Trial Outcomes & Findings for Study to Compare the Efficacy of GSK Biologicals' Adjuvants in Combination With the Antigen of the Hepatitis B Vaccine (NCT NCT00805389)

Last Updated: 2018-08-20

Results Overview

The number of HB-CD4+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD40L), Interleukin (IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs). Results for the Day 44 time point are the primary results among the outcome measure results presented.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

713 participants

Primary outcome timeframe

At Day 44

Results posted on

2018-08-20

Participant Flow

Approximately 75 subjects in each group, approximately 23 and 52 subjects/group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I and II subtypes \[Subset 1 and 2, respectively\], received a booster dose of HBsAg at Day 360.

Study duration was of 390 days for subjects in Subsets 1 and 2 (subjects identified with a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) vaccinated with an additional dose of Hepatitis B surface antigens (HBsAg)) and of 360 days for subjects not receiving this dose of HBsAg.

Participant milestones

Participant milestones
Measure	GSK223192A 1 Group Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 Group Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 Group Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Engerix-B Group Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Overall Study STARTED	143	142	141	145	142
Overall Study COMPLETED	136	137	129	128	129
Overall Study NOT COMPLETED	7	5	12	17	13

Reasons for withdrawal

Reasons for withdrawal
Measure	GSK223192A 1 Group Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 Group Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 Group Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Engerix-B Group Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Overall Study Adverse Event	0	0	1	2	0
Overall Study Lost to Follow-up	4	3	6	10	9
Overall Study Protocol Violation	0	0	1	0	0
Overall Study Withdrawal by Subject	3	2	4	5	4

Baseline Characteristics

Study to Compare the Efficacy of GSK Biologicals' Adjuvants in Combination With the Antigen of the Hepatitis B Vaccine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK223192A 1 Group n=143 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 Group n=142 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 Group n=141 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group n=145 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Engerix-B Group n=142 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Total n=713 Participants Total of all reporting groups
Age, Continuous	34.7 Years STANDARD_DEVIATION 6.94 • n=5 Participants	33.7 Years STANDARD_DEVIATION 7.28 • n=7 Participants	32.9 Years STANDARD_DEVIATION 7.58 • n=5 Participants	33.5 Years STANDARD_DEVIATION 7.41 • n=4 Participants	32.9 Years STANDARD_DEVIATION 7.50 • n=21 Participants	33.5 Years STANDARD_DEVIATION 7.34 • n=10 Participants
Sex: Female, Male Female	66 Participants n=5 Participants	66 Participants n=7 Participants	64 Participants n=5 Participants	66 Participants n=4 Participants	65 Participants n=21 Participants	327 Participants n=10 Participants
Sex: Female, Male Male	77 Participants n=5 Participants	76 Participants n=7 Participants	77 Participants n=5 Participants	79 Participants n=4 Participants	77 Participants n=21 Participants	386 Participants n=10 Participants
Race/Ethnicity, Customized White - Caucasian / European heritage	135 Participants n=5 Participants	138 Participants n=7 Participants	138 Participants n=5 Participants	142 Participants n=4 Participants	136 Participants n=21 Participants	689 Participants n=10 Participants

PRIMARY outcome

Timeframe: At Day 44

Population: Analyses were performed on the According-to-Protocol (ATP) cohort for adaptive immunogenicity up to Day 60, which included all evaluable subjects who complied with the vaccination schedule and for whom T cell, antibody and memory B cell response data were available for at least one amongst the Day 44 time point.

Outcome measures

Outcome measures
Measure	Engerix-B - HLA Subsets Group n=107 Participants This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 1 - Non-HLA Subsets Group n=114 Participants This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 - Non-HLA Subsets Group n=112 Participants This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 - Non-HLA Subsets Group n=109 Participants This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group n=112 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells .	299 HB-CD4+ T cells (per million cells) Interval 202.0 to 486.0	1345 HB-CD4+ T cells (per million cells) Interval 626.0 to 3100.0	1257 HB-CD4+ T cells (per million cells) Interval 540.0 to 2168.0	647 HB-CD4+ T cells (per million cells) Interval 436.0 to 1284.0	391 HB-CD4+ T cells (per million cells) Interval 242.0 to 557.0

SECONDARY outcome

Timeframe: At Days 0, 14, 30 and 60

The number of HB-CD4+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).

Outcome measures

Outcome measures
Measure	Engerix-B - HLA Subsets Group n=107 Participants This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 1 - Non-HLA Subsets Group n=114 Participants This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 - Non-HLA Subsets Group n=112 Participants This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 - Non-HLA Subsets Group n=109 Participants This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group n=112 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells HB-CD4+, at Day 30	249 HB-CD4+ T cells (per million cells) Interval 178.0 to 376.0	277 HB-CD4+ T cells (per million cells) Interval 190.0 to 430.0	333 HB-CD4+ T cells (per million cells) Interval 233.0 to 482.0	314 HB-CD4+ T cells (per million cells) Interval 249.0 to 496.0	255 HB-CD4+ T cells (per million cells) Interval 189.0 to 362.0
Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells HB-CD4+, at Day 0	235 HB-CD4+ T cells (per million cells) Interval 176.0 to 353.0	228 HB-CD4+ T cells (per million cells) Interval 163.0 to 332.0	230 HB-CD4+ T cells (per million cells) Interval 166.0 to 326.0	234 HB-CD4+ T cells (per million cells) Interval 171.0 to 312.0	234 HB-CD4+ T cells (per million cells) Interval 172.0 to 362.0
Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells HB-CD4+, at Day 14	245 HB-CD4+ T cells (per million cells) Interval 173.0 to 412.0	408 HB-CD4+ T cells (per million cells) Interval 225.0 to 656.0	447 HB-CD4+ T cells (per million cells) Interval 248.0 to 752.0	460 HB-CD4+ T cells (per million cells) Interval 309.0 to 819.0	289 HB-CD4+ T cells (per million cells) Interval 208.0 to 434.0
Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells HB-CD4+, at Day 60	308 HB-CD4+ T cells (per million cells) Interval 201.0 to 555.0	965 HB-CD4+ T cells (per million cells) Interval 560.0 to 1925.0	958 HB-CD4+ T cells (per million cells) Interval 450.0 to 1777.0	587 HB-CD4+ T cells (per million cells) Interval 360.0 to 1031.0	393 HB-CD4+ T cells (per million cells) Interval 250.0 to 582.0

SECONDARY outcome

Timeframe: At Days 0, 14, 30, 44, and 60

Population: Analysis was done on the According-to-Protocol (ATP) cohort for adaptive immunogenicity to Day 60, which included all evaluable subjects for whom T cell, antibody and memory B cell response data were available for at least one amongst the Day 0, 14, 30, 44, or 60 time points.

The number of HB-CD8+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD40L), Interleukin (IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).

Outcome measures

Outcome measures
Measure	Engerix-B - HLA Subsets Group n=105 Participants This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 1 - Non-HLA Subsets Group n=112 Participants This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 - Non-HLA Subsets Group n=112 Participants This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 - Non-HLA Subsets Group n=107 Participants This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group n=109 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Number of Hepatitis B (HB) - Specific Cluster of Differentiation 8 (CD8+) T Cells. HB-CD8+, at Day 14	177 HB-CD8+ T cells (per million cells) Interval 129.0 to 274.0	174 HB-CD8+ T cells (per million cells) Interval 121.0 to 290.0	160 HB-CD8+ T cells (per million cells) Interval 106.0 to 273.0	174 HB-CD8+ T cells (per million cells) Interval 121.0 to 234.0	193 HB-CD8+ T cells (per million cells) Interval 129.0 to 296.0
Number of Hepatitis B (HB) - Specific Cluster of Differentiation 8 (CD8+) T Cells. HB-CD8+, at Day 30	173 HB-CD8+ T cells (per million cells) Interval 133.0 to 259.0	185 HB-CD8+ T cells (per million cells) Interval 109.0 to 276.0	173 HB-CD8+ T cells (per million cells) Interval 118.0 to 255.0	160 HB-CD8+ T cells (per million cells) Interval 113.0 to 248.0	191 HB-CD8+ T cells (per million cells) Interval 132.0 to 254.0
Number of Hepatitis B (HB) - Specific Cluster of Differentiation 8 (CD8+) T Cells. HB-CD8+, at Day 0	184 HB-CD8+ T cells (per million cells) Interval 108.0 to 236.0	176 HB-CD8+ T cells (per million cells) Interval 107.0 to 286.0	174 HB-CD8+ T cells (per million cells) Interval 112.0 to 312.0	172 HB-CD8+ T cells (per million cells) Interval 123.0 to 236.0	201 HB-CD8+ T cells (per million cells) Interval 109.0 to 300.0
Number of Hepatitis B (HB) - Specific Cluster of Differentiation 8 (CD8+) T Cells. HB-CD8+, at Day 44	169 HB-CD8+ T cells (per million cells) Interval 118.0 to 246.0	212 HB-CD8+ T cells (per million cells) Interval 129.0 to 300.0	213 HB-CD8+ T cells (per million cells) Interval 148.0 to 338.0	177 HB-CD8+ T cells (per million cells) Interval 116.0 to 272.0	157 HB-CD8+ T cells (per million cells) Interval 106.0 to 274.0
Number of Hepatitis B (HB) - Specific Cluster of Differentiation 8 (CD8+) T Cells. HB-CD8+, at Day 60	166 HB-CD8+ T cells (per million cells) Interval 124.0 to 266.0	209 HB-CD8+ T cells (per million cells) Interval 129.0 to 308.0	228 HB-CD8+ T cells (per million cells) Interval 144.0 to 339.0	171 HB-CD8+ T cells (per million cells) Interval 123.0 to 281.0	184 HB-CD8+ T cells (per million cells) Interval 115.0 to 298.0

SECONDARY outcome

Timeframe: At Days 0, 180 and 360

Population: Analysis was done on the According-to-Protocol (ATP) cohort for persistence which included all subjects from the ATP cohort for adaptive immunogenicity up to Day 60 for whom adaptive immunogenicity data were available for at least one post-vaccination time point (Day 180 or Day 360).

Outcome measures

Outcome measures
Measure	Engerix-B - HLA Subsets Group n=101 Participants This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 1 - Non-HLA Subsets Group n=108 Participants This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 - Non-HLA Subsets Group n=107 Participants This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 - Non-HLA Subsets Group n=101 Participants This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group n=106 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Number of HB Specific CD4+ T Cells . HB-CD4+, at Day 0	240 HB-CD4+ T cells (per million cells) Interval 172.0 to 347.0	230 HB-CD4+ T cells (per million cells) Interval 163.0 to 333.0	231 HB-CD4+ T cells (per million cells) Interval 166.0 to 331.0	248 HB-CD4+ T cells (per million cells) Interval 179.0 to 313.0	223 HB-CD4+ T cells (per million cells) Interval 171.0 to 348.0
Number of HB Specific CD4+ T Cells . HB-CD4+, at Day 180	334 HB-CD4+ T cells (per million cells) Interval 256.0 to 493.0	1090 HB-CD4+ T cells (per million cells) Interval 573.0 to 1827.0	954 HB-CD4+ T cells (per million cells) Interval 508.0 to 1504.0	546 HB-CD4+ T cells (per million cells) Interval 382.0 to 911.0	360 HB-CD4+ T cells (per million cells) Interval 259.0 to 666.0
Number of HB Specific CD4+ T Cells . HB-CD4+, at Day 360	350 HB-CD4+ T cells (per million cells) Interval 246.0 to 499.0	960 HB-CD4+ T cells (per million cells) Interval 564.0 to 1566.0	829 HB-CD4+ T cells (per million cells) Interval 388.0 to 1509.0	564 HB-CD4+ T cells (per million cells) Interval 340.0 to 887.0	388 HB-CD4+ T cells (per million cells) Interval 217.0 to 627.0

SECONDARY outcome

Timeframe: At Days 0, 180 and 360

The number of HB-CD8+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).

Outcome measures

Outcome measures
Measure	Engerix-B - HLA Subsets Group n=101 Participants This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 1 - Non-HLA Subsets Group n=108 Participants This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 - Non-HLA Subsets Group n=107 Participants This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 - Non-HLA Subsets Group n=99 Participants This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group n=105 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Number of HB - Specific CD8+ T Cells. HB-CD8+, at Day 180	110 HB-CD8+ T cells (per million cells) Interval 64.0 to 171.0	120 HB-CD8+ T cells (per million cells) Interval 81.0 to 170.0	124 HB-CD8+ T cells (per million cells) Interval 81.0 to 187.0	92 HB-CD8+ T cells (per million cells) Interval 57.0 to 133.0	102 HB-CD8+ T cells (per million cells) Interval 57.0 to 153.0
Number of HB - Specific CD8+ T Cells. HB-CD8+, at Day 0	184 HB-CD8+ T cells (per million cells) Interval 107.0 to 237.0	175 HB-CD8+ T cells (per million cells) Interval 107.0 to 284.0	169 HB-CD8+ T cells (per million cells) Interval 110.0 to 312.0	176 HB-CD8+ T cells (per million cells) Interval 125.0 to 261.0	191 HB-CD8+ T cells (per million cells) Interval 107.0 to 286.0
Number of HB - Specific CD8+ T Cells. HB-CD8+, at Day 360	90 HB-CD8+ T cells (per million cells) Interval 57.0 to 159.0	114 HB-CD8+ T cells (per million cells) Interval 57.0 to 163.0	115 HB-CD8+ T cells (per million cells) Interval 57.0 to 163.0	112 HB-CD8+ T cells (per million cells) Interval 78.0 to 160.0	104 HB-CD8+ T cells (per million cells) Interval 57.0 to 154.0

SECONDARY outcome

Timeframe: At Days 0, 360 and 374

Population: Analysis was done on the Booster According-to-Protocol (ATP) cohort for immunogenicity which included all subjects from subsets 1 and 2 who received a booster vaccination at Day 360 for whom adaptive immunogenicity data were available for at least one post-booster time point.

Outcome measures

Outcome measures
Measure	Engerix-B - HLA Subsets Group n=48 Participants This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 1 - Non-HLA Subsets Group n=54 Participants This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 - Non-HLA Subsets Group n=51 Participants This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 - Non-HLA Subsets Group n=53 Participants This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group n=52 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Number of HB - Specific CD4+ T Cells. HB-CD4+, at Day 374	353 HB-CD4+ T cells (per million cells) Interval 271.0 to 599.0	1006 HB-CD4+ T cells (per million cells) Interval 725.0 to 1907.0	1037 HB-CD4+ T cells (per million cells) Interval 580.0 to 1882.0	688 HB-CD4+ T cells (per million cells) Interval 456.0 to 1129.0	401 HB-CD4+ T cells (per million cells) Interval 250.0 to 750.0
Number of HB - Specific CD4+ T Cells. HB-CD4+, at Day 0	266 HB-CD4+ T cells (per million cells) Interval 194.0 to 362.0	228 HB-CD4+ T cells (per million cells) Interval 175.0 to 346.0	233 HB-CD4+ T cells (per million cells) Interval 172.0 to 307.0	254 HB-CD4+ T cells (per million cells) Interval 177.0 to 347.0	234 HB-CD4+ T cells (per million cells) Interval 183.0 to 293.0
Number of HB - Specific CD4+ T Cells. HB-CD4+, at Day 360	360 HB-CD4+ T cells (per million cells) Interval 273.0 to 506.0	1029 HB-CD4+ T cells (per million cells) Interval 601.0 to 1781.0	770 HB-CD4+ T cells (per million cells) Interval 388.0 to 1511.0	538 HB-CD4+ T cells (per million cells) Interval 301.0 to 974.0	300 HB-CD4+ T cells (per million cells) Interval 199.0 to 590.0

SECONDARY outcome

Timeframe: At Days 0, 360 and 374

Outcome measures

Outcome measures
Measure	Engerix-B - HLA Subsets Group n=48 Participants This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 1 - Non-HLA Subsets Group n=54 Participants This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 - Non-HLA Subsets Group n=51 Participants This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 - Non-HLA Subsets Group n=51 Participants This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group n=52 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Number of HB - Specific CD8+ T Cells HB-CD8+, at Day 0	168 HB-CD8+ T cells (per million cells) Interval 125.0 to 234.0	187 HB-CD8+ T cells (per million cells) Interval 111.0 to 304.0	161 HB-CD8+ T cells (per million cells) Interval 100.0 to 256.0	196 HB-CD8+ T cells (per million cells) Interval 138.0 to 271.0	244 HB-CD8+ T cells (per million cells) Interval 120.0 to 316.0
Number of HB - Specific CD8+ T Cells HB-CD8+, at Day 360	90 HB-CD8+ T cells (per million cells) Interval 57.0 to 169.0	109 HB-CD8+ T cells (per million cells) Interval 57.0 to 151.0	118 HB-CD8+ T cells (per million cells) Interval 57.0 to 161.0	121 HB-CD8+ T cells (per million cells) Interval 77.0 to 183.0	99 HB-CD8+ T cells (per million cells) Interval 57.0 to 130.0
Number of HB - Specific CD8+ T Cells HB-CD8+, at Day 374	111 HB-CD8+ T cells (per million cells) Interval 85.0 to 212.0	107 HB-CD8+ T cells (per million cells) Interval 57.0 to 133.0	111 HB-CD8+ T cells (per million cells) Interval 57.0 to 166.0	122 HB-CD8+ T cells (per million cells) Interval 57.0 to 174.0	121 HB-CD8+ T cells (per million cells) Interval 75.0 to 185.0

SECONDARY outcome

Timeframe: At Days 0, 14, 30, 33, 37, 44 and 60

The number of HB-CD4+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), and Tumor Necrosis Factor-alpha (TNF-a) was measured by Intracellular Cytokine Staining (ICS), using whole blood. This analysis was performed solely on eligible subjects enrolled at the Centre for Vaccinology (CEVAC) in Ghent, Belgium.

Outcome measures

Outcome measures
Measure	Engerix-B - HLA Subsets Group n=14 Participants This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 1 - Non-HLA Subsets Group n=17 Participants This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 - Non-HLA Subsets Group n=14 Participants This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 - Non-HLA Subsets Group n=15 Participants This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group n=19 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Number of HB - Specific CD4+ T Cells HB-CD4+, at Day 30	110 HB-CD4+ T cells (per million cells) Interval 47.0 to 172.0	313 HB-CD4+ T cells (per million cells) Interval 161.0 to 424.0	314 HB-CD4+ T cells (per million cells) Interval 170.0 to 562.0	243 HB-CD4+ T cells (per million cells) Interval 87.0 to 344.0	67 HB-CD4+ T cells (per million cells) Interval 20.0 to 102.0
Number of HB - Specific CD4+ T Cells HB-CD4+, at Day 33	126 HB-CD4+ T cells (per million cells) Interval 37.0 to 166.0	114 HB-CD4+ T cells (per million cells) Interval 80.0 to 242.0	270 HB-CD4+ T cells (per million cells) Interval 160.0 to 445.0	110 HB-CD4+ T cells (per million cells) Interval 54.0 to 188.0	63 HB-CD4+ T cells (per million cells) Interval 14.0 to 91.0
Number of HB - Specific CD4+ T Cells HB-CD4+, at Day 44	265 HB-CD4+ T cells (per million cells) Interval 127.0 to 716.0	2021 HB-CD4+ T cells (per million cells) Interval 1187.0 to 3686.0	2890 HB-CD4+ T cells (per million cells) Interval 1232.0 to 4337.0	1253 HB-CD4+ T cells (per million cells) Interval 647.0 to 2197.0	271 HB-CD4+ T cells (per million cells) Interval 95.0 to 515.0
Number of HB - Specific CD4+ T Cells HB-CD4+, at Day 60	247 HB-CD4+ T cells (per million cells) Interval 107.0 to 398.0	1291 HB-CD4+ T cells (per million cells) Interval 396.0 to 2265.0	1477 HB-CD4+ T cells (per million cells) Interval 763.0 to 3920.0	768 HB-CD4+ T cells (per million cells) Interval 317.0 to 1458.0	200 HB-CD4+ T cells (per million cells) Interval 110.0 to 459.0
Number of HB - Specific CD4+ T Cells HB-CD4+, at Day 0	31 HB-CD4+ T cells (per million cells) Interval 11.0 to 94.0	68 HB-CD4+ T cells (per million cells) Interval 11.0 to 104.0	98 HB-CD4+ T cells (per million cells) Interval 11.0 to 159.0	25 HB-CD4+ T cells (per million cells) Interval 11.0 to 144.0	48 HB-CD4+ T cells (per million cells) Interval 11.0 to 106.0
Number of HB - Specific CD4+ T Cells HB-CD4+, at Day 14	85 HB-CD4+ T cells (per million cells) Interval 46.0 to 139.0	425 HB-CD4+ T cells (per million cells) Interval 199.0 to 687.0	498 HB-CD4+ T cells (per million cells) Interval 184.0 to 1204.0	149 HB-CD4+ T cells (per million cells) Interval 71.0 to 503.0	75 HB-CD4+ T cells (per million cells) Interval 11.0 to 125.0
Number of HB - Specific CD4+ T Cells HB-CD4+, at Day 37	174 HB-CD4+ T cells (per million cells) Interval 119.0 to 271.0	844 HB-CD4+ T cells (per million cells) Interval 598.0 to 1679.0	869 HB-CD4+ T cells (per million cells) Interval 473.0 to 3559.0	486 HB-CD4+ T cells (per million cells) Interval 223.0 to 1740.0	67 HB-CD4+ T cells (per million cells) Interval 32.0 to 178.0

SECONDARY outcome

Timeframe: At Days 0, 14, 30, 44, 60 and 180

The number of HB-CD8+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), and Tumor Necrosis Factor-alpha (TNF-a) was measured by Intracellular Cytokine Staining (ICS), using whole blood. This analysis was performed solely on eligible subjects enrolled at the Centre for Vaccinology (CEVAC) in Ghent, Belgium.

Outcome measures

Outcome measures
Measure	Engerix-B - HLA Subsets Group n=14 Participants This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 1 - Non-HLA Subsets Group n=16 Participants This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 - Non-HLA Subsets Group n=13 Participants This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 - Non-HLA Subsets Group n=16 Participants This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group n=15 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Number of HB - Specific CD8+ T Cells HB-CD4+, at Day 0	11 HB-CD8+ T cells (per million cells) Interval 11.0 to 11.0	11 HB-CD8+ T cells (per million cells) Interval 11.0 to 11.0	11 HB-CD8+ T cells (per million cells) Interval 11.0 to 64.0	11 HB-CD8+ T cells (per million cells) Interval 11.0 to 11.0	11 HB-CD8+ T cells (per million cells) Interval 11.0 to 40.0
Number of HB - Specific CD8+ T Cells HB-CD4+, at Day 14	11 HB-CD8+ T cells (per million cells) Interval 11.0 to 205.0	12 HB-CD8+ T cells (per million cells) Interval 11.0 to 91.0	11 HB-CD8+ T cells (per million cells) Interval 11.0 to 123.0	11 HB-CD8+ T cells (per million cells) Interval 11.0 to 67.0	11 HB-CD8+ T cells (per million cells) Interval 11.0 to 121.0
Number of HB - Specific CD8+ T Cells HB-CD4+, at Day 30	11 HB-CD8+ T cells (per million cells) Interval 11.0 to 92.0	64 HB-CD8+ T cells (per million cells) Interval 11.0 to 100.0	11 HB-CD8+ T cells (per million cells) Interval 11.0 to 11.0	11 HB-CD8+ T cells (per million cells) Interval 11.0 to 68.0	11 HB-CD8+ T cells (per million cells) Interval 11.0 to 52.0
Number of HB - Specific CD8+ T Cells HB-CD4+, at Day 33	11 HB-CD8+ T cells (per million cells) Interval 11.0 to 68.0	11 HB-CD8+ T cells (per million cells) Interval 11.0 to 106.0	11 HB-CD8+ T cells (per million cells) Interval 11.0 to 68.0	41 HB-CD8+ T cells (per million cells) Interval 11.0 to 82.0	11 HB-CD8+ T cells (per million cells) Interval 11.0 to 11.0
Number of HB - Specific CD8+ T Cells HB-CD4+, at Day 37	42 HB-CD8+ T cells (per million cells) Interval 11.0 to 98.0	11 HB-CD8+ T cells (per million cells) Interval 11.0 to 108.0	103 HB-CD8+ T cells (per million cells) Interval 11.0 to 207.0	11 HB-CD8+ T cells (per million cells) Interval 11.0 to 84.0	11 HB-CD8+ T cells (per million cells) Interval 11.0 to 11.0
Number of HB - Specific CD8+ T Cells HB-CD4+, at Day 44	11 HB-CD8+ T cells (per million cells) Interval 11.0 to 178.0	11 HB-CD8+ T cells (per million cells) Interval 11.0 to 97.0	99 HB-CD8+ T cells (per million cells) Interval 11.0 to 184.0	11 HB-CD8+ T cells (per million cells) Interval 11.0 to 130.0	11 HB-CD8+ T cells (per million cells) Interval 11.0 to 89.0
Number of HB - Specific CD8+ T Cells HB-CD4+, at Day 60	11 HB-CD8+ T cells (per million cells) Interval 11.0 to 69.0	37 HB-CD8+ T cells (per million cells) Interval 11.0 to 109.0	102 HB-CD8+ T cells (per million cells) Interval 11.0 to 229.0	11 HB-CD8+ T cells (per million cells) Interval 11.0 to 73.0	11 HB-CD8+ T cells (per million cells) Interval 11.0 to 64.0

SECONDARY outcome

Timeframe: At Days 0, 14, 30, 44 and 60

The number of HB-specific CD4+ T cells (per million cells) expressing Th1 and/or Th2 cytokine profile was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).

Outcome measures

Outcome measures
Measure	Engerix-B - HLA Subsets Group n=107 Participants This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 1 - Non-HLA Subsets Group n=114 Participants This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 - Non-HLA Subsets Group n=112 Participants This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 - Non-HLA Subsets Group n=109 Participants This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group n=112 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile HB-CD4+, Th1, at Day 14	66 HB-CD4+ T cells (per million cells) Interval 38.0 to 102.0	64 HB-CD4+ T cells (per million cells) Interval 40.0 to 103.0	75 HB-CD4+ T cells (per million cells) Interval 44.0 to 124.0	68 HB-CD4+ T cells (per million cells) Interval 40.0 to 102.0	81 HB-CD4+ T cells (per million cells) Interval 48.0 to 132.0
Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile HB-CD4+, Th2, at Day 14	57 HB-CD4+ T cells (per million cells) Interval 28.0 to 125.0	52 HB-CD4+ T cells (per million cells) Interval 28.0 to 99.0	58 HB-CD4+ T cells (per million cells) Interval 29.0 to 124.0	60 HB-CD4+ T cells (per million cells) Interval 28.0 to 105.0	42 HB-CD4+ T cells (per million cells) Interval 21.0 to 90.0
Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile HB-CD4+, Th1, at Day 44	64 HB-CD4+ T cells (per million cells) Interval 40.0 to 115.0	155 HB-CD4+ T cells (per million cells) Interval 78.0 to 382.0	174 HB-CD4+ T cells (per million cells) Interval 72.0 to 354.0	95 HB-CD4+ T cells (per million cells) Interval 46.0 to 184.0	74 HB-CD4+ T cells (per million cells) Interval 46.0 to 140.0
Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile HB-CD4+, Th1, at Day 60	61 HB-CD4+ T cells (per million cells) Interval 40.0 to 129.0	119 HB-CD4+ T cells (per million cells) Interval 63.0 to 244.0	141 HB-CD4+ T cells (per million cells) Interval 71.0 to 270.0	90 HB-CD4+ T cells (per million cells) Interval 53.0 to 146.0	94 HB-CD4+ T cells (per million cells) Interval 52.0 to 144.0
Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile HB-CD4+, Th2, at Day 0	52 HB-CD4+ T cells (per million cells) Interval 28.0 to 100.0	50 HB-CD4+ T cells (per million cells) Interval 26.0 to 95.0	63 HB-CD4+ T cells (per million cells) Interval 35.0 to 119.0	55 HB-CD4+ T cells (per million cells) Interval 17.0 to 102.0	53 HB-CD4+ T cells (per million cells) Interval 27.0 to 118.0
Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile HB-CD4+, Th2, at Day 30	47 HB-CD4+ T cells (per million cells) Interval 28.0 to 92.0	39 HB-CD4+ T cells (per million cells) Interval 16.0 to 91.0	52 HB-CD4+ T cells (per million cells) Interval 28.0 to 96.0	56 HB-CD4+ T cells (per million cells) Interval 25.0 to 100.0	45 HB-CD4+ T cells (per million cells) Interval 25.0 to 95.0
Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile HB-CD4+, Th2, at Day 44	74 HB-CD4+ T cells (per million cells) Interval 29.0 to 141.0	85 HB-CD4+ T cells (per million cells) Interval 33.0 to 133.0	77 HB-CD4+ T cells (per million cells) Interval 34.0 to 158.0	87 HB-CD4+ T cells (per million cells) Interval 37.0 to 155.0	55 HB-CD4+ T cells (per million cells) Interval 29.0 to 109.0
Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile HB-CD4+, Th2, at Day 60	59 HB-CD4+ T cells (per million cells) Interval 28.0 to 153.0	78 HB-CD4+ T cells (per million cells) Interval 41.0 to 125.0	58 HB-CD4+ T cells (per million cells) Interval 29.0 to 127.0	71 HB-CD4+ T cells (per million cells) Interval 38.0 to 127.0	53 HB-CD4+ T cells (per million cells) Interval 29.0 to 123.0
Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile HB-CD4+, Th1, at Day 0	67 HB-CD4+ T cells (per million cells) Interval 38.0 to 119.0	65 HB-CD4+ T cells (per million cells) Interval 38.0 to 113.0	62 HB-CD4+ T cells (per million cells) Interval 40.0 to 111.0	53 HB-CD4+ T cells (per million cells) Interval 29.0 to 101.0	70 HB-CD4+ T cells (per million cells) Interval 41.0 to 117.0
Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile HB-CD4+, Th1, at Day 30	72 HB-CD4+ T cells (per million cells) Interval 40.0 to 119.0	61 HB-CD4+ T cells (per million cells) Interval 36.0 to 91.0	66 HB-CD4+ T cells (per million cells) Interval 42.0 to 109.0	75 HB-CD4+ T cells (per million cells) Interval 45.0 to 120.0	64 HB-CD4+ T cells (per million cells) Interval 35.0 to 113.0

SECONDARY outcome

Timeframe: At Days 0 and 180

Outcome measures

Outcome measures
Measure	Engerix-B - HLA Subsets Group n=101 Participants This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 1 - Non-HLA Subsets Group n=106 Participants This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 - Non-HLA Subsets Group n=107 Participants This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 - Non-HLA Subsets Group n=98 Participants This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group n=106 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Number of HB Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing Th1/Th2 Cytokine Profile HB-CD4+, Th1, at Day 0	64 HB-CD4+ T cells (per million cells) Interval 38.0 to 117.0	66 HB-CD4+ T cells (per million cells) Interval 40.0 to 106.0	63 HB-CD4+ T cells (per million cells) Interval 44.0 to 123.0	53 HB-CD4+ T cells (per million cells) Interval 29.0 to 101.0	65 HB-CD4+ T cells (per million cells) Interval 41.0 to 114.0
Number of HB Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing Th1/Th2 Cytokine Profile HB-CD4+, Th2, at Day 0	48 HB-CD4+ T cells (per million cells) Interval 28.0 to 100.0	51 HB-CD4+ T cells (per million cells) Interval 27.0 to 95.0	64 HB-CD4+ T cells (per million cells) Interval 35.0 to 119.0	57 HB-CD4+ T cells (per million cells) Interval 25.0 to 105.0	50 HB-CD4+ T cells (per million cells) Interval 27.0 to 102.0
Number of HB Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing Th1/Th2 Cytokine Profile HB-CD4+, Th1, at Day 180	70 HB-CD4+ T cells (per million cells) Interval 40.0 to 108.0	129 HB-CD4+ T cells (per million cells) Interval 71.0 to 215.0	137 HB-CD4+ T cells (per million cells) Interval 73.0 to 244.0	76 HB-CD4+ T cells (per million cells) Interval 49.0 to 129.0	68 HB-CD4+ T cells (per million cells) Interval 40.0 to 122.0
Number of HB Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing Th1/Th2 Cytokine Profile HB-CD4+, Th2, at Day 180	49 HB-CD4+ T cells (per million cells) Interval 16.0 to 96.0	54 HB-CD4+ T cells (per million cells) Interval 20.0 to 106.0	63 HB-CD4+ T cells (per million cells) Interval 28.0 to 106.0	46 HB-CD4+ T cells (per million cells) Interval 20.0 to 85.0	54 HB-CD4+ T cells (per million cells) Interval 31.0 to 101.0

SECONDARY outcome

Timeframe: At Days 0, 30, 44, and 60

Anti-HBs antibody concentrations in serum were measured by CLIA Assay. Concentrations were presented as geometric mean concentrations, in milli-International Units per milliliter (mIU/mL). Analysis was initially planned to be performed by Enzyme-Linked Immunosorbent Assay (ELISA). A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). Following these laboratory quality issues, GSB Biologicals decided to stop testing with the HBs in-house ELISA and to have the anti-HB analysis performed using the new validated CLIA assay. This outcome measure concerns solely subjects part of the HLA Subsets 1 \& 2 who received the Day 360 booster dose of HBsAg.

Outcome measures

Outcome measures
Measure	Engerix-B - HLA Subsets Group n=57 Participants This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 1 - Non-HLA Subsets Group n=59 Participants This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 - Non-HLA Subsets Group n=57 Participants This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 - Non-HLA Subsets Group n=58 Participants This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group n=62 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Anti-Hepatitis B (Anti-HB) Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA) Anti HBs, Day 0	0 mIU/mL Interval 0.0 to 0.0	3.1 mIU/mL Interval 3.1 to 3.2	0 mIU/mL Interval 0.0 to 0.0	3.3 mIU/mL Interval 3.1 to 3.6	0 mIU/mL Interval 0.0 to 0.0
Anti-Hepatitis B (Anti-HB) Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA) Anti HBs, Day 30	3.5 mIU/mL Interval 2.9 to 4.2	108.0 mIU/mL Interval 65.0 to 179.6	59.6 mIU/mL Interval 31.9 to 111.5	66.3 mIU/mL Interval 35.7 to 123.0	6.1 mIU/mL Interval 4.2 to 9.1
Anti-Hepatitis B (Anti-HB) Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA) Anti HBs, Day 44	19.2 mIU/mL Interval 11.1 to 33.2	11986.2 mIU/mL Interval 8676.4 to 16558.7	7942.6 mIU/mL Interval 5288.7 to 11928.2	5525.4 mIU/mL Interval 3639.3 to 8389.2	220.2 mIU/mL Interval 126.5 to 383.3
Anti-Hepatitis B (Anti-HB) Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA) Anti HBs, Day 60	21.5 mIU/mL Interval 12.7 to 36.4	7454.3 mIU/mL Interval 5603.6 to 9916.2	5030.9 mIU/mL Interval 3396.4 to 7452.1	4194.3 mIU/mL Interval 2805.4 to 6270.8	251.9 mIU/mL Interval 150.6 to 421.5

SECONDARY outcome

Timeframe: At Days 0, 180 and 360

Outcome measures

Outcome measures
Measure	Engerix-B - HLA Subsets Group n=54 Participants This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 1 - Non-HLA Subsets Group n=58 Participants This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 - Non-HLA Subsets Group n=54 Participants This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 - Non-HLA Subsets Group n=55 Participants This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group n=56 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Anti-HB Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA) Anti HBs, Day 0	3.1 mIU/mL Interval 3.1 to 3.1	3.1 mIU/mL Interval 3.1 to 3.2	3.1 mIU/mL Interval 3.1 to 3.1	3.3 mIU/mL Interval 3.1 to 3.6	3.1 mIU/mL Interval 3.1 to 3.1
Anti-HB Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA) Anti HBs, Day 180	39.0 mIU/mL Interval 23.3 to 65.2	3840.7 mIU/mL Interval 2953.4 to 4994.6	2657.5 mIU/mL Interval 1972.1 to 3581.0	3330.2 mIU/mL Interval 2502.2 to 4432.1	254.5 mIU/mL Interval 169.9 to 381.2
Anti-HB Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA) Anti HBs, Day 360	19.8 mIU/mL Interval 12.5 to 31.3	2150.7 mIU/mL Interval 1602.7 to 2885.9	1650.6 mIU/mL Interval 1159.7 to 2349.4	2122.5 mIU/mL Interval 1542.3 to 2921.1	94.5 mIU/mL Interval 59.6 to 149.8

SECONDARY outcome

Timeframe: At Days 0, 374 and 390

Outcome measures

Outcome measures
Measure	Engerix-B - HLA Subsets Group n=50 Participants This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 1 - Non-HLA Subsets Group n=55 Participants This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 - Non-HLA Subsets Group n=52 Participants This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 - Non-HLA Subsets Group n=54 Participants This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group n=54 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Anti-HB Antibody Concentrations in Serum, as Measured by CLIA Anti HBs, Day 0	3.1 mIU/mL Interval 3.1 to 3.1	3.1 mIU/mL Interval 3.1 to 3.2	3.1 mIU/mL Interval 3.1 to 3.1	3.3 mIU/mL Interval 3.1 to 3.6	3.1 mIU/mL Interval 3.1 to 3.1
Anti-HB Antibody Concentrations in Serum, as Measured by CLIA Anti HBs, Day 374	341.3 mIU/mL Interval 143.7 to 810.4	51509.0 mIU/mL Interval 35731.5 to 74253.1	31985.9 mIU/mL Interval 22628.6 to 45212.7	27135.3 mIU/mL Interval 19376.8 to 38000.5	3788.4 mIU/mL Interval 2047.8 to 7008.6
Anti-HB Antibody Concentrations in Serum, as Measured by CLIA Anti HBs, Day 390	351.1 mIU/mL Interval 147.0 to 838.5	43674.6 mIU/mL Interval 29975.7 to 63633.8	27035.7 mIU/mL Interval 18737.0 to 39009.7	25105.7 mIU/mL Interval 17730.1 to 35549.4	3352.2 mIU/mL Interval 1756.0 to 6399.1

SECONDARY outcome

Timeframe: At Days 0, 30, 37, 44 and 60.

The number of HB-specific memory B-cells (HB mem-B cells), per million cells - expressed through tabulation of interquartile range data - was measured by B-cell Enzyme-Linked Immunosorbent Spot (ELISPOT) using Peripheral Blood Mononuclear Cells (PBMCs). This outcome measure concerns solely subjects part of the HLA Subsets 1 \& 2 who received the Day 360 booster dose of HBsAg.

Outcome measures

Outcome measures
Measure	Engerix-B - HLA Subsets Group n=52 Participants This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 1 - Non-HLA Subsets Group n=54 Participants This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 - Non-HLA Subsets Group n=53 Participants This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 - Non-HLA Subsets Group n=55 Participants This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group n=54 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Number of Hepatitis B (HB)-Specific Memory B Cells HB-mem B cells, at Day 0	1 HB mem-B cells (per million cells) Interval 1.0 to 55.0	14 HB mem-B cells (per million cells) Interval 1.0 to 64.0	1 HB mem-B cells (per million cells) Interval 1.0 to 44.0	1 HB mem-B cells (per million cells) Interval 1.0 to 39.0	1 HB mem-B cells (per million cells) Interval 1.0 to 38.0
Number of Hepatitis B (HB)-Specific Memory B Cells HB-mem B cells, at Day 30	1 HB mem-B cells (per million cells) Interval 1.0 to 54.0	296 HB mem-B cells (per million cells) Interval 38.0 to 1161.0	186 HB mem-B cells (per million cells) Interval 35.0 to 776.0	265 HB mem-B cells (per million cells) Interval 48.0 to 759.0	28 HB mem-B cells (per million cells) Interval 1.0 to 86.0
Number of Hepatitis B (HB)-Specific Memory B Cells HB-mem B cells, at Day 37	19 HB mem-B cells (per million cells) Interval 1.0 to 85.0	3817 HB mem-B cells (per million cells) Interval 1440.0 to 9196.0	3577 HB mem-B cells (per million cells) Interval 1486.0 to 9753.0	2597 HB mem-B cells (per million cells) Interval 1028.0 to 8770.0	71 HB mem-B cells (per million cells) Interval 1.0 to 167.0
Number of Hepatitis B (HB)-Specific Memory B Cells HB-mem B cells, at Day 44	28 HB mem-B cells (per million cells) Interval 1.0 to 114.0	4656 HB mem-B cells (per million cells) Interval 1430.0 to 7808.0	4808 HB mem-B cells (per million cells) Interval 1845.0 to 11274.0	2498 HB mem-B cells (per million cells) Interval 672.0 to 7782.0	51 HB mem-B cells (per million cells) Interval 1.0 to 299.0
Number of Hepatitis B (HB)-Specific Memory B Cells HB-mem B cells, at Day 60	44 HB mem-B cells (per million cells) Interval 1.0 to 161.0	3742 HB mem-B cells (per million cells) Interval 835.0 to 7997.0	3383 HB mem-B cells (per million cells) Interval 1467.0 to 8145.0	1806 HB mem-B cells (per million cells) Interval 599.0 to 5833.0	47 HB mem-B cells (per million cells) Interval 1.0 to 152.0

SECONDARY outcome

Timeframe: At Days 180 and 360

Outcome measures

Outcome measures
Measure	Engerix-B - HLA Subsets Group n=51 Participants This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 1 - Non-HLA Subsets Group n=53 Participants This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 - Non-HLA Subsets Group n=51 Participants This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 - Non-HLA Subsets Group n=52 Participants This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group n=50 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Number of HB-specific Memory B Cells HB-mem B cells, at Day 180	1 HB mem-B cells (per million cells) Interval 1.0 to 67.0	1454 HB mem-B cells (per million cells) Interval 395.0 to 2486.0	1013 HB mem-B cells (per million cells) Interval 227.0 to 2164.0	1410 HB mem-B cells (per million cells) Interval 567.0 to 2671.0	24 HB mem-B cells (per million cells) Interval 1.0 to 128.0
Number of HB-specific Memory B Cells HB-mem B cells, at Day 360	21 HB mem-B cells (per million cells) Interval 1.0 to 104.0	1070 HB mem-B cells (per million cells) Interval 747.0 to 2616.0	1437 HB mem-B cells (per million cells) Interval 306.0 to 2770.0	1473 HB mem-B cells (per million cells) Interval 463.0 to 2430.0	66 HB mem-B cells (per million cells) Interval 1.0 to 255.0

SECONDARY outcome

Timeframe: At Days 0, 0+ (Day 0 + 3 to 6 hours), 1, 30,30+ (Day 30 + 3 to 6 hours), 31, 33 and 37.

Population: Analysis was done on the According-to-Protocol (ATP) cohort for innate immunogenicity to Day 60, which included all evaluable subjects with immunogenicity and innate response (=early immune response \[i.e. cytokines in serum, gene expression signature, white blood cells counts\]) results available for at least one post-vaccination time point.

Concentrations of IFN-g, IL-1 beta (IL-1B), IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha (TNF-a), IFN-g-inducible protein-10 (IP-10) and monocyte chemotactic protein (MCP)-1 Concentrations of the IFN-g, IL-1B, IL-5, IL-6, IL-10, TNF-a, IP-10 and MCP-1 cytokines in serum were measured by Cytokine bead assay (CBA) and expressed in picograms per milliliter (pg/mL). This outcome measure concerns solely subjects part of the HLA Subsets 1 \& 2 who received the Day 360 booster dose of HBsAg.

Outcome measures

Outcome measures
Measure	Engerix-B - HLA Subsets Group n=55 Participants This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 1 - Non-HLA Subsets Group n=59 Participants This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 - Non-HLA Subsets Group n=57 Participants This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 - Non-HLA Subsets Group n=61 Participants This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group n=61 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum IL-6; Day 1	1.739 pg/mL Interval 1.159 to 2.819	4.07 pg/mL Interval 2.707 to 5.621	2.578 pg/mL Interval 1.748 to 3.807	2.223 pg/mL Interval 1.435 to 3.637	2.147 pg/mL Interval 1.658 to 3.273
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum MCP-1; Day 0+	95 pg/mL Interval 68.0 to 167.0	112 pg/mL Interval 73.0 to 183.0	141 pg/mL Interval 99.0 to 175.0	114 pg/mL Interval 83.0 to 175.0	131 pg/mL Interval 91.0 to 181.0
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum IFN-g; Day 0	3.704 pg/mL Interval 3.704 to 3.704	3.704 pg/mL Interval 3.704 to 3.704	3.704 pg/mL Interval 3.704 to 3.704	3.704 pg/mL Interval 3.704 to 3.704	3.704 pg/mL Interval 3.704 to 3.704
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum IFN-g; Day 0+	3.704 pg/mL Interval 3.704 to 3.704	3.704 pg/mL Interval 3.704 to 3.704	3.704 pg/mL Interval 3.704 to 3.704	3.704 pg/mL Interval 3.704 to 3.704	3.704 pg/mL Interval 3.704 to 3.704
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum IFN-g; Day 1	3.704 pg/mL Interval 3.704 to 3.704	3.704 pg/mL Interval 3.704 to 3.704	3.704 pg/mL Interval 3.704 to 3.704	3.704 pg/mL Interval 3.704 to 3.704	3.704 pg/mL Interval 3.704 to 3.704
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum IFN-g; Day 30	3.704 pg/mL Interval 3.704 to 3.704	3.704 pg/mL Interval 3.704 to 3.704	3.704 pg/mL Interval 3.704 to 3.704	3.704 pg/mL Interval 3.704 to 3.704	3.704 pg/mL Interval 3.704 to 3.704
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum IFN-g; Day 30+	3.704 pg/mL Interval 3.704 to 3.704	3.704 pg/mL Interval 3.704 to 3.704	3.704 pg/mL Interval 3.704 to 3.704	3.704 pg/mL Interval 3.704 to 3.704	3.704 pg/mL Interval 3.704 to 3.704
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum IFN-g; Day 31	3.704 pg/mL Interval 3.704 to 3.704	5.568 pg/mL Interval 3.704 to 57.695	3.704 pg/mL Interval 3.704 to 21.747	3.704 pg/mL Interval 3.704 to 5.575	3.704 pg/mL Interval 3.704 to 3.704
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum IFN-g; Day 33	3.704 pg/mL Interval 3.704 to 3.704	3.704 pg/mL Interval 3.704 to 3.704	3.704 pg/mL Interval 3.704 to 3.704	3.704 pg/mL Interval 3.704 to 3.704	3.704 pg/mL Interval 3.704 to 3.704
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum IFN-g; Day 37	3.704 pg/mL Interval 3.704 to 3.704	3.704 pg/mL Interval 3.704 to 3.704	3.704 pg/mL Interval 3.704 to 3.704	3.704 pg/mL Interval 3.704 to 3.704	3.704 pg/mL Interval 3.704 to 3.704
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum IL-1B; Day 0	0.411 pg/mL Interval 0.411 to 2.06	0.411 pg/mL Interval 0.411 to 1.837	1.379 pg/mL Interval 0.411 to 3.046	0.411 pg/mL Interval 0.411 to 1.937	0.411 pg/mL Interval 0.411 to 2.516
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum IL-1B; Day 0+	1.146 pg/mL Interval 0.411 to 2.674	1.636 pg/mL Interval 0.411 to 2.087	1.873 pg/mL Interval 0.411 to 2.742	0.856 pg/mL Interval 0.411 to 2.535	0.947 pg/mL Interval 0.411 to 2.394
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum IL-1B; Day 1	1.885 pg/mL Interval 1.094 to 3.819	2.024 pg/mL Interval 0.852 to 3.406	2.237 pg/mL Interval 1.302 to 4.214	1.912 pg/mL Interval 0.411 to 3.07	1.628 pg/mL Interval 0.856 to 2.449
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum IL-1B; Day 30	0.411 pg/mL Interval 0.411 to 2.326	1.232 pg/mL Interval 0.411 to 2.385	0.879 pg/mL Interval 0.411 to 2.26	1.017 pg/mL Interval 0.411 to 2.631	0.925 pg/mL Interval 0.411 to 2.516
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum IL-1B; Day 30+	1.349 pg/mL Interval 0.411 to 2.384	1.292 pg/mL Interval 0.411 to 2.333	1.099 pg/mL Interval 0.411 to 2.28	0.856 pg/mL Interval 0.411 to 2.332	1.214 pg/mL Interval 0.411 to 1.981
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum IL-1B; Day 31	1.135 pg/mL Interval 0.411 to 2.775	0.991 pg/mL Interval 0.411 to 2.577	1.263 pg/mL Interval 0.411 to 2.528	1.117 pg/mL Interval 0.411 to 3.164	1.159 pg/mL Interval 0.411 to 2.581
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum IL-1B; Day 33	0.86 pg/mL Interval 0.411 to 1.88	0.411 pg/mL Interval 0.411 to 1.432	0.411 pg/mL Interval 0.411 to 1.886	0.411 pg/mL Interval 0.411 to 2.182	0.411 pg/mL Interval 0.411 to 1.77
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum IL-1B; Day 37	0.411 pg/mL Interval 0.411 to 2.764	0.411 pg/mL Interval 0.411 to 1.585	0.411 pg/mL Interval 0.411 to 2.41	0.411 pg/mL Interval 0.411 to 1.506	0.411 pg/mL Interval 0.411 to 2.122
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum IL-10; Day 0	0.411 pg/mL Interval 0.411 to 0.411	0.411 pg/mL Interval 0.411 to 0.411	0.411 pg/mL Interval 0.411 to 1.051	0.411 pg/mL Interval 0.411 to 1.13	0.411 pg/mL Interval 0.411 to 0.411
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum IL-10; Day 0+	0.411 pg/mL Interval 0.411 to 1.46	0.411 pg/mL Interval 0.411 to 1.597	0.411 pg/mL Interval 0.411 to 1.516	0.411 pg/mL Interval 0.411 to 1.31	0.411 pg/mL Interval 0.411 to 0.904
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum IL-10; Day 1	0.916 pg/mL Interval 0.411 to 2.593	0.977 pg/mL Interval 0.411 to 2.135	1.08 pg/mL Interval 0.411 to 2.323	1.055 pg/mL Interval 0.411 to 2.518	0.893 pg/mL Interval 0.411 to 1.813
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum IL-10; Day 30	0.411 pg/mL Interval 0.411 to 0.967	0.411 pg/mL Interval 0.411 to 1.409	0.411 pg/mL Interval 0.411 to 1.165	0.411 pg/mL Interval 0.411 to 1.799	0.411 pg/mL Interval 0.411 to 1.289
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum IL-10; Day 30+	0.411 pg/mL Interval 0.411 to 0.908	0.411 pg/mL Interval 0.411 to 1.113	0.411 pg/mL Interval 0.411 to 1.027	0.411 pg/mL Interval 0.411 to 1.082	0.411 pg/mL Interval 0.411 to 0.867
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum IL-10; Day 31	0.411 pg/mL Interval 0.411 to 1.303	0.705 pg/mL Interval 0.411 to 2.233	0.411 pg/mL Interval 0.411 to 1.961	0.411 pg/mL Interval 0.411 to 2.046	0.411 pg/mL Interval 0.411 to 1.392
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum IL-10; Day 33	0.411 pg/mL Interval 0.411 to 0.411	0.411 pg/mL Interval 0.411 to 0.411	0.411 pg/mL Interval 0.411 to 1.165	0.411 pg/mL Interval 0.411 to 1.208	0.411 pg/mL Interval 0.411 to 0.989
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum IL-10; Day 37	0.411 pg/mL Interval 0.411 to 1.052	0.411 pg/mL Interval 0.411 to 0.844	0.411 pg/mL Interval 0.411 to 0.906	0.411 pg/mL Interval 0.411 to 0.984	0.411 pg/mL Interval 0.411 to 1.425
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum IL-5; Day 0	0.411 pg/mL Interval 0.411 to 1.619	0.411 pg/mL Interval 0.411 to 1.662	0.411 pg/mL Interval 0.411 to 2.413	0.905 pg/mL Interval 0.411 to 1.677	0.867 pg/mL Interval 0.411 to 1.917
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum IL-5; Day 0+	1.092 pg/mL Interval 0.411 to 2.105	1.161 pg/mL Interval 0.411 to 2.094	1.37 pg/mL Interval 0.411 to 2.089	0.905 pg/mL Interval 0.411 to 2.017	0.411 pg/mL Interval 0.411 to 1.77
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum IL-5; Day 1	1.942 pg/mL Interval 1.23 to 3.143	2.004 pg/mL Interval 0.932 to 2.758	2.089 pg/mL Interval 1.092 to 3.095	1.83 pg/mL Interval 0.411 to 3.049	1.77 pg/mL Interval 1.023 to 2.73
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum IL-5; Day 30	0.411 pg/mL Interval 0.411 to 2.381	1.202 pg/mL Interval 0.411 to 1.972	0.411 pg/mL Interval 0.411 to 1.663	1.011 pg/mL Interval 0.411 to 2.733	0.89 pg/mL Interval 0.411 to 2.403
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum IL-5; Day 30+	0.411 pg/mL Interval 0.411 to 2.273	0.884 pg/mL Interval 0.411 to 2.024	0.916 pg/mL Interval 0.411 to 2.028	0.411 pg/mL Interval 0.411 to 2.15	0.992 pg/mL Interval 0.411 to 1.89
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum IL-5; Day 31	0.99 pg/mL Interval 0.411 to 2.501	1.119 pg/mL Interval 0.411 to 2.719	0.951 pg/mL Interval 0.411 to 2.664	1.289 pg/mL Interval 0.411 to 2.901	1.113 pg/mL Interval 0.411 to 2.367
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum IL-5; Day 33	0.411 pg/mL Interval 0.411 to 2.221	0.411 pg/mL Interval 0.411 to 1.599	0.411 pg/mL Interval 0.411 to 2.134	1.192 pg/mL Interval 0.411 to 2.948	0.411 pg/mL Interval 0.411 to 2.047
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum IL-5; Day 37	0.411 pg/mL Interval 0.411 to 2.661	0.411 pg/mL Interval 0.411 to 1.509	0.411 pg/mL Interval 0.411 to 2.015	0.411 pg/mL Interval 0.411 to 1.43	0.411 pg/mL Interval 0.411 to 2.262
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum IL-6; Day 0	1.055 pg/mL Interval 0.411 to 1.768	1.291 pg/mL Interval 0.411 to 1.984	1.19 pg/mL Interval 0.411 to 2.783	1.291 pg/mL Interval 0.411 to 1.946	1.26 pg/mL Interval 0.411 to 2.176
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum IL-6; Day 0+	1.418 pg/mL Interval 0.411 to 2.049	2.882 pg/mL Interval 2.018 to 4.57	2.523 pg/mL Interval 1.55 to 3.977	1.605 pg/mL Interval 0.411 to 2.652	1.579 pg/mL Interval 1.174 to 2.278
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum IL-6; Day 30	1.218 pg/mL Interval 0.411 to 2.229	1.641 pg/mL Interval 0.92 to 2.839	1.377 pg/mL Interval 0.411 to 1.982	1.79 pg/mL Interval 0.411 to 2.564	1.653 pg/mL Interval 0.411 to 2.368
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum IL-6; Day 30+	1.394 pg/mL Interval 0.411 to 2.272	3.195 pg/mL Interval 2.056 to 5.288	2.53 pg/mL Interval 1.589 to 3.87	1.664 pg/mL Interval 1.074 to 2.223	1.753 pg/mL Interval 1.273 to 2.341
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum IL-6; Day 31	1.567 pg/mL Interval 0.861 to 2.316	7.459 pg/mL Interval 5.284 to 10.345	4.174 pg/mL Interval 2.925 to 7.202	3.457 pg/mL Interval 1.971 to 5.488	2.538 pg/mL Interval 1.521 to 4.016
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum IL-6; Day 33	1.389 pg/mL Interval 0.411 to 2.001	1.644 pg/mL Interval 1.1 to 3.287	1.253 pg/mL Interval 0.411 to 2.538	1.435 pg/mL Interval 0.411 to 2.405	1.676 pg/mL Interval 0.937 to 2.456
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum IL-6; Day 37	1.158 pg/mL Interval 0.411 to 2.17	1.003 pg/mL Interval 0.411 to 1.982	0.976 pg/mL Interval 0.411 to 1.875	0.95 pg/mL Interval 0.411 to 1.938	1.321 pg/mL Interval 0.411 to 1.946
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum IP-10; Day 0	91 pg/mL Interval 61.0 to 136.0	94 pg/mL Interval 70.0 to 162.0	92 pg/mL Interval 68.0 to 141.0	101.5 pg/mL Interval 62.0 to 136.0	102 pg/mL Interval 64.5 to 154.5
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum IP-10; Day 0+	75.5 pg/mL Interval 55.0 to 100.0	80 pg/mL Interval 53.0 to 117.0	81 pg/mL Interval 54.0 to 113.0	78 pg/mL Interval 46.0 to 113.0	80 pg/mL Interval 52.0 to 109.0
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum IP-10; Day 1	85 pg/mL Interval 52.0 to 140.0	147 pg/mL Interval 99.0 to 252.0	111 pg/mL Interval 71.0 to 154.0	92.5 pg/mL Interval 61.0 to 144.0	85.5 pg/mL Interval 71.5 to 106.0
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum IP-10; Day 30	107 pg/mL Interval 77.0 to 173.0	103 pg/mL Interval 72.0 to 154.0	109 pg/mL Interval 72.0 to 160.0	106 pg/mL Interval 77.0 to 180.0	104 pg/mL Interval 75.0 to 173.0
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum IP-10; Day 30+	70 pg/mL Interval 49.0 to 108.0	75 pg/mL Interval 49.0 to 101.0	63 pg/mL Interval 41.0 to 103.0	70.5 pg/mL Interval 30.5 to 105.0	68 pg/mL Interval 42.0 to 100.0
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum IP-10; Day 31	76 pg/mL Interval 48.0 to 117.0	295 pg/mL Interval 130.0 to 465.0	211 pg/mL Interval 129.0 to 377.0	176.5 pg/mL Interval 83.5 to 304.0	63 pg/mL Interval 51.0 to 100.0
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum IP-10; Day 33	84 pg/mL Interval 52.0 to 127.0	232 pg/mL Interval 163.0 to 393.0	170 pg/mL Interval 111.0 to 269.0	156 pg/mL Interval 99.0 to 274.0	86 pg/mL Interval 53.0 to 119.0
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum IP-10; Day 37	85 pg/mL Interval 54.0 to 144.0	119 pg/mL Interval 88.0 to 185.0	100.5 pg/mL Interval 62.5 to 151.5	90 pg/mL Interval 71.0 to 138.0	83.5 pg/mL Interval 54.0 to 123.0
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum MCP-1; Day 0	120 pg/mL Interval 83.0 to 182.0	130 pg/mL Interval 92.0 to 205.0	168 pg/mL Interval 100.0 to 211.0	148.5 pg/mL Interval 104.0 to 194.0	143 pg/mL Interval 93.5 to 219.5
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum MCP-1; Day 1	133 pg/mL Interval 80.0 to 187.0	144 pg/mL Interval 97.0 to 198.0	139 pg/mL Interval 88.0 to 208.0	111.5 pg/mL Interval 88.0 to 170.0	133.5 pg/mL Interval 92.5 to 193.0
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum MCP-1; Day 30	161 pg/mL Interval 94.0 to 227.0	151 pg/mL Interval 70.0 to 245.0	179 pg/mL Interval 111.0 to 233.0	164 pg/mL Interval 119.0 to 213.0	165 pg/mL Interval 109.0 to 275.0
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum MCP-1; Day 30+	114.5 pg/mL Interval 80.0 to 162.0	140 pg/mL Interval 72.0 to 193.0	114 pg/mL Interval 84.0 to 176.0	121.5 pg/mL Interval 80.5 to 185.0	121 pg/mL Interval 74.0 to 195.0
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum MCP-1; Day 31	105 pg/mL Interval 61.0 to 175.0	171 pg/mL Interval 112.0 to 283.0	155 pg/mL Interval 82.0 to 248.0	114.5 pg/mL Interval 91.5 to 186.5	120 pg/mL Interval 68.0 to 161.0
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum MCP-1; Day 33	88 pg/mL Interval 56.0 to 151.0	83 pg/mL Interval 48.0 to 134.0	92 pg/mL Interval 59.0 to 139.0	79 pg/mL Interval 50.0 to 136.0	122 pg/mL Interval 72.0 to 180.0
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum MCP-1; Day 37	133 pg/mL Interval 74.0 to 170.0	129 pg/mL Interval 75.0 to 182.0	138.5 pg/mL Interval 102.0 to 176.0	150 pg/mL Interval 111.0 to 196.0	140.5 pg/mL Interval 87.0 to 201.0
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum TNF-a; Day 0	0.411 pg/mL Interval 0.411 to 1.455	0.411 pg/mL Interval 0.411 to 1.348	1.262 pg/mL Interval 0.411 to 2.484	0.411 pg/mL Interval 0.411 to 1.707	0.651 pg/mL Interval 0.411 to 1.893
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum TNF-a; Day 0+	0.911 pg/mL Interval 0.411 to 2.274	1.482 pg/mL Interval 0.411 to 2.309	1.641 pg/mL Interval 0.411 to 2.276	0.411 pg/mL Interval 0.411 to 2.128	0.411 pg/mL Interval 0.411 to 1.889
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum TNF-a; Day 1	1.701 pg/mL Interval 0.411 to 2.907	1.902 pg/mL Interval 0.411 to 2.346	1.909 pg/mL Interval 1.079 to 3.135	1.727 pg/mL Interval 0.411 to 3.277	1.579 pg/mL Interval 0.411 to 2.274
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum TNF-a; Day 30	0.411 pg/mL Interval 0.411 to 2.032	0.969 pg/mL Interval 0.411 to 2.192	1.023 pg/mL Interval 0.411 to 1.809	1.203 pg/mL Interval 0.411 to 2.568	0.411 pg/mL Interval 0.411 to 2.298
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum TNF-a; Day 30+	1.323 pg/mL Interval 0.411 to 2.124	1.069 pg/mL Interval 0.411 to 1.796	1.08 pg/mL Interval 0.411 to 2.196	1.321 pg/mL Interval 0.411 to 2.204	1.243 pg/mL Interval 0.411 to 1.853
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum TNF-a; Day 31	1.375 pg/mL Interval 0.411 to 2.249	0.881 pg/mL Interval 0.411 to 2.507	1.151 pg/mL Interval 0.411 to 2.399	1.081 pg/mL Interval 0.411 to 3.366	1.091 pg/mL Interval 0.411 to 2.257
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum TNF-a; Day 33	0.411 pg/mL Interval 0.411 to 2.204	0.411 pg/mL Interval 0.411 to 1.568	0.981 pg/mL Interval 0.411 to 1.853	1.129 pg/mL Interval 0.411 to 2.486	0.411 pg/mL Interval 0.411 to 2.084
Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum TNF-a; Day 37	0.841 pg/mL Interval 0.411 to 2.399	0.411 pg/mL Interval 0.411 to 1.879	0.934 pg/mL Interval 0.411 to 2.158	0.411 pg/mL Interval 0.411 to 1.826	0.411 pg/mL Interval 0.411 to 2.483

SECONDARY outcome

Timeframe: At Days 0, 0+ (Day 0 + 3 to 6 hours), 1, 30, 30+ (Day 30 + 3 to 6 hours), 31, 33, 37 and 60.

Analysis of levels of CPK and WBC was performed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result - lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure concerns solely subjects part of the HLA Subsets 1 \& 2 who received the Day 360 booster dose of HBsAg.

Outcome measures

Outcome measures
Measure	Engerix-B - HLA Subsets Group n=55 Participants This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 1 - Non-HLA Subsets Group n=59 Participants This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 - Non-HLA Subsets Group n=57 Participants This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 - Non-HLA Subsets Group n=59 Participants This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group n=61 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) CPK; Day 1	86 IH Center normalized ratio Interval 70.0 to 123.514	109 IH Center normalized ratio Interval 81.135 to 136.947	89.784 IH Center normalized ratio Interval 73.0 to 115.0	104 IH Center normalized ratio Interval 76.443 to 141.0	102 IH Center normalized ratio Interval 78.541 to 163.297
Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) WBC; Day 0	6480 IH Center normalized ratio Interval 5320.0 to 7540.0	6840 IH Center normalized ratio Interval 5520.0 to 7647.619	6090 IH Center normalized ratio Interval 5230.0 to 7680.0	6650 IH Center normalized ratio Interval 5130.0 to 8210.0	6523.81 IH Center normalized ratio Interval 5542.857 to 7350.0
Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) WBC; Day 0+	7210 IH Center normalized ratio Interval 6300.0 to 9063.655	7729.231 IH Center normalized ratio Interval 6340.0 to 9157.895	7670 IH Center normalized ratio Interval 6111.111 to 9368.421	7520 IH Center normalized ratio Interval 6460.0 to 9290.0	7620 IH Center normalized ratio Interval 6860.0 to 8421.053
Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) WBC; Day 1	7130 IH Center normalized ratio Interval 5750.0 to 8110.0	8265 IH Center normalized ratio Interval 7000.0 to 9838.095	7850 IH Center normalized ratio Interval 6400.0 to 9066.667	7610 IH Center normalized ratio Interval 6540.0 to 9530.0	8400 IH Center normalized ratio Interval 7200.0 to 9200.0
Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) WBC; Day 30	6076.923 IH Center normalized ratio Interval 5430.0 to 7580.952	5960 IH Center normalized ratio Interval 5260.0 to 7866.667	6090 IH Center normalized ratio Interval 5230.0 to 7500.0	6290 IH Center normalized ratio Interval 5152.381 to 7797.342	6421.053 IH Center normalized ratio Interval 5570.0 to 7680.0
Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) WBC; Day 30+	7625 IH Center normalized ratio Interval 6270.0 to 8520.0	7570 IH Center normalized ratio Interval 6430.0 to 8838.095	7350 IH Center normalized ratio Interval 5894.737 to 8620.0	7120 IH Center normalized ratio Interval 5980.0 to 8720.0	7371.429 IH Center normalized ratio Interval 6133.333 to 8680.0
Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) WBC; Day 31	6550 IH Center normalized ratio Interval 5580.0 to 7410.0	8160 IH Center normalized ratio Interval 7110.0 to 10170.0	7533.333 IH Center normalized ratio Interval 6759.754 to 8920.0	7422.222 IH Center normalized ratio Interval 6405.0 to 8352.641	7980 IH Center normalized ratio Interval 6950.0 to 9090.0
Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) WBC; Day 33	6170 IH Center normalized ratio Interval 5314.286 to 8150.0	6450 IH Center normalized ratio Interval 5010.0 to 7971.429	6080 IH Center normalized ratio Interval 4990.0 to 7360.0	6290 IH Center normalized ratio Interval 5650.0 to 7560.0	7150 IH Center normalized ratio Interval 6210.0 to 8130.0
Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) WBC; Day 37	6870 IH Center normalized ratio Interval 5470.0 to 8333.333	6219.048 IH Center normalized ratio Interval 5520.0 to 7790.476	6464.341 IH Center normalized ratio Interval 5455.0 to 8130.0	6760 IH Center normalized ratio Interval 5530.0 to 8000.0	6740 IH Center normalized ratio Interval 5685.714 to 7560.0
Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) WBC; Day 60	5970 IH Center normalized ratio Interval 5100.0 to 7980.952	6400 IH Center normalized ratio Interval 5280.0 to 8230.0	6320 IH Center normalized ratio Interval 5466.667 to 7420.0	6090 IH Center normalized ratio Interval 5320.0 to 8430.0	6540 IH Center normalized ratio Interval 5257.143 to 7378.738
Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) CPK; Day 0	84.108 IH Center normalized ratio Interval 70.0 to 121.579	113 IH Center normalized ratio Interval 91.0 to 139.263	93 IH Center normalized ratio Interval 73.0 to 121.0	110 IH Center normalized ratio Interval 74.216 to 157.789	114 IH Center normalized ratio Interval 85.0 to 175.0
Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) CPK; Day 0+	94 IH Center normalized ratio Interval 74.0 to 114.842	117 IH Center normalized ratio Interval 90.0 to 156.0	99.297 IH Center normalized ratio Interval 77.0 to 120.054	112 IH Center normalized ratio Interval 73.351 to 159.0	114.842 IH Center normalized ratio Interval 89.784 to 170.941
Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) CPK, at Day 30	93 IH Center normalized ratio Interval 74.0 to 137.0	123.263 IH Center normalized ratio Interval 93.0 to 172.444	90 IH Center normalized ratio Interval 72.0 to 114.842	115.73 IH Center normalized ratio Interval 73.569 to 163.0	99 IH Center normalized ratio Interval 71.653 to 158.973
Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) CPK; Day 30+	93 IH Center normalized ratio Interval 75.081 to 143.0	120 IH Center normalized ratio Interval 96.0 to 174.541	91.772 IH Center normalized ratio Interval 75.0 to 118.741	115.73 IH Center normalized ratio Interval 74.216 to 158.108	106 IH Center normalized ratio Interval 78.0 to 144.27
Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) CPK; Day 31	98 IH Center normalized ratio Interval 75.081 to 142.541	109 IH Center normalized ratio Interval 83.0 to 153.529	90 IH Center normalized ratio Interval 70.211 to 105.0	106.973 IH Center normalized ratio Interval 74.5 to 141.973	103.614 IH Center normalized ratio Interval 76.0 to 153.784
Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) CPK; Day 33	91.772 IH Center normalized ratio Interval 75.485 to 119.0	107 IH Center normalized ratio Interval 80.316 to 149.459	87 IH Center normalized ratio Interval 71.053 to 113.135	104 IH Center normalized ratio Interval 69.0 to 147.0	101 IH Center normalized ratio Interval 75.485 to 136.588
Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) CPK; Day 37	93.689 IH Center normalized ratio Interval 69.0 to 126.0	112.118 IH Center normalized ratio Interval 81.0 to 153.529	93.986 IH Center normalized ratio Interval 67.921 to 116.395	118 IH Center normalized ratio Interval 78.359 to 172.811	106.311 IH Center normalized ratio Interval 77.0 to 170.216
Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK) CPK; Day 60	96 IH Center normalized ratio Interval 76.0 to 131.0	120 IH Center normalized ratio Interval 85.0 to 174.632	85 IH Center normalized ratio Interval 70.0 to 108.811	114 IH Center normalized ratio Interval 85.0 to 157.0	110.647 IH Center normalized ratio Interval 79.405 to 149.765

SECONDARY outcome

Timeframe: At Days 0, 0+ (Day 0 + 3 to 6 hours), 1, 30, 30+ (Day 30 + 3 to 6 hours), 31, 33 and 37.

Analysis of levels of CRP was performed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result - lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure concerns solely subjects part of the HLA Subsets 1 \& 2 who received the Day 360 booster dose of HBsAg.

Outcome measures

Outcome measures
Measure	Engerix-B - HLA Subsets Group n=55 Participants This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 1 - Non-HLA Subsets Group n=59 Participants This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 - Non-HLA Subsets Group n=57 Participants This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 - Non-HLA Subsets Group n=59 Participants This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group n=61 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Normalized Levels of C-reactive Protein (CRP) CRP; Day 0	0.248 IH Center normlized ratio Interval 0.09 to 0.486	0.248 IH Center normlized ratio Interval 0.18 to 0.326	0.248 IH Center normlized ratio Interval 0.15 to 0.51	0.248 IH Center normlized ratio Interval 0.13 to 0.55	0.248 IH Center normlized ratio Interval 0.17 to 0.486
Normalized Levels of C-reactive Protein (CRP) CRP; Day 0+	0.248 IH Center normlized ratio Interval 0.1 to 0.462	0.248 IH Center normlized ratio Interval 0.14 to 0.391	0.248 IH Center normlized ratio Interval 0.12 to 0.5	0.248 IH Center normlized ratio Interval 0.14 to 0.52	0.248 IH Center normlized ratio Interval 0.17 to 0.486
Normalized Levels of C-reactive Protein (CRP) CRP; Day 1	0.248 IH Center normlized ratio Interval 0.11 to 0.462	1.97 IH Center normlized ratio Interval 0.795 to 3.342	0.962 IH Center normlized ratio Interval 0.486 to 1.661	0.486 IH Center normlized ratio Interval 0.25 to 0.94	0.462 IH Center normlized ratio Interval 0.248 to 0.724
Normalized Levels of C-reactive Protein (CRP) CRP; Day 30	0.248 IH Center normlized ratio Interval 0.15 to 0.486	0.248 IH Center normlized ratio Interval 0.187 to 0.486	0.248 IH Center normlized ratio Interval 0.17 to 0.34	0.248 IH Center normlized ratio Interval 0.129 to 0.486	0.248 IH Center normlized ratio Interval 0.2 to 0.486
Normalized Levels of C-reactive Protein (CRP) CRP; Day 30+	0.248 IH Center normlized ratio Interval 0.15 to 0.486	0.248 IH Center normlized ratio Interval 0.192 to 0.53	0.248 IH Center normlized ratio Interval 0.18 to 0.34	0.248 IH Center normlized ratio Interval 0.13 to 0.486	0.248 IH Center normlized ratio Interval 0.2 to 0.52
Normalized Levels of C-reactive Protein (CRP) CRP; Day 31	0.248 IH Center normlized ratio Interval 0.129 to 0.486	1.521 IH Center normlized ratio Interval 0.87 to 2.39	1.047 IH Center normlized ratio Interval 0.498 to 1.518	0.61 IH Center normlized ratio Interval 0.248 to 1.224	0.486 IH Center normlized ratio Interval 0.248 to 0.724
Normalized Levels of C-reactive Protein (CRP) CRP; Day 33	0.248 IH Center normlized ratio Interval 0.129 to 0.486	2.6 IH Center normlized ratio Interval 1.438 to 4.333	1.2 IH Center normlized ratio Interval 0.637 to 2.186	0.707 IH Center normlized ratio Interval 0.46 to 1.365	0.486 IH Center normlized ratio Interval 0.248 to 0.962
Normalized Levels of C-reactive Protein (CRP) CRP; Day 37	0.248 IH Center normlized ratio Interval 0.12 to 0.468	0.319 IH Center normlized ratio Interval 0.229 to 0.641	0.248 IH Center normlized ratio Interval 0.17 to 0.486	0.248 IH Center normlized ratio Interval 0.13 to 0.41	0.248 IH Center normlized ratio Interval 0.229 to 0.478

SECONDARY outcome

Timeframe: At Days 0, 30, 37 and 60.

Population: Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.

Analysis of levels of CPK and WBC was performed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result - lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure concerns all subjects except subjects part of the HLA Subsets 1 and 2.

Outcome measures

Outcome measures
Measure	Engerix-B - HLA Subsets Group n=67 Participants This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 1 - Non-HLA Subsets Group n=68 Participants This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 - Non-HLA Subsets Group n=68 Participants This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 - Non-HLA Subsets Group n=66 Participants This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group n=71 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Normalized Levels of WBC and of CPK WBC; Day 0	6810 IH Center normalized ratio Interval 5573.77 to 8020.0	6627.764 IH Center normalized ratio Interval 5719.286 to 8273.819	6748.689 IH Center normalized ratio Interval 5403.462 to 8568.018	6782.414 IH Center normalized ratio Interval 5578.947 to 8350.0	7590 IH Center normalized ratio Interval 5810.0 to 8550.0
Normalized Levels of WBC and of CPK WBC; Day 30	6590 IH Center normalized ratio Interval 5720.0 to 8272.727	6870.05 IH Center normalized ratio Interval 5643.182 to 7705.0	6454.545 IH Center normalized ratio Interval 5735.385 to 7888.889	6600 IH Center normalized ratio Interval 5555.556 to 7900.0	6950.82 IH Center normalized ratio Interval 5475.41 to 8777.778
Normalized Levels of WBC and of CPK WBC; Day 37	6440 IH Center normalized ratio Interval 5770.0 to 8650.0	6736.842 IH Center normalized ratio Interval 5772.308 to 7960.0	7196.579 IH Center normalized ratio Interval 6113.846 to 8454.545	6550 IH Center normalized ratio Interval 5672.131 to 8622.951	6673.182 IH Center normalized ratio Interval 5550.0 to 8264.615
Normalized Levels of WBC and of CPK WBC; Day 60	6740 IH Center normalized ratio Interval 5530.0 to 8090.0	6738.636 IH Center normalized ratio Interval 5999.933 to 8061.393	6330 IH Center normalized ratio Interval 5333.333 to 8181.818	6625.789 IH Center normalized ratio Interval 5265.0 to 8110.526	7175.909 IH Center normalized ratio Interval 5420.0 to 9099.817
Normalized Levels of WBC and of CPK CPK; Day 0	120.857 IH Center normalized ratio Interval 71.622 to 184.4	105.529 IH Center normalized ratio Interval 76.0 to 140.279	102.696 IH Center normalized ratio Interval 82.842 to 135.314	109.756 IH Center normalized ratio Interval 86.706 to 184.919	114 IH Center normalized ratio Interval 87.0 to 159.474
Normalized Levels of WBC and of CPK CPK; Day 30	113.079 IH Center normalized ratio Interval 79.0 to 151.333	108.617 IH Center normalized ratio Interval 79.697 to 148.105	103.647 IH Center normalized ratio Interval 81.0 to 128.316	114 IH Center normalized ratio Interval 88.4 to 172.947	102.1 IH Center normalized ratio Interval 87.885 to 135.311
Normalized Levels of WBC and of CPK CPK; Day 37	124.667 IH Center normalized ratio Interval 82.0 to 203.081	105.351 IH Center normalized ratio Interval 84.824 to 141.676	99.399 IH Center normalized ratio Interval 77.294 to 132.891	109.294 IH Center normalized ratio Interval 88.054 to 147.655	122.66 IH Center normalized ratio Interval 88.919 to 161.059
Normalized Levels of WBC and of CPK CPK; Day 60	120.989 IH Center normalized ratio Interval 84.526 to 178.0	112.842 IH Center normalized ratio Interval 84.5 to 187.354	104 IH Center normalized ratio Interval 75.6 to 140.105	107.6 IH Center normalized ratio Interval 78.541 to 152.919	102.4 IH Center normalized ratio Interval 84.333 to 146.793

SECONDARY outcome

Timeframe: At Days 0, 30 and 37.

Population: Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.

Analysis of levels of CRP was performed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result - lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure concerns all subjects except subjects part of the HLA Subsets 1 and 2.

Outcome measures

Outcome measures
Measure	Engerix-B - HLA Subsets Group n=66 Participants This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 1 - Non-HLA Subsets Group n=66 Participants This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 - Non-HLA Subsets Group n=66 Participants This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 - Non-HLA Subsets Group n=64 Participants This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group n=69 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Normalized Levels of CRP CRP; Day 37	0.248 IH Center normalized levels Interval 0.114 to 0.739	0.486 IH Center normalized levels Interval 0.272 to 0.807	0.523 IH Center normalized levels Interval 0.248 to 1.224	0.486 IH Center normalized levels Interval 0.248 to 1.152	0.363 IH Center normalized levels Interval 0.229 to 0.836
Normalized Levels of CRP CRP; Day 0	0.365 IH Center normalized levels Interval 0.178 to 0.739	0.33 IH Center normalized levels Interval 0.153 to 0.755	0.486 IH Center normalized levels Interval 0.248 to 0.739	0.253 IH Center normalized levels Interval 0.229 to 0.739	0.296 IH Center normalized levels Interval 0.224 to 0.739
Normalized Levels of CRP CRP; Day 30	0.319 IH Center normalized levels Interval 0.105 to 0.739	0.248 IH Center normalized levels Interval 0.129 to 0.724	0.371 IH Center normalized levels Interval 0.208 to 0.739	0.38 IH Center normalized levels Interval 0.248 to 0.739	0.277 IH Center normalized levels Interval 0.19 to 0.739

SECONDARY outcome

Timeframe: At Days 0, 0+ (Day 0 + 3 to 6 hours), 1, 30, 30+ (Day 30 + 3 to 6 hours), 31, 33, 37 and 60.

Levels of white blood cells (WBC) as absolute counts, neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS) and basophils (BAS) were assessed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. This outcome measure presents the raw data collected in percent (%), expressed in IH Center normalized levels based on raw data in % (IH normalized %), and concerns solely subjects part of the HLA Subsets 1 \& 2 who received the Day 360 booster dose of HBsAg.

Outcome measures

Outcome measures
Measure	Engerix-B - HLA Subsets Group n=14 Participants This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 1 - Non-HLA Subsets Group n=21 Participants This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 - Non-HLA Subsets Group n=17 Participants This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 - Non-HLA Subsets Group n=14 Participants This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group n=22 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils BAS; Day 30+	0.333 IH normalized ratio Interval 0.25 to 0.4	0.25 IH normalized ratio Interval 0.2 to 0.368	0.25 IH normalized ratio Interval 0.214 to 0.45	0.25 IH normalized ratio Interval 0.15 to 0.4	0.211 IH normalized ratio Interval 0.15 to 0.45
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils BAS; Day 31	0.325 IH normalized ratio Interval 0.211 to 0.5	0.2 IH normalized ratio Interval 0.15 to 0.3	0.3 IH normalized ratio Interval 0.211 to 0.4	0.3 IH normalized ratio Interval 0.146 to 0.325	0.25 IH normalized ratio Interval 0.158 to 0.364
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils BAS; Day 30	0.3 IH normalized ratio Interval 0.25 to 0.4	0.4 IH normalized ratio Interval 0.25 to 0.5	0.35 IH normalized ratio Interval 0.25 to 0.5	0.35 IH normalized ratio Interval 0.182 to 0.45	0.333 IH normalized ratio Interval 0.2 to 0.5
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils WBC; Day 0+	0.662 IH normalized ratio Interval 0.498 to 0.927	0.702 IH normalized ratio Interval 0.427 to 0.886	1.123 IH normalized ratio Interval 0.476 to 1.205	0.578 IH normalized ratio Interval 0.395 to 1.051	0.647 IH normalized ratio Interval 0.518 to 0.926
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils WBC; Day 60	0.446 IH normalized ratio Interval 0.222 to 0.665	0.41 IH normalized ratio Interval 0.213 to 0.634	0.557 IH normalized ratio Interval 0.244 to 0.737	0.271 IH normalized ratio Interval 0.123 to 0.584	0.42 IH normalized ratio Interval 0.21 to 0.563
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils NEU; Day 31	0.589 IH normalized ratio Interval 0.357 to 0.684	1.161 IH normalized ratio Interval 1.067 to 1.373	0.959 IH normalized ratio Interval 0.797 to 1.135	0.921 IH normalized ratio Interval 0.478 to 1.118	0.78 IH normalized ratio Interval 0.672 to 0.943
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils LYM; Day 31	0.54 IH normalized ratio Interval 0.348 to 0.776	-0.086 IH normalized ratio Interval -0.2 to 0.0	-0.003 IH normalized ratio Interval -0.179 to 0.269	0.15 IH normalized ratio Interval -0.11 to 0.526	0.302 IH normalized ratio Interval 0.034 to 0.372
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils EOS; Day 31	0.43 IH normalized ratio Interval 0.3 to 0.525	0.145 IH normalized ratio Interval 0.1 to 0.275	0.38 IH normalized ratio Interval 0.3 to 0.62	0.25 IH normalized ratio Interval 0.167 to 0.493	0.505 IH normalized ratio Interval 0.26 to 0.85
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils EOS; Day 60	0.465 IH normalized ratio Interval 0.28 to 0.623	0.45 IH normalized ratio Interval 0.36 to 0.575	0.652 IH normalized ratio Interval 0.32 to 1.1	0.38 IH normalized ratio Interval 0.3 to 0.653	0.709 IH normalized ratio Interval 0.44 to 1.058
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils BAS; Day 0	0.375 IH normalized ratio Interval 0.25 to 0.5	0.25 IH normalized ratio Interval 0.158 to 0.35	0.35 IH normalized ratio Interval 0.143 to 0.5	0.325 IH normalized ratio Interval 0.214 to 0.421	0.25 IH normalized ratio Interval 0.15 to 0.455
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils BAS; Day 60	0.308 IH normalized ratio Interval 0.25 to 0.4	0.3 IH normalized ratio Interval 0.2 to 0.4	0.4 IH normalized ratio Interval 0.3 to 0.6	0.4 IH normalized ratio Interval 0.182 to 0.55	0.25 IH normalized ratio Interval 0.15 to 0.421
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils WBC; Day 0	0.479 IH normalized ratio Interval 0.329 to 0.608	0.498 IH normalized ratio Interval 0.323 to 0.608	0.509 IH normalized ratio Interval 0.422 to 0.93	0.341 IH normalized ratio Interval 0.143 to 0.756	0.43 IH normalized ratio Interval 0.246 to 0.517
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils WBC; Day 1	0.607 IH normalized ratio Interval 0.448 to 0.84	0.76 IH normalized ratio Interval 0.485 to 0.969	0.756 IH normalized ratio Interval 0.459 to 0.971	0.54 IH normalized ratio Interval 0.351 to 1.154	0.698 IH normalized ratio Interval 0.593 to 0.895
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils WBC; Day 30	0.517 IH normalized ratio Interval 0.392 to 0.684	0.456 IH normalized ratio Interval 0.246 to 0.644	0.596 IH normalized ratio Interval 0.219 to 0.878	0.263 IH normalized ratio Interval 0.193 to 0.549	0.385 IH normalized ratio Interval 0.249 to 0.479
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils WBC; Day 30+	0.76 IH normalized ratio Interval 0.479 to 0.86	0.69 IH normalized ratio Interval 0.546 to 0.844	0.789 IH normalized ratio Interval 0.479 to 1.098	0.574 IH normalized ratio Interval 0.371 to 0.814	0.556 IH normalized ratio Interval 0.356 to 0.737
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils WBC; Day 31	0.536 IH normalized ratio Interval 0.443 to 0.772	0.79 IH normalized ratio Interval 0.617 to 1.018	0.737 IH normalized ratio Interval 0.46 to 0.938	0.629 IH normalized ratio Interval 0.476 to 0.763	0.633 IH normalized ratio Interval 0.562 to 0.789
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils WBC; Day 33	0.537 IH normalized ratio Interval 0.219 to 0.772	0.441 IH normalized ratio Interval 0.229 to 0.662	0.491 IH normalized ratio Interval 0.222 to 0.719	0.404 IH normalized ratio Interval 0.303 to 0.646	0.441 IH normalized ratio Interval 0.299 to 0.579
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils WBC; Day 37	0.49 IH normalized ratio Interval 0.251 to 0.983	0.379 IH normalized ratio Interval 0.298 to 0.646	0.525 IH normalized ratio Interval 0.335 to 0.781	0.468 IH normalized ratio Interval 0.31 to 0.544	0.354 IH normalized ratio Interval 0.263 to 0.537
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils NEU; Day 0	0.445 IH normalized ratio Interval 0.41 to 0.541	0.648 IH normalized ratio Interval 0.422 to 0.83	0.53 IH normalized ratio Interval 0.478 to 0.894	0.58 IH normalized ratio Interval 0.3 to 0.837	0.663 IH normalized ratio Interval 0.343 to 0.85
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils NEU; Day 0+	0.654 IH normalized ratio Interval 0.443 to 0.713	0.84 IH normalized ratio Interval 0.652 to 0.957	0.752 IH normalized ratio Interval 0.627 to 0.993	0.693 IH normalized ratio Interval 0.47 to 0.797	0.767 IH normalized ratio Interval 0.581 to 0.87
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils NEU; Day 1	0.654 IH normalized ratio Interval 0.53 to 0.8	0.93 IH normalized ratio Interval 0.727 to 1.15	0.817 IH normalized ratio Interval 0.653 to 0.903	0.727 IH normalized ratio Interval 0.67 to 0.927	0.769 IH normalized ratio Interval 0.635 to 0.923
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils NEU; Day 30	0.581 IH normalized ratio Interval 0.46 to 0.699	0.604 IH normalized ratio Interval 0.46 to 0.757	0.6 IH normalized ratio Interval 0.387 to 0.791	0.387 IH normalized ratio Interval 0.322 to 0.757	0.578 IH normalized ratio Interval 0.35 to 0.719
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils NEU; Day 30+	0.642 IH normalized ratio Interval 0.465 to 0.717	0.9 IH normalized ratio Interval 0.497 to 1.107	0.717 IH normalized ratio Interval 0.583 to 0.887	0.609 IH normalized ratio Interval 0.377 to 0.84	0.663 IH normalized ratio Interval 0.521 to 0.95
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils NEU; Day 33	0.567 IH normalized ratio Interval 0.457 to 0.653	0.591 IH normalized ratio Interval 0.447 to 0.787	0.509 IH normalized ratio Interval 0.275 to 0.69	0.539 IH normalized ratio Interval 0.34 to 0.657	0.587 IH normalized ratio Interval 0.426 to 0.819
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils NEU; Day 37	0.542 IH normalized ratio Interval 0.373 to 0.67	0.63 IH normalized ratio Interval 0.459 to 0.726	0.652 IH normalized ratio Interval 0.503 to 0.77	0.443 IH normalized ratio Interval 0.313 to 0.553	0.569 IH normalized ratio Interval 0.365 to 0.823
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils NEU; Day 60	0.561 IH normalized ratio Interval 0.422 to 0.733	0.656 IH normalized ratio Interval 0.537 to 0.807	0.543 IH normalized ratio Interval 0.391 to 0.667	0.54 IH normalized ratio Interval 0.375 to 0.684	0.61 IH normalized ratio Interval 0.363 to 0.843
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils LYM; Day 0	0.68 IH normalized ratio Interval 0.459 to 0.779	0.474 IH normalized ratio Interval 0.345 to 0.607	0.366 IH normalized ratio Interval 0.341 to 0.524	0.531 IH normalized ratio Interval 0.359 to 0.839	0.403 IH normalized ratio Interval 0.235 to 0.557
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils LYM; Day 0+	0.609 IH normalized ratio Interval 0.354 to 0.745	0.328 IH normalized ratio Interval 0.045 to 0.438	0.407 IH normalized ratio Interval 0.048 to 0.552	0.543 IH normalized ratio Interval 0.41 to 0.679	0.361 IH normalized ratio Interval 0.148 to 0.479
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils LYM; Day 1	0.478 IH normalized ratio Interval 0.324 to 0.597	0.178 IH normalized ratio Interval -0.136 to 0.316	0.272 IH normalized ratio Interval 0.093 to 0.341	0.412 IH normalized ratio Interval 0.19 to 0.521	0.283 IH normalized ratio Interval 0.059 to 0.472
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils LYM; Day 30	0.536 IH normalized ratio Interval 0.335 to 0.838	0.452 IH normalized ratio Interval 0.274 to 0.552	0.51 IH normalized ratio Interval 0.221 to 0.538	0.528 IH normalized ratio Interval 0.336 to 0.745	0.433 IH normalized ratio Interval 0.207 to 0.634
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils LYM; Day 30+	0.54 IH normalized ratio Interval 0.313 to 0.628	0.3 IH normalized ratio Interval 0.026 to 0.513	0.386 IH normalized ratio Interval 0.222 to 0.5	0.497 IH normalized ratio Interval 0.345 to 0.831	0.413 IH normalized ratio Interval 0.266 to 0.479
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils LYM; Day 33	0.622 IH normalized ratio Interval 0.314 to 0.731	0.309 IH normalized ratio Interval 0.231 to 0.531	0.407 IH normalized ratio Interval 0.269 to 0.683	0.445 IH normalized ratio Interval 0.31 to 0.552	0.405 IH normalized ratio Interval 0.196 to 0.552
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils LYM; Day 37	0.572 IH normalized ratio Interval 0.27 to 0.779	0.503 IH normalized ratio Interval 0.279 to 0.57	0.357 IH normalized ratio Interval 0.225 to 0.561	0.555 IH normalized ratio Interval 0.493 to 0.683	0.423 IH normalized ratio Interval 0.224 to 0.593
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils LYM; Day 60	0.538 IH normalized ratio Interval 0.4 to 0.779	0.452 IH normalized ratio Interval 0.257 to 0.645	0.376 IH normalized ratio Interval 0.3 to 0.63	0.534 IH normalized ratio Interval 0.441 to 0.731	0.402 IH normalized ratio Interval 0.178 to 0.579
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils MON; Day 0	0.489 IH normalized ratio Interval 0.356 to 0.58	0.5 IH normalized ratio Interval 0.356 to 0.589	0.311 IH normalized ratio Interval 0.222 to 0.489	0.439 IH normalized ratio Interval 0.389 to 0.522	0.51 IH normalized ratio Interval 0.4 to 0.64
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils MON; Day 0+	0.389 IH normalized ratio Interval 0.322 to 0.456	0.422 IH normalized ratio Interval 0.311 to 0.533	0.367 IH normalized ratio Interval 0.32 to 0.4	0.367 IH normalized ratio Interval 0.3 to 0.567	0.439 IH normalized ratio Interval 0.321 to 0.54
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils MON; Day 1	0.45 IH normalized ratio Interval 0.333 to 0.5	0.594 IH normalized ratio Interval 0.367 to 0.834	0.522 IH normalized ratio Interval 0.422 to 0.622	0.522 IH normalized ratio Interval 0.44 to 0.611	0.477 IH normalized ratio Interval 0.359 to 0.622
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils MON; Day 30	0.422 IH normalized ratio Interval 0.289 to 0.478	0.533 IH normalized ratio Interval 0.411 to 0.644	0.411 IH normalized ratio Interval 0.322 to 0.522	0.5 IH normalized ratio Interval 0.344 to 0.533	0.472 IH normalized ratio Interval 0.378 to 0.551
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils MON; Day 30+	0.363 IH normalized ratio Interval 0.311 to 0.46	0.456 IH normalized ratio Interval 0.333 to 0.533	0.422 IH normalized ratio Interval 0.302 to 0.544	0.433 IH normalized ratio Interval 0.3 to 0.478	0.443 IH normalized ratio Interval 0.367 to 0.589
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils MON; Day 31	0.478 IH normalized ratio Interval 0.278 to 0.611	0.533 IH normalized ratio Interval 0.333 to 0.667	0.544 IH normalized ratio Interval 0.444 to 0.756	0.632 IH normalized ratio Interval 0.4 to 0.833	0.427 IH normalized ratio Interval 0.333 to 0.6
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils MON; Day 33	0.472 IH normalized ratio Interval 0.278 to 0.578	0.767 IH normalized ratio Interval 0.533 to 1.056	0.578 IH normalized ratio Interval 0.378 to 0.711	0.656 IH normalized ratio Interval 0.389 to 0.733	0.549 IH normalized ratio Interval 0.389 to 0.656
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils MON; Day 37	0.394 IH normalized ratio Interval 0.256 to 0.522	0.478 IH normalized ratio Interval 0.4 to 0.544	0.433 IH normalized ratio Interval 0.311 to 0.5	0.433 IH normalized ratio Interval 0.289 to 0.533	0.472 IH normalized ratio Interval 0.311 to 0.567
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils MON; Day 60	0.344 IH normalized ratio Interval 0.256 to 0.556	0.5 IH normalized ratio Interval 0.367 to 0.567	0.467 IH normalized ratio Interval 0.378 to 0.556	0.456 IH normalized ratio Interval 0.333 to 0.511	0.461 IH normalized ratio Interval 0.356 to 0.6
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils EOS; Day 0	0.495 IH normalized ratio Interval 0.42 to 0.82	0.5 IH normalized ratio Interval 0.34 to 0.594	0.594 IH normalized ratio Interval 0.475 to 0.875	0.37 IH normalized ratio Interval 0.24 to 0.54	0.596 IH normalized ratio Interval 0.4 to 1.1
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils EOS; Day 0+	0.42 IH normalized ratio Interval 0.375 to 0.58	0.3 IH normalized ratio Interval 0.225 to 0.4	0.429 IH normalized ratio Interval 0.32 to 0.575	0.25 IH normalized ratio Interval 0.125 to 0.44	0.423 IH normalized ratio Interval 0.29 to 0.58
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils EOS; Day 1	0.41 IH normalized ratio Interval 0.26 to 0.66	0.291 IH normalized ratio Interval 0.194 to 0.478	0.48 IH normalized ratio Interval 0.36 to 0.754	0.313 IH normalized ratio Interval 0.24 to 0.531	0.464 IH normalized ratio Interval 0.28 to 0.775
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils EOS; Day 30	0.53 IH normalized ratio Interval 0.32 to 0.75	0.45 IH normalized ratio Interval 0.3 to 0.6	0.673 IH normalized ratio Interval 0.362 to 0.9	0.42 IH normalized ratio Interval 0.26 to 0.878	0.693 IH normalized ratio Interval 0.42 to 1.08
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils EOS; Day 30+	0.38 IH normalized ratio Interval 0.348 to 0.56	0.32 IH normalized ratio Interval 0.25 to 0.348	0.475 IH normalized ratio Interval 0.375 to 0.696	0.34 IH normalized ratio Interval 0.174 to 0.6	0.496 IH normalized ratio Interval 0.355 to 0.7
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils EOS; Day 33	0.443 IH normalized ratio Interval 0.36 to 0.64	0.6 IH normalized ratio Interval 0.36 to 0.7	0.667 IH normalized ratio Interval 0.52 to 0.825	0.58 IH normalized ratio Interval 0.26 to 1.02	0.645 IH normalized ratio Interval 0.377 to 0.825
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils EOS; Day 37	0.52 IH normalized ratio Interval 0.28 to 0.78	0.46 IH normalized ratio Interval 0.325 to 0.625	0.64 IH normalized ratio Interval 0.42 to 0.768	0.44 IH normalized ratio Interval 0.3 to 0.939	0.69 IH normalized ratio Interval 0.452 to 1.188
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils BAS; Day 0+	0.225 IH normalized ratio Interval 0.15 to 0.4	0.25 IH normalized ratio Interval 0.2 to 0.35	0.3 IH normalized ratio Interval 0.2 to 0.4	0.232 IH normalized ratio Interval 0.158 to 0.4	0.25 IH normalized ratio Interval 0.1 to 0.3
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils BAS; Day 1	0.25 IH normalized ratio Interval 0.15 to 0.421	0.232 IH normalized ratio Interval 0.105 to 0.35	0.25 IH normalized ratio Interval 0.2 to 0.35	0.286 IH normalized ratio Interval 0.15 to 0.4	0.179 IH normalized ratio Interval 0.1 to 0.3
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils BAS; Day 33	0.3 IH normalized ratio Interval 0.263 to 0.5	0.35 IH normalized ratio Interval 0.3 to 0.526	0.4 IH normalized ratio Interval 0.25 to 0.65	0.35 IH normalized ratio Interval 0.2 to 0.5	0.3 IH normalized ratio Interval 0.182 to 0.5
Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils BAS; Day 37	0.3 IH normalized ratio Interval 0.2 to 0.4	0.316 IH normalized ratio Interval 0.25 to 0.45	0.421 IH normalized ratio Interval 0.3 to 0.55	0.286 IH normalized ratio Interval 0.2 to 0.4	0.286 IH normalized ratio Interval 0.15 to 0.5

SECONDARY outcome

Timeframe: At Days 0, 30, 37 and 60.

Population: Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.

Levels of white blood cells (WBC) as absolute counts, neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS) and basophils (BAS) were assessed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. This outcome measure presents the raw data collected in percent (%), expressed in IH Center normalized levels based on raw data in % (IH normalized %), and concerns all subjects except subjects part of the HLA Subsets 1 and 2.

Outcome measures

Outcome measures
Measure	Engerix-B - HLA Subsets Group n=47 Participants This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 1 - Non-HLA Subsets Group n=47 Participants This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 - Non-HLA Subsets Group n=47 Participants This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 - Non-HLA Subsets Group n=42 Participants This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group n=43 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Levels of WBC, NEU, LYM, MON, EOS and BAS EOS; Day 60	0.388 IH normalized ratio Interval 0.164 to 0.625	0.429 IH normalized ratio Interval 0.209 to 0.696	0.324 IH normalized ratio Interval 0.164 to 0.661	0.299 IH normalized ratio Interval 0.104 to 0.44	0.347 IH normalized ratio Interval 0.209 to 0.68
Levels of WBC, NEU, LYM, MON, EOS and BAS WBC; Day 60	0.478 IH normalized ratio Interval 0.28 to 0.832	0.44 IH normalized ratio Interval 0.311 to 0.718	0.44 IH normalized ratio Interval 0.222 to 0.697	0.439 IH normalized ratio Interval 0.166 to 0.754	0.607 IH normalized ratio Interval 0.426 to 0.967
Levels of WBC, NEU, LYM, MON, EOS and BAS NEU; Day 0	0.458 IH normalized ratio Interval 0.256 to 0.705	0.534 IH normalized ratio Interval 0.291 to 0.752	0.559 IH normalized ratio Interval 0.224 to 0.838	0.426 IH normalized ratio Interval 0.297 to 0.633	0.503 IH normalized ratio Interval 0.3 to 0.788
Levels of WBC, NEU, LYM, MON, EOS and BAS NEU; Day 30	0.532 IH normalized ratio Interval 0.326 to 0.796	0.457 IH normalized ratio Interval 0.17 to 0.703	0.524 IH normalized ratio Interval 0.26 to 0.686	0.491 IH normalized ratio Interval 0.075 to 0.726	0.5 IH normalized ratio Interval 0.291 to 0.714
Levels of WBC, NEU, LYM, MON, EOS and BAS NEU; Day 37	0.491 IH normalized ratio Interval 0.334 to 0.726	0.417 IH normalized ratio Interval 0.225 to 0.698	0.5 IH normalized ratio Interval 0.292 to 0.703	0.436 IH normalized ratio Interval 0.125 to 0.708	0.458 IH normalized ratio Interval 0.083 to 0.603
Levels of WBC, NEU, LYM, MON, EOS and BAS NEU; Day 60	0.474 IH normalized ratio Interval 0.294 to 0.731	0.47 IH normalized ratio Interval 0.333 to 0.715	0.496 IH normalized ratio Interval 0.3 to 0.772	0.389 IH normalized ratio Interval 0.167 to 0.57	0.471 IH normalized ratio Interval 0.194 to 0.671
Levels of WBC, NEU, LYM, MON, EOS and BAS LYM; Day 0	0.45 IH normalized ratio Interval 0.15 to 0.66	0.408 IH normalized ratio Interval 0.183 to 0.6	0.388 IH normalized ratio Interval 0.128 to 0.646	0.552 IH normalized ratio Interval 0.248 to 0.757	0.37 IH normalized ratio Interval -0.05 to 0.613
Levels of WBC, NEU, LYM, MON, EOS and BAS LYM; Day 30	0.43 IH normalized ratio Interval 0.111 to 0.6	0.45 IH normalized ratio Interval 0.24 to 0.7	0.404 IH normalized ratio Interval 0.26 to 0.69	0.55 IH normalized ratio Interval 0.228 to 0.893	0.373 IH normalized ratio Interval 0.15 to 0.69
Levels of WBC, NEU, LYM, MON, EOS and BAS LYM; Day 37	0.43 IH normalized ratio Interval 0.122 to 0.62	0.514 IH normalized ratio Interval 0.263 to 0.713	0.433 IH normalized ratio Interval 0.183 to 0.62	0.605 IH normalized ratio Interval 0.291 to 0.791	0.492 IH normalized ratio Interval 0.334 to 0.7
Levels of WBC, NEU, LYM, MON, EOS and BAS LYM; Day 60	0.417 IH normalized ratio Interval 0.233 to 0.593	0.45 IH normalized ratio Interval 0.177 to 0.634	0.388 IH normalized ratio Interval 0.168 to 0.65	0.578 IH normalized ratio Interval 0.38 to 0.9	0.426 IH normalized ratio Interval 0.25 to 0.683
Levels of WBC, NEU, LYM, MON, EOS and BAS MON; Day 0	0.55 IH normalized ratio Interval 0.288 to 0.7	0.52 IH normalized ratio Interval 0.256 to 0.675	0.473 IH normalized ratio Interval 0.333 to 0.64	0.5 IH normalized ratio Interval 0.325 to 0.656	0.438 IH normalized ratio Interval 0.3 to 0.611
Levels of WBC, NEU, LYM, MON, EOS and BAS MON; Day 30	0.506 IH normalized ratio Interval 0.3 to 0.667	0.556 IH normalized ratio Interval 0.367 to 0.765	0.471 IH normalized ratio Interval 0.267 to 0.783	0.538 IH normalized ratio Interval 0.311 to 0.667	0.431 IH normalized ratio Interval 0.319 to 0.733
Levels of WBC, NEU, LYM, MON, EOS and BAS MON; Day 37	0.5 IH normalized ratio Interval 0.349 to 0.667	0.471 IH normalized ratio Interval 0.298 to 0.673	0.456 IH normalized ratio Interval 0.333 to 0.738	0.465 IH normalized ratio Interval 0.233 to 0.66	0.465 IH normalized ratio Interval 0.261 to 0.744
Levels of WBC, NEU, LYM, MON, EOS and BAS MON; Day 60	0.5 IH normalized ratio Interval 0.363 to 0.738	0.463 IH normalized ratio Interval 0.333 to 0.625	0.41 IH normalized ratio Interval 0.256 to 0.8	0.444 IH normalized ratio Interval 0.222 to 0.688	0.456 IH normalized ratio Interval 0.322 to 0.733
Levels of WBC, NEU, LYM, MON, EOS and BAS EOS; Day 0	0.319 IH normalized ratio Interval 0.149 to 0.612	0.304 IH normalized ratio Interval 0.12 to 0.582	0.29 IH normalized ratio Interval 0.164 to 0.775	0.275 IH normalized ratio Interval 0.149 to 0.575	0.299 IH normalized ratio Interval 0.15 to 0.667
Levels of WBC, NEU, LYM, MON, EOS and BAS EOS; Day 30	0.333 IH normalized ratio Interval 0.174 to 0.612	0.4 IH normalized ratio Interval 0.16 to 0.851	0.4 IH normalized ratio Interval 0.179 to 0.806	0.35 IH normalized ratio Interval 0.225 to 0.49	0.375 IH normalized ratio Interval 0.269 to 0.716
Levels of WBC, NEU, LYM, MON, EOS and BAS EOS; Day 37	0.522 IH normalized ratio Interval 0.224 to 0.716	0.409 IH normalized ratio Interval 0.239 to 0.7	0.35 IH normalized ratio Interval 0.179 to 0.667	0.329 IH normalized ratio Interval 0.225 to 0.475	0.496 IH normalized ratio Interval 0.308 to 1.0
Levels of WBC, NEU, LYM, MON, EOS and BAS BAS; Day 0	0.353 IH normalized ratio Interval 0.118 to 0.471	0.263 IH normalized ratio Interval 0.118 to 0.4	0.286 IH normalized ratio Interval 0.176 to 0.5	0.3 IH normalized ratio Interval 0.171 to 0.4	0.353 IH normalized ratio Interval 0.229 to 0.6
Levels of WBC, NEU, LYM, MON, EOS and BAS BAS; Day 30	0.316 IH normalized ratio Interval 0.176 to 0.6	0.3 IH normalized ratio Interval 0.171 to 0.471	0.294 IH normalized ratio Interval 0.171 to 0.5	0.316 IH normalized ratio Interval 0.176 to 0.4	0.294 IH normalized ratio Interval 0.2 to 0.474
Levels of WBC, NEU, LYM, MON, EOS and BAS BAS; Day 37	0.3 IH normalized ratio Interval 0.176 to 0.5	0.351 IH normalized ratio Interval 0.249 to 0.536	0.294 IH normalized ratio Interval 0.114 to 0.4	0.377 IH normalized ratio Interval 0.211 to 0.6	0.353 IH normalized ratio Interval 0.174 to 0.5
Levels of WBC, NEU, LYM, MON, EOS and BAS BAS; Day 60	0.286 IH normalized ratio Interval 0.171 to 0.4	0.3 IH normalized ratio Interval 0.143 to 0.5	0.2 IH normalized ratio Interval 0.118 to 0.4	0.4 IH normalized ratio Interval 0.176 to 0.5	0.343 IH normalized ratio Interval 0.286 to 0.5
Levels of WBC, NEU, LYM, MON, EOS and BAS WBC; Day 0	0.465 IH normalized ratio Interval 0.258 to 0.722	0.426 IH normalized ratio Interval 0.262 to 0.79	0.413 IH normalized ratio Interval 0.246 to 0.857	0.497 IH normalized ratio Interval 0.273 to 0.722	0.672 IH normalized ratio Interval 0.344 to 0.912
Levels of WBC, NEU, LYM, MON, EOS and BAS WBC; Day 30	0.455 IH normalized ratio Interval 0.332 to 0.786	0.492 IH normalized ratio Interval 0.262 to 0.618	0.426 IH normalized ratio Interval 0.289 to 0.704	0.428 IH normalized ratio Interval 0.258 to 0.697	0.573 IH normalized ratio Interval 0.221 to 0.963
Levels of WBC, NEU, LYM, MON, EOS and BAS WBC; Day 37	0.426 IH normalized ratio Interval 0.275 to 0.826	0.455 IH normalized ratio Interval 0.293 to 0.644	0.574 IH normalized ratio Interval 0.328 to 0.784	0.405 IH normalized ratio Interval 0.243 to 0.77	0.523 IH normalized ratio Interval 0.284 to 0.81

SECONDARY outcome

Timeframe: At Days 0, 30, 37 and 60.

Population: Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.

Analysis of levels of red blood cells (RBC) and platelets (PLA) were assessed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result - lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure presents the raw data collected in absolute count, expressed in IH Center normalized levels based on absolute count data (IH normalized abs. count).

Outcome measures

Outcome measures
Measure	Engerix-B - HLA Subsets Group n=142 Participants This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 1 - Non-HLA Subsets Group n=143 Participants This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 - Non-HLA Subsets Group n=142 Participants This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 - Non-HLA Subsets Group n=141 Participants This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group n=145 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Normalized Levels of Red Blood Cells and Platelets RBC; Day 0	4.456 cells/mL Interval 4.293 to 4.65	4.45 cells/mL Interval 4.269 to 4.618	4.433 cells/mL Interval 4.265 to 4.657	4.464 cells/mL Interval 4.26 to 4.662	4.38 cells/mL Interval 4.243 to 4.6
Normalized Levels of Red Blood Cells and Platelets RBC; Day 30	4.486 cells/mL Interval 4.243 to 4.651	4.461 cells/mL Interval 4.278 to 4.584	4.382 cells/mL Interval 4.24 to 4.569	4.423 cells/mL Interval 4.257 to 4.65	4.388 cells/mL Interval 4.225 to 4.57
Normalized Levels of Red Blood Cells and Platelets RBC; Day 37	4.388 cells/mL Interval 4.23 to 4.61	4.372 cells/mL Interval 4.23 to 4.534	4.346 cells/mL Interval 4.162 to 4.514	4.395 cells/mL Interval 4.2 to 4.583	4.37 cells/mL Interval 4.206 to 4.521
Normalized Levels of Red Blood Cells and Platelets RBC; Day 60	4.4 cells/mL Interval 4.231 to 4.579	4.421 cells/mL Interval 4.243 to 4.555	4.393 cells/mL Interval 4.23 to 4.57	4.364 cells/mL Interval 4.214 to 4.579	4.371 cells/mL Interval 4.219 to 4.56
Normalized Levels of Red Blood Cells and Platelets PLA; Day 0	259000 cells/mL Interval 232000.0 to 308333.33	269318.18 cells/mL Interval 237500.0 to 309000.0	270833.33 cells/mL Interval 229000.0 to 313000.0	270000 cells/mL Interval 223333.33 to 309000.0	267187.5 cells/mL Interval 232000.0 to 325000.0
Normalized Levels of Red Blood Cells and Platelets PLA; Day 30	258333.33 cells/mL Interval 218661.97 to 302288.73	261363.64 cells/mL Interval 229166.67 to 305000.0	262000 cells/mL Interval 228000.0 to 304000.0	260470.78 cells/mL Interval 222183.1 to 317410.71	274431.82 cells/mL Interval 232071.43 to 322206.9
Normalized Levels of Red Blood Cells and Platelets PLA; Day 37	268622.45 cells/mL Interval 228000.0 to 322000.0	295000 cells/mL Interval 249166.67 to 338690.14	274431.82 cells/mL Interval 245596.15 to 333173.08	269000 cells/mL Interval 230403.85 to 321333.33	282477.27 cells/mL Interval 242500.0 to 335000.0
Normalized Levels of Red Blood Cells and Platelets PLA; Day 60	262588.03 cells/mL Interval 228000.0 to 307000.0	263333.33 cells/mL Interval 230952.38 to 307954.55	267045.46 cells/mL Interval 221666.67 to 307477.27	259000 cells/mL Interval 224038.46 to 309000.0	273239.44 cells/mL Interval 243181.82 to 328409.09

SECONDARY outcome

Timeframe: At Days 0, 30, 37 and 60.

Population: Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.

Analysis of levels of haemoglobin (Hgb), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were assessed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result - lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure presents the raw data collected in absolute count, expressed in IH Center normalized levels based on absolute count data (IH normalized abs. count).

Outcome measures

Outcome measures
Measure	Engerix-B - HLA Subsets Group n=142 Participants This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 1 - Non-HLA Subsets Group n=143 Participants This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 - Non-HLA Subsets Group n=142 Participants This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 - Non-HLA Subsets Group n=141 Participants This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group n=145 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase Hgb; Day 0	13.35 cells/mL Interval 12.825 to 13.909	13.4 cells/mL Interval 12.825 to 13.875	13.35 cells/mL Interval 12.75 to 13.9	13.4 cells/mL Interval 12.9 to 13.725	13.275 cells/mL Interval 12.7 to 13.725
Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase Hgb; Day 30	13.35 cells/mL Interval 12.73 to 13.875	13.35 cells/mL Interval 12.886 to 13.725	13.186 cells/mL Interval 12.7 to 13.725	13.275 cells/mL Interval 12.7 to 13.575	13.121 cells/mL Interval 12.501 to 13.715
Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase Hgb; Day 37	13.05 cells/mL Interval 12.5 to 13.705	13.05 cells/mL Interval 12.434 to 13.575	12.957 cells/mL Interval 12.513 to 13.382	13.025 cells/mL Interval 12.6 to 13.463	13.05 cells/mL Interval 12.525 to 13.568
Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase Hgb; Day 60	13.163 cells/mL Interval 12.545 to 13.7	13.275 cells/mL Interval 12.75 to 13.725	13.136 cells/mL Interval 12.468 to 13.675	13.1 cells/mL Interval 12.6 to 13.575	12.975 cells/mL Interval 12.467 to 13.568
Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase ALT; Day 0	21.32 cells/mL Interval 16.0 to 31.16	21.086 cells/mL Interval 15.5 to 31.061	18.792 cells/mL Interval 13.968 to 27.675	18.636 cells/mL Interval 14.9 to 25.42	21.8 cells/mL Interval 15.6 to 29.294
Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase ALT; Day 30	18.743 cells/mL Interval 14.9 to 26.8	21.32 cells/mL Interval 15.375 to 32.303	18.743 cells/mL Interval 13.12 to 26.2	19.897 cells/mL Interval 14.548 to 26.9	20.5 cells/mL Interval 15.375 to 27.89
Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase ALT; Day 37	19.8 cells/mL Interval 14.76 to 27.88	21.221 cells/mL Interval 15.623 to 33.061	18.767 cells/mL Interval 13.021 to 25.574	18.596 cells/mL Interval 13.999 to 26.917	20.7 cells/mL Interval 15.229 to 27.06
Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase ALT; Day 60	18.518 cells/mL Interval 13.94 to 28.7	21.161 cells/mL Interval 14.909 to 29.042	17.447 cells/mL Interval 13.16 to 24.848	18.07 cells/mL Interval 13.146 to 27.333	20.541 cells/mL Interval 15.58 to 28.576
Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase AST; Day 0	20.478 cells/mL Interval 17.8 to 24.8	21 cells/mL Interval 18.0 to 25.065	20 cells/mL Interval 16.28 to 24.9	20 cells/mL Interval 17.0 to 23.727	21 cells/mL Interval 16.71 to 24.8
Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase AST; Day 30	19.097 cells/mL Interval 16.71 to 23.871	20.72 cells/mL Interval 18.0 to 27.0	19.24 cells/mL Interval 16.28 to 23.7	20.188 cells/mL Interval 17.76 to 24.314	20 cells/mL Interval 16.555 to 25.032
Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase AST; Day 37	20 cells/mL Interval 16.28 to 23.68	20.881 cells/mL Interval 17.01 to 25.371	19.097 cells/mL Interval 15.35 to 23.433	20.043 cells/mL Interval 17.267 to 22.97	20 cells/mL Interval 16.5 to 25.065
Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase AST; Day 60	19.339 cells/mL Interval 16.6 to 24.314	20.72 cells/mL Interval 17.02 to 24.667	17.986 cells/mL Interval 14.971 to 22.45	20.76 cells/mL Interval 16.313 to 23.871	21 cells/mL Interval 17.0 to 24.314

SECONDARY outcome

Timeframe: At Days 0, 30, 37 and 60.

Population: Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.

Analysis of levels of serum creatinine (S-CREA), urea and lactate dehydrogenase (LDH) were assessed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result - lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure presents the raw data collected in absolute count, expressed in IH Center normalized levels based on absolute count data (IH normalized abs. count).

Outcome measures

Outcome measures
Measure	Engerix-B - HLA Subsets Group n=142 Participants This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 1 - Non-HLA Subsets Group n=143 Participants This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 - Non-HLA Subsets Group n=142 Participants This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 - Non-HLA Subsets Group n=141 Participants This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group n=145 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase S-CREA; Day 0	0.85 cells/mL Interval 0.718 to 1.043	0.893 cells/mL Interval 0.745 to 1.046	0.841 cells/mL Interval 0.705 to 0.982	0.889 cells/mL Interval 0.76 to 1.02	0.86 cells/mL Interval 0.722 to 1.025
Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase S-CREA, at Day 30	0.87 cells/mL Interval 0.73 to 1.05	0.9 cells/mL Interval 0.764 to 1.044	0.84 cells/mL Interval 0.7 to 0.983	0.874 cells/mL Interval 0.74 to 1.03	0.888 cells/mL Interval 0.718 to 1.046
Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase S-CREA; Day 37	0.909 cells/mL Interval 0.741 to 1.034	0.906 cells/mL Interval 0.737 to 1.037	0.83 cells/mL Interval 0.701 to 0.98	0.883 cells/mL Interval 0.719 to 1.042	0.92 cells/mL Interval 0.74 to 1.043
Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase S-CREA; Day 60	0.915 cells/mL Interval 0.77 to 1.05	0.92 cells/mL Interval 0.75 to 1.063	0.84 cells/mL Interval 0.727 to 1.003	0.873 cells/mL Interval 0.757 to 1.043	0.934 cells/mL Interval 0.76 to 1.052
Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase UREA; Day 0	29.202 cells/mL Interval 25.11 to 33.6	29.5 cells/mL Interval 25.333 to 33.5	28.667 cells/mL Interval 24.895 to 32.833	30.095 cells/mL Interval 25.7 to 34.5	30 cells/mL Interval 26.167 to 34.5
Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase UREA; Day 30	30.095 cells/mL Interval 24.692 to 34.5	30.127 cells/mL Interval 25.946 to 33.667	28.667 cells/mL Interval 25.333 to 32.988	30.462 cells/mL Interval 26.524 to 34.5	30.048 cells/mL Interval 26.293 to 34.404
Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase UREA; Day 37	28.667 cells/mL Interval 25.11 to 33.7	29.5 cells/mL Interval 25.1 to 33.533	27.833 cells/mL Interval 23.623 to 31.183	30.333 cells/mL Interval 25.791 to 34.5	31 cells/mL Interval 26.9 to 34.5
Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase UREA; Day 60	29.65 cells/mL Interval 25.4 to 33.5	29.8 cells/mL Interval 24.692 to 33.875	28.905 cells/mL Interval 24.895 to 33.35	29.5 cells/mL Interval 26.0 to 34.5	30.095 cells/mL Interval 26.6 to 34.308
Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase LHD; Day 0	325.85 cells/mL Interval 285.0 to 372.069	336.364 cells/mL Interval 281.169 to 381.973	335.281 cells/mL Interval 283.1 to 372.0	328.3 cells/mL Interval 278.231 to 368.831	336.054 cells/mL Interval 291.991 to 384.156
Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase LHD; Day 30	320.671 cells/mL Interval 285.498 to 374.479	343.75 cells/mL Interval 298.9 to 389.063	329.6 cells/mL Interval 283.333 to 375.0	330.32 cells/mL Interval 290.6 to 364.966	337.428 cells/mL Interval 289.068 to 385.753
Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase LHD; Day 37	319.048 cells/mL Interval 282.251 to 375.0	348.894 cells/mL Interval 297.246 to 388.037	342.857 cells/mL Interval 288.8 to 380.0	331.967 cells/mL Interval 293.45 to 373.089	340.606 cells/mL Interval 289.5 to 378.0
Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase LHD; Day 60	320.927 cells/mL Interval 285.526 to 382.9	341.975 cells/mL Interval 296.32 to 391.0	335.141 cells/mL Interval 270.7 to 376.435	324.675 cells/mL Interval 278.2 to 366.146	348.438 cells/mL Interval 295.2 to 378.571

SECONDARY outcome

Timeframe: At Day 0 and up to Day 60.

Population: Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.

Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), C-reactive protein (CRP) and creatine phosphokinase (CPK) at the Day 0 baseline versus their status post vaccination (Day 60). This outcome measure concerns solely subjects part of the HLA Subsets 1 \& 2 who received the Day 360 booster dose of HBsAg.

Outcome measures

Outcome measures
Measure	Engerix-B - HLA Subsets Group n=75 Participants This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 1 - Non-HLA Subsets Group n=75 Participants This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 - Non-HLA Subsets Group n=74 Participants This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 - Non-HLA Subsets Group n=75 Participants This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group n=74 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. BAS Abn. Day 0 - Abn. Day 60	4 Participants	3 Participants	2 Participants	2 Participants	3 Participants
Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. BAS Abn. Day 0 - Nor. Day 60	0 Participants	0 Participants	0 Participants	2 Participants	2 Participants
Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. BAS Nor. Day 0 - Abn. Day 60	7 Participants	11 Participants	10 Participants	9 Participants	5 Participants
Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. BAS Nor. Day 0 - Nor. Day 60	64 Participants	61 Participants	62 Participants	62 Participants	64 Participants
Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. CPK Abn. Day 0 - Abn. Day 60	8 Participants	12 Participants	11 Participants	13 Participants	12 Participants
Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. CPK Abn. Day 0 - Nor. Day 60	2 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. CPK Nor. Day 0 - Abn. Day 60	14 Participants	21 Participants	9 Participants	18 Participants	20 Participants
Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. CPK Nor. Day 0 - Nor. Day 60	51 Participants	42 Participants	54 Participants	44 Participants	40 Participants
Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. CRP Abn. Day 0 - Abn. Day 60	3 Participants	3 Participants	8 Participants	5 Participants	4 Participants
Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. CRP Abn. Day 0 - Nor. Day 60	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. CRP Nor. Day 0 - Abn. Day 60	8 Participants	56 Participants	33 Participants	22 Participants	14 Participants
Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. CRP Nor. Day 0 - Nor. Day 60	62 Participants	16 Participants	33 Participants	48 Participants	56 Participants
Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. EOS Abn. Day 0 - Abn. Day 60]	3 Participants	3 Participants	6 Participants	3 Participants	7 Participants
Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. EOS Abn. Day 0 - Nor. Day 60	1 Participants	1 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. EOS Nor. Day 0 - Abn. Day 60	6 Participants	13 Participants	9 Participants	6 Participants	6 Participants
Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. EOS Nor. Day 0 - Nor. Day 60	65 Participants	58 Participants	59 Participants	65 Participants	60 Participants
Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. LYM Abn. Day 0 - Abn. Day 60	5 Participants	10 Participants	6 Participants	7 Participants	6 Participants
Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. LYM Abn. Day 0 - Nor. Day 60	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. LYM Nor. Day 0 - Abn. Day 60	10 Participants	30 Participants	29 Participants	16 Participants	11 Participants
Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. LYM Nor. Day 0 - Nor. Day 60	59 Participants	35 Participants	39 Participants	51 Participants	56 Participants
Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. MON Abn. Day 0 - Abn. Day 60	0 Participants	1 Participants	3 Participants	4 Participants	4 Participants
Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. MON Abn. Day 0 - Nor. Day 60	0 Participants	0 Participants	2 Participants	3 Participants	0 Participants
Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. MON Nor. Day 0 - Abn. Day 60	6 Participants	29 Participants	15 Participants	12 Participants	8 Participants
Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. MON Nor. Day 0 - Nor. Day 60	69 Participants	45 Participants	54 Participants	56 Participants	62 Participants
Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. NEU Abn. Day 0 - Abn. Day 60	0 Participants	7 Participants	2 Participants	3 Participants	3 Participants
Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. NEU Abn. Day 0 - Nor. Day 60	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. NEU Nor. Day 0 - Abn. Day 60	8 Participants	32 Participants	27 Participants	19 Participants	13 Participants
Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. NEU Nor. Day 0 - Nor. Day 60	67 Participants	36 Participants	44 Participants	53 Participants	57 Participants
Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. WBC Abn. Day 0 - Abn. Day 60	6 Participants	6 Participants	5 Participants	9 Participants	2 Participants
Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. WBC Abn. Day 0 - Nor. Day 60	1 Participants	0 Participants	1 Participants	1 Participants	1 Participants
Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. WBC Nor. Day 0 - Abn. Day 60	14 Participants	30 Participants	26 Participants	19 Participants	19 Participants
Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. WBC Nor. Day 0 - Nor. Day 60	54 Participants	39 Participants	42 Participants	46 Participants	52 Participants

SECONDARY outcome

Timeframe: At Day 0 and up to Day 60.

Population: Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.

Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), C-reactive protein (CRP) and creatine phosphokinase (CPK) at the Day 0 baseline versus their status post vaccination (Day 60). This outcome measure concerns all subjects except subjects part of the HLA Subsets 1 and 2.

Outcome measures

Outcome measures
Measure	Engerix-B - HLA Subsets Group n=66 Participants This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 1 - Non-HLA Subsets Group n=68 Participants This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 - Non-HLA Subsets Group n=67 Participants This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 - Non-HLA Subsets Group n=65 Participants This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group n=70 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. EOS Nor. Day 0 - Nor. Day 60	51 Participants	51 Participants	49 Participants	52 Participants	50 Participants
Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. CRP Nor. Day 0 - Abn. Day 60	6 Participants	6 Participants	9 Participants	9 Participants	4 Participants
Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. CRP Nor. Day 0 - Nor. Day 60	50 Participants	51 Participants	42 Participants	45 Participants	58 Participants
Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. EOS Nor. Day 0 - Abn. Day 60	8 Participants	8 Participants	8 Participants	8 Participants	14 Participants
Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. EOS Abn. Day 0 - Nor. Day 60	2 Participants	1 Participants	3 Participants	0 Participants	2 Participants
Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. BAS Abn. Day 0 - Nor. Day 60	2 Participants	3 Participants	0 Participants	1 Participants	3 Participants
Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. BAS Nor. Day 0 - Abn. Day 60	3 Participants	5 Participants	6 Participants	3 Participants	6 Participants
Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. BAS Nor. Day 0 - Nor. Day 60	60 Participants	59 Participants	56 Participants	60 Participants	58 Participants
Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. CPK Abn. Day 0 - Abn. Day 60	11 Participants	10 Participants	6 Participants	12 Participants	8 Participants
Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. CPK Abn. Day 0 - Nor. Day 60	6 Participants	2 Participants	1 Participants	6 Participants	5 Participants
Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. CPK Nor. Day 0 - Abn. Day 60	12 Participants	14 Participants	9 Participants	9 Participants	12 Participants
Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. CPK Nor. Day 0 - Nor. Day 60	37 Participants	42 Participants	51 Participants	38 Participants	45 Participants
Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. CRP Abn. Day 0 - Abn. Day 60	5 Participants	5 Participants	11 Participants	8 Participants	4 Participants
Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. CRP Abn. Day 0 - Nor. Day 60	3 Participants	3 Participants	1 Participants	1 Participants	1 Participants
Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. LYM Abn. Day 0 - Abn. Day 60	7 Participants	5 Participants	4 Participants	6 Participants	9 Participants
Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. LYM Abn. Day 0 - Nor. Day 60	4 Participants	3 Participants	6 Participants	1 Participants	5 Participants
Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. LYM Nor. Day 0 - Abn. Day 60	12 Participants	10 Participants	10 Participants	13 Participants	6 Participants
Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. LYM Nor. Day 0 - Nor. Day 60	43 Participants	50 Participants	46 Participants	45 Participants	50 Participants
Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. MON Abn. Day 0 - Abn. Day 60	2 Participants	0 Participants	2 Participants	3 Participants	2 Participants
Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. MON Abn. Day 0 - Nor. Day 60	1 Participants	4 Participants	1 Participants	0 Participants	2 Participants
Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. MON Nor. Day 0 - Abn. Day 60	6 Participants	8 Participants	9 Participants	9 Participants	4 Participants
Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. MON Nor. Day 0 - Nor. Day 60	57 Participants	56 Participants	54 Participants	53 Participants	62 Participants
Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. NEU Abn. Day 0 - Abn. Day 60	5 Participants	3 Participants	4 Participants	3 Participants	3 Participants
Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. NEU Abn. Day 0 - Nor. Day 60	3 Participants	2 Participants	4 Participants	3 Participants	3 Participants
Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. NEU Nor. Day 0 - Abn. Day 60	5 Participants	9 Participants	12 Participants	17 Participants	13 Participants
Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. NEU Nor. Day 0 - Nor. Day 60	53 Participants	54 Participants	46 Participants	42 Participants	51 Participants
Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. WBC Abn. Day 0 - Abn. Day 60	8 Participants	5 Participants	7 Participants	5 Participants	11 Participants
Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. WBC Abn. Day 0 - Nor. Day 60	1 Participants	2 Participants	3 Participants	4 Participants	1 Participants
Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. WBC Nor. Day 0 - Abn. Day 60	6 Participants	7 Participants	7 Participants	7 Participants	10 Participants
Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. WBC Nor. Day 0 - Nor. Day 60	51 Participants	54 Participants	50 Participants	49 Participants	48 Participants
Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. BAS Abn. Day 0 - Abn. Day 60	1 Participants	1 Participants	4 Participants	1 Participants	3 Participants
Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. EOS Abn. Day 0 - Abn. Day 60	5 Participants	8 Participants	6 Participants	5 Participants	4 Participants

SECONDARY outcome

Timeframe: Post vaccination (up to Day 360)

Population: Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.

Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), C-reactive protein (CRP) and creatine phosphokinase (CPK) at the Day 0 baseline versus their status post vaccination (Day 180 or 360). Day 180 or 360 results were chosen based on assessment of grading of the abnormality observed, with results for higher grading being tabulated.

Outcome measures

Outcome measures
Measure	Engerix-B - HLA Subsets Group n=135 Participants This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 1 - Non-HLA Subsets Group n=138 Participants This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 - Non-HLA Subsets Group n=140 Participants This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 - Non-HLA Subsets Group n=131 Participants This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group n=133 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. BAS Abn.	12 Subjects	12 Subjects	13 Subjects	13 Subjects	11 Subjects
Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. BAS Nor.	123 Subjects	126 Subjects	127 Subjects	118 Subjects	122 Subjects
Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. CPK Abn.	37 Subjects	35 Subjects	25 Subjects	36 Subjects	38 Subjects
Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. CPK Nor.	98 Subjects	103 Subjects	115 Subjects	95 Subjects	95 Subjects
Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. EOS Abn.	10 Subjects	13 Subjects	20 Subjects	20 Subjects	19 Subjects
Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. EOS Nor.	125 Subjects	125 Subjects	120 Subjects	111 Subjects	114 Subjects
Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. LYM Abn.	25 Subjects	19 Subjects	22 Subjects	19 Subjects	22 Subjects
Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. LYM Nor.	110 Subjects	119 Subjects	118 Subjects	112 Subjects	111 Subjects
Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. MON Abn.	9 Subjects	12 Subjects	10 Subjects	13 Subjects	14 Subjects
Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. MON Nor.	126 Subjects	126 Subjects	130 Subjects	118 Subjects	119 Subjects
Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. NEU Abn.	15 Subjects	14 Subjects	18 Subjects	24 Subjects	16 Subjects
Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. NEU Nor.	120 Subjects	124 Subjects	122 Subjects	107 Subjects	117 Subjects
Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. WBC Abn.	20 Subjects	20 Subjects	18 Subjects	25 Subjects	14 Subjects
Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase. WBC Nor.	115 Subjects	118 Subjects	122 Subjects	106 Subjects	119 Subjects

SECONDARY outcome

Timeframe: At Days 360 and 390.

Population: Analysis was done on the Booster Total Vaccinated cohort which included all HLA Subsets 1 and 2 subjects who received the booster dose of HBsAg.

Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), C-reactive protein (CRP) and creatine phosphokinase (CPK) at the Day 360 baseline versus their status post vaccination (Day 390). This outcome measure concerns solely subjects part of the HLA Subsets 1 \& 2 who received the Day 360 booster dose of HBsAg.

Outcome measures

Outcome measures
Measure	Engerix-B - HLA Subsets Group n=54 Participants This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 1 - Non-HLA Subsets Group n=59 Participants This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 - Non-HLA Subsets Group n=56 Participants This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 - Non-HLA Subsets Group n=56 Participants This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group n=54 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. BAS Abn. Day 360 - Abn. Day 390	1 Participants	2 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. BAS Abn. Day 360 - Nor. Day 390	1 Participants	1 Participants	3 Participants	2 Participants	1 Participants
Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. BAS Nor. Day 360 - Abn. Day 390	2 Participants	1 Participants	1 Participants	4 Participants	1 Participants
Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. BAS Nor. Day 360 - Nor. Day 390	50 Participants	55 Participants	51 Participants	50 Participants	52 Participants
Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. CPK Abn. Day 360 - Abn. Day 390	5 Participants	10 Participants	0 Participants	4 Participants	3 Participants
Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. CPK Abn. Day 360 - Nor. Day 390	1 Participants	5 Participants	4 Participants	7 Participants	3 Participants
Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. CPK Nor. Day 360 - Abn. Day 390	1 Participants	5 Participants	2 Participants	7 Participants	10 Participants
Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. CPK Nor. Day 360 - Nor. Day 390	46 Participants	39 Participants	50 Participants	38 Participants	39 Participants
Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. EOS Abn. Day 360 - Abn. Day 390	0 Participants	0 Participants	1 Participants	1 Participants	3 Participants
Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. EOS Abn. Day 360 - Nor. Day 390	0 Participants	2 Participants	1 Participants	1 Participants	1 Participants
Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. EOS Nor. Day 360 - Abn. Day 390	1 Participants	1 Participants	3 Participants	1 Participants	0 Participants
Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. EOS Nor. Day 360 - Nor. Day 390	53 Participants	56 Participants	51 Participants	53 Participants	50 Participants
Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. LYM Abn. Day 360 - Abn. Day 390	5 Participants	5 Participants	2 Participants	5 Participants	4 Participants
Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. LYM Abn. Day 360 - Nor. Day 390	2 Participants	4 Participants	3 Participants	3 Participants	0 Participants
Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. LYM Nor. Day 360 - Abn. Day 390	1 Participants	3 Participants	3 Participants	1 Participants	3 Participants
Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. LYM Nor. Day 360 - Nor. Day 390	46 Participants	47 Participants	48 Participants	47 Participants	47 Participants
Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. MON Abn. Day 360 - Abn. Day 390	0 Participants	0 Participants	1 Participants	1 Participants	2 Participants
Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. MON Abn. Day 360 - Nor. Day 390	1 Participants	1 Participants	0 Participants	2 Participants	1 Participants
Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. MON Nor. Day 360 - Abn. Day 390	0 Participants	2 Participants	1 Participants	1 Participants	2 Participants
Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. MON Nor. Day 360 - Nor. Day 390	53 Participants	56 Participants	54 Participants	52 Participants	49 Participants
Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. NEU Abn. Day 360 - Abn. Day 390	0 Participants	4 Participants	0 Participants	2 Participants	2 Participants
Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. NEU Abn. Day 360 - Nor. Day 390	3 Participants	4 Participants	4 Participants	3 Participants	2 Participants
Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. NEU Nor. Day 360 - Abn. Day 390	2 Participants	4 Participants	2 Participants	0 Participants	3 Participants
Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. NEU Nor. Day 360 - Nor. Day 390	49 Participants	47 Participants	50 Participants	51 Participants	47 Participants
Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. WBC Abn. Day 360 - Abn. Day 390	2 Participants	3 Participants	1 Participants	4 Participants	1 Participants
Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. WBC Abn. Day 360 - Nor. Day 390	3 Participants	6 Participants	2 Participants	4 Participants	1 Participants
Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. WBC Nor. Day 360 - Abn. Day 390	2 Participants	6 Participants	2 Participants	2 Participants	2 Participants
Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK. WBC Nor. Day 360 - Nor. Day 390	47 Participants	44 Participants	51 Participants	46 Participants	50 Participants

SECONDARY outcome

Timeframe: At Day 0 and up to Day 60.

Population: Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.

Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of red blood cells (RBC), platelets (PLA), haemoglobin (HGB), alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum creatinine (S-CREA), urea and lactate dehydrogenase (LDH) at the Day 0 baseline versus their status post vaccination (Day 60).

Outcome measures

Outcome measures
Measure	Engerix-B - HLA Subsets Group n=139 Participants This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 1 - Non-HLA Subsets Group n=141 Participants This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 - Non-HLA Subsets Group n=141 Participants This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 - Non-HLA Subsets Group n=138 Participants This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group n=141 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase PLA Nor. Day 0 - Nor. Day 60	126 Participants	122 Participants	122 Participants	122 Participants	122 Participants
Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase ALT Abn. Day 0 - Nor. Day 60	5 Participants	1 Participants	4 Participants	4 Participants	7 Participants
Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase ALT Nor. Day 0 - Abn. Day 60	9 Participants	12 Participants	5 Participants	10 Participants	8 Participants
Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase S-CREA Abn. Day 0 - Abn. Day 60	12 Participants	4 Participants	3 Participants	4 Participants	6 Participants
Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase S-CREA Abn. Day 0 - Nor. Day 60	3 Participants	1 Participants	3 Participants	3 Participants	1 Participants
Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase S-CREA Nor. Day 0 - Abn. Day 60	5 Participants	8 Participants	8 Participants	7 Participants	12 Participants
Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase AST Nor. Day 0 - Nor. Day 60	128 Participants	125 Participants	136 Participants	128 Participants	129 Participants
Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase HGB Abn. Day 0 - Abn. Day 60	9 Participants	15 Participants	9 Participants	8 Participants	11 Participants
Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase HGB Abn. Day 0 - Nor. Day 60	4 Participants	4 Participants	6 Participants	4 Participants	2 Participants
Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase HGB Nor. Day 0 - Abn. Day 60	16 Participants	10 Participants	13 Participants	11 Participants	9 Participants
Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase HGB Nor. Day 0 - Nor. Day 60	110 Participants	112 Participants	113 Participants	115 Participants	119 Participants
Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase LDH Abn. Day 0 - Abn. Day 60	8 Participants	10 Participants	7 Participants	5 Participants	2 Participants
Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase LDH Abn. Day 0 - Nor. Day 60	1 Participants	1 Participants	1 Participants	1 Participants	6 Participants
Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase LDH Nor. Day 0 - Abn. Day 60	9 Participants	11 Participants	9 Participants	6 Participants	9 Participants
Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase LDH Nor. Day 0 - Nor. Day 60	121 Participants	119 Participants	123 Participants	126 Participants	124 Participants
Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase PLA Abn. Day 0 - Abn. Day 60	7 Participants	9 Participants	8 Participants	6 Participants	8 Participants
Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase PLA Abn. Day 0 - Nor. Day 60	1 Participants	1 Participants	0 Participants	0 Participants	3 Participants
Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase PLA Nor. Day 0 - Abn. Day 60	5 Participants	9 Participants	11 Participants	10 Participants	8 Participants
Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase RBC Abn. Day 0 - Abn. Day 60	4 Participants	5 Participants	9 Participants	2 Participants	2 Participants
Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase RBC Abn. Day 0 - Nor. Day 60	5 Participants	2 Participants	4 Participants	6 Participants	4 Participants
Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase RBC Nor. Day 0 - Abn. Day 60	6 Participants	7 Participants	12 Participants	17 Participants	14 Participants
Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase RBC Nor. Day 0 - Nor. Day 60	124 Participants	127 Participants	116 Participants	113 Participants	121 Participants
Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase S-CREA Nor. Day 0 - Nor. Day 60	119 Participants	128 Participants	127 Participants	124 Participants	122 Participants
Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase UREA Abn. Day 0 - Abn. Day 60	3 Participants	2 Participants	2 Participants	4 Participants	8 Participants
Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase UREA Abn. Day 0 - Nor. Day 60	3 Participants	4 Participants	1 Participants	5 Participants	3 Participants
Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase UREA Nor. Day 0 - Abn. Day 60	8 Participants	18 Participants	11 Participants	16 Participants	14 Participants
Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase UREA Nor. Day 0 - Nor. Day 60	125 Participants	117 Participants	127 Participants	113 Participants	116 Participants
Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase ALT Abn. Day 0 - Abn. Day 60	12 Participants	15 Participants	10 Participants	9 Participants	6 Participants
Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase ALT Nor. Day 0 - Nor. Day 60	113 Participants	113 Participants	122 Participants	115 Participants	120 Participants
Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase AST Abn. Day 0 - Abn. Day 60	3 Participants	4 Participants	3 Participants	1 Participants	1 Participants
Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase AST Abn. Day 0 - Nor. Day 60	2 Participants	0 Participants	1 Participants	2 Participants	3 Participants
Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase AST Nor. Day 0 - Abn. Day 60	6 Participants	12 Participants	1 Participants	7 Participants	8 Participants

SECONDARY outcome

Timeframe: post vaccination (up to Day 360).

Population: Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.

Outcome measures

Outcome measures
Measure	Engerix-B - HLA Subsets Group n=135 Participants This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 1 - Non-HLA Subsets Group n=138 Participants This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 - Non-HLA Subsets Group n=140 Participants This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 - Non-HLA Subsets Group n=131 Participants This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group n=133 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH RBC Nor.	123 Participants	123 Participants	120 Participants	115 Participants	126 Participants
Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH S-CREA Abn.	18 Participants	11 Participants	11 Participants	12 Participants	9 Participants
Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH S-CREA Nor.	117 Participants	127 Participants	129 Participants	119 Participants	124 Participants
Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH UREA Abn.	8 Participants	11 Participants	14 Participants	19 Participants	17 Participants
Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH UREA Nor.	127 Participants	127 Participants	126 Participants	112 Participants	116 Participants
Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH AST Nor.	126 Participants	127 Participants	135 Participants	122 Participants	128 Participants
Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH HGB Abn.	15 Participants	24 Participants	13 Participants	12 Participants	17 Participants
Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH HGB Nor.	120 Participants	114 Participants	127 Participants	119 Participants	116 Participants
Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH LDH Abn.	11 Participants	10 Participants	14 Participants	10 Participants	4 Participants
Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH LDH Nor.	124 Participants	128 Participants	126 Participants	121 Participants	129 Participants
Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH PLA Abn.	10 Participants	11 Participants	9 Participants	7 Participants	13 Participants
Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH PLA Nor.	125 Participants	127 Participants	131 Participants	124 Participants	120 Participants
Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH RBC Abn.	12 Participants	15 Participants	20 Participants	16 Participants	7 Participants
Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH ALT Abn.	17 Participants	26 Participants	17 Participants	18 Participants	23 Participants
Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH ALT Nor.	118 Participants	112 Participants	123 Participants	113 Participants	110 Participants
Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH AST Abn.	9 Participants	11 Participants	5 Participants	9 Participants	5 Participants

SECONDARY outcome

Timeframe: At Days 360 and 390.

Population: Analysis was done on the Booster Total Vaccinated cohort which included all HLA Subsets 1 and 2 subjects who received the booster dose of HBsAg.

Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of red blood cells (RBC), platelets (PLA), haemoglobin (HGB), alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum creatinine (S-CREA), urea and lactate dehydrogenase (LDH) at the Day 360 baseline versus their status post vaccination (Day 390). This outcome measure concerns solely subjects part of the HLA Subsets 1 \& 2 who received the Day 360 booster dose of HBsAg.

Outcome measures

Outcome measures
Measure	Engerix-B - HLA Subsets Group n=53 Participants This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 1 - Non-HLA Subsets Group n=59 Participants This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 - Non-HLA Subsets Group n=56 Participants This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 - Non-HLA Subsets Group n=54 Participants This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group n=55 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase ALT Nor. Day 360 - Nor. Day 390	49 Participants	51 Participants	51 Participants	46 Participants	45 Participants
Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase ALT Abn. Day 360 - Abn. Day 390	3 Participants	4 Participants	2 Participants	6 Participants	3 Participants
Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase ALT Abn. Day 360 - Nor. Day 390	1 Participants	3 Participants	1 Participants	4 Participants	2 Participants
Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase ALT Nor. Day 360 - Abn. Day 390	0 Participants	1 Participants	2 Participants	0 Participants	5 Participants
Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase AST Abn. Day 360 - Abn. Day 390	0 Participants	2 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase AST Abn. Day 360 - Nor. Day 390	1 Participants	2 Participants	0 Participants	3 Participants	0 Participants
Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase AST Nor. Day 360 - Abn. Day 390	1 Participants	3 Participants	2 Participants	1 Participants	4 Participants
Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase AST Nor. Day 360 - Nor. Day 390	51 Participants	52 Participants	54 Participants	51 Participants	51 Participants
Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase HGB Abn. Day 360 - Abn. Day 390	4 Participants	2 Participants	2 Participants	2 Participants	3 Participants
Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase HGB Nor. Day 360 - Abn. Day 390	2 Participants	2 Participants	0 Participants	1 Participants	2 Participants
Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase HGB Nor. Day 360 - Nor. Day 390	47 Participants	53 Participants	53 Participants	53 Participants	48 Participants
Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase PLA Abn. Day 360 - Nor. Day 390	0 Participants	1 Participants	1 Participants	2 Participants	2 Participants
Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase S-CREA Nor. Day 360 - Nor. Day 390	47 Participants	58 Participants	56 Participants	53 Participants	50 Participants
Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase UREA Abn. Day 360 - Abn. Day 390	1 Participants	2 Participants	0 Participants	2 Participants	1 Participants
Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase LDH Abn. Day 360 - Abn. Day 390	1 Participants	2 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase UREA Nor. Day 360 - Abn. Day 390	1 Participants	1 Participants	4 Participants	2 Participants	0 Participants
Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase HGB Abn. Day 360 - Nor. Day 390	1 Participants	2 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase LDH Abn. Day 360 - Nor. Day 390	1 Participants	2 Participants	0 Participants	3 Participants	0 Participants
Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase LDH Nor. Day 360 - Abn. Day 390	0 Participants	1 Participants	0 Participants	2 Participants	3 Participants
Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase LDH Nor. Day 360 - Nor. Day 390	51 Participants	54 Participants	55 Participants	51 Participants	52 Participants
Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase PLA Abn. Day 360 - Abn. Day 390	4 Participants	3 Participants	0 Participants	0 Participants	3 Participants
Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase PLA Nor. Day 360 - Abn. Day 390	0 Participants	3 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase PLA Nor. Day 360 - Nor. Day 390	50 Participants	52 Participants	55 Participants	53 Participants	48 Participants
Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase RBC Abn. Day 360 - Abn. Day 390	4 Participants	1 Participants	2 Participants	1 Participants	1 Participants
Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase RBC Abn. Day 360 - Nor. Day 390	0 Participants	1 Participants	2 Participants	2 Participants	2 Participants
Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase RBC Nor. Day 360 - Abn. Day 390	0 Participants	2 Participants	1 Participants	3 Participants	3 Participants
Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase RBC Nor. Day 360 - Nor. Day 390	50 Participants	55 Participants	51 Participants	50 Participants	48 Participants
Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase S-CREA Abn. Day 360 - Abn. Day 390	3 Participants	0 Participants	0 Participants	2 Participants	1 Participants
Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase S-CREA Abn. Day 360 - Nor. Day 390	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase S-CREA Nor. Day 360 - Abn. Day 390	2 Participants	1 Participants	0 Participants	0 Participants	3 Participants
Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase UREA Abn. Day 360 - Nor. Day 390	3 Participants	1 Participants	4 Participants	5 Participants	4 Participants
Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase UREA Nor. Day 360 - Nor. Day 390	48 Participants	55 Participants	48 Participants	47 Participants	50 Participants

SECONDARY outcome

Timeframe: Within the 14-day (Days 0-13) follow up period following primary vaccination with the GSK223192A, Fendrix™ or Engerix-B™ vaccines.

Population: Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, with analysis performed solely on subjects with results from post-primary vaccination available.

Solicited local symptoms assessed were pain, redness and swelling. All solicited local symptoms were considered as related to study vaccination. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above (\>) 50 millimeters (mm). Occurrence of a solicited local symptoms collected post-vaccination was a priori considered as related to vaccination.

Outcome measures

Outcome measures
Measure	Engerix-B - HLA Subsets Group n=139 Participants This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 1 - Non-HLA Subsets Group n=142 Participants This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 - Non-HLA Subsets Group n=140 Participants This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 - Non-HLA Subsets Group n=138 Participants This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group n=143 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Primary Vaccination. Any Redness	23 Participants	71 Participants	39 Participants	35 Participants	53 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Primary Vaccination. Redness > 50 mm	0 Participants	11 Participants	2 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Primary Vaccination. Any Swelling	16 Participants	46 Participants	36 Participants	34 Participants	43 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Primary Vaccination. Swelling > 50 mm	0 Participants	9 Participants	3 Participants	2 Participants	2 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Primary Vaccination. Any Pain	70 Participants	134 Participants	129 Participants	123 Participants	128 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Primary Vaccination. Grade 3 Pain	0 Participants	9 Participants	5 Participants	2 Participants	6 Participants

SECONDARY outcome

Timeframe: Within the 14-day (Days 0-13) follow up period following primary vaccination with the GSK223192A, Fendrix™ or Engerix-B™ vaccine.

Population: Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, with analysis performed solely on subjects with results from post-primary vaccination available.

Solicited general symptoms assessed were Fatigue, Fever - oral temperature equal to or above (\>=) 37.5 degrees Celsius (°C) -, Gastrointestinal symptoms (Gastr.), Headache, Malaise and Myalgia. Any = occurrence of a general symptom regardless of its intensity grade or relationship to vaccination. Related = occurrence of a general symptom assessed by the investigator to be causally related to vaccination. Grade 3 fever = oral temperature above (\>) 39.0 °C. Grade 3 for Gastr., Headache, Malaise and Myalgia = occurrence of the specified solicited general symptom which prevented normal activity.

Outcome measures

Outcome measures
Measure	Engerix-B - HLA Subsets Group n=139 Participants This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 1 - Non-HLA Subsets Group n=142 Participants This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 - Non-HLA Subsets Group n=140 Participants This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 - Non-HLA Subsets Group n=138 Participants This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group n=144 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. Related Headache	35 Participants	74 Participants	52 Participants	46 Participants	41 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. Grade 3 Malaise	2 Participants	9 Participants	5 Participants	4 Participants	4 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. Grade 3 Myalgia	2 Participants	10 Participants	4 Participants	3 Participants	2 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. Related Fever	5 Participants	42 Participants	17 Participants	17 Participants	6 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. Any Gastr.	35 Participants	30 Participants	27 Participants	29 Participants	36 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. Any Fatigue	62 Participants	91 Participants	76 Participants	67 Participants	70 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. Grade 3 Fatigue	3 Participants	5 Participants	5 Participants	5 Participants	4 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. Related Fatigue	42 Participants	83 Participants	67 Participants	57 Participants	55 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. Any Fever	17 Participants	45 Participants	23 Participants	24 Participants	12 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. Grade 3 Fever	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. Grade 3 Gastr.	7 Participants	2 Participants	5 Participants	5 Participants	4 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. Related Gastr.	19 Participants	21 Participants	13 Participants	19 Participants	20 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. Any Headache	59 Participants	90 Participants	67 Participants	66 Participants	62 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. Grade 3 Headache	5 Participants	8 Participants	6 Participants	8 Participants	3 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. Any Malaise	28 Participants	60 Participants	44 Participants	39 Participants	35 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. Related Malaise	16 Participants	53 Participants	36 Participants	30 Participants	27 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. Any Myalgia	34 Participants	85 Participants	57 Participants	55 Participants	58 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination. Related Myalgia	22 Participants	79 Participants	49 Participants	47 Participants	50 Participants

SECONDARY outcome

Timeframe: Within the 7-day (Days 0-6) follow up period following booster vaccination with HBsAg antigens

Population: Analysis was done on the Booster Total Vaccinated cohort which included all HLA Subsets 1 and 2 subjects who received the booster dose of HBsAg, on subjects for whom results were available for the timepoint/outcome analyzed.

Outcome measures

Outcome measures
Measure	Engerix-B - HLA Subsets Group n=54 Participants This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 1 - Non-HLA Subsets Group n=59 Participants This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 - Non-HLA Subsets Group n=56 Participants This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 - Non-HLA Subsets Group n=56 Participants This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group n=56 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Booster Vaccination. Grade 3 Pain	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Booster Vaccination. Any Redness	2 Participants	6 Participants	3 Participants	8 Participants	6 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Booster Vaccination. Any Pain	10 Participants	19 Participants	19 Participants	13 Participants	16 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Booster Vaccination. Redness > 50 mm	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Booster Vaccination. Any Swelling	1 Participants	3 Participants	4 Participants	2 Participants	5 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Booster Vaccination. Swelling > 50 mm	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Within the 7-day (Days 0-6) follow up period following booster vaccination with HBsAg antigens

Outcome measures

Outcome measures
Measure	Engerix-B - HLA Subsets Group n=54 Participants This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 1 - Non-HLA Subsets Group n=59 Participants This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 - Non-HLA Subsets Group n=56 Participants This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 - Non-HLA Subsets Group n=56 Participants This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group n=56 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. Any Fatigue	12 Participants	15 Participants	14 Participants	7 Participants	15 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. Grade 3 Fatigue	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. Related Fatigue	10 Participants	15 Participants	12 Participants	5 Participants	13 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. Any Fever	1 Participants	3 Participants	1 Participants	0 Participants	3 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. Grade 3 Fever	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. Related Fever	1 Participants	1 Participants	1 Participants	0 Participants	2 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. Any Gastr.	5 Participants	4 Participants	5 Participants	4 Participants	3 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. Grade 3 Gastr.	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. Related Gastr.	3 Participants	4 Participants	5 Participants	2 Participants	2 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. Any Headache	14 Participants	15 Participants	7 Participants	7 Participants	8 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. Grade 3 Headache	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. Related Headache	9 Participants	13 Participants	5 Participants	6 Participants	7 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. Any Malaise	4 Participants	6 Participants	5 Participants	2 Participants	4 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. Grade 3 Malaise	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. Related Malaise	4 Participants	6 Participants	4 Participants	2 Participants	4 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. Any Myalgia	1 Participants	4 Participants	3 Participants	2 Participants	5 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. Grade 3 Myalgia	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination. Related Myalgia	1 Participants	4 Participants	2 Participants	2 Participants	5 Participants

SECONDARY outcome

Timeframe: Within the 31-day (Days 0-30) follow up period following primary vaccination with the GSK223192A, Fendrix™ or Engerix-B™ vaccine

Population: Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects.

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

Outcome measures

Outcome measures
Measure	Engerix-B - HLA Subsets Group n=142 Participants This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 1 - Non-HLA Subsets Group n=143 Participants This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 - Non-HLA Subsets Group n=142 Participants This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 - Non-HLA Subsets Group n=141 Participants This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group n=145 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Primary Vaccination Subjects with any AE(s)	71 Participants	80 Participants	73 Participants	76 Participants	67 Participants
Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Primary Vaccination Subjects with Grade 3 AE(s)	15 Participants	17 Participants	11 Participants	12 Participants	19 Participants
Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Primary Vaccination Subjects with related AE(s)	19 Participants	32 Participants	19 Participants	27 Participants	21 Participants
Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Primary Vaccination Subjects with Grade 3 and related AE(s)	2 Participants	7 Participants	1 Participants	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Within the 31-day (Days 0-30) follow up period following booster vaccination with HBsAg antigens

Population: Analysis was done on the Booster Total Vaccinated cohort which included all HLA Subsets 1 and 2 subjects who received the booster dose of HBsAg.

Outcome measures

Outcome measures
Measure	Engerix-B - HLA Subsets Group n=54 Participants This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 1 - Non-HLA Subsets Group n=59 Participants This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 - Non-HLA Subsets Group n=56 Participants This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 - Non-HLA Subsets Group n=56 Participants This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group n=56 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Booster Vaccination Subjects with any AE(s)	10 Participants	12 Participants	8 Participants	9 Participants	14 Participants
Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Booster Vaccination Subjects with any grade 3 AE(s)	1 Participants	2 Participants	2 Participants	2 Participants	4 Participants
Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Booster Vaccination Subjects with related AE(s)	2 Participants	3 Participants	1 Participants	0 Participants	2 Participants
Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Booster Vaccination Subjects with Grade 3 and related AE(s)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: During the entire study period, from Day 0 to study end, at Day 360 for subjects not in Subsets 1 & 2 and at Day 390 for subjects in Subsets 1 & 2.

Population: Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects.

AESIs included Autoimmune Disease (AID), neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, and other autoimmune/inflammatory events. Any AESI(s) = occurrence of any AESI(s) in a subject regardless of assessment of relationship to study vaccination. Related AESI(s) = Occurrence of AESI(s) in a subject assessed by the investigator as causally related to the study vaccination.

Outcome measures

Outcome measures
Measure	Engerix-B - HLA Subsets Group n=142 Participants This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 1 - Non-HLA Subsets Group n=143 Participants This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 - Non-HLA Subsets Group n=142 Participants This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 - Non-HLA Subsets Group n=141 Participants This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group n=145 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Number of Subjects Reporting Any and Related Adverse Events of Specific Interest (AESIs) Any AESI(s)	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any and Related Adverse Events of Specific Interest (AESIs) Related AESI(s)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: During the entire study period, from Day 0 to study end, at Day 360 for subjects not in Subsets 1 & 2 and at Day 390 for subjects in Subsets 1 & 2.

Population: Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects.

A SAE was defined as a medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = occurrence of SAE(s) in a subject regardless of assessment of relationship to study vaccination. Related SAE(s) = occurrence of occurrence of SAE(s) in a subject assessed by the investigators as causally related to the study vaccination.

Outcome measures

Outcome measures
Measure	Engerix-B - HLA Subsets Group n=142 Participants This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 1 - Non-HLA Subsets Group n=143 Participants This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 - Non-HLA Subsets Group n=142 Participants This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 - Non-HLA Subsets Group n=141 Participants This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group n=145 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Number of Subjects Reporting Any Serious Adverse Events (SAEs) and SAEs Related to Study Vaccination Any SAE(s)	7 Participants	7 Participants	4 Participants	10 Participants	7 Participants
Number of Subjects Reporting Any Serious Adverse Events (SAEs) and SAEs Related to Study Vaccination Related SAE(s)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At Days 0, 1, 14, 30, 31, 33 and 37

Population: The ATP cohort for innate immunogenicity up to Day 60 included all evaluable subjects, who complied with the vaccination schedule, for whom data concerning immunogenicity outcome measures were available and for whom innate immunogenicity data were available for at least one post-vaccination time point.

The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Tumor Necrosis Factor (TNF), Tumor Necrosis Factor Receptor Superfamily (TNFRSF9).

Outcome measures

Outcome measures
Measure	Engerix-B - HLA Subsets Group n=21 Participants This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 1 - Non-HLA Subsets Group n=18 Participants This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 - Non-HLA Subsets Group n=23 Participants This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 - Non-HLA Subsets Group n=28 Participants This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group n=22 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) TNF.mRNA, Day 1	1.06 copies Interval 0.63 to 2.09	1.33 copies Interval 0.71 to 2.48	1.08 copies Interval 0.44 to 3.01	1.1 copies Interval 0.4 to 2.58	1 copies Interval 0.56 to 2.39
Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) TNF.mRNA, Day 0	1.18 copies Interval 0.76 to 2.89	1.18 copies Interval 0.55 to 2.66	1.09 copies Interval 0.78 to 1.75	1.24 copies Interval 0.84 to 2.64	1.18 copies Interval 0.78 to 3.18
Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) TNF.mRNA, Day 14	1.13 copies Interval 0.52 to 1.67	0.95 copies Interval 0.63 to 2.14	1.07 copies Interval 0.57 to 1.8	1 copies Interval 0.63 to 2.96	1.03 copies Interval 0.62 to 1.58
Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) TNF.mRNA, Day 30	1.09 copies Interval 0.48 to 2.97	1.03 copies Interval 0.74 to 1.63	1.21 copies Interval 0.55 to 2.56	1.25 copies Interval 0.58 to 2.89	1.19 copies Interval 0.64 to 2.0
Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) TNF.mRNA, Day 31	1.1 copies Interval 0.49 to 2.24	1.31 copies Interval 0.66 to 2.2	1.26 copies Interval 0.58 to 2.13	1.41 copies Interval 0.5 to 3.42	1.15 copies Interval 0.46 to 2.59
Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) TNF.mRNA, Day 33	0.97 copies Interval 0.57 to 2.48	0.99 copies Interval 0.44 to 2.47	1.04 copies Interval 0.67 to 2.1	1.12 copies Interval 0.54 to 2.99	1.18 copies Interval 0.47 to 2.27
Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) TNF.mRNA, Day 37	1.06 copies Interval 0.38 to 3.39	0.82 copies Interval 0.36 to 1.56	1.04 copies Interval 0.32 to 1.69	1 copies Interval 0.39 to 2.39	1.07 copies Interval 0.42 to 1.99
Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) TNFRSF9.mRNA, Day 0	1.11 copies Interval 0.8 to 1.98	1.04 copies Interval 0.81 to 2.17	1.11 copies Interval 0.74 to 1.52	1.14 copies Interval 0.7 to 2.64	1.14 copies Interval 0.86 to 2.11
Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) TNFRSF9.mRNA, Day 1	1.01 copies Interval 0.55 to 1.53	1.14 copies Interval 0.74 to 1.67	1.14 copies Interval 0.59 to 2.5	1.24 copies Interval 0.72 to 2.13	1.24 copies Interval 0.73 to 3.19
Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) TNFRSF9.mRNA, Day 14	1.02 copies Interval 0.46 to 1.69	0.98 copies Interval 0.52 to 1.74	1.02 copies Interval 0.52 to 1.97	1.19 copies Interval 0.63 to 3.31	1.15 copies Interval 0.59 to 2.13
Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) TNFRSF9.mRNA, Day 30	1.14 copies Interval 0.66 to 1.65	1.06 copies Interval 0.67 to 1.51	1.02 copies Interval 0.73 to 1.61	1.08 copies Interval 0.78 to 1.89	1.03 copies Interval 0.72 to 1.42
Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) TNFRSF9.mRNA, Day 31	1.07 copies Interval 0.68 to 1.75	1.14 copies Interval 0.8 to 1.98	1.09 copies Interval 0.55 to 1.49	1 copies Interval 0.57 to 1.8	0.97 copies Interval 0.73 to 2.01
Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) TNFRSF9.mRNA, Day 33	1.07 copies Interval 0.67 to 1.86	0.67 copies Interval 0.46 to 2.76	0.7 copies Interval 0.32 to 1.45	0.73 copies Interval 0.49 to 1.7	1.12 copies Interval 0.84 to 1.95
Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR) TNFRSF9.mRNA, Day 37	1.14 copies Interval 0.55 to 2.01	0.77 copies Interval 0.41 to 3.06	1.01 copies Interval 0.6 to 1.61	0.91 copies Interval 0.55 to 3.2	1.01 copies Interval 0.59 to 1.78

SECONDARY outcome

Timeframe: At Days 0, 1, 14, 30, 31, 33 and 37

The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Fas associated factor 1 (FAF1), Signal Transducer And Activator Of Transcription 1(STAT1).

Outcome measures

Outcome measures
Measure	Engerix-B - HLA Subsets Group n=21 Participants This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 1 - Non-HLA Subsets Group n=18 Participants This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 - Non-HLA Subsets Group n=23 Participants This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 - Non-HLA Subsets Group n=28 Participants This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group n=22 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
mRNA Levels as Measured by qPCR STAT1.mRNA, Day 33	1 copies Interval 0.25 to 1.54	2.03 copies Interval 0.82 to 4.86	1.25 copies Interval 0.49 to 4.19	1.12 copies Interval 0.42 to 2.95	1.01 copies Interval 0.21 to 1.55
mRNA Levels as Measured by qPCR STAT1.mRNA, Day 37	1.02 copies Interval 0.19 to 1.81	0.87 copies Interval 0.63 to 1.45	0.89 copies Interval 0.35 to 1.45	0.86 copies Interval 0.23 to 1.37	0.95 copies Interval 0.16 to 1.43
mRNA Levels as Measured by qPCR FAF1.mRNA, Day 0	1.07 copies Interval 0.85 to 1.39	1.08 copies Interval 0.66 to 1.54	1.02 copies Interval 0.74 to 1.34	1.06 copies Interval 0.72 to 1.39	1.06 copies Interval 0.68 to 1.61
mRNA Levels as Measured by qPCR FAF1.mRNA, Day 1	1.08 copies Interval 0.72 to 1.44	0.83 copies Interval 0.66 to 1.04	0.88 copies Interval 0.62 to 1.63	0.89 copies Interval 0.57 to 1.28	0.93 copies Interval 0.71 to 1.29
mRNA Levels as Measured by qPCR FAF1.mRNA, Day 14	1.01 copies Interval 0.75 to 1.3	1.05 copies Interval 0.69 to 1.32	1.06 copies Interval 0.7 to 1.68	0.97 copies Interval 0.7 to 1.48	1 copies Interval 0.65 to 1.26
mRNA Levels as Measured by qPCR FAF1.mRNA, Day 30	1.02 copies Interval 0.7 to 1.54	0.93 copies Interval 0.73 to 1.29	1.03 copies Interval 0.77 to 1.79	1.03 copies Interval 0.77 to 1.58	0.99 copies Interval 0.8 to 1.25
mRNA Levels as Measured by qPCR FAF1.mRNA, Day 31	1.02 copies Interval 0.79 to 1.72	0.6 copies Interval 0.46 to 1.09	0.67 copies Interval 0.49 to 1.35	0.83 copies Interval 0.4 to 1.43	0.9 copies Interval 0.66 to 1.46
mRNA Levels as Measured by qPCR FAF1.mRNA, Day 33	0.98 copies Interval 0.54 to 1.89	0.85 copies Interval 0.65 to 1.37	0.95 copies Interval 0.72 to 1.23	0.94 copies Interval 0.71 to 1.38	1.01 copies Interval 0.7 to 1.34
mRNA Levels as Measured by qPCR FAF1.mRNA, Day 37	1.07 copies Interval 0.71 to 1.95	0.93 copies Interval 0.63 to 1.38	0.97 copies Interval 0.79 to 1.73	0.97 copies Interval 0.77 to 1.65	0.97 copies Interval 0.73 to 1.54
mRNA Levels as Measured by qPCR STAT1.mRNA, Day 0	0.95 copies Interval 0.8 to 1.19	0.92 copies Interval 0.7 to 1.21	0.99 copies Interval 0.79 to 1.3	0.97 copies Interval 0.77 to 1.41	0.96 copies Interval 0.6 to 1.25
mRNA Levels as Measured by qPCR STAT1.mRNA, Day 1	0.95 copies Interval 0.56 to 1.97	2.31 copies Interval 0.71 to 5.23	2.88 copies Interval 0.24 to 6.32	1.31 copies Interval 0.54 to 6.66	0.92 copies Interval 0.66 to 1.36
mRNA Levels as Measured by qPCR STAT1.mRNA, Day 14	0.96 copies Interval 0.42 to 2.44	1.02 copies Interval 0.15 to 2.84	0.96 copies Interval 0.18 to 1.93	0.98 copies Interval 0.2 to 2.41	1.04 copies Interval 0.74 to 5.74
mRNA Levels as Measured by qPCR STAT1.mRNA, Day 30	0.96 copies Interval 0.71 to 1.21	0.96 copies Interval 0.63 to 1.2	0.88 copies Interval 0.6 to 1.17	0.96 copies Interval 0.73 to 1.45	0.89 copies Interval 0.6 to 1.22
mRNA Levels as Measured by qPCR STAT1.mRNA, Day 31	0.96 copies Interval 0.19 to 1.25	4.95 copies Interval 1.5 to 7.8	3.83 copies Interval 1.61 to 7.2	3.13 copies Interval 1.06 to 7.93	0.88 copies Interval 0.26 to 1.29

SECONDARY outcome

Timeframe: At Days 0, 1, 14, 30, 31, 33 and 37

The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Interferon Regulatory Factor 1 (IRF1), MX Dynamin-Like GTPase 1(MX1).

Outcome measures

Outcome measures
Measure	Engerix-B - HLA Subsets Group n=21 Participants This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 1 - Non-HLA Subsets Group n=18 Participants This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 - Non-HLA Subsets Group n=23 Participants This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 - Non-HLA Subsets Group n=28 Participants This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group n=22 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) IRF1.mRNA, Day 0	1 copies Interval 0.87 to 1.25	0.96 copies Interval 0.61 to 1.53	0.99 copies Interval 0.65 to 1.83	0.95 copies Interval 0.65 to 1.42	1.03 copies Interval 0.84 to 1.69
mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) IRF1.mRNA, Day 1	0.95 copies Interval 0.7 to 1.34	1.51 copies Interval 0.8 to 2.98	1.59 copies Interval 0.44 to 3.23	1.24 copies Interval 0.54 to 2.81	1.08 copies Interval 0.76 to 1.45
mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) IRF1.mRNA, Day 14	0.97 copies Interval 0.6 to 2.0	1.02 copies Interval 0.25 to 1.79	1.01 copies Interval 0.49 to 1.93	1.02 copies Interval 0.4 to 1.87	1.14 copies Interval 0.82 to 4.12
mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) IRF1.mRNA, Day 30	0.99 copies Interval 0.65 to 1.67	1 copies Interval 0.59 to 1.82	0.93 copies Interval 0.69 to 1.62	0.92 copies Interval 0.71 to 1.45	0.96 copies Interval 0.71 to 1.2
mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) IRF1.mRNA, Day 31	0.99 copies Interval 0.45 to 1.47	3.14 copies Interval 1.12 to 8.06	2.63 copies Interval 1.32 to 3.95	1.73 copies Interval 0.8 to 5.63	1.05 copies Interval 0.35 to 1.5
mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) IRF1.mRNA, Day 33	1.05 copies Interval 0.52 to 1.62	1.33 copies Interval 0.78 to 2.63	1.03 copies Interval 0.62 to 1.72	0.9 copies Interval 0.54 to 1.6	1.11 copies Interval 0.43 to 1.59
mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) IRF1.mRNA, Day 37	1 copies Interval 0.54 to 1.78	0.99 copies Interval 0.42 to 2.24	0.93 copies Interval 0.59 to 1.3	0.9 copies Interval 0.35 to 1.63	0.97 copies Interval 0.27 to 1.38
mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) MX1.mRNA, Day 0	0.98 copies Interval 0.66 to 1.29	1 copies Interval 0.77 to 1.21	1.01 copies Interval 0.77 to 1.38	0.98 copies Interval 0.7 to 1.32	1.01 copies Interval 0.82 to 2.02
mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) MX1.mRNA, Day 1	0.9 copies Interval 0.58 to 1.35	1.61 copies Interval 0.96 to 3.42	1.59 copies Interval 0.14 to 3.29	1.18 copies Interval 0.45 to 4.98	1.01 copies Interval 0.48 to 1.4
mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) MX1.mRNA, Day 14	1.08 copies Interval 0.26 to 3.54	0.95 copies Interval 0.05 to 8.35	1.03 copies Interval 0.08 to 4.12	0.91 copies Interval 0.06 to 5.32	1.11 copies Interval 0.4 to 9.7
mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) MX1.mRNA, Day 30	0.94 copies Interval 0.58 to 1.5	0.96 copies Interval 0.41 to 1.46	0.92 copies Interval 0.74 to 2.02	0.92 copies Interval 0.69 to 1.51	0.96 copies Interval 0.55 to 1.26
mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) MX1.mRNA, Day 31	0.92 copies Interval 0.17 to 1.69	3.06 copies Interval 0.69 to 6.38	2.19 copies Interval 1.18 to 9.95	2.06 copies Interval 0.84 to 6.64	0.96 copies Interval 0.28 to 1.22
mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) MX1.mRNA, Day 33	0.98 copies Interval 0.12 to 1.54	2.92 copies Interval 0.6 to 8.49	1.83 copies Interval 0.32 to 7.39	1.87 copies Interval 0.38 to 5.45	1.07 copies Interval 0.16 to 1.35
mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) MX1.mRNA, Day 37	1.08 copies Interval 0.08 to 4.66	0.93 copies Interval 0.63 to 5.86	0.9 copies Interval 0.19 to 1.75	0.86 copies Interval 0.1 to 1.74	1.07 copies Interval 0.06 to 2.17

SECONDARY outcome

Timeframe: At Days 0, 1, 14, 30, 31, 33 and 37

The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Interleukin-12A (IL-12A), Marker Of Proliferation Ki-67 (MKI67).

Outcome measures

Outcome measures
Measure	Engerix-B - HLA Subsets Group n=21 Participants This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 1 - Non-HLA Subsets Group n=18 Participants This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 - Non-HLA Subsets Group n=23 Participants This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 - Non-HLA Subsets Group n=28 Participants This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group n=22 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) MKI67.mRNA, Day 0	1.03 copies Interval 0.61 to 2.51	0.91 copies Interval 0.23 to 1.63	0.89 copies Interval 0.45 to 2.72	0.98 copies Interval 0.45 to 1.74	0.83 copies Interval 0.51 to 2.12
Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) MKI67.mRNA, Day 1	1.03 copies Interval 0.48 to 1.79	0.89 copies Interval 0.33 to 1.7	0.9 copies Interval 0.46 to 2.63	0.99 copies Interval 0.55 to 1.48	0.94 copies Interval 0.37 to 1.85
Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) MKI67.mRNA, Day 14	1.07 copies Interval 0.4 to 3.71	1.06 copies Interval 0.57 to 2.83	1.14 copies Interval 0.39 to 3.17	1.18 copies Interval 0.32 to 2.74	0.99 copies Interval 0.6 to 2.75
Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) MKI67.mRNA, Day 30	0.97 copies Interval 0.5 to 1.7	1 copies Interval 0.56 to 1.61	0.92 copies Interval 0.68 to 1.56	1.1 copies Interval 0.48 to 1.77	0.98 copies Interval 0.42 to 1.8
Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) MKI67.mRNA, Day 31	1.12 copies Interval 0.52 to 4.01	0.84 copies Interval 0.45 to 1.57	0.83 copies Interval 0.5 to 1.87	0.97 copies Interval 0.42 to 2.44	0.95 copies Interval 0.3 to 1.52
Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) MKI67.mRNA, Day 33	1.03 copies Interval 0.55 to 8.12	0.96 copies Interval 0.44 to 2.13	1.02 copies Interval 0.5 to 2.72	1.14 copies Interval 0.38 to 2.52	0.89 copies Interval 0.28 to 1.42
Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) MKI67.mRNA, Day 37	1.08 copies Interval 0.35 to 1.76	1.52 copies Interval 0.38 to 3.28	1.56 copies Interval 0.58 to 4.01	1.38 copies Interval 0.37 to 3.94	1.06 copies Interval 0.58 to 2.01
Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) IL-12A.mRNA, Day 0	1.07 copies Interval 0.55 to 1.69	1.01 copies Interval 0.53 to 2.3	0.97 copies Interval 0.54 to 1.36	0.95 copies Interval 0.53 to 1.88	0.9 copies Interval 0.31 to 1.73
Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) IL-12A.mRNA, Day 1	1.06 copies Interval 0.44 to 2.56	1.04 copies Interval 0.5 to 2.68	1.01 copies Interval 0.56 to 2.97	1.04 copies Interval 0.45 to 2.23	0.94 copies Interval 0.39 to 1.71
Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) IL-12A.mRNA, Day 14	0.96 copies Interval 0.5 to 2.1	0.97 copies Interval 0.6 to 1.73	0.97 copies Interval 0.42 to 2.64	1.09 copies Interval 0.36 to 2.06	0.77 copies Interval 0.57 to 1.72
Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) IL-12A.mRNA, Day 30	1.03 copies Interval 0.38 to 1.76	1.01 copies Interval 0.5 to 1.61	1 copies Interval 0.44 to 5.85	0.87 copies Interval 0.46 to 1.8	1.1 copies Interval 0.39 to 2.52
Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) IL-12A.mRNA, Day 31	1.01 copies Interval 0.43 to 2.22	1.32 copies Interval 0.68 to 3.55	1.2 copies Interval 0.61 to 2.61	1.04 copies Interval 0.47 to 2.35	0.9 copies Interval 0.36 to 1.41
Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) IL-12A.mRNA, Day 33	1.05 copies Interval 0.37 to 2.72	0.94 copies Interval 0.61 to 2.92	0.85 copies Interval 0.44 to 1.64	0.86 copies Interval 0.41 to 1.78	0.89 copies Interval 0.46 to 1.52
Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR) IL-12A.mRNA, Day 37	1.22 copies Interval 0.61 to 1.78	1.14 copies Interval 0.56 to 1.73	1.08 copies Interval 0.42 to 2.75	0.95 copies Interval 0.47 to 2.45	1.09 copies Interval 0.33 to 3.13

SECONDARY outcome

Timeframe: At Days 0, 1, 14, 30, 31, 33 and 37

The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Chemokine Ligand 10 (CXCL10), Interleukin-1B (IL-1B).

Outcome measures

Outcome measures
Measure	Engerix-B - HLA Subsets Group n=21 Participants This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 1 - Non-HLA Subsets Group n=18 Participants This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 - Non-HLA Subsets Group n=23 Participants This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 - Non-HLA Subsets Group n=28 Participants This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group n=22 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Levels of mRNA as Measured by qPCR IL-1B.mRNA, Day 0	0.96 copies Interval 0.53 to 1.35	1.04 copies Interval 0.41 to 1.54	1.12 copies Interval 0.6 to 2.33	1.02 copies Interval 0.51 to 2.24	1.04 copies Interval 0.59 to 2.21
Levels of mRNA as Measured by qPCR IL-1B.mRNA, Day 1	0.92 copies Interval 0.4 to 1.48	1.56 copies Interval 0.56 to 2.8	1.31 copies Interval 0.67 to 2.1	1.21 copies Interval 0.55 to 2.58	1.24 copies Interval 0.82 to 2.68
Levels of mRNA as Measured by qPCR IL-1B.mRNA, Day 14	1 copies Interval 0.52 to 1.78	0.94 copies Interval 0.24 to 1.95	0.93 copies Interval 0.43 to 3.61	0.97 copies Interval 0.34 to 2.24	1.23 copies Interval 0.72 to 3.1
Levels of mRNA as Measured by qPCR IL-1B.mRNA, Day 30	1.05 copies Interval 0.57 to 1.86	1.2 copies Interval 0.43 to 2.08	0.98 copies Interval 0.55 to 1.51	1.04 copies Interval 0.68 to 1.51	0.94 copies Interval 0.58 to 1.48
Levels of mRNA as Measured by qPCR IL-1B.mRNA, Day 31	1.06 copies Interval 0.44 to 1.54	2.02 copies Interval 1.38 to 5.6	1.47 copies Interval 0.78 to 2.2	1.23 copies Interval 0.64 to 2.87	1.14 copies Interval 0.47 to 1.92
Levels of mRNA as Measured by qPCR IL-1B.mRNA, Day 33	1.01 copies Interval 0.49 to 2.16	1.31 copies Interval 0.81 to 6.05	1.07 copies Interval 0.54 to 1.76	0.93 copies Interval 0.58 to 1.59	1.02 copies Interval 0.72 to 1.95
Levels of mRNA as Measured by qPCR IL-1B.mRNA, Day 37	1.01 copies Interval 0.45 to 2.01	0.97 copies Interval 0.38 to 2.6	0.87 copies Interval 0.36 to 1.83	0.85 copies Interval 0.29 to 1.8	0.83 copies Interval 0.35 to 1.52
Levels of mRNA as Measured by qPCR CXCL10.mRNA, Day 0	1.07 copies Interval 0.55 to 1.99	0.92 copies Interval 0.55 to 1.36	0.97 copies Interval 0.52 to 1.79	0.92 copies Interval 0.37 to 1.97	0.97 copies Interval 0.31 to 1.73
Levels of mRNA as Measured by qPCR CXCL10.mRNA, Day 1	0.96 copies Interval 0.44 to 2.56	0.96 copies Interval 0.28 to 4.43	1.14 copies Interval 0.27 to 9.62	1.06 copies Interval 0.12 to 12.97	0.97 copies Interval 0.39 to 1.91
Levels of mRNA as Measured by qPCR CXCL10.mRNA, Day 14	0.97 copies Interval 0.6 to 3.39	0.88 copies Interval 0.16 to 1.99	0.95 copies Interval 0.13 to 2.64	1.06 copies Interval 0.06 to 2.92	0.9 copies Interval 0.39 to 48.74
Levels of mRNA as Measured by qPCR CXCL10.mRNA, Day 30	0.92 copies Interval 0.43 to 1.76	1.08 copies Interval 0.64 to 2.04	1.03 copies Interval 0.61 to 5.85	0.88 copies Interval 0.46 to 2.62	1.1 copies Interval 0.33 to 1.81
Levels of mRNA as Measured by qPCR CXCL10.mRNA, Day 31	1.18 copies Interval 0.29 to 1.54	6.25 copies Interval 0.68 to 32.91	2.93 copies Interval 0.75 to 16.09	1.59 copies Interval 0.47 to 16.85	0.95 copies Interval 0.04 to 1.44
Levels of mRNA as Measured by qPCR CXCL10.mRNA, Day 33	1.05 copies Interval 0.31 to 2.48	1.35 copies Interval 0.61 to 5.9	1.06 copies Interval 0.6 to 2.73	0.86 copies Interval 0.38 to 2.6	1.13 copies Interval 0.02 to 1.94
Levels of mRNA as Measured by qPCR CXCL10.mRNA, Day 37	1.09 copies Interval 0.51 to 2.37	0.91 copies Interval 0.51 to 5.33	1.02 copies Interval 0.53 to 2.75	0.94 copies Interval 0.35 to 2.45	1.03 copies Interval 0.02 to 2.06

SECONDARY outcome

Timeframe: At Days 0, 1, 14, 30, 31, 33 and 37

The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Prostaglandin-Endoperoxide Synthase 2 (PTGS2), Dual Specificity Phosphatase 1 (DUSP1).

Outcome measures

Outcome measures
Measure	Engerix-B - HLA Subsets Group n=21 Participants This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 1 - Non-HLA Subsets Group n=18 Participants This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 - Non-HLA Subsets Group n=23 Participants This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 - Non-HLA Subsets Group n=28 Participants This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group n=22 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR PTGS2.mRNA, Day 14	1.13 copies Interval 0.49 to 1.29	1.07 copies Interval 0.65 to 1.69	0.92 copies Interval 0.7 to 1.66	1.01 copies Interval 0.4 to 2.08	1.06 copies Interval 0.67 to 2.4
Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR PTGS2.mRNA, Day 0	1.04 copies Interval 0.63 to 1.28	1.06 copies Interval 0.63 to 1.59	1.01 copies Interval 0.67 to 1.66	1.07 copies Interval 0.64 to 1.73	1.06 copies Interval 0.77 to 1.76
Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR PTGS2.mRNA, Day 1	0.95 copies Interval 0.71 to 1.32	1.25 copies Interval 0.74 to 1.74	1.15 copies Interval 0.69 to 2.55	1.16 copies Interval 0.77 to 2.13	1.05 copies Interval 0.73 to 1.47
Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR PTGS2.mRNA, Day 30	1.09 copies Interval 0.67 to 1.56	1.14 copies Interval 0.58 to 1.5	0.94 copies Interval 0.67 to 1.38	1.02 copies Interval 0.69 to 1.51	0.98 copies Interval 0.58 to 1.22
Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR PTGS2.mRNA, Day 31	1.04 copies Interval 0.63 to 1.43	1.66 copies Interval 1.17 to 2.83	1.33 copies Interval 0.97 to 2.4	1.11 copies Interval 0.74 to 1.99	1.08 copies Interval 0.72 to 1.63
Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR PTGS2.mRNA, Day 33	1.01 copies Interval 0.6 to 2.03	0.97 copies Interval 0.66 to 3.53	0.85 copies Interval 0.52 to 1.22	0.82 copies Interval 0.57 to 1.64	1.07 copies Interval 0.77 to 2.73
Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR PTGS2.mRNA, Day 37	1.15 copies Interval 0.55 to 1.68	0.87 copies Interval 0.33 to 3.76	0.94 copies Interval 0.59 to 1.65	0.91 copies Interval 0.57 to 2.15	0.96 copies Interval 0.62 to 1.35
Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR DUSP1.mRNA, Day 0	0.9 copies Interval 0.5 to 1.27	0.84 copies Interval 0.45 to 1.52	0.96 copies Interval 0.52 to 1.8	1.02 copies Interval 0.58 to 2.27	0.89 copies Interval 0.55 to 1.96
Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR DUSP1.mRNA, Day 1	0.85 copies Interval 0.53 to 1.81	1.09 copies Interval 0.67 to 1.95	1.1 copies Interval 0.52 to 2.03	1.12 copies Interval 0.68 to 2.46	1.14 copies Interval 0.6 to 1.99
Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR DUSP1.mRNA, Day 14	1 copies Interval 0.45 to 1.55	0.95 copies Interval 0.6 to 1.81	0.85 copies Interval 0.63 to 1.91	1.2 copies Interval 0.32 to 2.45	1.07 copies Interval 0.81 to 1.86
Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR DUSP1.mRNA, Day 30	0.96 copies Interval 0.53 to 1.8	1.03 copies Interval 0.44 to 2.14	0.81 copies Interval 0.48 to 1.46	0.92 copies Interval 0.55 to 2.04	0.86 copies Interval 0.63 to 1.28
Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR DUSP1.mRNA, Day 31	0.94 copies Interval 0.57 to 1.85	1.34 copies Interval 0.8 to 3.56	1.3 copies Interval 0.64 to 1.95	1.05 copies Interval 0.63 to 1.67	1.31 copies Interval 0.76 to 1.97
Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR DUSP1.mRNA, Day 33	0.99 copies Interval 0.42 to 1.91	0.97 copies Interval 0.58 to 5.29	0.84 copies Interval 0.43 to 1.42	0.81 copies Interval 0.52 to 1.56	1.18 copies Interval 0.78 to 2.69
Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR DUSP1.mRNA, Day 37	1 copies Interval 0.45 to 2.3	0.91 copies Interval 0.27 to 4.05	0.94 copies Interval 0.34 to 1.57	0.95 copies Interval 0.51 to 1.61	0.94 copies Interval 0.68 to 1.53

SECONDARY outcome

Timeframe: At Days 0, 1, 14, 30, 31, 33 and 37

The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Nuclear Factor Of Activated T-Cells, Cytoplasmic, Calcineurin-Dependent 2 (NFATC2) and Interferon-gamma (IFN-γ).

Outcome measures

Outcome measures
Measure	Engerix-B - HLA Subsets Group n=21 Participants This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 1 - Non-HLA Subsets Group n=18 Participants This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 - Non-HLA Subsets Group n=23 Participants This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 - Non-HLA Subsets Group n=28 Participants This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group n=22 Participants Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) NFATC2.mRNA, Day 1	1.04 copies Interval 0.73 to 1.57	0.66 copies Interval 0.48 to 1.06	0.73 copies Interval 0.43 to 2.55	0.83 copies Interval 0.47 to 1.56	0.83 copies Interval 0.6 to 1.23
Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) NFATC2.mRNA, Day 14	1.1 copies Interval 0.64 to 1.59	1 copies Interval 0.48 to 1.69	0.98 copies Interval 0.42 to 2.12	1.09 copies Interval 0.61 to 1.78	0.89 copies Interval 0.53 to 1.39
Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) NFATC2.mRNA, Day 30	1.08 copies Interval 0.79 to 1.44	0.92 copies Interval 0.7 to 1.64	0.99 copies Interval 0.72 to 1.37	1 copies Interval 0.78 to 1.57	1.05 copies Interval 0.82 to 1.5
Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) NFATC2.mRNA, Day 31	1.1 copies Interval 0.83 to 1.33	0.46 copies Interval 0.32 to 1.06	0.58 copies Interval 0.34 to 1.15	0.78 copies Interval 0.33 to 1.46	0.87 copies Interval 0.69 to 1.78
Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) NFATC2.mRNA, Day 37	1.11 copies Interval 0.69 to 1.91	1.03 copies Interval 0.74 to 1.22	1.03 copies Interval 0.66 to 1.59	0.98 copies Interval 0.72 to 1.99	1.16 copies Interval 0.83 to 1.56
Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) NFATC2.mRNA, Day 0	1.11 copies Interval 0.64 to 1.5	0.98 copies Interval 0.52 to 1.25	0.94 copies Interval 0.64 to 1.64	1.03 copies Interval 0.74 to 1.91	0.93 copies Interval 0.51 to 1.56
Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) NFATC2.mRNA, Day 33	1.05 copies Interval 0.75 to 1.62	0.79 copies Interval 0.59 to 1.36	0.9 copies Interval 0.56 to 1.79	0.87 copies Interval 0.63 to 1.55	1.05 copies Interval 0.63 to 1.43
Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) IFN-γ.mRNA, Day 0	1.07 copies Interval 0.55 to 1.99	0.97 copies Interval 0.55 to 1.36	0.97 copies Interval 0.54 to 1.79	0.94 copies Interval 0.59 to 1.97	0.97 copies Interval 0.31 to 1.73
Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) IFN-γ.mRNA, Day 1	0.96 copies Interval 0.44 to 2.56	0.89 copies Interval 0.5 to 1.74	1.01 copies Interval 0.6 to 2.97	1.03 copies Interval 0.45 to 1.94	0.97 copies Interval 0.39 to 1.91
Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) IFN-γ.mRNA, Day 14	0.96 copies Interval 0.6 to 2.1	0.88 copies Interval 0.55 to 1.99	0.97 copies Interval 0.44 to 2.64	1.11 copies Interval 0.48 to 2.08	0.82 copies Interval 0.39 to 1.72
Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) IFN-γ.mRNA, Day 30	0.92 copies Interval 0.48 to 1.76	1.08 copies Interval 0.64 to 2.04	1.03 copies Interval 0.61 to 5.85	0.88 copies Interval 0.46 to 3.19	1.13 copies Interval 0.47 to 1.81
Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) IFN-γ.mRNA, Day 31	1.18 copies Interval 0.45 to 1.54	0.91 copies Interval 0.61 to 2.46	0.86 copies Interval 0.44 to 2.61	0.89 copies Interval 0.4 to 1.53	0.96 copies Interval 0.41 to 1.89
Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) IFN-γ.mRNA, Day 33	1.05 copies Interval 0.53 to 2.48	0.9 copies Interval 0.61 to 4.25	0.92 copies Interval 0.6 to 2.04	0.83 copies Interval 0.38 to 2.6	1.13 copies Interval 0.47 to 1.94
Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR) IFN-γ.mRNA, Day 37	1.09 copies Interval 0.71 to 2.37	0.89 copies Interval 0.51 to 5.33	1.02 copies Interval 0.53 to 2.75	0.94 copies Interval 0.47 to 2.45	1.09 copies Interval 0.6 to 2.06

Adverse Events

GSK223192A 1 Group

Serious events: 7 serious events

Other events: 137 other events

Deaths: 0 deaths

GSK223192A 2 Group

Serious events: 4 serious events

Other events: 135 other events

Deaths: 0 deaths

GSK223192A 3 Group

Serious events: 10 serious events

Other events: 131 other events

Deaths: 0 deaths

Fendrix Group

Serious events: 7 serious events

Other events: 141 other events

Deaths: 0 deaths

Engerix-B Group

Serious events: 7 serious events

Other events: 114 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	GSK223192A 1 Group n=143 participants at risk Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 Group n=142 participants at risk Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 Group n=141 participants at risk Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group n=145 participants at risk Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Engerix-B Group n=142 participants at risk Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Psychiatric disorders Depression	0.00% 0/143 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/141 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	1.4% 2/145 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.70% 1/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.
Infections and infestations Appendicitis	0.70% 1/143 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.70% 1/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/141 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/145 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/143 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.71% 1/141 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.69% 1/145 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.70% 1/143 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/141 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.69% 1/145 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.
Respiratory, thoracic and mediastinal disorders Tonsillar hypertrophy	0.70% 1/143 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.71% 1/141 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/145 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.
Injury, poisoning and procedural complications Abdominal injury	0.00% 0/143 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.70% 1/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/141 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/145 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.
Psychiatric disorders Acute stress disorder	0.00% 0/143 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/141 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/145 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.70% 1/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.
Psychiatric disorders Anxiety disorder	0.00% 0/143 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/141 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/145 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.70% 1/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/143 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.70% 1/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/141 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/145 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.
Reproductive system and breast disorders Cervical dysplasia	0.00% 0/143 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/141 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/145 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.70% 1/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.
Musculoskeletal and connective tissue disorders Chondropathy	0.70% 1/143 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/141 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/145 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.
Nervous system disorders Cluster headache	0.70% 1/143 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/141 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/145 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.
Gastrointestinal disorders Colitis	0.00% 0/143 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/141 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.69% 1/145 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.
Gastrointestinal disorders Constipation	0.00% 0/143 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.71% 1/141 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/145 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.
Infections and infestations Diverticulitis	0.00% 0/143 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/141 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/145 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.70% 1/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.
Metabolism and nutrition disorders Dyslipidaemia	0.00% 0/143 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.71% 1/141 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/145 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.
Injury, poisoning and procedural complications Epicondylitis	0.70% 1/143 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/141 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/145 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/143 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.71% 1/141 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/145 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.
Musculoskeletal and connective tissue disorders Foot deformity	0.70% 1/143 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/141 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/145 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma	0.00% 0/143 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.71% 1/141 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/145 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.
Vascular disorders Hypertension	0.00% 0/143 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.71% 1/141 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/145 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.
Gastrointestinal disorders Inguinal hernia	0.70% 1/143 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/141 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/145 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/143 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/141 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/145 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.70% 1/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.
Injury, poisoning and procedural complications Laceration	0.70% 1/143 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/141 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/145 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.
Injury, poisoning and procedural complications Ligament rupture	0.00% 0/143 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.70% 1/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/141 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/145 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.
Reproductive system and breast disorders Ovarian cyst torsion	0.70% 1/143 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/141 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/145 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.
Respiratory, thoracic and mediastinal disorders Paranasal cyst	0.00% 0/143 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/141 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.69% 1/145 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.
Infections and infestations Pharyngitis	0.00% 0/143 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/141 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/145 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.70% 1/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.
Psychiatric disorders Post-traumatic stress disorder	0.00% 0/143 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/141 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.69% 1/145 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.
Infections and infestations Pyelonephritis	0.00% 0/143 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.71% 1/141 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/145 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/143 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.70% 1/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/141 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/145 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/143 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/141 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/145 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.70% 1/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.
Psychiatric disorders Somatisation disorder	0.00% 0/143 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/141 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/145 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.70% 1/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/143 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.71% 1/141 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/145 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.
Infections and infestations Tonsillitis	0.00% 0/143 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.71% 1/141 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/145 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/143 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.71% 1/141 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/145 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.
Reproductive system and breast disorders Varicocele	0.00% 0/143 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.71% 1/141 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/145 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.
Investigations Weight decreased	0.00% 0/143 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.70% 1/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/141 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/145 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.
Gastrointestinal disorders Diarrhoea	0.00% 0/143 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/141 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.69% 1/145 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.

Other adverse events

Other adverse events
Measure	GSK223192A 1 Group n=143 participants at risk Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 2 Group n=142 participants at risk Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	GSK223192A 3 Group n=141 participants at risk Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Fendrix Group n=145 participants at risk Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.	Engerix-B Group n=142 participants at risk Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
General disorders Gastrointestinal symptoms	6.8% 4/59 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	8.9% 5/56 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	21.0% 29/138 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	25.0% 36/144 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	25.2% 35/139 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.
General disorders Headache	63.4% 90/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	47.9% 67/140 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	47.8% 66/138 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	43.1% 62/144 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	42.4% 59/139 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.
General disorders Malaise	42.3% 60/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	31.4% 44/140 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	28.3% 39/138 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	24.3% 35/144 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	20.1% 28/139 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.
General disorders Myalgia	59.9% 85/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	40.7% 57/140 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	39.9% 55/138 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	40.3% 58/144 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	24.5% 34/139 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.
Infections and infestations Nasopharyngitis	5.1% 3/59 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/56 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	1.8% 1/56 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/56 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/54 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.
Nervous system disorders Headache	2.1% 3/143 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	1.4% 2/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	2.8% 4/141 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	2.1% 3/145 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	5.6% 8/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.
General disorders Pain	32.2% 19/59 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	33.9% 19/56 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	23.2% 13/56 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	28.6% 16/56 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	18.5% 10/54 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.
General disorders Redness	10.2% 6/59 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	5.4% 3/56 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	14.3% 8/56 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	10.7% 6/56 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	3.7% 2/54 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.
General disorders Swelling	5.1% 3/59 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	7.1% 4/56 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	3.6% 2/56 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	8.9% 5/56 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	1.9% 1/54 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.
General disorders Fatigue	25.4% 15/59 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	25.0% 14/56 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	12.5% 7/56 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	26.8% 15/56 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	22.2% 12/54 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.
General disorders Fever (Oral temperature >= 37.5°C)	31.7% 45/142 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	16.4% 23/140 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	17.4% 24/138 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	8.3% 12/144 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	12.2% 17/139 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.
General disorders Fever (Oral temperature > = 37.5°C)	5.1% 3/59 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	1.8% 1/56 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	0.00% 0/56 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	5.4% 3/56 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.	1.9% 1/54 • Solicited symptoms post primary/booster vaccination: 14/7-day follow-up period after vaccination; Unsolicited adverse events (AEs): 31-day follow-up period after vaccination; Serious AEs: From Day 0 to Day 360 (non-Subsets 1 & 2)/390 (Subsets 1 & 2) Solicited symptoms data below result from analyses on the Total Vaccinated cohort, inclusive of all vaccinated subjects, and on the Booster Total Vaccinated cohort, inclusive of all vaccinated subjects from Subsets 1and 2 vaccinated with HBsAg antigens at Day 360, performed solely on subjects from whose symptom sheets were collected.

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