10.5 to 17.3	10.8 Titers Interval 8.6 to 13.6	10.0 Titers Interval 7.8 to 12.8	12.9 Titers Interval 10.2 to 16.4	11.4 Titers Interval 9.4 to 13.9
Titers for HI Antibodies Against the A/California Virus Strain A/California strain (18-64 y), Day 0	14.2 Titers Interval 9.9 to 20.4	13.9 Titers Interval 9.9 to 19.6	10.5 Titers Interval 8.0 to 13.9	12.3 Titers Interval 8.7 to 17.2	15.0 Titers Interval 10.8 to 20.8	11.2 Titers Interval 8.0 to 15.7	11.3 Titers Interval 8.4 to 15.3	9.4 Titers Interval 6.9 to 12.9
Titers for HI Antibodies Against the A/California Virus Strain A/California strain (> 64 y), Day 0	11.3 Titers Interval 9.1 to 14.0	10.2 Titers Interval 8.2 to 12.7	13.9 Titers Interval 10.1 to 19.0	14.3 Titers Interval 11.1 to 18.6	10.7 Titers Interval 8.5 to 13.6	9.5 Titers Interval 7.4 to 12.3	12.8 Titers Interval 10.0 to 16.4	11.6 Titers Interval 9.5 to 14.1
Titers for HI Antibodies Against the A/California Virus Strain A/California strain (18-60 y), Day 0	14.8 Titers Interval 10.1 to 21.5	14.3 Titers Interval 9.8 to 20.7	10.9 Titers Interval 8.2 to 14.5	13.4 Titers Interval 9.3 to 19.3	15.2 Titers Interval 10.8 to 21.4	10.6 Titers Interval 7.5 to 14.9	11.0 Titers Interval 8.0 to 15.1	9.5 Titers Interval 6.8 to 13.1
Titers for HI Antibodies Against the A/California Virus Strain A/California strain (18-60 y), Day 42	565.0 Titers Interval 447.1 to 714.1	468.9 Titers Interval 351.1 to 626.1	139.2 Titers Interval 100.6 to 192.7	301.1 Titers Interval 206.4 to 439.2	99.9 Titers Interval 65.2 to 153.1	197.4 Titers Interval 142.1 to 274.1	203.8 Titers Interval 140.6 to 295.4	84.3 Titers Interval 55.1 to 128.8
Titers for HI Antibodies Against the A/California Virus Strain A/California strain (> 60 y), Day 42	235.1 Titers Interval 178.2 to 310.2	146.1 Titers Interval 107.4 to 198.6	76.8 Titers Interval 57.9 to 101.8	108.6 Titers Interval 83.0 to 142.1	65.1 Titers Interval 46.5 to 91.2	55.9 Titers Interval 39.3 to 79.4	41.8 Titers Interval 30.1 to 58.0	58.2 Titers Interval 43.2 to 78.4
Titers for HI Antibodies Against the A/California Virus Strain A/California strain (18-64 y), Day 42	503.9 Titers Interval 386.3 to 657.4	424.9 Titers Interval 319.5 to 565.0	125.0 Titers Interval 91.2 to 171.2	254.6 Titers Interval 171.8 to 377.2	97.6 Titers Interval 65.5 to 145.3	214.5 Titers Interval 153.5 to 299.6	210.2 Titers Interval 147.5 to 299.6	81.9 Titers Interval 55.7 to 120.4
Titers for HI Antibodies Against the A/California Virus Strain A/California strain (> 64 y), Day 42	243.7 Titers Interval 183.7 to 323.2	142.7 Titers Interval 103.1 to 197.5	79.1 Titers Interval 58.8 to 106.6	114.4 Titers Interval 87.2 to 150.2	64.8 Titers Interval 45.5 to 92.2	50.5 Titers Interval 36.2 to 70.4	36.6 Titers Interval 26.8 to 50.0	58.0 Titers Interval 42.3 to 79.6

SECONDARY outcome

Timeframe: At Day 42

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who received the vaccine/ placebo doses on both Days 0 and 21 and from whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.

A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥ 1:40 and at least a 4-fold increase in pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) and results were tabulated for subjects between 18-60 years of age and older (>60y) and for subjects between 18-64 years old and >64 years.

Outcome measures

Measure	GSK2340274A F1 Group n=64 Participants Pooled group comprising the subjects from GSK2340274A F1\_2D Group and GSK2340274A F1\_1D Group.	GSK2340274A F2 Group n=69 Participants Pooled group comprising the subjects from GSK2340274A F2\_1D Group and GSK2340274A F2\_2D Group.	GSK2340274A F2_1D Group n=68 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F1_1D Group n=67 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F1_1D Group n=64 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_2D Group n=64 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_1D Group n=63 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.	GSK2340273A F3_2D Group n=69 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Number of Seroconverted (SCR) Subjects for HI Antibodies Against A/California Virus Strain A/California strain, 18-60 y	36 Participants	37 Participants	31 Participants	37 Participants	21 Participants	38 Participants	32 Participants	25 Participants
Number of Seroconverted (SCR) Subjects for HI Antibodies Against A/California Virus Strain A/California strain, 18-64 y	38 Participants	41 Participants	33 Participants	39 Participants	23 Participants	40 Participants	36 Participants	28 Participants
Number of Seroconverted (SCR) Subjects for HI Antibodies Against A/California Virus Strain A/California strain, > 64 y	52 Participants	50 Participants	35 Participants	48 Participants	36 Participants	28 Participants	18 Participants	33 Participants
Number of Seroconverted (SCR) Subjects for HI Antibodies Against A/California Virus Strain A/California strain, > 60 y	54 Participants	54 Participants	37 Participants	50 Participants	38 Participants	30 Participants	22 Participants	36 Participants

SECONDARY outcome

Timeframe: At Days 0 and 42

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who received the vaccine/ placebo doses on both Days 0 and 21 and from whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.

A seroprotected subject was defined as a vaccinated subject with serum HI antibody titers ≥ 1:40. The Flu strain assessed was A/California/7/09 (H1N1)v-like) and results were tabulated for subjects between 18-60 years of age and older (>60y) and for subjects between 18-64 years old and >64 years.

Outcome measures

Measure	GSK2340274A F1 Group n=64 Participants Pooled group comprising the subjects from GSK2340274A F1\_2D Group and GSK2340274A F1\_1D Group.	GSK2340274A F2 Group n=69 Participants Pooled group comprising the subjects from GSK2340274A F2\_1D Group and GSK2340274A F2\_2D Group.	GSK2340274A F2_1D Group n=68 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F1_1D Group n=67 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F1_1D Group n=64 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_2D Group n=64 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_1D Group n=63 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.	GSK2340273A F3_2D Group n=69 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Strain A/California (18-60 y), Day 42	39 Participants	39 Participants	35 Participants	38 Participants	32 Participants	42 Participants	40 Participants	30 Participants
Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Strain A/California (18-64 y), Day 42	42 Participants	44 Participants	38 Participants	40 Participants	35 Participants	44 Participants	44 Participants	34 Participants
Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Strain A/California (> 64 y), Day 0	3 Participants	8 Participants	12 Participants	11 Participants	10 Participants	6 Participants	11 Participants	6 Participants
Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Strain A/California (> 64 y), Day 42	59 Participants	55 Participants	47 Participants	56 Participants	43 Participants	37 Participants	32 Participants	40 Participants
Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Strain A/California (> 60 y), Day 0	3 Participants	9 Participants	13 Participants	11 Participants	11 Participants	7 Participants	12 Participants	7 Participants
Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Strain A/California (> 60 y), Day 42	62 Participants	60 Participants	50 Participants	58 Participants	46 Participants	39 Participants	36 Participants	44 Participants
Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Strain A/California (18-64 y), Day 0	10 Participants	10 Participants	7 Participants	9 Participants	10 Participants	8 Participants	7 Participants	5 Participants
Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Strain A/California (18-60 y), Day 0	10 Participants	9 Participants	6 Participants	9 Participants	9 Participants	7 Participants	6 Participants	4 Participants

SECONDARY outcome

Timeframe: At Day 42

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who received the vaccine/ placebo doses on both Days 0 and 21 and from whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.

SCF was defined as the fold increase in serum HI geometric mean ratio (mean[log10(POST/PRE)]) vaccination compared to Day 21. The flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18-60 years of age and older (> 60y) and for subjects between 18-64 years old and > 64 years.

Outcome measures

Measure	GSK2340274A F1 Group n=64 Participants Pooled group comprising the subjects from GSK2340274A F1\_2D Group and GSK2340274A F1\_1D Group.	GSK2340274A F2 Group n=69 Participants Pooled group comprising the subjects from GSK2340274A F2\_1D Group and GSK2340274A F2\_2D Group.	GSK2340274A F2_1D Group n=68 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F1_1D Group n=67 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F1_1D Group n=64 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_2D Group n=64 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_1D Group n=63 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.	GSK2340273A F3_2D Group n=69 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Seroconversion Factor (SCF) for HI Antibodies Against A/California Virus Strain A/California strain, 18-60 y	38.3 Fold increase Interval 25.6 to 57.2	32.9 Fold increase Interval 21.2 to 51.0	12.8 Fold increase Interval 8.7 to 18.8	22.4 Fold increase Interval 15.0 to 33.6	6.6 Fold increase Interval 4.1 to 10.6	18.7 Fold increase Interval 12.7 to 27.4	18.5 Fold increase Interval 11.5 to 29.7	8.9 Fold increase Interval 5.7 to 13.8
Seroconversion Factor (SCF) for HI Antibodies Against A/California Virus Strain A/California strain, 18-64 y	35.4 Fold increase Interval 23.6 to 53.1	30.5 Fold increase Interval 20.0 to 46.6	11.9 Fold increase Interval 8.4 to 16.8	20.8 Fold increase Interval 14.1 to 30.6	6.5 Fold increase Interval 4.2 to 10.2	19.1 Fold increase Interval 13.2 to 27.6	18.6 Fold increase Interval 11.9 to 28.9	8.7 Fold increase Interval 5.8 to 13.1
Seroconversion Factor (SCF) for HI Antibodies Against A/California Virus Strain A/California strain, > 60 y	21.1 Fold increase Interval 14.8 to 29.9	14.2 Fold increase Interval 10.2 to 19.7	5.8 Fold increase Interval 4.4 to 7.6	8.1 Fold increase Interval 6.2 to 10.4	6.0 Fold increase Interval 4.3 to 8.5	5.6 Fold increase Interval 4.0 to 7.7	3.2 Fold increase Interval 2.4 to 4.3	5.1 Fold increase Interval 3.8 to 6.8
Seroconversion Factor (SCF) for HI Antibodies Against A/California Virus Strain A/California strain, > 64 y	21.6 Fold increase Interval 15.1 to 30.8	14.0 Fold increase Interval 9.9 to 19.7	5.7 Fold increase Interval 4.2 to 7.7	8.0 Fold increase Interval 6.1 to 10.4	6.0 Fold increase Interval 4.2 to 8.6	5.3 Fold increase Interval 3.8 to 7.3	2.9 Fold increase Interval 2.2 to 3.7	5.0 Fold increase Interval 3.7 to 6.8

SECONDARY outcome

Timeframe: At Days 0 and 182

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who received the vaccine/ placebo doses on both Days 0 and 21 and from whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.

A seropositive subject against the A/California/ virus strain was defined as a subject with H1N1 reciprocal HI antibody titers greater than or equal to (≥) the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 60 years (y) old and > 60 years and subjects between 18 and 64 years old and > 64 years, respectively.

Outcome measures

Measure	GSK2340274A F1 Group n=136 Participants Pooled group comprising the subjects from GSK2340274A F1\_2D Group and GSK2340274A F1\_1D Group.	GSK2340274A F2 Group n=66 Participants Pooled group comprising the subjects from GSK2340274A F2\_1D Group and GSK2340274A F2\_2D Group.	GSK2340274A F2_1D Group n=67 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F1_1D Group n=134 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F1_1D Group n=132 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_2D Group n=64 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_1D Group n=63 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.	GSK2340273A F3_2D Group n=137 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Number of Subjects Seropositive for HI Antibodies Against the A/California Virus Strain A/California strain (> 60 y), Day 0	89 Participants	33 Participants	39 Participants	76 Participants	73 Participants	31 Participants	41 Participants	82 Participants
Number of Subjects Seropositive for HI Antibodies Against the A/California Virus Strain A/California strain (> 60 y), Day 182	136 Participants	66 Participants	60 Participants	133 Participants	114 Participants	52 Participants	54 Participants	116 Participants
Number of Subjects Seropositive for HI Antibodies Against the A/California Virus Strain A/California strain (> 64 y), Day 182	124 Participants	61 Participants	56 Participants	127 Participants	105 Participants	50 Participants	50 Participants	108 Participants
Number of Subjects Seropositive for HI Antibodies Against the A/California Virus Strain A/California strain (18-60 y), Day 0	46 Participants	25 Participants	23 Participants	44 Participants	50 Participants	20 Participants	20 Participants	35 Participants
Number of Subjects Seropositive for HI Antibodies Against the A/California Virus Strain A/California strain (18-60 y), Day 182	75 Participants	42 Participants	40 Participants	79 Participants	72 Participants	43 Participants	40 Participants	76 Participants
Number of Subjects Seropositive for HI Antibodies Against the A/California Virus Strain A/California strain (18-64 y), Day 0	54 Participants	28 Participants	24 Participants	44 Participants	55 Participants	22 Participants	23 Participants	38 Participants
Number of Subjects Seropositive for HI Antibodies Against the A/California Virus Strain A/California strain (18-64 y), Day 182	87 Participants	47 Participants	44 Participants	85 Participants	81 Participants	45 Participants	44 Participants	84 Participants
Number of Subjects Seropositive for HI Antibodies Against the A/California Virus Strain A/California strain (> 64 y), Day 0	81 Participants	30 Participants	38 Participants	76 Participants	68 Participants	29 Participants	38 Participants	79 Participants

SECONDARY outcome

Timeframe: At Days 0 and 182

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who received the vaccine/ placebo doses on both Days 0 and 21 and from whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.

Antibody titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 60 years (y) old and > 60 years and subjects between 18 and 64 years old and > 64 years, respectively.

Outcome measures

Measure	GSK2340274A F1 Group n=136 Participants Pooled group comprising the subjects from GSK2340274A F1\_2D Group and GSK2340274A F1\_1D Group.	GSK2340274A F2 Group n=66 Participants Pooled group comprising the subjects from GSK2340274A F2\_1D Group and GSK2340274A F2\_2D Group.	GSK2340274A F2_1D Group n=67 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F1_1D Group n=134 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F1_1D Group n=132 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_2D Group n=64 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_1D Group n=63 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.	GSK2340273A F3_2D Group n=137 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Titers for HI Antibodies Against the A/California Virus Strain A/California strain (18-60 y), Day 182	250.3 Titers Interval 195.0 to 321.3	184.1 Titers Interval 130.7 to 259.3	77.9 Titers Interval 55.3 to 109.8	149.2 Titers Interval 113.9 to 195.4	92.1 Titers Interval 67.9 to 124.9	92.4 Titers Interval 65.1 to 131.3	133.3 Titers Interval 89.9 to 197.7	66.6 Titers Interval 50.9 to 87.2
Titers for HI Antibodies Against the A/California Virus Strain A/California strain (18-64 y), Day 0	14.0 Titers Interval 11.2 to 17.6	14.1 Titers Interval 10.0 to 20.0	11.1 Titers Interval 8.5 to 14.6	12.5 Titers Interval 9.7 to 16.2	14.5 Titers Interval 11.5 to 18.3	10.9 Titers Interval 7.8 to 15.2	11.2 Titers Interval 8.1 to 15.3	10.3 Titers Interval 8.3 to 12.8
Titers for HI Antibodies Against the A/California Virus Strain A/California strain (18-64 y), Day 182	232.7 Titers Interval 183.5 to 295.0	166.0 Titers Interval 118.2 to 233.1	65.7 Titers Interval 46.1 to 93.6	132.3 Titers Interval 100.6 to 174.0	90.7 Titers Interval 68.5 to 120.0	100.7 Titers Interval 70.6 to 143.8	138.8 Titers Interval 96.2 to 200.2	63.0 Titers Interval 48.7 to 81.4
Titers for HI Antibodies Against the A/California Virus Strain A/California strain (>64 y), Day 0	12.8 Titers Interval 10.8 to 15.1	10.2 Titers Interval 8.0 to 12.8	14.1 Titers Interval 10.3 to 19.4	12.4 Titers Interval 10.3 to 14.8	12.2 Titers Interval 10.1 to 14.7	9.5 Titers Interval 7.4 to 12.3	13.0 Titers Interval 10.2 to 16.6	12.3 Titers Interval 10.4 to 14.6
Titers for HI Antibodies Against the A/California Virus Strain A/California strain (>64 y), Day 182	103.3 Titers Interval 84.6 to 126.3	58.5 Titers Interval 43.1 to 79.3	40.6 Titers Interval 28.9 to 57.0	51.1 Titers Interval 42.3 to 61.8	40.5 Titers Interval 31.7 to 51.8	31.8 Titers Interval 22.3 to 45.3	34.5 Titers Interval 24.5 to 48.7	33.9 Titers Interval 26.8 to 42.8
Titers for HI Antibodies Against the A/California Virus Strain A/California strain (18-60 y), Day 0	14.5 Titers Interval 11.3 to 18.6	14.5 Titers Interval 9.9 to 21.1	11.5 Titers Interval 8.7 to 15.3	13.4 Titers Interval 10.2 to 17.6	15.1 Titers Interval 11.7 to 19.4	10.2 Titers Interval 7.3 to 14.3	10.8 Titers Interval 7.7 to 15.1	10.4 Titers Interval 8.3 to 13.1
Titers for HI Antibodies Against the A/California Virus Strain A/California strain (>60 y), Day 0	12.6 Titers Interval 10.8 to 14.8	10.3 Titers Interval 8.2 to 12.9	13.5 Titers Interval 10.0 to 18.3	11.9 Titers Interval 9.9 to 14.2	12.1 Titers Interval 10.1 to 14.4	10.0 Titers Interval 7.8 to 12.8	13.2 Titers Interval 10.4 to 16.7	12.1 Titers Interval 10.3 to 14.2
Titers for HI Antibodies Against the A/California Virus Strain A/California strain (>60 y), Day 182	106.6 Titers Interval 87.9 to 129.2	59.2 Titers Interval 44.2 to 79.5	37.9 Titers Interval 27.3 to 52.6	49.7 Titers Interval 41.2 to 59.8	42.5 Titers Interval 33.6 to 53.7	34.9 Titers Interval 24.2 to 50.4	38.7 Titers Interval 27.4 to 54.6	34.2 Titers Interval 27.3 to 42.7

SECONDARY outcome

Timeframe: At Day 182

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who received the vaccine/ placebo doses on both Days 0 and 21 and from whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.

A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥ 1:40 and at least a 4-fold increase in pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) and results were tabulated for subjects between 18-60 years of age and older (>60y) and for subjects between 18-64 years old and >64 years.

Outcome measures

Measure	GSK2340274A F1 Group n=136 Participants Pooled group comprising the subjects from GSK2340274A F1\_2D Group and GSK2340274A F1\_1D Group.	GSK2340274A F2 Group n=66 Participants Pooled group comprising the subjects from GSK2340274A F2\_1D Group and GSK2340274A F2\_2D Group.	GSK2340274A F2_1D Group n=67 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F1_1D Group n=134 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F1_1D Group n=132 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_2D Group n=64 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_1D Group n=63 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.	GSK2340273A F3_2D Group n=137 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Number of Seroconverted (SCR) Subjects for HI Antibodies A/California strain, 18-60 y	71 Participants	36 Participants	26 Participants	57 Participants	44 Participants	29 Participants	28 Participants	45 Participants
Number of Seroconverted (SCR) Subjects for HI Antibodies A/California strain, > 60 y	93 Participants	34 Participants	16 Participants	55 Participants	52 Participants	25 Participants	21 Participants	40 Participants
Number of Seroconverted (SCR) Subjects for HI Antibodies A/California strain, 18-64 y	79 Participants	38 Participants	26 Participants	59 Participants	50 Participants	31 Participants	32 Participants	46 Participants
Number of Seroconverted (SCR) Subjects for HI Antibodies A/California strain, > 64 y	85 Participants	32 Participants	16 Participants	53 Participants	46 Participants	23 Participants	17 Participants	39 Participants

SECONDARY outcome

Timeframe: At Days 0 and 182

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who received the vaccine/ placebo doses on both Days 0 and 21 and from whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.

A seroprotected subject was defined as a vaccinated subject with serum HI antibody titers ≥ 1:40. The Flu strain assessed was A/California/7/09 (H1N1)v-like) and results were tabulated for subjects between 18-60 years of age and older (>60y) and for subjects between 18-64 years old and >64 years.

Outcome measures

Measure	GSK2340274A F1 Group n=136 Participants Pooled group comprising the subjects from GSK2340274A F1\_2D Group and GSK2340274A F1\_1D Group.	GSK2340274A F2 Group n=66 Participants Pooled group comprising the subjects from GSK2340274A F2\_1D Group and GSK2340274A F2\_2D Group.	GSK2340274A F2_1D Group n=67 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F1_1D Group n=134 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F1_1D Group n=132 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_2D Group n=64 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_1D Group n=63 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.	GSK2340273A F3_2D Group n=137 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Virus Strain A/California strain (18-60 y), Day 182	75 Participants	39 Participants	33 Participants	70 Participants	58 Participants	35 Participants	33 Participants	57 Participants
Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Virus Strain A/California strain (> 60 y), Day 0	15 Participants	9 Participants	13 Participants	18 Participants	23 Participants	7 Participants	12 Participants	18 Participants
Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Virus Strain A/California strain (18-64 y), Day 0	19 Participants	11 Participants	8 Participants	17 Participants	18 Participants	7 Participants	7 Participants	13 Participants
Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Virus Strain A/California strain (18-64 y), Day 182	85 Participants	42 Participants	34 Participants	72 Participants	65 Participants	37 Participants	37 Participants	61 Participants
Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Virus Strain A/California strain (> 64 y), Day 0	14 Participants	8 Participants	12 Participants	18 Participants	22 Participants	6 Participants	11 Participants	17 Participants
Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Virus Strain A/California strain (18-60 y), Day 0	18 Participants	10 Participants	7 Participants	17 Participants	17 Participants	6 Participants	6 Participants	12 Participants
Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Virus Strain A/California strain (> 60 y), Day 182	109 Participants	44 Participants	32 Participants	85 Participants	75 Participants	31 Participants	33 Participants	69 Participants
Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Virus Strain A/California strain (> 64 y), Day 182	99 Participants	41 Participants	31 Participants	83 Participants	68 Participants	29 Participants	29 Participants	65 Participants

SECONDARY outcome

Timeframe: At Day 182

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who received the vaccine/ placebo doses on both Days 0 and 21 and from whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.

SCF was defined as the fold increase in serum HI geometric mean ratio (mean[log10(POST/PRE)]) vaccination compared to Day 21. The flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18-60 years of age and older (> 60y) and for subjects between 18-64 years old and > 64 years.

Outcome measures

Measure	GSK2340274A F1 Group n=136 Participants Pooled group comprising the subjects from GSK2340274A F1\_2D Group and GSK2340274A F1\_1D Group.	GSK2340274A F2 Group n=66 Participants Pooled group comprising the subjects from GSK2340274A F2\_1D Group and GSK2340274A F2\_2D Group.	GSK2340274A F2_1D Group n=67 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F1_1D Group n=134 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F1_1D Group n=132 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_2D Group n=64 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_1D Group n=63 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.	GSK2340273A F3_2D Group n=137 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Seroconversion Factor (SCF) for HI Antibodies Against A/California Virus Strain A/California strain, 18-60 y	17.2 Fold increase Interval 12.8 to 23.3	12.7 Fold increase Interval 8.5 to 19.1	6.8 Fold increase Interval 4.7 to 9.8	11.1 Fold increase Interval 8.2 to 15.1	6.1 Fold increase Interval 4.4 to 8.5	9.0 Fold increase Interval 6.1 to 13.4	12.3 Fold increase Interval 7.5 to 20.4	6.4 Fold increase Interval 4.8 to 8.5
Seroconversion Factor (SCF) for HI Antibodies Against A/California Virus Strain A/California strain, > 60 y	8.4 Fold increase Interval 6.9 to 10.3	5.8 Fold increase Interval 4.3 to 7.7	2.8 Fold increase Interval 2.1 to 3.7	4.2 Fold increase Interval 3.5 to 5.0	3.5 Fold increase Interval 2.8 to 4.4	3.5 Fold increase Interval 2.5 to 4.9	2.9 Fold increase Interval 2.3 to 3.8	2.8 Fold increase Interval 2.4 to 3.4
Seroconversion Factor (SCF) for HI Antibodies Against A/California Virus Strain A/California strain, 18-64 y	16.6 Fold increase Interval 12.6 to 21.9	11.7 Fold increase Interval 7.9 to 17.5	5.9 Fold increase Interval 4.2 to 8.4	10.6 Fold increase Interval 7.9 to 14.1	6.3 Fold increase Interval 4.6 to 8.5	9.3 Fold increase Interval 6.3 to 13.6	12.4 Fold increase Interval 7.8 to 19.8	6.1 Fold increase Interval 4.7 to 8.0
Seroconversion Factor (SCF) for HI Antibodies Against A/California Virus Strain A/California strain, > 64 y	8.1 Fold increase Interval 6.5 to 10.0	5.8 Fold increase Interval 4.3 to 7.7	2.9 Fold increase Interval 2.2 to 3.8	4.1 Fold increase Interval 3.5 to 5.0	3.3 Fold increase Interval 2.6 to 4.2	3.3 Fold increase Interval 2.4 to 4.6	2.7 Fold increase Interval 2.1 to 3.4	2.7 Fold increase Interval 2.3 to 3.3

SECONDARY outcome

Timeframe: At Day 21

Population: The analysis was performed on the ATP cohort for immunogenicity,which included all subjects who received the vaccine/placebo doses on Days 0 and 21 and for whom assay results for antibodies against vaccine antigen for blood samples taken were available. This analysis focused on subjects receiving GSK2340274A F1 vaccine versus GSK2340273A F3 vaccine

Titers were presented as geometric mean titers (GMTs). Adjusted GMT was defined as the geometric mean antibody titer adjusted for Previous Vaccination baseline titers and results were tabulated for subjects between 18-60 years, > 60 years, 18-64 years and > 64 years, from the pooled group GSK2340274A F1 and GSK2340273A F3_2D Group.

Outcome measures

Measure	GSK2340274A F1 Group n=275 Participants Pooled group comprising the subjects from GSK2340274A F1\_2D Group and GSK2340274A F1\_1D Group.	GSK2340274A F2 Group n=136 Participants Pooled group comprising the subjects from GSK2340274A F2\_1D Group and GSK2340274A F2\_2D Group.	GSK2340274A F2_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F1_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F1_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_2D Group Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.	GSK2340273A F3_2D Group Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Adjusted Geometric Mean Titer (GMT) Ratios of A/California Virus Strain Adjusted A/California ratio, 18-64y	381.7 Titers	101.6 Titers	—	—	—	—	—	—
Adjusted Geometric Mean Titer (GMT) Ratios of A/California Virus Strain Adjusted A/California ratio, 18-60y	404.9 Titers	104.5 Titers	—	—	—	—	—	—
Adjusted Geometric Mean Titer (GMT) Ratios of A/California Virus Strain Adjusted A/California ratio, > 60y	152.7 Titers	55.0 Titers	—	—	—	—	—	—
Adjusted Geometric Mean Titer (GMT) Ratios of A/California Virus Strain Adjusted A/California ratio, > 64y	156.0 Titers	56.2 Titers	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At Day 21

Population: The analysis was performed on the ATP cohort for immunogenicity,which included all subjects who received the vaccine/placebo doses on Days 0 and 21 and for whom assay results for antibodies against vaccine antigen for blood samples taken were available. This analysis focused on subjects receiving GSK2340274A F1 vaccine versus GSK2340273A F2 vaccine

Titers were presented as geometric mean titers (GMTs). Adjusted GMT was defined as the geometric mean antibody titer adjusted for Previous Vaccination baseline titers and results were tabulated for subjects between 18-60 years, > 60 years, 18-64 years and > 64 years, from the pooled groups GSK2340274A F1 and GSK2340273A F2.

Outcome measures

Measure	GSK2340274A F1 Group n=275 Participants Pooled group comprising the subjects from GSK2340274A F1\_2D Group and GSK2340274A F1\_1D Group.	GSK2340274A F2 Group n=131 Participants Pooled group comprising the subjects from GSK2340274A F2\_1D Group and GSK2340274A F2\_2D Group.	GSK2340274A F2_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F1_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F1_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_2D Group Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.	GSK2340273A F3_2D Group Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Adjusted Geometric Mean Titer (GMT) Ratios of A/California Strain Adjusted A/California ratio, 18-60y	400.8 Titer	215.3 Titer	—	—	—	—	—	—
Adjusted Geometric Mean Titer (GMT) Ratios of A/California Strain Adjusted A/California ratio, > 60y	162.3 Titer	61.4 Titer	—	—	—	—	—	—
Adjusted Geometric Mean Titer (GMT) Ratios of A/California Strain Adjusted A/California ratio, 18-64y	385.7 Titer	220.2 Titer	—	—	—	—	—	—
Adjusted Geometric Mean Titer (GMT) Ratios of A/California Strain Adjusted A/California ratio, > 64y	159.2 Titer	56.8 Titer	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At Day 21

Population: The analysis was performed on the ATP cohort for immunogenicity,which included all subjects who received the vaccine/placebo doses on Days 0 and 21 and for whom assay results for antibodies against vaccine antigen for blood samples taken were available. This analysis focused on subjects receiving GSK2340274A F1 vaccine vs GSK2340273A F1\_1D vaccine

Titers were presented as geometric mean titers (GMTs). Adjusted GMT was defined as the geometric mean antibody titer adjusted for Previous Vaccination baseline titers and results were tabulated for subjects between 18-60 years, > 60 years, 18-64 years and > 64 years, from the pooled group GSK2340274A F1 and the GSK2340273A F1_1D Group.

Outcome measures

Measure	GSK2340274A F1 Group n=275 Participants Pooled group comprising the subjects from GSK2340274A F1\_2D Group and GSK2340274A F1\_1D Group.	GSK2340274A F2 Group n=137 Participants Pooled group comprising the subjects from GSK2340274A F2\_1D Group and GSK2340274A F2\_2D Group.	GSK2340274A F2_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F1_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F1_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_2D Group Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.	GSK2340273A F3_2D Group Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Adjusted GMT Ratios of A/California Virus Strain Adjusted A/California ratio, 18-60y	414.8 Titer	153.1 Titer	—	—	—	—	—	—
Adjusted GMT Ratios of A/California Virus Strain Adjusted A/California ratio, > 60y	172.9 Titer	95.6 Titer	—	—	—	—	—	—
Adjusted GMT Ratios of A/California Virus Strain Adjusted A/California ratio, 18-64y	393.8 Titer	151.6 Titer	—	—	—	—	—	—
Adjusted GMT Ratios of A/California Virus Strain Adjusted A/California ratio, > 64y	169.9 Titer	94.2 Titer	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At Day 21

Population: The analysis was performed on the ATP cohort for immunogenicity,which included all subjects who received the vaccine/placebo doses on Days 0 and 21 and for whom assay results for antibodies against vaccine antigen for blood samples taken were available. This analysis focused on subjects receiving GSK2340274A F2 vaccine versus GSK2340273A F3 vaccine

Titers were presented as geometric mean titers (GMTs). Adjusted GMT was defined as the geometric mean antibody titer adjusted for Previous Vaccination baseline titers and results were tabulated for subjects between 18-60 years, > 60 years, 18-64 years and > 64 years, from the pooled group GSK2340274A F2 and the GSK2340273A F3_2D Group.

Outcome measures

Measure	GSK2340274A F1 Group n=138 Participants Pooled group comprising the subjects from GSK2340274A F1\_2D Group and GSK2340274A F1\_1D Group.	GSK2340274A F2 Group n=136 Participants Pooled group comprising the subjects from GSK2340274A F2\_1D Group and GSK2340274A F2\_2D Group.	GSK2340274A F2_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F1_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F1_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_2D Group Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.	GSK2340273A F3_2D Group Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Adjusted GMT Ratios of A/California Strain Adjusted A/California ratio, 18-60y	238.2 Titer	102.3 Titer	—	—	—	—	—	—
Adjusted GMT Ratios of A/California Strain Adjusted A/California ratio, > 60y	113.3 Titer	61.3 Titer	—	—	—	—	—	—
Adjusted GMT Ratios of A/California Strain Adjusted A/California ratio, 18-64y	213.9 Titer	99.5 Titer	—	—	—	—	—	—
Adjusted GMT Ratios of A/California Strain Adjusted A/California ratio, > 64y	117.2 Titer	60.5 Titer	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At Day 21

Population: The analysis was performed on the ATP cohort for immunogenicity,which included all subjects who received the vaccine/placebo doses on Days 0 and 21 and for whom assay results for antibodies against vaccine antigen for blood samples taken were available. This analysis focused on subjects receiving GSK2340274A F2 vaccine versus GSK2340273A F2 vaccine

Titers were presented as geometric mean titers (GMTs). Adjusted GMT was defined as the geometric mean antibody titer adjusted for Previous Vaccination baseline titers and results were tabulated for subjects between 18-60 years, > 60 years, 18-64 years and > 64 years, from the pooled groups GSK2340274A F2 and GSK2340273A F2.

Outcome measures

Measure	GSK2340274A F1 Group n=138 Participants Pooled group comprising the subjects from GSK2340274A F1\_2D Group and GSK2340274A F1\_1D Group.	GSK2340274A F2 Group n=131 Participants Pooled group comprising the subjects from GSK2340274A F2\_1D Group and GSK2340274A F2\_2D Group.	GSK2340274A F2_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F1_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F1_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_2D Group Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.	GSK2340273A F3_2D Group Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Adjusted GMT Ratios for A/California Virus Strain Adjusted A/California ratio, > 64y	118.2 Titer	61.6 Titer	—	—	—	—	—	—
Adjusted GMT Ratios for A/California Virus Strain Adjusted A/California ratio, 18-60y	234.3 Titer	208.6 Titer	—	—	—	—	—	—
Adjusted GMT Ratios for A/California Virus Strain Adjusted A/California ratio, > 60y	119.9 Titer	68.3 Titer	—	—	—	—	—	—
Adjusted GMT Ratios for A/California Virus Strain Adjusted A/California ratio, 18-64y	213.7 Titer	216.7 Titer	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At Day 21

Population: The analysis was performed on the ATP cohort for immunogenicity,which included all subjects who received the vaccine/placebo doses on Days 0 and 21 and for whom assay results for antibodies against vaccine antigen for blood samples taken were available. This analysis focused on subjects receiving GSK2340274A F2 vaccine vs. GSK2340273A F1\_1D vaccine

Titers were presented as geometric mean titers (GMTs). Adjusted GMT was defined as the geometric mean antibody titer adjusted for Previous Vaccination baseline titers and results were tabulated for subjects between 18-60 years, > 60 years, 18-64 years and > 64 years, from the pooled group GSK2340274A F2 and the GSK2340273A F1_1D Group.

Outcome measures

Measure	GSK2340274A F1 Group n=138 Participants Pooled group comprising the subjects from GSK2340274A F1\_2D Group and GSK2340274A F1\_1D Group.	GSK2340274A F2 Group n=137 Participants Pooled group comprising the subjects from GSK2340274A F2\_1D Group and GSK2340274A F2\_2D Group.	GSK2340274A F2_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F1_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F1_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_2D Group Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.	GSK2340273A F3_2D Group Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Adjusted GMT Ratios for A/California Strain Adjusted A/California ratio, 18-60y	246.4 Titer	150.9 Titer	—	—	—	—	—	—
Adjusted GMT Ratios for A/California Strain Adjusted A/California ratio, > 60y	129.6 Titer	110.2 Titer	—	—	—	—	—	—
Adjusted GMT Ratios for A/California Strain Adjusted A/California ratio, 18-64y	221.8 Titer	150.4 Titer	—	—	—	—	—	—
Adjusted GMT Ratios for A/California Strain Adjusted A/California ratio, > 64y	130.7 Titer	106.3 Titer	—	—	—	—	—	—

SECONDARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses, for subjects between 18-64 years of age

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects who received at least 1 study vaccination and had their symptom sheets filled in.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that 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

Measure	GSK2340274A F1 Group n=93 Participants Pooled group comprising the subjects from GSK2340274A F1\_2D Group and GSK2340274A F1\_1D Group.	GSK2340274A F2 Group n=47 Participants Pooled group comprising the subjects from GSK2340274A F2\_1D Group and GSK2340274A F2\_2D Group.	GSK2340274A F2_1D Group n=47 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F1_1D Group n=91 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F1_1D Group n=92 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_2D Group n=49 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_1D Group n=47 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.	GSK2340273A F3_2D Group n=92 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 1	4 Participants	3 Participants	0 Participants	2 Participants	0 Participants	0 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	0 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	0 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Across doses	81 Participants	43 Participants	36 Participants	80 Participants	28 Participants	15 Participants	13 Participants	23 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Across doses	6 Participants	5 Participants	0 Participants	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Across doses	6 Participants	0 Participants	2 Participants	7 Participants	1 Participants	0 Participants	0 Participants	3 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	0 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 1	2 Participants	0 Participants	2 Participants	7 Participants	0 Participants	0 Participants	0 Participants	3 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	0 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 1	3 Participants	0 Participants	1 Participants	9 Participants	2 Participants	0 Participants	0 Participants	2 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 1	74 Participants	39 Participants	35 Participants	80 Participants	25 Participants	10 Participants	11 Participants	16 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	0 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 2	68 Participants	37 Participants	4 Participants	12 Participants	15 Participants	7 Participants	4 Participants	10 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 2	5 Participants	3 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 2	3 Participants	3 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 2	5 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Across doses	7 Participants	3 Participants	1 Participants	9 Participants	3 Participants	0 Participants	0 Participants	3 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	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: During the 7-day (Day 0-6) post-vaccination period following each dose and across doses, for subjects > 64 years of age

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects who received at least 1 study vaccination and had their symptom sheets filled in.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that 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

Measure	GSK2340274A F1 Group n=129 Participants Pooled group comprising the subjects from GSK2340274A F1\_2D Group and GSK2340274A F1\_1D Group.	GSK2340274A F2 Group n=66 Participants Pooled group comprising the subjects from GSK2340274A F2\_1D Group and GSK2340274A F2\_2D Group.	GSK2340274A F2_1D Group n=65 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F1_1D Group n=130 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F1_1D Group n=130 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_2D Group n=65 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_1D Group n=64 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.	GSK2340273A F3_2D Group n=130 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 1	73 Participants	28 Participants	21 Participants	75 Participants	17 Participants	4 Participants	4 Participants	10 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 2	63 Participants	23 Participants	1 Participants	4 Participants	3 Participants	6 Participants	3 Participants	7 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	0 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Across doses	87 Participants	33 Participants	21 Participants	76 Participants	19 Participants	10 Participants	7 Participants	15 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Across doses	3 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Across doses	16 Participants	0 Participants	1 Participants	7 Participants	1 Participants	1 Participants	0 Participants	2 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	0 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Across doses	13 Participants	5 Participants	3 Participants	11 Participants	4 Participants	2 Participants	0 Participants	2 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	0 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 1	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 1	6 Participants	0 Participants	0 Participants	6 Participants	1 Participants	1 Participants	0 Participants	2 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	0 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 1	9 Participants	3 Participants	3 Participants	9 Participants	4 Participants	2 Participants	0 Participants	1 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	0 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 2	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 2	12 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 2	8 Participants	3 Participants	1 Participants	3 Participants	0 Participants	0 Participants	0 Participants	1 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	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: During the 7-day (Day 0-6) post-vaccination period following each dose and across doses, for subjects between 18-64 years of age

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects who received at least 1 study vaccination and had their symptom sheets filled in.

Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)], headache, joint pain at other location, muscle aches, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = 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 = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

Outcome measures

Measure	GSK2340274A F1 Group n=93 Participants Pooled group comprising the subjects from GSK2340274A F1\_2D Group and GSK2340274A F1\_1D Group.	GSK2340274A F2 Group n=47 Participants Pooled group comprising the subjects from GSK2340274A F2\_1D Group and GSK2340274A F2\_2D Group.	GSK2340274A F2_1D Group n=47 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F1_1D Group n=91 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F1_1D Group n=92 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_2D Group n=49 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_1D Group n=47 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.	GSK2340273A F3_2D Group n=92 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Dose 1	2 Participants	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Temperature, Dose 1	2 Participants	1 Participants	0 Participants	1 Participants	2 Participants	0 Participants	2 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Joint pain at other location, Dose 1	2 Participants	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Joint pain at other location, Dose 1	14 Participants	10 Participants	2 Participants	12 Participants	10 Participants	3 Participants	1 Participants	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Muscle aches, Dose 1	32 Participants	19 Participants	7 Participants	33 Participants	15 Participants	10 Participants	4 Participants	17 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Dose 2	11 Participants	3 Participants	1 Participants	2 Participants	6 Participants	4 Participants	0 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Sweating, Dose 1	6 Participants	3 Participants	0 Participants	4 Participants	7 Participants	2 Participants	5 Participants	8 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	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Sweating, Dose 1	5 Participants	3 Participants	0 Participants	3 Participants	5 Participants	2 Participants	3 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature, Dose 1	3 Participants	1 Participants	0 Participants	1 Participants	3 Participants	0 Participants	3 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Temperature, Dose 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Dose 2	26 Participants	16 Participants	4 Participants	13 Participants	15 Participants	10 Participants	7 Participants	15 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Dose 2	4 Participants	3 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Dose 2	22 Participants	13 Participants	3 Participants	11 Participants	13 Participants	10 Participants	6 Participants	8 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Dose 2	23 Participants	15 Participants	3 Participants	14 Participants	22 Participants	17 Participants	12 Participants	18 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Dose 2	3 Participants	2 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose 2	20 Participants	12 Participants	1 Participants	11 Participants	15 Participants	16 Participants	8 Participants	13 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Joint pain at other location, Dose 2	3 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Joint pain at other location, Dose 2	18 Participants	4 Participants	1 Participants	2 Participants	7 Participants	4 Participants	5 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Muscle aches, Dose 2	29 Participants	13 Participants	2 Participants	7 Participants	12 Participants	7 Participants	5 Participants	13 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Muscle aches, Dose 2	6 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Muscle aches, Dose 2	27 Participants	12 Participants	2 Participants	6 Participants	10 Participants	7 Participants	5 Participants	8 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Dose 2	13 Participants	5 Participants	1 Participants	3 Participants	8 Participants	4 Participants	0 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Dose 2	3 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Sweating, Dose 2	9 Participants	2 Participants	0 Participants	2 Participants	6 Participants	0 Participants	2 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Sweating, Dose 2	8 Participants	2 Participants	0 Participants	2 Participants	5 Participants	0 Participants	1 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature, Dose 2	3 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Temperature, Dose 2	3 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Across doses	5 Participants	3 Participants	0 Participants	1 Participants	3 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Across doses	35 Participants	22 Participants	7 Participants	26 Participants	26 Participants	17 Participants	9 Participants	18 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Across doses	43 Participants	22 Participants	15 Participants	37 Participants	34 Participants	23 Participants	18 Participants	36 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Across doses	4 Participants	3 Participants	1 Participants	0 Participants	2 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Across doses	38 Participants	19 Participants	8 Participants	26 Participants	24 Participants	22 Participants	12 Participants	28 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Joint pain at other location, Across doses	26 Participants	11 Participants	5 Participants	17 Participants	16 Participants	7 Participants	6 Participants	13 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Joint pain at other location, Across doses	4 Participants	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Joint pain at other location, Across doses	25 Participants	11 Participants	3 Participants	14 Participants	12 Participants	6 Participants	6 Participants	8 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Muscle aches, Across doses	42 Participants	22 Participants	8 Participants	34 Participants	21 Participants	14 Participants	8 Participants	24 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Muscle aches, Across doses	7 Participants	4 Participants	0 Participants	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Muscle aches, Across doses	40 Participants	21 Participants	8 Participants	27 Participants	15 Participants	13 Participants	7 Participants	15 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Across doses	21 Participants	8 Participants	1 Participants	11 Participants	12 Participants	5 Participants	3 Participants	11 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Across doses	3 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Sweating, Across doses	14 Participants	4 Participants	0 Participants	6 Participants	12 Participants	2 Participants	6 Participants	9 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Sweating, Across doses	13 Participants	4 Participants	0 Participants	5 Participants	9 Participants	2 Participants	3 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature, Across doses	6 Participants	2 Participants	0 Participants	2 Participants	4 Participants	0 Participants	3 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Temperature, Across doses	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Temperature, Across doses	5 Participants	2 Participants	0 Participants	2 Participants	2 Participants	0 Participants	2 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Muscle aches, Dose 1	2 Participants	2 Participants	0 Participants	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Dose 1	27 Participants	15 Participants	8 Participants	26 Participants	24 Participants	13 Participants	8 Participants	20 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Dose 1	2 Participants	1 Participants	0 Participants	0 Participants	3 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Dose 1	27 Participants	15 Participants	5 Participants	21 Participants	20 Participants	12 Participants	5 Participants	13 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Dose 1	33 Participants	13 Participants	15 Participants	32 Participants	26 Participants	15 Participants	11 Participants	27 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose 1	28 Participants	13 Participants	8 Participants	20 Participants	18 Participants	11 Participants	9 Participants	22 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Joint pain at other location, Dose 1	15 Participants	10 Participants	5 Participants	15 Participants	13 Participants	4 Participants	2 Participants	10 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Muscle aches, Dose 1	29 Participants	19 Participants	6 Participants	26 Participants	11 Participants	8 Participants	2 Participants	9 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Dose 1	10 Participants	7 Participants	0 Participants	8 Participants	9 Participants	2 Participants	3 Participants	9 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Dose 1	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Dose 1	9 Participants	7 Participants	0 Participants	6 Participants	7 Participants	2 Participants	3 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Joint pain at other location, Dose 2	18 Participants	6 Participants	1 Participants	2 Participants	9 Participants	4 Participants	5 Participants	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Sweating, Dose 2	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Temperature, Dose 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Across doses	37 Participants	24 Participants	9 Participants	33 Participants	30 Participants	18 Participants	12 Participants	25 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Across doses	18 Participants	7 Participants	1 Participants	8 Participants	10 Participants	5 Participants	3 Participants	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Sweating, Across doses	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: During the 7-day (Day 0-6) post-vaccination period following each dose and across doses, for subjects > 64 years of age

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects who received at least 1 study vaccination and had their symptom sheets filled in.

Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)], headache, joint pain at other location, muscle aches, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = 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 = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

Outcome measures

Measure	GSK2340274A F1 Group n=129 Participants Pooled group comprising the subjects from GSK2340274A F1\_2D Group and GSK2340274A F1\_1D Group.	GSK2340274A F2 Group n=66 Participants Pooled group comprising the subjects from GSK2340274A F2\_1D Group and GSK2340274A F2\_2D Group.	GSK2340274A F2_1D Group n=65 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F1_1D Group n=130 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F1_1D Group n=130 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_2D Group n=65 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_1D Group n=64 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.	GSK2340273A F3_2D Group n=130 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Dose 1	23 Participants	12 Participants	5 Participants	27 Participants	16 Participants	5 Participants	11 Participants	14 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Dose 1	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Dose 1	21 Participants	8 Participants	4 Participants	24 Participants	14 Participants	5 Participants	7 Participants	11 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Dose 1	20 Participants	11 Participants	5 Participants	14 Participants	18 Participants	5 Participants	6 Participants	11 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Dose 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose 1	17 Participants	7 Participants	4 Participants	12 Participants	12 Participants	3 Participants	6 Participants	10 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Joint pain at other location, Dose 1	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Joint pain at other location, Dose 1	10 Participants	5 Participants	3 Participants	10 Participants	6 Participants	3 Participants	0 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Muscle aches, Dose 1	25 Participants	11 Participants	4 Participants	29 Participants	16 Participants	6 Participants	7 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Muscle aches, Dose 1	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Muscle aches, Dose 1	22 Participants	9 Participants	2 Participants	25 Participants	11 Participants	5 Participants	5 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Sweating, Dose 1	3 Participants	2 Participants	1 Participants	3 Participants	4 Participants	0 Participants	1 Participants	2 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	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Sweating, Dose 1	3 Participants	1 Participants	0 Participants	3 Participants	4 Participants	0 Participants	1 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature, Dose 1	1 Participants	0 Participants	0 Participants	2 Participants	4 Participants	2 Participants	2 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Temperature, Dose 1	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Temperature, Dose 1	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Dose 2	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Dose 2	23 Participants	7 Participants	5 Participants	12 Participants	10 Participants	1 Participants	7 Participants	12 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose 2	20 Participants	7 Participants	2 Participants	9 Participants	4 Participants	1 Participants	7 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Joint pain at other location, Dose 2	16 Participants	12 Participants	2 Participants	12 Participants	9 Participants	2 Participants	3 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Joint pain at other location, Dose 2	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Muscle aches, Dose 2	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Muscle aches, Dose 2	27 Participants	17 Participants	1 Participants	8 Participants	8 Participants	4 Participants	3 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Dose 2	8 Participants	5 Participants	0 Participants	2 Participants	6 Participants	3 Participants	1 Participants	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Dose 2	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Dose 2	7 Participants	5 Participants	0 Participants	1 Participants	5 Participants	3 Participants	1 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Sweating, Dose 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Sweating, Dose 2	5 Participants	2 Participants	0 Participants	0 Participants	3 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Temperature, Dose 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Temperature, Dose 2	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Across doses	3 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Across doses	36 Participants	15 Participants	4 Participants	27 Participants	21 Participants	7 Participants	11 Participants	15 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Across doses	34 Participants	13 Participants	9 Participants	23 Participants	25 Participants	6 Participants	11 Participants	17 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Across doses	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Across doses	29 Participants	10 Participants	6 Participants	19 Participants	15 Participants	4 Participants	11 Participants	13 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Joint pain at other location, Across doses	22 Participants	14 Participants	5 Participants	18 Participants	15 Participants	4 Participants	3 Participants	9 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Joint pain at other location, Across doses	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Joint pain at other location, Across doses	20 Participants	13 Participants	4 Participants	17 Participants	9 Participants	4 Participants	2 Participants	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Muscle aches, Across doses	41 Participants	18 Participants	6 Participants	31 Participants	23 Participants	10 Participants	11 Participants	9 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Muscle aches, Across doses	35 Participants	18 Participants	3 Participants	27 Participants	17 Participants	9 Participants	8 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Across doses	13 Participants	9 Participants	2 Participants	5 Participants	10 Participants	6 Participants	2 Participants	13 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Across doses	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Across doses	10 Participants	7 Participants	2 Participants	5 Participants	7 Participants	5 Participants	2 Participants	11 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Sweating, Across doses	8 Participants	4 Participants	1 Participants	4 Participants	7 Participants	2 Participants	1 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Sweating, Across doses	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Sweating, Across doses	7 Participants	3 Participants	0 Participants	3 Participants	7 Participants	1 Participants	1 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Temperature, Across doses	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Joint pain at other location, Dose 1	11 Participants	7 Participants	4 Participants	11 Participants	7 Participants	3 Participants	1 Participants	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Dose 1	6 Participants	5 Participants	2 Participants	4 Participants	4 Participants	3 Participants	2 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Sweating, Dose 2	6 Participants	2 Participants	1 Participants	1 Participants	3 Participants	2 Participants	0 Participants	1 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	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Dose 1	4 Participants	3 Participants	2 Participants	4 Participants	2 Participants	2 Participants	2 Participants	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Dose 2	29 Participants	12 Participants	3 Participants	15 Participants	17 Participants	4 Participants	8 Participants	11 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Dose 2	28 Participants	12 Participants	1 Participants	10 Participants	11 Participants	3 Participants	6 Participants	8 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Dose 2	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Joint pain at other location, Dose 2	15 Participants	12 Participants	2 Participants	9 Participants	4 Participants	2 Participants	2 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Muscle aches, Dose 2	30 Participants	17 Participants	2 Participants	11 Participants	13 Participants	4 Participants	5 Participants	8 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature, Dose 2	1 Participants	0 Participants	1 Participants	2 Participants	4 Participants	1 Participants	0 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Across doses	38 Participants	18 Participants	6 Participants	31 Participants	28 Participants	8 Participants	17 Participants	20 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Muscle aches, Across doses	2 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature, Across doses	2 Participants	0 Participants	1 Participants	3 Participants	7 Participants	2 Participants	2 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Temperature, Across doses	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: During the 7-day (Days 0-6) post-Dose 3 vaccination period, for subjects > 60 years of age

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects who received at least 1 study vaccination and had their symptom sheets filled in. This analysis focused on subjects who received an additional dose of GSK2340273A F2 vaccine from GSK2340273A F2\_1D Group.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that 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. Results were tabulated for subjects in GSK2340273A F2_1D Group, who were older than 60 years of age (>60y).

Outcome measures

Measure	GSK2340274A F1 Group n=64 Participants Pooled group comprising the subjects from GSK2340274A F1\_2D Group and GSK2340274A F1\_1D Group.	GSK2340274A F2 Group Pooled group comprising the subjects from GSK2340274A F2\_1D Group and GSK2340274A F2\_2D Group.	GSK2340274A F2_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F1_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F1_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_2D Group Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.	GSK2340273A F3_2D Group Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain	6 Participants	—	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness	0 Participants	—	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling	0 Participants	—	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain	0 Participants	—	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness	1 Participants	—	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling	0 Participants	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: During the 7-day (Days 0-6) post-Dose 3 vaccination period, for subjects > 60 years of age

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects who received at least 1 study vaccination and had their symptom sheets filled in. This analysis focused on subjects who received an additional dose of GSK2340273A F2 vaccine from GSK2340273A F2\_1D Group.

Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)], headache, joint pain at other location, muscle aches, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = 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 = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Results were tabulated for subjects in GSK2340273A F2_1D Group, who were older than 60 years of age (>60y).

Outcome measures

Measure	GSK2340274A F1 Group n=63 Participants Pooled group comprising the subjects from GSK2340274A F1\_2D Group and GSK2340274A F1\_1D Group.	GSK2340274A F2 Group Pooled group comprising the subjects from GSK2340274A F2\_1D Group and GSK2340274A F2\_2D Group.	GSK2340274A F2_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F1_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F1_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_2D Group Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_1D Group Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.	GSK2340273A F3_2D Group Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Number of Subjects With Any and Grade 3 Solicited General Symptoms Any Fatigue	6 Participants	—	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited General Symptoms Grade 3 Fatigue	0 Participants	—	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited General Symptoms Related Fatigue	6 Participants	—	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited General Symptoms Grade 3 Muscle aches	0 Participants	—	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited General Symptoms Related Muscle aches	3 Participants	—	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited General Symptoms Grade 3 Shivering	0 Participants	—	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited General Symptoms Any Sweating	1 Participants	—	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited General Symptoms Grade 3 Sweating	0 Participants	—	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited General Symptoms Related Sweating	1 Participants	—	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited General Symptoms Any Temperature	0 Participants	—	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited General Symptoms Grade 3 Temperature	0 Participants	—	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited General Symptoms Any Headache	6 Participants	—	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited General Symptoms Grade 3 Headache	0 Participants	—	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited General Symptoms Related Headache	4 Participants	—	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited General Symptoms Any Joint pain at other location	3 Participants	—	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited General Symptoms Grade 3 Joint pain at other location	0 Participants	—	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited General Symptoms Related Joint pain at other location	2 Participants	—	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited General Symptoms Any Muscle aches	4 Participants	—	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited General Symptoms Any Shivering	1 Participants	—	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited General Symptoms Related Shivering	0 Participants	—	—	—	—	—	—	—
Number of Subjects With Any and Grade 3 Solicited General Symptoms Related Temperature	0 Participants	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At Days 7, 21, 28, 42 and 182, for subjects between 18-64 years of age

Population: The analysis was performed on the Total Vaccinated cohort included all subjects who received at least 1 study vaccination.

Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], alkaline phosphatase [AP], aspartate aminotransferase [AST], basophils [BAS], bilirubin [BIL], bilirubin conjugated/direct [BIL/CD] creatinine [CREA], eosinophils [EOS], hematocrit [HEM], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC], blood urea nitrogen [BUN] and white blood cells [WBC].

Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were - unknown, below, within and above the reference range defined for the specified time point and laboratory parameter.

Outcome measures

Measure	GSK2340274A F1 Group n=93 Participants Pooled group comprising the subjects from GSK2340274A F1\_2D Group and GSK2340274A F1\_1D Group.	GSK2340274A F2 Group n=47 Participants Pooled group comprising the subjects from GSK2340274A F2\_1D Group and GSK2340274A F2\_2D Group.	GSK2340274A F2_1D Group n=47 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F1_1D Group n=91 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F1_1D Group n=92 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_2D Group n=49 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_1D Group n=47 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.	GSK2340273A F3_2D Group n=92 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Number of Subjects With Abnormal Biochemical and Haematological Levels AP, Day 21 · Within	92 Participants	46 Participants	47 Participants	90 Participants	91 Participants	47 Participants	46 Participants	89 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL, Day 42 · Within	90 Participants	46 Participants	45 Participants	88 Participants	91 Participants	48 Participants	46 Participants	88 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL/CD, Day 7 · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels EOS, Day 21 · Below	2 Participants	3 Participants	0 Participants	5 Participants	7 Participants	1 Participants	1 Participants	5 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels EOS, Day 21 · Within	89 Participants	44 Participants	46 Participants	86 Participants	83 Participants	45 Participants	45 Participants	83 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels ALT, Day 7 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels ALT, Day 7 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels ALT, Day 7 · Within	92 Participants	46 Participants	47 Participants	90 Participants	89 Participants	49 Participants	46 Participants	91 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels ALT, Day 7 · Above	1 Participants	1 Participants	0 Participants	1 Participants	2 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels ALT, Day 21 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels ALT, Day 21 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels ALT, Day 21 · Within	92 Participants	47 Participants	45 Participants	89 Participants	89 Participants	48 Participants	46 Participants	92 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels ALT, Day 21 · Above	1 Participants	0 Participants	2 Participants	2 Participants	3 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels ALT, Day 28 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels ALT, Day 28 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels ALT, Day 28 · Within	91 Participants	47 Participants	46 Participants	87 Participants	90 Participants	47 Participants	45 Participants	88 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels ALT, Day 28 · Above	1 Participants	0 Participants	1 Participants	4 Participants	1 Participants	0 Participants	2 Participants	3 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels ALT, Day 42 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels ALT, Day 42 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels ALT, Day 42 · Within	90 Participants	45 Participants	44 Participants	88 Participants	89 Participants	48 Participants	45 Participants	87 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels ALT, Day 42 · Above	2 Participants	1 Participants	2 Participants	3 Participants	2 Participants	0 Participants	2 Participants	3 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels ALT, Day 182 · Unknown	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels ALT, Day 182 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels ALT, Day 182 · Within	87 Participants	47 Participants	46 Participants	86 Participants	86 Participants	46 Participants	46 Participants	89 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels ALT, Day 182 · Above	0 Participants	0 Participants	0 Participants	2 Participants	2 Participants	1 Participants	0 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AP, Day 7 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AP, Day 7 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AP, Day 7 · Within	92 Participants	46 Participants	47 Participants	90 Participants	91 Participants	47 Participants	44 Participants	90 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AP, Day 7 · Above	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants	2 Participants	3 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AP, Day 21 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AP, Day 21 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AP, Day 21 · Above	1 Participants	1 Participants	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants	3 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AP, Day 28 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AP, Day 28 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AP, Day 28 · Within	91 Participants	46 Participants	47 Participants	90 Participants	89 Participants	46 Participants	46 Participants	89 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AP, Day 28 · Above	1 Participants	1 Participants	0 Participants	1 Participants	2 Participants	1 Participants	1 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AP, Day 42 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AP, Day 42 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AP, Day 42 · Within	90 Participants	45 Participants	46 Participants	90 Participants	91 Participants	46 Participants	46 Participants	90 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AP, Day 42 · Above	2 Participants	1 Participants	0 Participants	1 Participants	0 Participants	2 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AP, Day 182 · Unknown	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AP, Day 182 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AP, Day 182 · Within	86 Participants	47 Participants	46 Participants	87 Participants	88 Participants	45 Participants	46 Participants	87 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AP, Day 182 · Above	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants	4 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AST, Day 7 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AST, Day 21 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AST, Day 21 · Within	92 Participants	47 Participants	46 Participants	89 Participants	90 Participants	48 Participants	46 Participants	92 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AST, Day 21 · Above	1 Participants	0 Participants	1 Participants	2 Participants	2 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AST, Day 28 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AST, Day 28 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AST, Day 28 · Above	1 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants	3 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AST, Day 42 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AST, Day 42 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AST, Day 182 · Unknown	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AST, Day 182 · Within	87 Participants	46 Participants	46 Participants	86 Participants	86 Participants	46 Participants	46 Participants	89 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BAS, Day 21 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BAS, Day 21 · Within	93 Participants	47 Participants	47 Participants	91 Participants	91 Participants	46 Participants	47 Participants	91 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BAS, Day 28 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BAS, Day 28 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BAS, Day 28 · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BAS, Day 42 · Unknown	0 Participants	1 Participants	2 Participants	1 Participants	1 Participants	1 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BAS, Day 182 · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL, Day 7 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL, Day 7 · Above	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels EOS, Day 21 · Above	2 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	3 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL, Day 21 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL, Day 21 · Within	91 Participants	45 Participants	46 Participants	91 Participants	92 Participants	48 Participants	46 Participants	91 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL, Day 21 · Above	2 Participants	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL, Day 28 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL, Day 28 · Within	92 Participants	46 Participants	46 Participants	88 Participants	89 Participants	47 Participants	46 Participants	88 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels EOS, Day 28 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL, Day 28 · Above	0 Participants	1 Participants	1 Participants	3 Participants	2 Participants	0 Participants	1 Participants	3 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL, Day 42 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL, Day 42 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL, Day 42 · Above	2 Participants	0 Participants	1 Participants	3 Participants	0 Participants	0 Participants	1 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL, Day 182 · Unknown	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL, Day 182 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL, Day 182 · Within	87 Participants	46 Participants	45 Participants	88 Participants	88 Participants	47 Participants	45 Participants	90 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL, Day 182 · Above	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL/CD, Day 7 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL/CD, Day 7 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL/CD, Day 7 · Within	93 Participants	47 Participants	47 Participants	91 Participants	91 Participants	49 Participants	47 Participants	92 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL/CD, Day 182 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL/CD, Day 21 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL/CD, Day 21 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL/CD, Day 21 · Within	93 Participants	47 Participants	47 Participants	91 Participants	92 Participants	48 Participants	47 Participants	92 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL/CD, Day 21 · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL/CD, Day 28 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL/CD, Day 28 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL/CD, Day 28 · Within	92 Participants	47 Participants	47 Participants	91 Participants	91 Participants	47 Participants	46 Participants	91 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL/CD, Day 28 · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL/CD, Day 42 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL/CD, Day 42 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL/CD, Day 42 · Within	92 Participants	45 Participants	46 Participants	91 Participants	91 Participants	48 Participants	47 Participants	90 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL/CD, Day 42 · Above	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL/CD, Day 182 · Unknown	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL/CD, Day 182 · Within	87 Participants	47 Participants	46 Participants	88 Participants	88 Participants	47 Participants	45 Participants	90 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL/CD, Day 182 · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels CREA, Day 7 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels CREA, Day 7 · Below	5 Participants	1 Participants	4 Participants	2 Participants	8 Participants	2 Participants	3 Participants	6 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels CREA, Day 7 · Within	88 Participants	45 Participants	43 Participants	86 Participants	83 Participants	47 Participants	44 Participants	85 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels CREA, Day 7 · Above	0 Participants	1 Participants	0 Participants	3 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels CREA, Day 21 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels CREA, Day 21 · Below	10 Participants	3 Participants	5 Participants	8 Participants	8 Participants	3 Participants	3 Participants	11 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels CREA, Day 21 · Within	82 Participants	43 Participants	41 Participants	83 Participants	83 Participants	45 Participants	44 Participants	79 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels CREA, Day 21 · Above	1 Participants	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels CREA, Day 28 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels CREA, Day 28 · Below	9 Participants	1 Participants	4 Participants	4 Participants	12 Participants	4 Participants	3 Participants	9 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels CREA, Day 28 · Within	82 Participants	46 Participants	42 Participants	87 Participants	77 Participants	42 Participants	44 Participants	82 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels CREA, Day 28 · Above	1 Participants	0 Participants	1 Participants	0 Participants	2 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels CREA, Day 42 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels CREA, Day 42 · Below	11 Participants	3 Participants	6 Participants	8 Participants	14 Participants	2 Participants	4 Participants	12 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels CREA, Day 42 · Within	79 Participants	43 Participants	40 Participants	83 Participants	77 Participants	46 Participants	43 Participants	76 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels CREA, Day 42 · Above	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels CREA, Day 182 · Unknown	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels CREA, Day 182 · Below	7 Participants	2 Participants	9 Participants	7 Participants	13 Participants	3 Participants	6 Participants	10 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels CREA, Day 182 · Within	79 Participants	44 Participants	37 Participants	81 Participants	75 Participants	44 Participants	40 Participants	79 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels CREA, Day 182 · Above	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels EOS, Day 7 · Unknown	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels EOS, Day 7 · Below	2 Participants	0 Participants	1 Participants	5 Participants	5 Participants	1 Participants	1 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels EOS, Day 7 · Within	88 Participants	45 Participants	44 Participants	84 Participants	82 Participants	47 Participants	46 Participants	88 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels EOS, Day 7 · Above	2 Participants	2 Participants	2 Participants	2 Participants	5 Participants	1 Participants	0 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels EOS, Day 21 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels EOS, Day 28 · Below	3 Participants	0 Participants	2 Participants	4 Participants	7 Participants	3 Participants	3 Participants	3 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels EOS, Day 28 · Within	86 Participants	47 Participants	44 Participants	85 Participants	80 Participants	43 Participants	42 Participants	84 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels EOS, Day 28 · Above	3 Participants	0 Participants	1 Participants	2 Participants	3 Participants	1 Participants	2 Participants	3 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels EOS, Day 42 · Unknown	0 Participants	1 Participants	2 Participants	1 Participants	1 Participants	1 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels EOS, Day 42 · Below	4 Participants	6 Participants	2 Participants	6 Participants	5 Participants	3 Participants	2 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels EOS, Day 42 · Within	87 Participants	39 Participants	42 Participants	84 Participants	81 Participants	43 Participants	42 Participants	87 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels EOS, Day 42 · Above	1 Participants	0 Participants	0 Participants	0 Participants	4 Participants	1 Participants	2 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels EOS, Day 182 · Unknown	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels EOS, Day 182 · Below	1 Participants	4 Participants	4 Participants	2 Participants	4 Participants	2 Participants	3 Participants	3 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels EOS, Day 182 · Within	85 Participants	42 Participants	41 Participants	86 Participants	80 Participants	43 Participants	41 Participants	86 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels EOS, Day 182 · Above	1 Participants	1 Participants	0 Participants	0 Participants	3 Participants	2 Participants	2 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HEM, Day 7 · Unknown	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HEM, Day 7 · Below	1 Participants	2 Participants	0 Participants	3 Participants	3 Participants	0 Participants	0 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HEM, Day 7 · Within	89 Participants	43 Participants	46 Participants	85 Participants	89 Participants	48 Participants	47 Participants	88 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HEM, Day 7 · Above	2 Participants	2 Participants	1 Participants	3 Participants	0 Participants	1 Participants	0 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HEM, Day 21 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HEM, Day 21 · Below	2 Participants	1 Participants	1 Participants	3 Participants	4 Participants	3 Participants	1 Participants	3 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HEM, Day 21 · Within	88 Participants	43 Participants	46 Participants	85 Participants	88 Participants	43 Participants	45 Participants	89 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HEM, Day 28 · Within	85 Participants	42 Participants	45 Participants	86 Participants	88 Participants	46 Participants	45 Participants	85 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HEM, Day 28 · Above	2 Participants	1 Participants	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HEM, Day 182 · Unknown	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HEM, Day 182 · Within	85 Participants	44 Participants	44 Participants	81 Participants	79 Participants	45 Participants	41 Participants	83 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HgB, Day 7 · Within	89 Participants	46 Participants	44 Participants	84 Participants	87 Participants	48 Participants	47 Participants	88 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HgB, Day 21 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HgB, Day 21 · Within	88 Participants	45 Participants	47 Participants	84 Participants	86 Participants	44 Participants	44 Participants	91 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HgB, Day 28 · Above	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HgB, Day 182 · Within	83 Participants	44 Participants	44 Participants	81 Participants	83 Participants	44 Participants	42 Participants	86 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HgB, Day 182 · Above	1 Participants	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels LYM, Day 7 · Unknown	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels LYM, Day 7 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels LYM, Day 7 · Within	91 Participants	46 Participants	47 Participants	90 Participants	92 Participants	49 Participants	46 Participants	90 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels LYM, Day 21 · Below	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels LYM, Day 21 · Within	92 Participants	47 Participants	47 Participants	89 Participants	90 Participants	46 Participants	46 Participants	90 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels LYM, Day 28 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels LYM, Day 42 · Unknown	0 Participants	1 Participants	2 Participants	1 Participants	1 Participants	1 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels LYM, Day 42 · Within	89 Participants	45 Participants	42 Participants	89 Participants	89 Participants	47 Participants	45 Participants	90 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels MON, Day 28 · Within	65 Participants	36 Participants	41 Participants	70 Participants	78 Participants	39 Participants	38 Participants	72 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels MON, Day 42 · Below	29 Participants	8 Participants	9 Participants	17 Participants	15 Participants	9 Participants	7 Participants	15 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels MON, Day 42 · Above	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels MON, Day 182 · Below	18 Participants	11 Participants	8 Participants	18 Participants	19 Participants	13 Participants	7 Participants	19 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels NEU, Day 7 · Within	87 Participants	45 Participants	45 Participants	87 Participants	91 Participants	47 Participants	44 Participants	89 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels NEU, Day 21 · Below	5 Participants	1 Participants	2 Participants	2 Participants	1 Participants	1 Participants	0 Participants	4 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels NEU, Day 42 · Unknown	0 Participants	1 Participants	2 Participants	1 Participants	1 Participants	1 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels NEU, Day 42 · Above	3 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	2 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels PLA, Day 7 · Unknown	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels PLA, Day 7 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels PLA, Day 7 · Within	91 Participants	47 Participants	47 Participants	91 Participants	91 Participants	49 Participants	46 Participants	90 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels PLA, Day 28 · Within	91 Participants	47 Participants	47 Participants	91 Participants	89 Participants	47 Participants	46 Participants	91 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels PLA, Day 28 · Above	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels RBC, Day 7 · Below	1 Participants	2 Participants	1 Participants	3 Participants	5 Participants	2 Participants	4 Participants	3 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels RBC, Day 7 · Above	1 Participants	1 Participants	0 Participants	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels RBC, Day 42 · Below	6 Participants	3 Participants	4 Participants	2 Participants	5 Participants	0 Participants	3 Participants	5 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels RBC, Day 42 · Within	85 Participants	41 Participants	40 Participants	87 Participants	85 Participants	47 Participants	43 Participants	86 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels RBC, Day 182 · Unknown	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BUN, Day 7 · Below	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BUN, Day 21 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BUN, Day 21 · Below	2 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BUN, Day 21 · Within	91 Participants	46 Participants	46 Participants	89 Participants	90 Participants	47 Participants	45 Participants	89 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BUN, Day 28 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BUN, Day 28 · Below	3 Participants	0 Participants	1 Participants	2 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BUN, Day 42 · Below	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BUN, Day 42 · Above	1 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BUN, Day 182 · Unknown	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BUN, Day 182 · Below	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BUN, Day 182 · Within	85 Participants	44 Participants	44 Participants	88 Participants	87 Participants	46 Participants	46 Participants	91 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BUN, Day 182 · Above	1 Participants	2 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels WBC, Day 7 · Unknown	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels WBC, Day 7 · Below	3 Participants	2 Participants	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels WBC, Day 21 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels WBC, Day 21 · Below	5 Participants	1 Participants	2 Participants	2 Participants	2 Participants	0 Participants	0 Participants	4 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels WBC, Day 28 · Within	84 Participants	42 Participants	44 Participants	87 Participants	88 Participants	46 Participants	44 Participants	86 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels RBC, Day 7 · Within	90 Participants	44 Participants	46 Participants	86 Participants	86 Participants	47 Participants	43 Participants	89 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels RBC, Day 21 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels RBC, Day 21 · Below	4 Participants	1 Participants	2 Participants	3 Participants	3 Participants	2 Participants	5 Participants	6 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels RBC, Day 21 · Within	88 Participants	45 Participants	45 Participants	88 Participants	87 Participants	43 Participants	42 Participants	86 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL, Day 21 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL, Day 28 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AST, Day 7 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AST, Day 7 · Within	93 Participants	47 Participants	47 Participants	90 Participants	90 Participants	49 Participants	47 Participants	91 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AST, Day 7 · Above	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AST, Day 21 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AST, Day 28 · Within	91 Participants	46 Participants	47 Participants	90 Participants	90 Participants	47 Participants	46 Participants	88 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AST, Day 42 · Within	92 Participants	45 Participants	46 Participants	90 Participants	89 Participants	47 Participants	46 Participants	88 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AST, Day 42 · Above	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AST, Day 182 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AST, Day 182 · Above	0 Participants	1 Participants	0 Participants	2 Participants	1 Participants	1 Participants	0 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BAS, Day 7 · Unknown	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HgB, Day 7 · Above	0 Participants	1 Participants	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BAS, Day 7 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BAS, Day 7 · Within	92 Participants	47 Participants	47 Participants	91 Participants	92 Participants	49 Participants	47 Participants	92 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BAS, Day 7 · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BAS, Day 21 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BAS, Day 21 · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BAS, Day 28 · Within	92 Participants	47 Participants	47 Participants	91 Participants	90 Participants	47 Participants	47 Participants	90 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BAS, Day 42 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BAS, Day 42 · Within	92 Participants	45 Participants	44 Participants	90 Participants	90 Participants	47 Participants	46 Participants	91 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BAS, Day 42 · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BAS, Day 182 · Unknown	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BAS, Day 182 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BAS, Day 182 · Within	87 Participants	47 Participants	45 Participants	88 Participants	87 Participants	47 Participants	46 Participants	90 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL, Day 7 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL, Day 7 · Within	93 Participants	46 Participants	47 Participants	90 Participants	91 Participants	49 Participants	46 Participants	90 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HEM, Day 42 · Above	1 Participants	0 Participants	1 Participants	3 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels NEU, Day 42 · Below	7 Participants	5 Participants	1 Participants	1 Participants	0 Participants	1 Participants	2 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HEM, Day 182 · Below	2 Participants	3 Participants	0 Participants	6 Participants	7 Participants	2 Participants	4 Participants	6 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HEM, Day 182 · Above	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HgB, Day 7 · Unknown	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HgB, Day 7 · Below	3 Participants	0 Participants	2 Participants	5 Participants	5 Participants	1 Participants	0 Participants	3 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels RBC, Day 7 · Unknown	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels WBC, Day 21 · Above	2 Participants	1 Participants	0 Participants	3 Participants	2 Participants	0 Participants	1 Participants	3 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HEM, Day 21 · Above	3 Participants	3 Participants	0 Participants	3 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HEM, Day 28 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HEM, Day 28 · Below	5 Participants	4 Participants	1 Participants	3 Participants	2 Participants	1 Participants	2 Participants	4 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HEM, Day 42 · Unknown	0 Participants	1 Participants	2 Participants	1 Participants	1 Participants	1 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HEM, Day 42 · Below	8 Participants	1 Participants	2 Participants	4 Participants	7 Participants	1 Participants	3 Participants	3 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HEM, Day 42 · Within	83 Participants	44 Participants	41 Participants	83 Participants	83 Participants	46 Participants	43 Participants	88 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels LYM, Day 7 · Above	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels LYM, Day 21 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels LYM, Day 21 · Above	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HgB, Day 21 · Below	5 Participants	1 Participants	0 Participants	5 Participants	6 Participants	2 Participants	2 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HgB, Day 21 · Above	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HgB, Day 28 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HgB, Day 28 · Below	7 Participants	3 Participants	1 Participants	2 Participants	2 Participants	1 Participants	2 Participants	4 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels LYM, Day 28 · Below	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HgB, Day 28 · Within	85 Participants	44 Participants	45 Participants	88 Participants	88 Participants	46 Participants	45 Participants	85 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels MON, Day 42 · Unknown	0 Participants	1 Participants	2 Participants	1 Participants	1 Participants	1 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HgB, Day 42 · Unknown	0 Participants	1 Participants	2 Participants	1 Participants	1 Participants	1 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HgB, Day 42 · Below	6 Participants	2 Participants	1 Participants	3 Participants	3 Participants	0 Participants	2 Participants	4 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HgB, Day 42 · Within	85 Participants	42 Participants	42 Participants	84 Participants	86 Participants	47 Participants	43 Participants	86 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels LYM, Day 28 · Within	90 Participants	46 Participants	47 Participants	89 Participants	89 Participants	47 Participants	46 Participants	87 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels LYM, Day 28 · Above	2 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	3 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HgB, Day 42 · Above	1 Participants	1 Participants	1 Participants	3 Participants	1 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HgB, Day 182 · Unknown	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels LYM, Day 42 · Below	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels LYM, Day 42 · Above	2 Participants	0 Participants	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels LYM, Day 182 · Unknown	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels LYM, Day 182 · Below	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels LYM, Day 182 · Within	86 Participants	47 Participants	45 Participants	87 Participants	86 Participants	46 Participants	43 Participants	88 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels LYM, Day 182 · Above	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels MON, Day 7 · Unknown	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels MON, Day 7 · Below	21 Participants	11 Participants	10 Participants	17 Participants	16 Participants	8 Participants	4 Participants	13 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels MON, Day 7 · Within	71 Participants	36 Participants	37 Participants	74 Participants	76 Participants	41 Participants	43 Participants	78 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels MON, Day 7 · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels MON, Day 21 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels MON, Day 21 · Below	21 Participants	14 Participants	8 Participants	18 Participants	21 Participants	6 Participants	8 Participants	23 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels MON, Day 21 · Within	72 Participants	33 Participants	39 Participants	73 Participants	70 Participants	40 Participants	39 Participants	68 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels MON, Day 21 · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels MON, Day 28 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels MON, Day 28 · Below	27 Participants	11 Participants	6 Participants	21 Participants	12 Participants	8 Participants	9 Participants	18 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels MON, Day 28 · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HgB, Day 182 · Below	3 Participants	3 Participants	0 Participants	6 Participants	3 Participants	2 Participants	4 Participants	3 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels MON, Day 42 · Within	62 Participants	37 Participants	35 Participants	73 Participants	75 Participants	38 Participants	39 Participants	76 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels NEU, Day 42 · Within	82 Participants	40 Participants	43 Participants	88 Participants	89 Participants	46 Participants	42 Participants	87 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels NEU, Day 182 · Unknown	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels NEU, Day 182 · Below	4 Participants	5 Participants	2 Participants	2 Participants	1 Participants	1 Participants	2 Participants	4 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels NEU, Day 182 · Within	82 Participants	41 Participants	43 Participants	86 Participants	85 Participants	46 Participants	41 Participants	85 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels NEU, Day 182 · Above	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	3 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels PLA, Day 7 · Above	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels PLA, Day 21 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels PLA, Day 21 · Below	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels PLA, Day 21 · Within	91 Participants	47 Participants	47 Participants	90 Participants	92 Participants	46 Participants	46 Participants	92 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels PLA, Day 21 · Above	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels PLA, Day 28 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels MON, Day 182 · Unknown	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels MON, Day 182 · Within	69 Participants	36 Participants	37 Participants	70 Participants	68 Participants	34 Participants	39 Participants	71 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels MON, Day 182 · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels NEU, Day 7 · Unknown	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels NEU, Day 7 · Below	3 Participants	2 Participants	1 Participants	1 Participants	0 Participants	1 Participants	2 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels NEU, Day 7 · Above	2 Participants	0 Participants	1 Participants	3 Participants	1 Participants	1 Participants	1 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels NEU, Day 21 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels NEU, Day 21 · Within	86 Participants	45 Participants	45 Participants	88 Participants	89 Participants	45 Participants	46 Participants	85 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels NEU, Day 21 · Above	2 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels NEU, Day 28 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels NEU, Day 28 · Below	4 Participants	5 Participants	1 Participants	4 Participants	1 Participants	0 Participants	2 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels NEU, Day 28 · Within	84 Participants	41 Participants	45 Participants	87 Participants	88 Participants	47 Participants	45 Participants	88 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels NEU, Day 28 · Above	4 Participants	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels PLA, Day 28 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels PLA, Day 182 · Within	86 Participants	47 Participants	44 Participants	87 Participants	87 Participants	46 Participants	46 Participants	90 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels PLA, Day 182 · Above	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels RBC, Day 182 · Below	7 Participants	3 Participants	2 Participants	10 Participants	3 Participants	1 Participants	4 Participants	9 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels RBC, Day 182 · Within	79 Participants	44 Participants	43 Participants	78 Participants	82 Participants	46 Participants	42 Participants	81 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels RBC, Day 182 · Above	1 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BUN, Day 7 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BUN, Day 7 · Within	92 Participants	47 Participants	46 Participants	91 Participants	89 Participants	48 Participants	47 Participants	90 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BUN, Day 7 · Above	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BUN, Day 21 · Above	0 Participants	1 Participants	0 Participants	2 Participants	2 Participants	0 Participants	2 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BUN, Day 28 · Within	89 Participants	47 Participants	46 Participants	89 Participants	89 Participants	46 Participants	47 Participants	91 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BUN, Day 28 · Above	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BUN, Day 42 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BUN, Day 42 · Within	90 Participants	46 Participants	45 Participants	89 Participants	91 Participants	48 Participants	46 Participants	90 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels PLA, Day 42 · Unknown	0 Participants	1 Participants	2 Participants	1 Participants	1 Participants	1 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels PLA, Day 42 · Below	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels PLA, Day 42 · Within	91 Participants	44 Participants	44 Participants	90 Participants	89 Participants	47 Participants	46 Participants	91 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels PLA, Day 42 · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels PLA, Day 182 · Unknown	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels WBC, Day 7 · Within	88 Participants	45 Participants	45 Participants	86 Participants	90 Participants	48 Participants	44 Participants	87 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels WBC, Day 7 · Above	1 Participants	0 Participants	1 Participants	5 Participants	1 Participants	1 Participants	2 Participants	3 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels WBC, Day 21 · Within	86 Participants	45 Participants	45 Participants	86 Participants	87 Participants	46 Participants	46 Participants	84 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels WBC, Day 28 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels WBC, Day 28 · Below	5 Participants	4 Participants	1 Participants	3 Participants	1 Participants	1 Participants	1 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels WBC, Day 28 · Above	3 Participants	1 Participants	2 Participants	1 Participants	1 Participants	0 Participants	2 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels WBC, Day 42 · Unknown	0 Participants	1 Participants	2 Participants	1 Participants	1 Participants	1 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels WBC, Day 42 · Below	6 Participants	4 Participants	0 Participants	2 Participants	2 Participants	2 Participants	1 Participants	4 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels WBC, Day 42 · Within	82 Participants	41 Participants	43 Participants	87 Participants	87 Participants	45 Participants	44 Participants	85 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels WBC, Day 42 · Above	4 Participants	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants	1 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels WBC, Day 182 · Unknown	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels WBC, Day 182 · Below	7 Participants	4 Participants	2 Participants	2 Participants	2 Participants	0 Participants	1 Participants	6 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels WBC, Day 182 · Within	79 Participants	42 Participants	42 Participants	85 Participants	84 Participants	46 Participants	42 Participants	81 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels WBC, Day 182 · Above	1 Participants	1 Participants	1 Participants	1 Participants	1 Participants	1 Participants	3 Participants	3 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels RBC, Day 21 · Above	1 Participants	1 Participants	0 Participants	0 Participants	2 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels RBC, Day 28 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels RBC, Day 28 · Below	3 Participants	4 Participants	3 Participants	3 Participants	3 Participants	1 Participants	3 Participants	7 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels RBC, Day 28 · Within	88 Participants	42 Participants	44 Participants	87 Participants	86 Participants	46 Participants	44 Participants	84 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels RBC, Day 28 · Above	1 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels RBC, Day 42 · Unknown	0 Participants	1 Participants	2 Participants	1 Participants	1 Participants	1 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels RBC, Day 42 · Above	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels PLA, Day 182 · Below	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At Days 7, 21, 28, 42 and 182, for subjects > 64 years of age

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects who received at least 1 study vaccination.

Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], alkaline phosphatase [AP], aspartate aminotransferase [AST], basophils [BAS], bilirubin [BIL], bilirubin conjugated/direct [BIL/CD] creatinine [CREA], eosinophils [EOS], hematocrit [HEM], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC], blood urea nitrogen [BUN] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were - unknown, below, within and above the reference range defined for the specified time point and laboratory parameter.

Outcome measures

Measure	GSK2340274A F1 Group n=129 Participants Pooled group comprising the subjects from GSK2340274A F1\_2D Group and GSK2340274A F1\_1D Group.	GSK2340274A F2 Group n=66 Participants Pooled group comprising the subjects from GSK2340274A F2\_1D Group and GSK2340274A F2\_2D Group.	GSK2340274A F2_1D Group n=65 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F1_1D Group n=130 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F1_1D Group n=130 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_2D Group n=65 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_1D Group n=64 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.	GSK2340273A F3_2D Group n=130 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Number of Subjects With Abnormal Biochemical and Haematological Levels ALT, Day 21 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels ALT, Day 21 · Above	1 Participants	0 Participants	1 Participants	2 Participants	2 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels ALT, Day 42 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels ALT, Day 42 · Within	128 Participants	65 Participants	62 Participants	127 Participants	125 Participants	65 Participants	63 Participants	128 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels ALT, Day 42 · Above	0 Participants	0 Participants	1 Participants	3 Participants	4 Participants	0 Participants	0 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels ALT, Day 182 · Unknown	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels ALT, Day 182 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels ALT, Day 182 · Above	2 Participants	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AST, Day 42 · Within	128 Participants	65 Participants	62 Participants	128 Participants	127 Participants	65 Participants	63 Participants	130 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels LYM, Day 28 · Within	121 Participants	64 Participants	63 Participants	127 Participants	129 Participants	62 Participants	63 Participants	124 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels LYM, Day 28 · Above	2 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels LYM, Day 42 · Within	120 Participants	59 Participants	60 Participants	128 Participants	120 Participants	61 Participants	62 Participants	125 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels LYM, Day 42 · Above	1 Participants	1 Participants	0 Participants	1 Participants	2 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels LYM, Day 182 · Below	4 Participants	1 Participants	1 Participants	0 Participants	0 Participants	2 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels LYM, Day 182 · Above	0 Participants	1 Participants	0 Participants	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels MON, Day 7 · Unknown	0 Participants	0 Participants	0 Participants	1 Participants	3 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels MON, Day 7 · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels MON, Day 21 · Above	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels MON, Day 28 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels PLA, Day 7 · Within	127 Participants	66 Participants	64 Participants	127 Participants	129 Participants	63 Participants	63 Participants	123 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels MON, Day 42 · Within	112 Participants	59 Participants	53 Participants	117 Participants	114 Participants	59 Participants	58 Participants	108 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels MON, Day 182 · Below	14 Participants	7 Participants	7 Participants	21 Participants	15 Participants	9 Participants	7 Participants	21 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels MON, Day 182 · Within	111 Participants	56 Participants	55 Participants	108 Participants	114 Participants	56 Participants	56 Participants	109 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels NEU, Day 7 · Unknown	0 Participants	0 Participants	0 Participants	1 Participants	3 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels NEU, Day 7 · Below	3 Participants	0 Participants	2 Participants	3 Participants	2 Participants	1 Participants	1 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels NEU, Day 7 · Within	125 Participants	65 Participants	62 Participants	125 Participants	124 Participants	63 Participants	62 Participants	129 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels NEU, Day 7 · Above	1 Participants	1 Participants	1 Participants	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels NEU, Day 21 · Unknown	1 Participants	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants	2 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels NEU, Day 21 · Below	4 Participants	2 Participants	1 Participants	2 Participants	5 Participants	3 Participants	3 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels NEU, Day 21 · Within	119 Participants	63 Participants	62 Participants	124 Participants	122 Participants	62 Participants	58 Participants	126 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels NEU, Day 21 · Above	3 Participants	1 Participants	0 Participants	3 Participants	1 Participants	0 Participants	1 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels NEU, Day 28 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels NEU, Day 28 · Below	3 Participants	1 Participants	0 Participants	3 Participants	2 Participants	1 Participants	2 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels NEU, Day 28 · Within	121 Participants	65 Participants	62 Participants	124 Participants	126 Participants	62 Participants	61 Participants	125 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels NEU, Day 28 · Above	3 Participants	0 Participants	1 Participants	3 Participants	1 Participants	2 Participants	0 Participants	3 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels NEU, Day 42 · Unknown	3 Participants	2 Participants	2 Participants	0 Participants	2 Participants	1 Participants	0 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels NEU, Day 42 · Below	3 Participants	1 Participants	1 Participants	3 Participants	4 Participants	1 Participants	1 Participants	3 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels NEU, Day 42 · Within	119 Participants	62 Participants	60 Participants	126 Participants	123 Participants	63 Participants	61 Participants	123 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels NEU, Day 42 · Above	3 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels NEU, Day 182 · Unknown	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels NEU, Day 182 · Below	4 Participants	0 Participants	2 Participants	3 Participants	4 Participants	2 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels NEU, Day 182 · Within	120 Participants	62 Participants	58 Participants	124 Participants	125 Participants	62 Participants	61 Participants	130 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels NEU, Day 182 · Above	1 Participants	1 Participants	2 Participants	2 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels PLA, Day 7 · Unknown	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels PLA, Day 7 · Below	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	2 Participants	0 Participants	3 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels PLA, Day 7 · Above	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels PLA, Day 21 · Unknown	1 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels PLA, Day 21 · Below	2 Participants	0 Participants	0 Participants	2 Participants	1 Participants	2 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels PLA, Day 21 · Within	124 Participants	66 Participants	63 Participants	126 Participants	127 Participants	63 Participants	62 Participants	124 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels PLA, Day 28 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels PLA, Day 28 · Below	2 Participants	0 Participants	1 Participants	2 Participants	3 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels PLA, Day 28 · Within	125 Participants	66 Participants	62 Participants	125 Participants	126 Participants	65 Participants	62 Participants	124 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels PLA, Day 28 · Above	0 Participants	0 Participants	0 Participants	3 Participants	0 Participants	0 Participants	1 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels PLA, Day 42 · Unknown	3 Participants	2 Participants	1 Participants	0 Participants	2 Participants	1 Participants	0 Participants	3 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels PLA, Day 42 · Below	1 Participants	0 Participants	1 Participants	3 Participants	1 Participants	1 Participants	0 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels PLA, Day 42 · Within	124 Participants	63 Participants	61 Participants	126 Participants	126 Participants	63 Participants	62 Participants	122 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels PLA, Day 182 · Below	3 Participants	1 Participants	2 Participants	3 Participants	2 Participants	2 Participants	1 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels PLA, Day 182 · Above	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	3 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels RBC, Day 7 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels RBC, Day 7 · Below	1 Participants	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants	2 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels RBC, Day 21 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels RBC, Day 182 · Below	3 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	2 Participants	3 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BUN, Day 42 · Within	125 Participants	64 Participants	62 Participants	128 Participants	125 Participants	63 Participants	63 Participants	127 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels WBC, Day 21 · Below	6 Participants	2 Participants	1 Participants	3 Participants	5 Participants	3 Participants	2 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels WBC, Day 21 · Above	4 Participants	1 Participants	0 Participants	4 Participants	0 Participants	0 Participants	1 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels WBC, Day 28 · Below	6 Participants	1 Participants	0 Participants	1 Participants	2 Participants	1 Participants	2 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels WBC, Day 42 · Unknown	3 Participants	2 Participants	2 Participants	0 Participants	2 Participants	1 Participants	0 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels MON, Day 182 · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL, Day 182 · Above	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AP, Day 21 · Above	2 Participants	0 Participants	2 Participants	0 Participants	2 Participants	2 Participants	1 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AP, Day 28 · Unknown	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AP, Day 7 · Within	126 Participants	66 Participants	64 Participants	127 Participants	127 Participants	64 Participants	62 Participants	129 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels ALT, Day 7 · Unknown	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels ALT, Day 7 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels ALT, Day 7 · Within	126 Participants	66 Participants	65 Participants	127 Participants	129 Participants	65 Participants	63 Participants	130 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels ALT, Day 7 · Above	2 Participants	0 Participants	0 Participants	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels ALT, Day 21 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels ALT, Day 21 · Within	126 Participants	66 Participants	62 Participants	128 Participants	128 Participants	64 Participants	63 Participants	128 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels ALT, Day 28 · Unknown	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AP, Day 21 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AP, Day 21 · Within	125 Participants	66 Participants	61 Participants	130 Participants	128 Participants	62 Participants	63 Participants	127 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AP, Day 28 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AP, Day 28 · Within	121 Participants	65 Participants	61 Participants	129 Participants	128 Participants	64 Participants	61 Participants	125 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels ALT, Day 28 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels ALT, Day 28 · Within	126 Participants	65 Participants	63 Participants	126 Participants	125 Participants	64 Participants	60 Participants	127 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels ALT, Day 28 · Above	1 Participants	0 Participants	0 Participants	3 Participants	4 Participants	1 Participants	2 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels ALT, Day 42 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AP, Day 28 · Above	6 Participants	0 Participants	2 Participants	0 Participants	1 Participants	1 Participants	1 Participants	4 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AP, Day 42 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AP, Day 42 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AP, Day 42 · Within	122 Participants	65 Participants	61 Participants	129 Participants	125 Participants	64 Participants	62 Participants	128 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AP, Day 42 · Above	6 Participants	0 Participants	2 Participants	1 Participants	4 Participants	1 Participants	1 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AP, Day 182 · Unknown	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AP, Day 182 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AP, Day 182 · Within	123 Participants	63 Participants	62 Participants	128 Participants	125 Participants	64 Participants	63 Participants	130 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AP, Day 182 · Above	2 Participants	0 Participants	1 Participants	1 Participants	3 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AST, Day 7 · Unknown	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AST, Day 7 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AST, Day 7 · Within	128 Participants	66 Participants	65 Participants	128 Participants	129 Participants	65 Participants	63 Participants	130 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AST, Day 7 · Above	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AST, Day 21 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AST, Day 21 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AST, Day 21 · Within	127 Participants	66 Participants	62 Participants	130 Participants	129 Participants	64 Participants	64 Participants	128 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AST, Day 21 · Above	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AST, Day 28 · Unknown	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AST, Day 28 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AST, Day 28 · Within	127 Participants	65 Participants	63 Participants	128 Participants	129 Participants	65 Participants	61 Participants	129 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AST, Day 28 · Above	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AST, Day 42 · Unknown	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels ALT, Day 182 · Within	123 Participants	63 Participants	63 Participants	128 Participants	126 Participants	65 Participants	63 Participants	130 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AP, Day 7 · Unknown	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BAS, Day 7 · Within	129 Participants	66 Participants	65 Participants	129 Participants	127 Participants	65 Participants	63 Participants	130 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BAS, Day 7 · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AST, Day 42 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AST, Day 42 · Above	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AST, Day 182 · Unknown	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AST, Day 182 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AST, Day 182 · Within	124 Participants	63 Participants	63 Participants	129 Participants	126 Participants	64 Participants	63 Participants	130 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AST, Day 182 · Above	1 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BAS, Day 7 · Unknown	0 Participants	0 Participants	0 Participants	1 Participants	3 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BAS, Day 7 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AP, Day 7 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AP, Day 7 · Above	2 Participants	0 Participants	1 Participants	2 Participants	3 Participants	1 Participants	1 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels AP, Day 21 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HgB, Day 42 · Below	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	2 Participants	3 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HgB, Day 42 · Within	121 Participants	63 Participants	61 Participants	128 Participants	122 Participants	63 Participants	60 Participants	122 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HgB, Day 42 · Above	3 Participants	0 Participants	1 Participants	2 Participants	4 Participants	0 Participants	1 Participants	3 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HgB, Day 182 · Unknown	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HgB, Day 182 · Below	1 Participants	0 Participants	3 Participants	0 Participants	1 Participants	0 Participants	1 Participants	5 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HgB, Day 182 · Within	123 Participants	63 Participants	59 Participants	128 Participants	126 Participants	65 Participants	61 Participants	120 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HgB, Day 182 · Above	1 Participants	0 Participants	1 Participants	1 Participants	2 Participants	0 Participants	1 Participants	5 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels LYM, Day 7 · Unknown	0 Participants	0 Participants	0 Participants	1 Participants	3 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels LYM, Day 7 · Below	3 Participants	1 Participants	0 Participants	0 Participants	2 Participants	2 Participants	1 Participants	3 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels LYM, Day 7 · Within	126 Participants	65 Participants	65 Participants	129 Participants	124 Participants	63 Participants	61 Participants	126 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels LYM, Day 7 · Above	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels LYM, Day 21 · Unknown	1 Participants	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants	2 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels LYM, Day 21 · Below	2 Participants	2 Participants	0 Participants	1 Participants	2 Participants	1 Participants	1 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels LYM, Day 21 · Within	123 Participants	64 Participants	63 Participants	128 Participants	126 Participants	64 Participants	60 Participants	127 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BAS, Day 21 · Unknown	1 Participants	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants	2 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels LYM, Day 21 · Above	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BAS, Day 21 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels LYM, Day 28 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels LYM, Day 28 · Below	4 Participants	2 Participants	0 Participants	2 Participants	0 Participants	3 Participants	0 Participants	3 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels LYM, Day 42 · Unknown	3 Participants	2 Participants	2 Participants	0 Participants	2 Participants	1 Participants	0 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels LYM, Day 42 · Below	4 Participants	3 Participants	1 Participants	1 Participants	5 Participants	2 Participants	1 Participants	3 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BAS, Day 21 · Within	126 Participants	66 Participants	63 Participants	129 Participants	128 Participants	65 Participants	62 Participants	129 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BAS, Day 21 · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BAS, Day 28 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BAS, Day 28 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BAS, Day 28 · Within	127 Participants	66 Participants	63 Participants	130 Participants	129 Participants	65 Participants	63 Participants	128 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BAS, Day 28 · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BAS, Day 42 · Unknown	3 Participants	2 Participants	2 Participants	0 Participants	2 Participants	1 Participants	0 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BAS, Day 42 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BAS, Day 42 · Within	125 Participants	63 Participants	61 Participants	130 Participants	127 Participants	64 Participants	63 Participants	128 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BAS, Day 42 · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BAS, Day 182 · Unknown	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BAS, Day 182 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BAS, Day 182 · Within	125 Participants	63 Participants	62 Participants	129 Participants	129 Participants	65 Participants	63 Participants	130 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BAS, Day 182 · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL, Day 7 · Unknown	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL, Day 7 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL, Day 7 · Within	126 Participants	66 Participants	65 Participants	128 Participants	130 Participants	65 Participants	63 Participants	129 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL, Day 7 · Above	2 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL, Day 21 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL, Day 21 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL, Day 21 · Within	126 Participants	66 Participants	62 Participants	129 Participants	130 Participants	64 Participants	64 Participants	129 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL, Day 21 · Above	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL, Day 28 · Unknown	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL, Day 28 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL, Day 28 · Within	126 Participants	65 Participants	63 Participants	128 Participants	129 Participants	65 Participants	62 Participants	127 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL, Day 28 · Above	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL, Day 42 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL, Day 42 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL, Day 42 · Within	126 Participants	65 Participants	63 Participants	129 Participants	127 Participants	65 Participants	63 Participants	128 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL, Day 42 · Above	2 Participants	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants	0 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL, Day 182 · Unknown	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL, Day 182 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL, Day 182 · Within	124 Participants	63 Participants	63 Participants	129 Participants	127 Participants	65 Participants	63 Participants	129 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels EOS, Day 21 · Below	3 Participants	0 Participants	0 Participants	3 Participants	5 Participants	1 Participants	4 Participants	5 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL/CD, Day 7 · Unknown	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels EOS, Day 21 · Within	119 Participants	65 Participants	60 Participants	121 Participants	116 Participants	62 Participants	56 Participants	119 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL/CD, Day 7 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL/CD, Day 7 · Within	128 Participants	66 Participants	65 Participants	129 Participants	130 Participants	65 Participants	63 Participants	130 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL/CD, Day 7 · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL/CD, Day 21 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL/CD, Day 21 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL/CD, Day 21 · Within	127 Participants	66 Participants	63 Participants	130 Participants	130 Participants	64 Participants	64 Participants	129 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL/CD, Day 21 · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL/CD, Day 28 · Unknown	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL/CD, Day 28 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL/CD, Day 28 · Within	127 Participants	65 Participants	63 Participants	129 Participants	129 Participants	65 Participants	62 Participants	129 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL/CD, Day 28 · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL/CD, Day 42 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL/CD, Day 42 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL/CD, Day 42 · Within	128 Participants	65 Participants	63 Participants	130 Participants	129 Participants	65 Participants	63 Participants	130 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL/CD, Day 42 · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL/CD, Day 182 · Unknown	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL/CD, Day 182 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL/CD, Day 182 · Within	125 Participants	63 Participants	63 Participants	129 Participants	128 Participants	65 Participants	63 Participants	130 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BIL/CD, Day 182 · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels CREA, Day 7 · Unknown	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels CREA, Day 7 · Below	6 Participants	7 Participants	5 Participants	11 Participants	10 Participants	4 Participants	5 Participants	5 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels CREA, Day 7 · Within	119 Participants	59 Participants	60 Participants	117 Participants	120 Participants	61 Participants	57 Participants	124 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels CREA, Day 7 · Above	3 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels CREA, Day 21 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels CREA, Day 21 · Below	13 Participants	7 Participants	7 Participants	12 Participants	7 Participants	6 Participants	4 Participants	6 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels CREA, Day 21 · Within	112 Participants	59 Participants	56 Participants	118 Participants	122 Participants	57 Participants	59 Participants	119 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels CREA, Day 21 · Above	2 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	4 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels CREA, Day 28 · Unknown	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels CREA, Day 28 · Below	8 Participants	6 Participants	7 Participants	14 Participants	7 Participants	6 Participants	5 Participants	6 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels CREA, Day 28 · Within	118 Participants	59 Participants	56 Participants	113 Participants	122 Participants	58 Participants	56 Participants	121 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels CREA, Day 28 · Above	1 Participants	0 Participants	0 Participants	2 Participants	0 Participants	1 Participants	1 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels CREA, Day 42 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels CREA, Day 42 · Below	12 Participants	5 Participants	7 Participants	12 Participants	8 Participants	5 Participants	6 Participants	9 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels CREA, Day 42 · Within	115 Participants	60 Participants	54 Participants	118 Participants	121 Participants	58 Participants	56 Participants	119 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels CREA, Day 42 · Above	1 Participants	0 Participants	2 Participants	0 Participants	0 Participants	2 Participants	1 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels CREA, Day 182 · Unknown	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels CREA, Day 182 · Below	15 Participants	7 Participants	5 Participants	15 Participants	7 Participants	5 Participants	5 Participants	11 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels CREA, Day 182 · Within	107 Participants	56 Participants	58 Participants	110 Participants	120 Participants	60 Participants	56 Participants	119 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels CREA, Day 182 · Above	3 Participants	0 Participants	0 Participants	4 Participants	1 Participants	0 Participants	2 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels EOS, Day 7 · Unknown	0 Participants	0 Participants	0 Participants	1 Participants	3 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels EOS, Day 7 · Below	4 Participants	1 Participants	1 Participants	4 Participants	1 Participants	3 Participants	3 Participants	5 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels EOS, Day 7 · Within	123 Participants	64 Participants	61 Participants	121 Participants	120 Participants	61 Participants	56 Participants	122 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels EOS, Day 7 · Above	2 Participants	1 Participants	3 Participants	4 Participants	6 Participants	1 Participants	4 Participants	3 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels EOS, Day 21 · Unknown	1 Participants	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants	2 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels EOS, Day 21 · Above	4 Participants	1 Participants	3 Participants	5 Participants	7 Participants	2 Participants	2 Participants	5 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels EOS, Day 28 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels EOS, Day 28 · Below	2 Participants	0 Participants	1 Participants	5 Participants	5 Participants	4 Participants	4 Participants	6 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels EOS, Day 28 · Within	122 Participants	63 Participants	58 Participants	120 Participants	120 Participants	57 Participants	56 Participants	118 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels EOS, Day 28 · Above	3 Participants	3 Participants	4 Participants	5 Participants	4 Participants	4 Participants	3 Participants	4 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels EOS, Day 42 · Unknown	3 Participants	2 Participants	2 Participants	0 Participants	2 Participants	1 Participants	0 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels EOS, Day 42 · Below	4 Participants	0 Participants	1 Participants	1 Participants	2 Participants	2 Participants	6 Participants	8 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels EOS, Day 42 · Within	116 Participants	62 Participants	57 Participants	123 Participants	123 Participants	60 Participants	55 Participants	116 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels EOS, Day 42 · Above	5 Participants	1 Participants	3 Participants	6 Participants	2 Participants	2 Participants	2 Participants	4 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels EOS, Day 182 · Unknown	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels EOS, Day 182 · Below	7 Participants	0 Participants	2 Participants	7 Participants	2 Participants	0 Participants	3 Participants	6 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels EOS, Day 182 · Within	112 Participants	62 Participants	56 Participants	117 Participants	124 Participants	62 Participants	58 Participants	119 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels EOS, Day 182 · Above	6 Participants	1 Participants	4 Participants	5 Participants	3 Participants	3 Participants	2 Participants	5 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HEM, Day 7 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HEM, Day 7 · Below	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HEM, Day 7 · Within	127 Participants	66 Participants	65 Participants	126 Participants	125 Participants	64 Participants	60 Participants	124 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HEM, Day 7 · Above	2 Participants	0 Participants	0 Participants	2 Participants	3 Participants	1 Participants	2 Participants	6 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HEM, Day 21 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HEM, Day 21 · Below	0 Participants	0 Participants	1 Participants	2 Participants	3 Participants	1 Participants	0 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HEM, Day 21 · Within	125 Participants	63 Participants	62 Participants	126 Participants	121 Participants	64 Participants	61 Participants	121 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HEM, Day 21 · Above	2 Participants	3 Participants	0 Participants	2 Participants	4 Participants	0 Participants	2 Participants	6 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HEM, Day 28 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HEM, Day 28 · Below	1 Participants	0 Participants	1 Participants	1 Participants	4 Participants	1 Participants	1 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HEM, Day 28 · Within	123 Participants	65 Participants	62 Participants	127 Participants	122 Participants	64 Participants	61 Participants	123 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HEM, Day 28 · Above	3 Participants	1 Participants	0 Participants	2 Participants	3 Participants	0 Participants	1 Participants	5 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HEM, Day 42 · Unknown	3 Participants	2 Participants	1 Participants	0 Participants	2 Participants	1 Participants	0 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HEM, Day 42 · Below	2 Participants	0 Participants	0 Participants	2 Participants	4 Participants	1 Participants	2 Participants	3 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HEM, Day 42 · Within	120 Participants	63 Participants	62 Participants	127 Participants	118 Participants	63 Participants	60 Participants	121 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HEM, Day 42 · Above	3 Participants	0 Participants	0 Participants	1 Participants	5 Participants	0 Participants	1 Participants	4 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HEM, Day 182 · Unknown	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HEM, Day 182 · Below	5 Participants	0 Participants	2 Participants	0 Participants	2 Participants	0 Participants	1 Participants	8 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HEM, Day 182 · Within	118 Participants	62 Participants	60 Participants	128 Participants	126 Participants	65 Participants	61 Participants	118 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HEM, Day 182 · Above	2 Participants	1 Participants	1 Participants	1 Participants	1 Participants	0 Participants	1 Participants	4 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HgB, Day 7 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HgB, Day 7 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HgB, Day 7 · Within	127 Participants	66 Participants	65 Participants	128 Participants	129 Participants	65 Participants	60 Participants	128 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HgB, Day 7 · Above	2 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	2 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HgB, Day 21 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HgB, Day 21 · Below	2 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	2 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HgB, Day 21 · Within	122 Participants	66 Participants	63 Participants	127 Participants	124 Participants	65 Participants	59 Participants	123 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HgB, Day 21 · Above	3 Participants	0 Participants	0 Participants	3 Participants	2 Participants	0 Participants	2 Participants	4 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels RBC, Day 28 · Within	123 Participants	65 Participants	62 Participants	130 Participants	127 Participants	63 Participants	62 Participants	127 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HgB, Day 28 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HgB, Day 28 · Below	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HgB, Day 28 · Within	122 Participants	66 Participants	63 Participants	128 Participants	127 Participants	64 Participants	61 Participants	126 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HgB, Day 28 · Above	4 Participants	0 Participants	0 Participants	2 Participants	1 Participants	0 Participants	1 Participants	3 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels HgB, Day 42 · Unknown	3 Participants	2 Participants	0 Participants	0 Participants	2 Participants	1 Participants	0 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels LYM, Day 182 · Unknown	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BUN, Day 28 · Unknown	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels LYM, Day 182 · Within	121 Participants	61 Participants	61 Participants	128 Participants	127 Participants	63 Participants	63 Participants	129 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels MON, Day 7 · Below	20 Participants	6 Participants	12 Participants	12 Participants	13 Participants	3 Participants	9 Participants	15 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels MON, Day 7 · Within	109 Participants	60 Participants	53 Participants	117 Participants	114 Participants	62 Participants	54 Participants	115 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels PLA, Day 21 · Above	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	1 Participants	3 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels PLA, Day 42 · Above	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	3 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels PLA, Day 182 · Unknown	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels PLA, Day 182 · Within	122 Participants	61 Participants	61 Participants	125 Participants	126 Participants	63 Participants	62 Participants	124 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels RBC, Day 7 · Within	127 Participants	64 Participants	64 Participants	130 Participants	125 Participants	64 Participants	60 Participants	129 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels RBC, Day 7 · Above	1 Participants	2 Participants	1 Participants	0 Participants	2 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels RBC, Day 21 · Below	2 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	2 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels RBC, Day 21 · Within	124 Participants	64 Participants	63 Participants	129 Participants	124 Participants	65 Participants	60 Participants	127 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels RBC, Day 21 · Above	1 Participants	1 Participants	0 Participants	0 Participants	3 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels RBC, Day 28 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels RBC, Day 28 · Below	2 Participants	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants	1 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels RBC, Day 28 · Above	2 Participants	1 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels RBC, Day 42 · Unknown	3 Participants	2 Participants	1 Participants	0 Participants	2 Participants	1 Participants	0 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels RBC, Day 42 · Below	1 Participants	0 Participants	0 Participants	1 Participants	2 Participants	2 Participants	1 Participants	3 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels RBC, Day 42 · Within	122 Participants	61 Participants	62 Participants	129 Participants	121 Participants	62 Participants	62 Participants	122 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels RBC, Day 42 · Above	2 Participants	2 Participants	0 Participants	0 Participants	4 Participants	0 Participants	0 Participants	3 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels RBC, Day 182 · Unknown	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels RBC, Day 182 · Within	120 Participants	62 Participants	63 Participants	128 Participants	127 Participants	64 Participants	61 Participants	124 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels RBC, Day 182 · Above	2 Participants	1 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	3 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BUN, Day 7 · Unknown	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BUN, Day 7 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BUN, Day 7 · Within	124 Participants	66 Participants	65 Participants	126 Participants	128 Participants	65 Participants	63 Participants	129 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BUN, Day 7 · Above	4 Participants	0 Participants	0 Participants	3 Participants	2 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BUN, Day 21 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BUN, Day 21 · Below	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BUN, Day 21 · Within	123 Participants	65 Participants	62 Participants	127 Participants	128 Participants	63 Participants	64 Participants	124 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BUN, Day 21 · Above	4 Participants	0 Participants	0 Participants	3 Participants	2 Participants	1 Participants	0 Participants	5 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BUN, Day 28 · Below	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BUN, Day 28 · Within	124 Participants	63 Participants	63 Participants	127 Participants	126 Participants	64 Participants	62 Participants	128 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BUN, Day 28 · Above	3 Participants	1 Participants	0 Participants	2 Participants	3 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BUN, Day 42 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BUN, Day 42 · Below	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BUN, Day 42 · Above	3 Participants	0 Participants	1 Participants	2 Participants	4 Participants	2 Participants	0 Participants	3 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BUN, Day 182 · Unknown	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BUN, Day 182 · Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BUN, Day 182 · Within	121 Participants	63 Participants	60 Participants	124 Participants	125 Participants	65 Participants	63 Participants	128 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels BUN, Day 182 · Above	4 Participants	0 Participants	3 Participants	5 Participants	3 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels WBC, Day 7 · Unknown	0 Participants	0 Participants	0 Participants	1 Participants	3 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels WBC, Day 7 · Below	3 Participants	0 Participants	1 Participants	2 Participants	3 Participants	1 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels WBC, Day 7 · Within	125 Participants	66 Participants	63 Participants	125 Participants	123 Participants	62 Participants	62 Participants	129 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels WBC, Day 7 · Above	1 Participants	0 Participants	1 Participants	2 Participants	1 Participants	2 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels WBC, Day 21 · Unknown	1 Participants	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants	2 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels MON, Day 21 · Unknown	1 Participants	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants	2 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels MON, Day 21 · Below	11 Participants	10 Participants	9 Participants	20 Participants	16 Participants	11 Participants	8 Participants	14 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels MON, Day 21 · Within	115 Participants	56 Participants	54 Participants	108 Participants	112 Participants	54 Participants	54 Participants	115 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels MON, Day 28 · Below	15 Participants	10 Participants	6 Participants	15 Participants	15 Participants	8 Participants	3 Participants	19 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels MON, Day 28 · Within	112 Participants	56 Participants	57 Participants	115 Participants	114 Participants	57 Participants	60 Participants	108 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels MON, Day 28 · Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels MON, Day 42 · Unknown	3 Participants	2 Participants	2 Participants	0 Participants	2 Participants	1 Participants	0 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels MON, Day 42 · Below	13 Participants	4 Participants	8 Participants	13 Participants	12 Participants	5 Participants	5 Participants	20 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels MON, Day 42 · Above	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels MON, Day 182 · Unknown	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels WBC, Day 21 · Within	116 Participants	63 Participants	62 Participants	122 Participants	123 Participants	62 Participants	59 Participants	125 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels WBC, Day 28 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels WBC, Day 28 · Within	118 Participants	65 Participants	62 Participants	126 Participants	126 Participants	62 Participants	60 Participants	122 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels WBC, Day 28 · Above	3 Participants	0 Participants	1 Participants	3 Participants	1 Participants	2 Participants	1 Participants	4 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels WBC, Day 42 · Below	3 Participants	1 Participants	2 Participants	1 Participants	4 Participants	1 Participants	1 Participants	2 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels WBC, Day 42 · Within	118 Participants	61 Participants	59 Participants	126 Participants	123 Participants	62 Participants	61 Participants	123 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels WBC, Day 42 · Above	4 Participants	1 Participants	0 Participants	3 Participants	0 Participants	1 Participants	1 Participants	3 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels WBC, Day 182 · Unknown	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels WBC, Day 182 · Below	4 Participants	0 Participants	1 Participants	4 Participants	3 Participants	2 Participants	1 Participants	1 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels WBC, Day 182 · Within	120 Participants	62 Participants	60 Participants	122 Participants	126 Participants	62 Participants	61 Participants	129 Participants
Number of Subjects With Abnormal Biochemical and Haematological Levels WBC, Day 182 · Above	1 Participants	1 Participants	1 Participants	3 Participants	0 Participants	1 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Days 0 to 385

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects who received at least 1 study vaccination.

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 was defined as the occurrence of any MAE regardless of intensity grade or relation to vaccination. Results were tabulated for subjects aged between 18 and 64 years and older (>64y).

Outcome measures

Measure	GSK2340274A F1 Group n=129 Participants Pooled group comprising the subjects from GSK2340274A F1\_2D Group and GSK2340274A F1\_1D Group.	GSK2340274A F2 Group n=66 Participants Pooled group comprising the subjects from GSK2340274A F2\_1D Group and GSK2340274A F2\_2D Group.	GSK2340274A F2_1D Group n=65 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F1_1D Group n=130 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F1_1D Group n=131 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_2D Group n=65 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_1D Group n=64 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.	GSK2340273A F3_2D Group n=130 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Number of Subjects With Any Medically-attended Adverse Events (MAEs) Any MAEs, 18-64y	49 Participants	24 Participants	14 Participants	32 Participants	38 Participants	23 Participants	23 Participants	36 Participants
Number of Subjects With Any Medically-attended Adverse Events (MAEs) Any MAEs, >64y	60 Participants	37 Participants	39 Participants	67 Participants	62 Participants	35 Participants	40 Participants	59 Participants

SECONDARY outcome

Timeframe: Days 0 to 365

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects who received at least 1 study vaccination.

Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Results were tabulated for subjects aged between 18-64 years and above 65 years (+65y).

Outcome measures

Measure	GSK2340274A F1 Group n=129 Participants Pooled group comprising the subjects from GSK2340274A F1\_2D Group and GSK2340274A F1\_1D Group.	GSK2340274A F2 Group n=66 Participants Pooled group comprising the subjects from GSK2340274A F2\_1D Group and GSK2340274A F2\_2D Group.	GSK2340274A F2_1D Group n=65 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F1_1D Group n=130 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F1_1D Group n=131 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_2D Group n=65 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_1D Group n=64 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.	GSK2340273A F3_2D Group n=130 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) Any pIMDs, + 65y	2 Participants	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) Any pIMDs, 18-64y	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Within the 42-day (Days 0-41) post-vaccination period

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects who received at least 1 study vaccination.

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

Measure	GSK2340274A F1 Group n=222 Participants Pooled group comprising the subjects from GSK2340274A F1\_2D Group and GSK2340274A F1\_1D Group.	GSK2340274A F2 Group n=114 Participants Pooled group comprising the subjects from GSK2340274A F2\_1D Group and GSK2340274A F2\_2D Group.	GSK2340274A F2_1D Group n=112 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F1_1D Group n=221 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F1_1D Group n=223 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_2D Group n=115 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_1D Group n=111 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.	GSK2340273A F3_2D Group n=222 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Number of Subjects With Any Unsolicited Adverse Events (AEs)	97 Participants	55 Participants	38 Participants	93 Participants	82 Participants	43 Participants	55 Participants	86 Participants

SECONDARY outcome

Timeframe: Within the 84-day (Days 0-83) post-vaccination period

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects who received at least 1 study vaccination.

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. Results were tabulated for subjects aged between 18-64 years and older (>64y).

Outcome measures

Measure	GSK2340274A F1 Group n=129 Participants Pooled group comprising the subjects from GSK2340274A F1\_2D Group and GSK2340274A F1\_1D Group.	GSK2340274A F2 Group n=66 Participants Pooled group comprising the subjects from GSK2340274A F2\_1D Group and GSK2340274A F2\_2D Group.	GSK2340274A F2_1D Group n=65 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F1_1D Group n=130 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F1_1D Group n=131 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_2D Group n=65 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_1D Group n=64 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.	GSK2340273A F3_2D Group n=130 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Number of Subjects With Any Unsolicited Adverse Events (AEs) Any AE(s), 18-64y	51 Participants	29 Participants	18 Participants	46 Participants	36 Participants	26 Participants	27 Participants	44 Participants
Number of Subjects With Any Unsolicited Adverse Events (AEs) Any AE(s), > 64y	66 Participants	32 Participants	32 Participants	62 Participants	61 Participants	30 Participants	35 Participants	64 Participants

SECONDARY outcome

Timeframe: During the entire study period (from Day 0 to Day 385)

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects who received at least 1 study vaccination.

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Results were tabulated for subjects aged between 18-64 years and older (>64y).

Outcome measures

Measure	GSK2340274A F1 Group n=129 Participants Pooled group comprising the subjects from GSK2340274A F1\_2D Group and GSK2340274A F1\_1D Group.	GSK2340274A F2 Group n=66 Participants Pooled group comprising the subjects from GSK2340274A F2\_1D Group and GSK2340274A F2\_2D Group.	GSK2340274A F2_1D Group n=65 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F1_1D Group n=130 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F1_1D Group n=131 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_2D Group n=65 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_1D Group n=64 Participants Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.	GSK2340273A F3_2D Group n=130 Participants Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Number of Subjects With Serious Adverse Events (SAEs) Any SAE(s), 18-64y	7 Participants	0 Participants	2 Participants	1 Participants	2 Participants	1 Participants	2 Participants	3 Participants
Number of Subjects With Serious Adverse Events (SAEs) Any SAE(s), > 64y	12 Participants	5 Participants	4 Participants	7 Participants	6 Participants	4 Participants	7 Participants	8 Participants

Adverse Events

GSK2340274A F1_2D Group

Serious events: 19 serious events

Other events: 189 other events

Deaths: 1 deaths

GSK2340274A F2_2D Group

Serious events: 5 serious events

Other events: 86 other events

Deaths: 1 deaths

GSK2340274A F2_1D Group

Serious events: 6 serious events

Other events: 79 other events

Deaths: 0 deaths

GSK2340274A F1_1D Group

Serious events: 8 serious events

Other events: 188 other events

Deaths: 0 deaths

GSK2340273A F1_1D Group

Serious events: 8 serious events

Other events: 126 other events

Deaths: 0 deaths

GSK2340273A F2_2D Group

Serious events: 5 serious events

Other events: 74 other events

Deaths: 0 deaths

GSK2340273A F2_1D Group

Serious events: 9 serious events

Other events: 76 other events

Deaths: 0 deaths

GSK2340273A F3_2D Group

Serious events: 11 serious events

Other events: 130 other events

Deaths: 1 deaths

Serious adverse events

Measure	GSK2340274A F1_2D Group n=222 participants at risk Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 1 (F1) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F2_2D Group n=114 participants at risk Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F2_1D Group n=112 participants at risk Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F1_1D Group n=221 participants at risk Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F1_1D Group n=223 participants at risk Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_2D Group n=115 participants at risk Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_1D Group n=111 participants at risk Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.	GSK2340273A F3_2D Group n=222 participants at risk Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Cardiac disorders Acute myocardial infarction	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.88% 1/114 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.90% 2/222 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Cardiac disorders Atrioventricular block first degree	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.89% 1/112 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Cardiac disorders Bradycardia	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.89% 1/112 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Cardiac disorders Cardiac failure congestive	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.45% 1/221 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Blood and lymphatic system disorders Anaemia	1.4% 3/222 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.45% 1/222 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.88% 1/114 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.45% 1/223 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Blood and lymphatic system disorders Thrombocytopenia	0.90% 2/222 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.45% 1/221 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Cardiac disorders Coronary artery disease	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.45% 1/221 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.45% 1/222 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Cardiac disorders Myocardial infarction	0.90% 2/222 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Cardiac disorders Sick sinus syndrome	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.45% 1/223 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Cardiac disorders Supraventricular tachycardia	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.88% 1/114 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Cardiac disorders Ventricular tachycardia	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.88% 1/114 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Endocrine disorders Autoimmune thyroiditis	0.45% 1/222 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Eye disorders Amaurosis fugax	0.45% 1/222 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Eye disorders Blindness transient	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.88% 1/114 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Gastrointestinal disorders Abdominal pain	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.89% 1/112 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Gastrointestinal disorders Abdominal pain upper	0.45% 1/222 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.45% 1/222 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Gastrointestinal disorders Gastritis	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.45% 1/221 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Gastrointestinal disorders Gastritis erosive	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.45% 1/222 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Gastrointestinal disorders Gastrointestinal toxicity	0.45% 1/222 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.88% 1/114 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.45% 1/222 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Gastrointestinal disorders Intestinal perforation	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.87% 1/115 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Gastrointestinal disorders Large intestine perforation	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.88% 1/114 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Gastrointestinal disorders Oesophagitis	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.45% 1/221 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Gastrointestinal disorders Pancreatic disorder	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.45% 1/221 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Gastrointestinal disorders Peritonitis	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.88% 1/114 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.45% 1/221 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.45% 1/222 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
General disorders Chest discomfort	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.90% 1/111 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
General disorders Chest pain	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.45% 1/223 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.90% 1/111 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
General disorders Non-cardiac chest pain	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.90% 1/111 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
General disorders Pyrexia	0.45% 1/222 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Hepatobiliary disorders Cholecystitis	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.87% 1/115 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Hepatobiliary disorders Cholelithiasis	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.87% 1/115 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Immune system disorders Anaphylactic reaction	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.90% 1/111 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Immune system disorders Drug hypersensitivity	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.45% 1/221 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Infections and infestations Abscess limb	0.45% 1/222 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Infections and infestations Appendicitis	0.45% 1/222 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Infections and infestations Cellulitis	0.45% 1/222 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Infections and infestations Gastroenteritis	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.45% 1/222 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Infections and infestations Lobar pneumonia	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.90% 1/111 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Infections and infestations Pneumonia	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.89% 1/112 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.45% 1/222 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Infections and infestations Urosepsis	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.88% 1/114 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Injury, poisoning and procedural complications Alcohol poisoning	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.90% 1/111 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Injury, poisoning and procedural complications Ankle fracture	0.45% 1/222 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.45% 1/221 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Injury, poisoning and procedural complications Contusion	0.45% 1/222 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Injury, poisoning and procedural complications Fall	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.45% 1/221 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Injury, poisoning and procedural complications Hip fracture	0.45% 1/222 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.45% 1/221 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Injury, poisoning and procedural complications Open fracture	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.87% 1/115 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.45% 1/222 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Injury, poisoning and procedural complications Traumatic lung injury	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.45% 1/222 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.90% 1/111 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Injury, poisoning and procedural complications Ureteric injury	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.45% 1/223 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.90% 1/111 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.45% 1/222 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Metabolism and nutrition disorders Gout	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.45% 1/222 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Metabolism and nutrition disorders Hyponatraemia	0.45% 1/222 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.45% 1/221 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.45% 1/221 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.45% 1/221 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.45% 1/222 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.45% 1/222 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.45% 1/222 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.45% 1/223 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.89% 1/112 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign bone neoplasm	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.45% 1/221 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of thyroid gland	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.45% 1/223 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.90% 2/222 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.88% 1/114 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.89% 1/112 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.45% 1/222 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm malignant	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.45% 1/223 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.45% 1/222 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.89% 1/112 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.45% 1/222 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.45% 1/222 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.88% 1/114 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Paget's disease of the breast	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.90% 1/111 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.45% 1/223 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.45% 1/222 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.90% 1/111 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.45% 1/222 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer stage unspecified	0.45% 1/222 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Nervous system disorders Cerebrovascular accident	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.45% 1/223 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Nervous system disorders Transient ischaemic attack	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.45% 1/222 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.45% 1/222 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous incomplete	0.45% 1/222 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.89% 1/112 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Psychiatric disorders Anxiety	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.45% 1/221 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Psychiatric disorders Mental status changes	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	1.8% 2/111 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Renal and urinary disorders Nephrolithiasis	0.45% 1/222 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.45% 1/222 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.45% 1/222 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.88% 1/114 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.87% 1/115 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.90% 1/111 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Vascular disorders Aortic aneurysm rupture	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.90% 1/111 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Vascular disorders Hypertension	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.90% 1/111 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Vascular disorders Hypotension	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.87% 1/115 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Vascular disorders Thrombosis	0.00% 0/222 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/221 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/223 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.45% 1/222 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.

Other adverse events

Measure	GSK2340274A F1_2D Group n=222 participants at risk Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 1 (F1) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F2_2D Group n=114 participants at risk Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F2_1D Group n=112 participants at risk Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340274A F1_1D Group n=221 participants at risk Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F1_1D Group n=223 participants at risk Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_2D Group n=115 participants at risk Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.	GSK2340273A F2_1D Group n=111 participants at risk Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.	GSK2340273A F3_2D Group n=222 participants at risk Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
Musculoskeletal and connective tissue disorders Arthralgia	22.1% 49/222 • Number of events 63 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	22.8% 26/114 • Number of events 36 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	9.8% 11/112 • Number of events 15 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	15.8% 35/221 • Number of events 40 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	15.7% 35/223 • Number of events 46 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	9.6% 11/115 • Number of events 13 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	9.9% 11/111 • Number of events 16 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	10.8% 24/222 • Number of events 30 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Musculoskeletal and connective tissue disorders Back pain	0.90% 2/222 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	5.3% 6/114 • Number of events 7 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	1.8% 2/112 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	1.8% 4/221 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.45% 1/223 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/115 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	3.6% 4/111 • Number of events 6 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.90% 2/222 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
General disorders Chills	15.3% 34/222 • Number of events 37 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	14.9% 17/114 • Number of events 22 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	3.6% 4/112 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	7.7% 17/221 • Number of events 18 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	9.9% 22/223 • Number of events 27 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	10.4% 12/115 • Number of events 13 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	6.3% 7/111 • Number of events 9 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	11.3% 25/222 • Number of events 27 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Respiratory, thoracic and mediastinal disorders Cough	5.9% 13/222 • Number of events 15 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	6.1% 7/114 • Number of events 7 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	5.4% 6/112 • Number of events 7 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	4.5% 10/221 • Number of events 10 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	4.9% 11/223 • Number of events 11 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	3.5% 4/115 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	4.5% 5/111 • Number of events 6 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	5.9% 13/222 • Number of events 13 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Gastrointestinal disorders Diarrhoea	0.90% 2/222 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	5.3% 6/114 • Number of events 6 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	2.7% 6/221 • Number of events 7 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	4.5% 10/223 • Number of events 12 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.87% 1/115 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.90% 1/111 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	2.7% 6/222 • Number of events 11 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Skin and subcutaneous tissue disorders Erythema	9.9% 22/222 • Number of events 25 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	2.7% 3/112 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	6.3% 14/221 • Number of events 14 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.90% 2/223 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	1.7% 2/115 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	1.8% 2/111 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	3.2% 7/222 • Number of events 7 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
General disorders Fatigue	33.8% 75/222 • Number of events 108 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	36.8% 42/114 • Number of events 55 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	13.4% 15/112 • Number of events 21 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	30.3% 67/221 • Number of events 84 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	26.0% 58/223 • Number of events 72 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	22.6% 26/115 • Number of events 34 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	27.9% 31/111 • Number of events 41 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	20.3% 45/222 • Number of events 61 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Nervous system disorders Headache	36.5% 81/222 • Number of events 108 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	32.5% 37/114 • Number of events 48 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	24.1% 27/112 • Number of events 34 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	29.0% 64/221 • Number of events 80 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	26.9% 60/223 • Number of events 81 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	27.8% 32/115 • Number of events 46 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	30.6% 34/111 • Number of events 49 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	24.8% 55/222 • Number of events 77 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Skin and subcutaneous tissue disorders Hyperhidrosis	10.4% 23/222 • Number of events 25 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	7.0% 8/114 • Number of events 9 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	1.8% 2/112 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	4.5% 10/221 • Number of events 10 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	8.5% 19/223 • Number of events 20 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	3.5% 4/115 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	8.1% 9/111 • Number of events 10 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	5.4% 12/222 • Number of events 15 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Musculoskeletal and connective tissue disorders Myalgia	37.4% 83/222 • Number of events 117 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	35.1% 40/114 • Number of events 60 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	12.5% 14/112 • Number of events 17 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	30.3% 67/221 • Number of events 82 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	19.7% 44/223 • Number of events 57 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	20.9% 24/115 • Number of events 27 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	20.7% 23/111 • Number of events 26 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	15.3% 34/222 • Number of events 44 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.0% 11/222 • Number of events 13 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	6.1% 7/114 • Number of events 8 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	2.7% 3/112 • Number of events 5 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	3.6% 8/221 • Number of events 8 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	4.5% 10/223 • Number of events 11 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.87% 1/115 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	1.8% 2/111 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	2.7% 6/222 • Number of events 6 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Infections and infestations Nasopharyngitis	4.1% 9/222 • Number of events 9 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	3.5% 4/114 • Number of events 5 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	2.7% 3/112 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	3.2% 7/221 • Number of events 7 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	6.7% 15/223 • Number of events 15 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	7.0% 8/115 • Number of events 8 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	4.5% 5/111 • Number of events 6 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	6.3% 14/222 • Number of events 15 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Gastrointestinal disorders Nausea	0.90% 2/222 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	3.5% 4/114 • Number of events 6 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.89% 1/112 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.45% 1/221 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	3.6% 8/223 • Number of events 8 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	5.2% 6/115 • Number of events 6 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	1.4% 3/222 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	4.1% 9/222 • Number of events 9 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	7.9% 9/114 • Number of events 9 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	5.4% 6/112 • Number of events 6 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	3.6% 8/221 • Number of events 8 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	6.3% 14/223 • Number of events 15 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	7.0% 8/115 • Number of events 11 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	6.3% 7/111 • Number of events 7 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	6.3% 14/222 • Number of events 15 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
General disorders Pain	75.7% 168/222 • Number of events 279 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	66.7% 76/114 • Number of events 128 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	50.9% 57/112 • Number of events 61 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	70.6% 156/221 • Number of events 173 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	21.5% 48/223 • Number of events 62 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	23.5% 27/115 • Number of events 30 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	22.5% 25/111 • Number of events 28 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	18.9% 42/222 • Number of events 47 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
General disorders Pyrexia	5.0% 11/222 • Number of events 11 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	2.6% 3/114 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.89% 1/112 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	2.7% 6/221 • Number of events 7 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	5.8% 13/223 • Number of events 14 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	2.6% 3/115 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	6.3% 7/111 • Number of events 7 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	3.2% 7/222 • Number of events 8 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	2.7% 6/222 • Number of events 6 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/114 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/112 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.90% 2/221 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	4.0% 9/223 • Number of events 11 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	2.6% 3/115 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	8.1% 9/111 • Number of events 11 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	1.8% 4/222 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
General disorders Swelling	9.0% 20/222 • Number of events 25 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	7.0% 8/114 • Number of events 9 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	3.6% 4/112 • Number of events 5 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	9.0% 20/221 • Number of events 21 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	3.1% 7/223 • Number of events 7 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	1.7% 2/115 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	0.00% 0/111 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	2.3% 5/222 • Number of events 5 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.
Infections and infestations Upper respiratory tract infection	4.1% 9/222 • Number of events 9 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	4.4% 5/114 • Number of events 5 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	4.5% 5/112 • Number of events 5 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	3.2% 7/221 • Number of events 7 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	1.3% 3/223 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	3.5% 4/115 • Number of events 5 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	4.5% 5/111 • Number of events 5 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.	5.9% 13/222 • Number of events 14 • Solicited local and general symptoms: during the 7-day (Days 0-6) period post vaccine/placebo administration. Unsolicited AEs: during the 184-day (Days 0-183) post vaccine/placebo administration. Serious Adverse events (SAE): from Day 0 to Day 385.

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