Trial Outcomes & Findings for Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine With Various Formulations in Adults >= 50 Years (NCT NCT00802464)

NCT ID: NCT00802464

Last Updated: 2019-06-26

Results Overview

The analysis focused on CD4+ T-cells expressing at least 2 immunological activation markers among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L). Frequencies were determined by in vitro Intracellular Cytokine Staining (ICS).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 410 participants
• Primary outcome timeframe: One month after the second vaccination (Month 3)
• Results posted on: 2019-06-26

Participant Flow

Participant milestones

Measure	Placebo Group Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 3 Group Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 2 Group Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 1 Group Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
Month 0 - Month 8 STARTED	38	73	149	150
Month 0 - Month 8 COMPLETED	38	70	142	141
Month 0 - Month 8 NOT COMPLETED	0	3	7	9
Month 8 - Month 14 STARTED	34	65	130	126
Month 8 - Month 14 COMPLETED	33	63	129	126
Month 8 - Month 14 NOT COMPLETED	1	2	1	0

Reasons for withdrawal

Measure	Placebo Group Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 3 Group Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 2 Group Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 1 Group Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
Month 0 - Month 8 Adverse Event	0	1	1	2
Month 0 - Month 8 Protocol Violation	0	0	1	0
Month 0 - Month 8 Withdrawal by Subject	0	1	2	5
Month 0 - Month 8 Lost to Follow-up	0	1	2	2
Month 0 - Month 8 Other	0	0	1	0
Month 8 - Month 14 Adverse Event	0	1	0	0
Month 8 - Month 14 Withdrawal by Subject	1	1	0	0
Month 8 - Month 14 Lost to Follow-up	0	0	1	0

Baseline Characteristics

Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine With Various Formulations in Adults >= 50 Years

Baseline characteristics by cohort

Measure	Placebo Group n=38 Participants Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 3 Group n=73 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 2 Group n=149 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 1 Group n=150 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	Total n=410 Participants Total of all reporting groups
Age, Continuous	65.0 Years STANDARD_DEVIATION 9.0 • n=5 Participants	65.1 Years STANDARD_DEVIATION 8.7 • n=7 Participants	65.1 Years STANDARD_DEVIATION 9.9 • n=5 Participants	65.0 Years STANDARD_DEVIATION 8.9 • n=4 Participants	65.0 Years STANDARD_DEVIATION 9.2 • n=21 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	40 Participants n=7 Participants	89 Participants n=5 Participants	81 Participants n=4 Participants	232 Participants n=21 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	33 Participants n=7 Participants	60 Participants n=5 Participants	69 Participants n=4 Participants	178 Participants n=21 Participants
Race/Ethnicity, Customized Race/Ethnicity · African Heritage / African American	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants	9 Participants n=21 Participants
Race/Ethnicity, Customized Race/Ethnicity · American Indian or Alaskan Native	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants
Race/Ethnicity, Customized Race/Ethnicity · Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Race/Ethnicity · White - Arabic / North African Heritage	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Race/Ethnicity · White - Caucasian / European Heritage	38 Participants n=5 Participants	72 Participants n=7 Participants	145 Participants n=5 Participants	141 Participants n=4 Participants	396 Participants n=21 Participants

PRIMARY outcome

Timeframe: One month after the second vaccination (Month 3)

Population: The analyses were performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects from Month 0 to 3. This included those subjects who met all eligibility criteria, complied with the protocol, with no elimination criteria during this part of the study and for whom immunogenicity measures were available.

The analysis focused on CD4+ T-cells expressing at least 2 immunological activation markers among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L). Frequencies were determined by in vitro Intracellular Cytokine Staining (ICS).

Outcome measures

Measure	Placebo Group n=32 Participants Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 3 Group n=70 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 2 Group n=126 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 1 Group n=125 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
Frequency of gE-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing at Least 2 Different Immunological Activation Markers	231.82 gE-specific CD4+ T-cells/million T-cells Standard Deviation 411.84	570.36 gE-specific CD4+ T-cells/million T-cells Standard Deviation 610.10	2172.37 gE-specific CD4+ T-cells/million T-cells Standard Deviation 1805.51	2582.80 gE-specific CD4+ T-cells/million T-cells Standard Deviation 2154.92

PRIMARY outcome

Timeframe: One month after the second vaccination (Month 3)

Population: The analyses were performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects from Month 0 to 3. This included those subjects who met all eligibility criteria, complied with the protocol, with no elimination criteria during this part of the study and for whom immunogenicity measures were available.

The analysis focused on CD4+ T-cells expressing at least 2 immunological activation markers among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L). Frequencies were determined by in vitro Intracellular Cytokine Staining (ICS).

Outcome measures

Measure	Placebo Group n=32 Participants Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 3 Group n=70 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 2 Group n=126 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 1 Group n=125 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
Frequency of Varicella-Zoster Virus (VZV)-Specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers	457.43 VZV-specific CD4+ T-cells/million T-cell Standard Deviation 275.25	523.12 VZV-specific CD4+ T-cells/million T-cell Standard Deviation 396.01	1093.08 VZV-specific CD4+ T-cells/million T-cell Standard Deviation 927.18	1270.79 VZV-specific CD4+ T-cells/million T-cell Standard Deviation 1106.45

PRIMARY outcome

Timeframe: One month after the second vaccination (Month 3)

Population: The analyses were performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects from Month 0 to 3. This included those subjects who met all eligibility criteria, complied with the protocol, with no elimination criteria during this part of the study and for whom immunogenicity measures were available.

Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).

Outcome measures

Measure	Placebo Group n=36 Participants Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 3 Group n=70 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 2 Group n=133 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 1 Group n=132 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
Anti-glycoprotein E (gE) Antibody Concentrations	1987.0 mIU/mL Interval 1405.8 to 2808.6	14627.6 mIU/mL Interval 11347.9 to 18855.1	49531.5 mIU/mL Interval 44269.3 to 55419.2	68798.2 mIU/mL Interval 61596.8 to 76841.5

PRIMARY outcome

Timeframe: One month after the second vaccination (Month 3)

Population: The analyses were performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects from Month 0 to 3. This included those subjects who met all eligibility criteria, complied with the protocol, with no elimination criteria during this part of the study and for whom immunogenicity measures were available.

Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).

Outcome measures

Measure	Placebo Group n=36 Participants Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 3 Group n=70 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 2 Group n=133 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 1 Group n=132 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
Anti-VZV Antibody Concentrations	1423.2 mIU/mL Interval 1097.8 to 1845.0	2786.4 mIU/mL Interval 2445.1 to 3175.3	4565.4 mIU/mL Interval 4357.0 to 4783.7	4972.8 mIU/mL Interval 4802.7 to 5148.8

SECONDARY outcome

Timeframe: At Month 0 and at Month 2

Population: The analyses were performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects from Month 0 to 3. This included those subjects who met all eligibility criteria, complied with the protocol, with no elimination criteria during this part of the study and for whom immunogenicity measures were available.

The analysis focused on CD4+ T-cells expressing at least 2 immunological activation markers among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L). Frequencies were determined by in vitro Intracellular Cytokine Staining (ICS).

Outcome measures

Measure	Placebo Group n=35 Participants Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 3 Group n=70 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 2 Group n=132 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 1 Group n=133 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
Frequencies of gE-specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers Month 0	210.18 gE-specific CD4+ T-cells/million T-cells Standard Deviation 363.37	130.98 gE-specific CD4+ T-cells/million T-cells Standard Deviation 115.90	196.52 gE-specific CD4+ T-cells/million T-cells Standard Deviation 217.94	173.48 gE-specific CD4+ T-cells/million T-cells Standard Deviation 203.54
Frequencies of gE-specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers Month 2	185.59 gE-specific CD4+ T-cells/million T-cells Standard Deviation 310.06	189.46 gE-specific CD4+ T-cells/million T-cells Standard Deviation 188.80	463.79 gE-specific CD4+ T-cells/million T-cells Standard Deviation 386.94	430.50 gE-specific CD4+ T-cells/million T-cells Standard Deviation 323.88

SECONDARY outcome

Timeframe: At Month 0 and at Month 2

Population: The analyses were performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects from Month 0 to 3. This included those subjects who met all eligibility criteria, complied with the protocol, with no elimination criteria during this part of the study and for whom immunogenicity measures were available.

The analysis focused on CD4+ T-cells expressing at least 2 immunological activation markers among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L). Frequencies were determined by in vitro Intracellular Cytokine Staining (ICS).

Outcome measures

Measure	Placebo Group n=35 Participants Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 3 Group n=68 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 2 Group n=131 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 1 Group n=133 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
Frequency of VZV-specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers Month 0	533.97 VZV-specific CD4+ T-cells/million T-cell Standard Deviation 422.46	352.71 VZV-specific CD4+ T-cells/million T-cell Standard Deviation 283.42	457.28 VZV-specific CD4+ T-cells/million T-cell Standard Deviation 402.04	482.63 VZV-specific CD4+ T-cells/million T-cell Standard Deviation 512.05
Frequency of VZV-specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers Month 2	491.12 VZV-specific CD4+ T-cells/million T-cell Standard Deviation 330.34	410.69 VZV-specific CD4+ T-cells/million T-cell Standard Deviation 356.65	595.10 VZV-specific CD4+ T-cells/million T-cell Standard Deviation 588.51	574.54 VZV-specific CD4+ T-cells/million T-cell Standard Deviation 586.85

SECONDARY outcome

Timeframe: At Month 0 and at Month 2

Population: The analyses were performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects from Month 0 to 3. This included those subjects who met all eligibility criteria, complied with the protocol, with no elimination criteria during this part of the study and for whom immunogenicity measures were available.

Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).

Outcome measures

Measure	Placebo Group n=37 Participants Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 3 Group n=71 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 2 Group n=137 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 1 Group n=140 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
Anti-gE Antibody Concentrations Month 0	1907.7 mIU/mL Interval 1374.9 to 2646.9	1640.3 mIU/mL Interval 1307.9 to 2057.3	1526.7 mIU/mL Interval 1306.6 to 1783.8	1398.3 mIU/mL Interval 1212.6 to 1612.5
Anti-gE Antibody Concentrations Month 2	2022.3 mIU/mL Interval 1484.6 to 2754.7	10022.8 mIU/mL Interval 7593.7 to 13228.7	19962.3 mIU/mL Interval 16894.4 to 23587.3	23942.4 mIU/mL Interval 20536.9 to 27912.6

SECONDARY outcome

Timeframe: At Month 0 and at Month 2

Population: The analyses were performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects from Month 0 to 3. This included those subjects who met all eligibility criteria, complied with the protocol, with no elimination criteria during this part of the study and for whom immunogenicity measures were available.

Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).

Outcome measures

Measure	Placebo Group n=37 Participants Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 3 Group n=71 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 2 Group n=137 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 1 Group n=140 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
Anti-VZV Antibody Concentrations Month 0	1505.5 mIU/mL Interval 1191.7 to 1901.9	1289.6 mIU/mL Interval 1100.3 to 1511.6	1215.9 mIU/mL Interval 1077.4 to 1372.2	1175.8 mIU/mL Interval 1051.0 to 1315.5
Anti-VZV Antibody Concentrations Month 2	1365.5 mIU/mL Interval 1074.4 to 1735.4	2392.8 mIU/mL Interval 2074.8 to 2759.5	3125.6 mIU/mL Interval 2902.8 to 3365.5	3355.1 mIU/mL Interval 3110.6 to 3618.9

SECONDARY outcome

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

Population: The analyses were performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented, who had their symptom sheets filled in.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

Outcome measures

Measure	Placebo Group n=38 Participants Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 3 Group n=73 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 2 Group n=149 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 1 Group n=150 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Across Doses	0 Participants	0 Participants	3 Participants	2 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 1	1 Participants	8 Participants	89 Participants	112 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 1	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 1	0 Participants	0 Participants	15 Participants	26 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 1	0 Participants	0 Participants	2 Participants	2 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 1	0 Participants	1 Participants	9 Participants	8 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 1	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 2	2 Participants	9 Participants	82 Participants	106 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 2	0 Participants	0 Participants	1 Participants	6 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 2	0 Participants	3 Participants	19 Participants	37 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 2	0 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 2	0 Participants	2 Participants	20 Participants	18 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 2	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Across Doses	3 Participants	14 Participants	104 Participants	125 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Across Doses	0 Participants	0 Participants	2 Participants	6 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Across Doses	0 Participants	3 Participants	26 Participants	44 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Across Doses	0 Participants	3 Participants	25 Participants	23 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Across Doses	0 Participants	0 Participants	1 Participants	1 Participants

SECONDARY outcome

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

Population: The analyses were performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented, who had their symptom sheets filled in.

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

Outcome measures

Measure	Placebo Group n=38 Participants Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 3 Group n=73 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 2 Group n=149 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 1 Group n=150 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Any Fatigue, Dose 1	3 Participants	10 Participants	32 Participants	42 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Fatigue, Dose 1	0 Participants	1 Participants	2 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Fatigue, Dose 1	3 Participants	9 Participants	28 Participants	39 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Any Gastr. sympt., Dose 1	1 Participants	1 Participants	10 Participants	8 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Gastr. sympt., Dose 1	1 Participants	0 Participants	2 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Gastr. sympt., Dose 1	0 Participants	0 Participants	7 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Any Headache, Dose 1	2 Participants	8 Participants	22 Participants	32 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Headache, Dose 1	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Headache, Dose 1	1 Participants	5 Participants	14 Participants	29 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Any Myalgia, Dose 1	1 Participants	8 Participants	36 Participants	42 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Myalgia, Dose 1	0 Participants	0 Participants	0 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Myalgia, Dose 1	1 Participants	6 Participants	29 Participants	40 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Any Temperature, Dose 1	0 Participants	0 Participants	7 Participants	11 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Temperature, Dose 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Temperature, Dose 1	0 Participants	0 Participants	3 Participants	8 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Any Fatigue, Dose 2	5 Participants	10 Participants	41 Participants	58 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Fatigue, Dose 2	1 Participants	1 Participants	3 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Fatigue, Dose 2	3 Participants	9 Participants	34 Participants	56 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Any Gastr. sympt., Dose 2	2 Participants	4 Participants	12 Participants	12 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Gastr. sympt., Dose 2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Gastr. sympt., Dose 2	1 Participants	3 Participants	8 Participants	9 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Any Headache, Dose 2	3 Participants	5 Participants	25 Participants	42 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Headache, Dose 2	0 Participants	0 Participants	0 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Headache, Dose 2	1 Participants	5 Participants	20 Participants	38 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Any Myalgia, Dose 2	2 Participants	8 Participants	33 Participants	49 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Myalgia, Dose 2	1 Participants	0 Participants	2 Participants	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Myalgia, Dose 2	2 Participants	8 Participants	26 Participants	48 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Any Temperature, Dose 2	1 Participants	0 Participants	14 Participants	21 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Temperature, Dose 2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Temperature, Dose 2	1 Participants	0 Participants	11 Participants	20 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Any Fatigue, Across Doses	7 Participants	16 Participants	52 Participants	72 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Fatigue, Across Doses	1 Participants	2 Participants	5 Participants	9 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Fatigue, Across Doses	6 Participants	14 Participants	45 Participants	71 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Any Gastr. sympt., Across Doses	3 Participants	5 Participants	18 Participants	17 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Gastr. sympt., Across Doses	1 Participants	0 Participants	2 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Gastr. sympt., Across Doses	1 Participants	3 Participants	12 Participants	15 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Any Headache, Across Doses	4 Participants	10 Participants	37 Participants	56 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Headache, Across Doses	0 Participants	0 Participants	0 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Headache, Across Doses	2 Participants	8 Participants	29 Participants	53 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Any Myalgia, Across Doses	2 Participants	12 Participants	49 Participants	62 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Myalgia, Across Doses	1 Participants	0 Participants	2 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Myalgia, Across Doses	2 Participants	11 Participants	41 Participants	62 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Any Temperature, Across Doses	1 Participants	0 Participants	18 Participants	25 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Temperature, Across Doses	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Related Temperature, Across Doses	1 Participants	0 Participants	13 Participants	23 Participants

SECONDARY outcome

Timeframe: Within the 30-day (Days 0-29) post-vaccination period

Population: The analyses were performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

Outcome measures

Measure	Placebo Group n=38 Participants Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 3 Group n=73 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 2 Group n=149 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 1 Group n=150 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Any AE(s)	6 Participants	18 Participants	37 Participants	46 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Grade 3 AE(s)	1 Participants	1 Participants	3 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Related AE(s)	0 Participants	2 Participants	15 Participants	24 Participants

SECONDARY outcome

Timeframe: From Month 0 up to Month 8

Population: The analyses were performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.

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

Outcome measures

Measure	Placebo Group n=38 Participants Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 3 Group n=73 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 2 Group n=149 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 1 Group n=150 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
Number of Subjects With Serious Adverse Events (SAEs) Up to Month 3	2 Participants	3 Participants	4 Participants	4 Participants
Number of Subjects With Serious Adverse Events (SAEs) After Month 3 up to Month 8	1 Participants	4 Participants	2 Participants	2 Participants

SECONDARY outcome

Timeframe: During the period after Month 8 up to the end of the study at Month 14

Population: The analyses were performed on the Total Vaccinated Cohort for the Safety Follow-up (SFU) Month 14, which included all vaccinated subjects who were not withdrawn from the study during the period up to Month 3 nor from the SFU Month 8, and who signed the supplementary informed consent for participating to the End of study telephone contact.

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

Outcome measures

Measure	Placebo Group n=34 Participants Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 3 Group n=65 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 2 Group n=130 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 1 Group n=126 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
Number of Subjects With Serious Adverse Events (SAEs)	1 Participants	3 Participants	1 Participants	4 Participants

SECONDARY outcome

Timeframe: From Month 0 until Month 8

Population: The analyses were performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.

Any new onset of autoimmune diseases were to be reported throughout the entire study period, whether or not they were considered to be possibly related to the treatment administration. These included neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, other autoimmune/inflammatory events, autoimmune bullous skin diseases, vasculitis and liver autoimmune diseases.

Outcome measures

Measure	Placebo Group n=38 Participants Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 3 Group n=73 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 2 Group n=149 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 1 Group n=150 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs)	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: During the period after Month 8 up to the end of the study at Month 14

Population: The analyses were performed on the Total Vaccinated Cohort for the Safety Follow-up (SFU) Month 14, which included all vaccinated subjects who were not withdrawn from the study during the period up to Month 3 nor from the SFU Month 8, and who signed the supplementary informed consent for participating to the End of study telephone contact.

Any new onset of autoimmune diseases were to be reported throughout the entire study period, whether or not they were considered to be possibly related to the treatment administration. These included neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, other autoimmune/inflammatory events, autoimmune bullous skin diseases, vasculitis and liver autoimmune diseases.

Outcome measures

Measure	Placebo Group n=34 Participants Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 3 Group n=65 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 2 Group n=130 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 1 Group n=126 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs)	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Month 0 until Month 8

Population: The analyses were performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.

A suspected case of HZ was defined as a rash consistent with HZ.

Outcome measures

Measure	Placebo Group n=38 Participants Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 3 Group n=73 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 2 Group n=149 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 1 Group n=150 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
Number of Subjects With Suspected Cases of Herpes Zoster (HZ)	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: During the period after Month 8 up to the end of the study at Month 14

Population: The analyses were performed on the Total Vaccinated Cohort for the Safety Follow-up (SFU) Month 14, which included all vaccinated subjects who were not withdrawn from the study during the period up to Month 3 nor from the SFU Month 8, and who signed the supplementary informed consent for participating to the End of study telephone contact.

A suspected case of HZ is defined as a rash consistent with HZ.

Outcome measures

Measure	Placebo Group n=34 Participants Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 3 Group n=65 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 2 Group n=130 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 1 Group n=126 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
Number of Subjects With Suspected Cases of Herpes Zoster (HZ)	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At Month 0

Population: The analyses were performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.

Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hematocrit (HCT), Hemoglobin (HGB), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Mean Corpuscular Volume (MCV), Monocytes (MON), Neutrophils (NEU), Partial Thromboplastin Time (PTT), Platelets (PLAT), Prothrombin Time (PT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).

Outcome measures

Measure	Placebo Group n=38 Participants Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 3 Group n=150 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 2 Group n=149 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 1 Group n=73 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges HCT · Below	2 Participants	12 Participants	9 Participants	1 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges ALT · Unknown	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges ALT · Below	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges ALT · Normal	35 Participants	146 Participants	142 Participants	71 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges ALT · Above	3 Participants	4 Participants	7 Participants	2 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges AST · Unknown	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges AST · Below	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges AST · Normal	38 Participants	148 Participants	146 Participants	71 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges AST · Above	0 Participants	2 Participants	3 Participants	2 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges BAS · Unknown	1 Participants	2 Participants	1 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges BAS · Below	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges BAS · Normal	37 Participants	148 Participants	148 Participants	73 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges BAS · Above	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges CAL · Unknown	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges CAL · Below	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges CAL · Normal	38 Participants	150 Participants	144 Participants	73 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges CAL · Above	0 Participants	0 Participants	5 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges CREA · Unknown	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges CREA · Below	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges CREA · Normal	36 Participants	144 Participants	142 Participants	70 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges CREA · Above	2 Participants	6 Participants	7 Participants	3 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges EOS · Unknown	1 Participants	2 Participants	1 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges EOS · Below	0 Participants	11 Participants	12 Participants	8 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges EOS · Normal	36 Participants	132 Participants	135 Participants	65 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges EOS · Above	1 Participants	5 Participants	1 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges FIBR · Unknown	0 Participants	3 Participants	2 Participants	1 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges FIBR · Below	1 Participants	2 Participants	3 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges FIBR · Normal	34 Participants	127 Participants	126 Participants	56 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges FIBR · Above	3 Participants	18 Participants	18 Participants	16 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges HCT · Unknown	1 Participants	2 Participants	1 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges HCT · Normal	35 Participants	135 Participants	135 Participants	71 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges HCT · Above	0 Participants	1 Participants	4 Participants	1 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges HGB · Unknown	1 Participants	2 Participants	1 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges HGB · Below	1 Participants	6 Participants	7 Participants	1 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges HGB · Normal	36 Participants	141 Participants	137 Participants	70 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges HGB · Above	0 Participants	1 Participants	4 Participants	2 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges LDH · Unknown	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges LDH · Below	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges LDH · Normal	38 Participants	149 Participants	149 Participants	73 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges LDH · Above	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges LYM · Unknown	1 Participants	2 Participants	1 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges LYM · Below	1 Participants	2 Participants	1 Participants	1 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges LYM · Normal	35 Participants	146 Participants	145 Participants	72 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges LYM · Above	1 Participants	0 Participants	2 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges MCV · Unknown	1 Participants	2 Participants	1 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges MCV · Below	0 Participants	5 Participants	1 Participants	2 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges MCV · Normal	37 Participants	140 Participants	145 Participants	69 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges MCV · Above	0 Participants	3 Participants	2 Participants	2 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges MON · Unknown	1 Participants	2 Participants	1 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges MON · Below	1 Participants	6 Participants	4 Participants	2 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges MON · Normal	36 Participants	142 Participants	144 Participants	71 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges MON · Above	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges NEU · Unknown	1 Participants	2 Participants	1 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges NEU · Below	0 Participants	3 Participants	0 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges NEU · Normal	37 Participants	142 Participants	146 Participants	71 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges NEU · Above	0 Participants	3 Participants	2 Participants	2 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges PTT · Unknown	0 Participants	4 Participants	2 Participants	1 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges PTT · Below	1 Participants	10 Participants	5 Participants	1 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges PTT · Normal	36 Participants	135 Participants	137 Participants	70 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges PTT · Above	1 Participants	1 Participants	5 Participants	1 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges PLAT · Unknown	2 Participants	2 Participants	2 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges PLAT · Below	0 Participants	3 Participants	3 Participants	1 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges PLAT · Normal	35 Participants	144 Participants	143 Participants	70 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges PLAT · Above	1 Participants	1 Participants	1 Participants	2 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges PT · Unknown	0 Participants	4 Participants	2 Participants	1 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges PT · Below	2 Participants	7 Participants	2 Participants	3 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges PT · Normal	35 Participants	135 Participants	137 Participants	67 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges PT · Above	1 Participants	4 Participants	8 Participants	2 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges RBC · Unknown	1 Participants	2 Participants	1 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges RBC · Below	0 Participants	7 Participants	4 Participants	2 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges RBC · Normal	37 Participants	141 Participants	142 Participants	68 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges RBC · Above	0 Participants	0 Participants	2 Participants	3 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges TP · Unknown	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges TP · Below	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges TP · Normal	38 Participants	149 Participants	148 Participants	73 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges TP · Above	0 Participants	1 Participants	1 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges WBC · Unknown	1 Participants	2 Participants	1 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges WBC · Below	0 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges WBC · Normal	37 Participants	145 Participants	140 Participants	70 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges WBC · Above	0 Participants	2 Participants	8 Participants	2 Participants

SECONDARY outcome

Timeframe: At Month 2

Population: The analyses were performed on the Month 2 Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and who completed the Month 2 study visit.

Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hematocrit (HCT), Hemoglobin (HGB), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Mean Corpuscular Volume (MCV), Monocytes (MON), Neutrophils (NEU), Partial Thromboplastin Time (PTT), Platelets (PLAT), Prothrombin Time (PT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).

Outcome measures

Measure	Placebo Group n=38 Participants Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 3 Group n=143 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 2 Group n=144 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 1 Group n=72 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges ALT · Unknown	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges ALT · Below	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges ALT · Normal	36 Participants	139 Participants	138 Participants	68 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges ALT · Above	2 Participants	4 Participants	6 Participants	4 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges AST · Unknown	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges AST · Below	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges AST · Normal	38 Participants	139 Participants	140 Participants	67 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges AST · Above	0 Participants	4 Participants	4 Participants	4 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges BAS · Unknown	1 Participants	3 Participants	2 Participants	2 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges BAS · Below	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges BAS · Normal	37 Participants	140 Participants	142 Participants	70 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges BAS · Above	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges CAL · Unknown	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges CAL · Below	0 Participants	2 Participants	1 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges CAL · Normal	38 Participants	137 Participants	136 Participants	71 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges CAL · Above	0 Participants	4 Participants	7 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges CREA · Unknown	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges CREA · Below	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges CREA · Normal	37 Participants	138 Participants	138 Participants	67 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges CREA · Above	1 Participants	5 Participants	6 Participants	4 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges EOS · Unknown	1 Participants	3 Participants	2 Participants	2 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges EOS · Below	1 Participants	12 Participants	12 Participants	7 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges EOS · Normal	35 Participants	125 Participants	129 Participants	62 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges EOS · Above	1 Participants	3 Participants	1 Participants	1 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges FIBR · Unknown	0 Participants	2 Participants	3 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges FIBR · Below	1 Participants	12 Participants	4 Participants	9 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges FIBR · Normal	34 Participants	124 Participants	131 Participants	59 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges FIBR · Above	3 Participants	5 Participants	6 Participants	4 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges HCT · Unknown	1 Participants	3 Participants	2 Participants	1 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges HCT · Below	2 Participants	12 Participants	11 Participants	4 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges HCT · Normal	35 Participants	126 Participants	126 Participants	65 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges HCT · Above	0 Participants	2 Participants	5 Participants	2 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges WBC · Above	1 Participants	1 Participants	3 Participants	2 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges HGB · Unknown	1 Participants	3 Participants	2 Participants	1 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges HGB · Below	1 Participants	9 Participants	7 Participants	3 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges HGB · Normal	35 Participants	129 Participants	134 Participants	66 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges HGB · Above	1 Participants	2 Participants	1 Participants	2 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges LDH · Unknown	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges LDH · Below	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges LDH · Normal	38 Participants	143 Participants	144 Participants	71 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges LDH · Above	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges LYM · Unknown	1 Participants	3 Participants	2 Participants	2 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges LYM · Below	0 Participants	2 Participants	2 Participants	3 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges LYM · Normal	37 Participants	137 Participants	139 Participants	67 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges LYM · Above	0 Participants	1 Participants	1 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges MCV · Unknown	1 Participants	3 Participants	2 Participants	1 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges MCV · Below	0 Participants	2 Participants	1 Participants	3 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges MCV · Normal	37 Participants	134 Participants	139 Participants	67 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges MCV · Above	0 Participants	4 Participants	2 Participants	1 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges MON · Unknown	1 Participants	3 Participants	2 Participants	2 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges MON · Below	3 Participants	10 Participants	9 Participants	6 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges MON · Normal	34 Participants	130 Participants	133 Participants	64 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges MON · Above	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges NEU · Unknown	1 Participants	3 Participants	2 Participants	2 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges NEU · Below	1 Participants	3 Participants	1 Participants	1 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges NEU · Normal	36 Participants	136 Participants	138 Participants	68 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges NEU · Above	0 Participants	1 Participants	3 Participants	1 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges PTT · Unknown	0 Participants	2 Participants	3 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges PTT · Below	0 Participants	1 Participants	1 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges PTT · Normal	37 Participants	132 Participants	129 Participants	64 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges PTT · Above	1 Participants	8 Participants	11 Participants	8 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges PLAT · Unknown	1 Participants	3 Participants	4 Participants	2 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges PLAT · Below	1 Participants	3 Participants	5 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges PLAT · Normal	36 Participants	137 Participants	135 Participants	68 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges PLAT · Above	0 Participants	0 Participants	0 Participants	2 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges PT · Unknown	0 Participants	2 Participants	3 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges PT · Below	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges PT · Normal	37 Participants	136 Participants	132 Participants	67 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges PT · Above	1 Participants	5 Participants	8 Participants	5 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges RBC · Unknown	1 Participants	3 Participants	2 Participants	1 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges RBC · Below	1 Participants	8 Participants	10 Participants	3 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges RBC · Normal	36 Participants	131 Participants	131 Participants	66 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges RBC · Above	0 Participants	1 Participants	1 Participants	2 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges TP · Unknown	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges TP · Below	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges TP · Normal	38 Participants	142 Participants	144 Participants	72 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges TP · Above	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges WBC · Unknown	1 Participants	3 Participants	2 Participants	2 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges WBC · Below	1 Participants	6 Participants	0 Participants	1 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges WBC · Normal	35 Participants	133 Participants	139 Participants	67 Participants

SECONDARY outcome

Timeframe: At Month 3

Population: The analyses were performed on the Month 3 Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and who completed the Month 3 study visit.

Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hematocrit (HCT), Hemoglobin (HGB), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Mean Corpuscular Volume (MCV), Monocytes (MON), Neutrophils (NEU), Partial Thromboplastin Time (PTT), Platelets (PLAT), Prothrombin Time (PT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).

Outcome measures

Measure	Placebo Group n=38 Participants Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 3 Group n=142 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 2 Group n=142 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 1 Group n=72 Participants Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges WBC · Unknown	0 Participants	3 Participants	3 Participants	3 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges WBC · Below	0 Participants	6 Participants	2 Participants	2 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges WBC · Normal	37 Participants	132 Participants	137 Participants	64 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges WBC · Above	1 Participants	1 Participants	0 Participants	3 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges PT · Below	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges PT · Normal	37 Participants	131 Participants	137 Participants	68 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges PT · Above	1 Participants	8 Participants	5 Participants	2 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges RBC · Unknown	0 Participants	3 Participants	3 Participants	4 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges RBC · Below	2 Participants	7 Participants	8 Participants	2 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges RBC · Normal	36 Participants	131 Participants	131 Participants	64 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges RBC · Above	0 Participants	1 Participants	0 Participants	2 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges TP · Unknown	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges TP · Below	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges TP · Normal	38 Participants	142 Participants	142 Participants	72 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges TP · Above	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges ALT · Unknown	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges ALT · Below	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges ALT · Normal	36 Participants	138 Participants	139 Participants	70 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges ALT · Above	2 Participants	4 Participants	3 Participants	2 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges AST · Unknown	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges AST · Below	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges AST · Normal	38 Participants	139 Participants	140 Participants	70 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges AST · Above	0 Participants	3 Participants	2 Participants	2 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges BAS · Unknown	0 Participants	3 Participants	3 Participants	3 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges BAS · Below	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges BAS · Normal	38 Participants	139 Participants	139 Participants	69 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges BAS · Above	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges CAL · Unknown	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges CAL · Below	0 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges CAL · Normal	38 Participants	140 Participants	138 Participants	71 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges CAL · Above	0 Participants	1 Participants	4 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges CREA · Unknown	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges CREA · Below	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges CREA · Normal	37 Participants	135 Participants	134 Participants	68 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges CREA · Above	1 Participants	7 Participants	8 Participants	4 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges EOS · Unknown	0 Participants	3 Participants	3 Participants	3 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges EOS · Below	1 Participants	7 Participants	13 Participants	11 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges EOS · Normal	36 Participants	131 Participants	122 Participants	57 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges EOS · Above	1 Participants	1 Participants	4 Participants	1 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges FIBR · Unknown	0 Participants	3 Participants	0 Participants	2 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges FIBR · Below	1 Participants	5 Participants	4 Participants	2 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges FIBR · Normal	35 Participants	125 Participants	133 Participants	61 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges FIBR · Above	2 Participants	9 Participants	5 Participants	7 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges HCT · Unknown	0 Participants	3 Participants	3 Participants	4 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges HCT · Below	4 Participants	12 Participants	10 Participants	6 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges HCT · Normal	34 Participants	126 Participants	126 Participants	61 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges HCT · Above	0 Participants	1 Participants	3 Participants	1 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges HGB · Unknown	0 Participants	3 Participants	3 Participants	3 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges HGB · Below	2 Participants	10 Participants	5 Participants	3 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges HGB · Normal	35 Participants	127 Participants	133 Participants	65 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges HGB · Above	1 Participants	2 Participants	1 Participants	1 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges LDH · Unknown	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges LDH · Below	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges LDH · Normal	38 Participants	141 Participants	142 Participants	71 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges LDH · Above	0 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges LYM · Unknown	0 Participants	3 Participants	3 Participants	3 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges LYM · Below	0 Participants	3 Participants	2 Participants	1 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges LYM · Normal	38 Participants	136 Participants	136 Participants	68 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges LYM · Above	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges MCV · Unknown	0 Participants	3 Participants	3 Participants	4 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges MCV · Below	0 Participants	3 Participants	1 Participants	4 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges MCV · Normal	38 Participants	133 Participants	137 Participants	63 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges MCV · Above	0 Participants	3 Participants	1 Participants	1 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges MON · Unknown	0 Participants	3 Participants	3 Participants	3 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges MON · Below	0 Participants	9 Participants	13 Participants	8 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges MON · Normal	38 Participants	130 Participants	126 Participants	61 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges MON · Above	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges NEU · Unknown	0 Participants	3 Participants	3 Participants	3 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges NEU · Below	0 Participants	4 Participants	0 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges NEU · Normal	38 Participants	135 Participants	138 Participants	65 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges NEU · Above	0 Participants	0 Participants	1 Participants	4 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges PTT · Unknown	0 Participants	3 Participants	0 Participants	2 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges PTT · Below	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges PTT · Normal	37 Participants	131 Participants	136 Participants	68 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges PTT · Above	1 Participants	8 Participants	6 Participants	2 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges PLAT · Unknown	1 Participants	7 Participants	3 Participants	4 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges PLAT · Below	0 Participants	4 Participants	4 Participants	1 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges PLAT · Normal	37 Participants	131 Participants	134 Participants	66 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges PLAT · Above	0 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges PT · Unknown	0 Participants	3 Participants	0 Participants	2 Participants

Adverse Events

Placebo Group

Serious events: 3 serious events

Other events: 9 other events

Deaths: 0 deaths

GSK1437173A Formulation 3 Group

Serious events: 8 serious events

Other events: 31 other events

Deaths: 2 deaths

GSK1437173A Formulation 2 Group

Serious events: 6 serious events

Other events: 114 other events

Deaths: 0 deaths

GSK1437173A Formulation 1 Group

Serious events: 10 serious events

Other events: 131 other events

Deaths: 1 deaths

Serious adverse events

Measure	Placebo Group n=38 participants at risk Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 3 Group n=73 participants at risk Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 2 Group n=149 participants at risk Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 1 Group n=150 participants at risk Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
Cardiac disorders Acute myocardial infarction	0.00% 0/38 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	1.4% 1/73 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/149 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/150 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).
Cardiac disorders Atrial fibrillation	0.00% 0/38 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/73 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/149 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.67% 1/150 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).
Cardiac disorders Bradycardia	0.00% 0/38 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/73 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/149 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.67% 1/150 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).
Cardiac disorders Cardiac failure	0.00% 0/38 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	1.4% 1/73 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/149 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/150 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).
Cardiac disorders Coronary artery occlusion	0.00% 0/38 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	1.4% 1/73 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/149 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/150 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).
Cardiac disorders Myocardial infarction	0.00% 0/38 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/73 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/149 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.67% 1/150 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).
Cardiac disorders Myocardial ischaemia	0.00% 0/38 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/73 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/149 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.67% 1/150 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).
Cardiac disorders Sinus node dysfunction	0.00% 0/38 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/73 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/149 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.67% 1/150 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).
Gastrointestinal disorders Hiatus hernia	2.6% 1/38 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/73 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/149 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/150 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).
Gastrointestinal disorders Ileus	0.00% 0/38 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/73 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.67% 1/149 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.67% 1/150 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).
Gastrointestinal disorders Pancreatic mass	0.00% 0/38 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/73 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/149 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.67% 1/150 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).
Gastrointestinal disorders Subileus	0.00% 0/38 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/73 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.67% 1/149 • Number of events 2 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/150 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/38 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/73 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.67% 1/149 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/150 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).
General disorders Chest pain	0.00% 0/38 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/73 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/149 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.67% 1/150 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).
General disorders Hernia	0.00% 0/38 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	1.4% 1/73 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/149 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/150 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).
Hepatobiliary disorders Bile duct obstruction	0.00% 0/38 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	1.4% 1/73 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/149 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/150 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).
Hepatobiliary disorders Cholelithiasis	2.6% 1/38 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	1.4% 1/73 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/149 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/150 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).
Infections and infestations Appendicitis	0.00% 0/38 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/73 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.67% 1/149 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/150 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).
Infections and infestations Diverticulitis	0.00% 0/38 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	1.4% 1/73 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/149 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/150 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).
Infections and infestations Escherichia sepsis	0.00% 0/38 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	1.4% 1/73 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/149 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/150 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).
Infections and infestations Pneumonia	0.00% 0/38 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/73 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/149 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.67% 1/150 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).
Injury, poisoning and procedural complications Femur fracture	0.00% 0/38 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/73 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.67% 1/149 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/150 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).
Musculoskeletal and connective tissue disorders Osteoarthritis	2.6% 1/38 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/73 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.67% 1/149 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/150 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/38 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	1.4% 1/73 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/149 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.67% 1/150 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.00% 0/38 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	1.4% 1/73 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/149 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/150 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).
Nervous system disorders Cerebrovascular disorder	0.00% 0/38 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/73 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/149 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.67% 1/150 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).
Nervous system disorders Syncope	0.00% 0/38 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	1.4% 1/73 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/149 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/150 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).
Nervous system disorders Transient ischaemic attack	0.00% 0/38 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	1.4% 1/73 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/149 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/150 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).
Psychiatric disorders Depression	0.00% 0/38 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/73 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.67% 1/149 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/150 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).
Renal and urinary disorders Acute kidney injury	0.00% 0/38 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	1.4% 1/73 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/149 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/150 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).
Renal and urinary disorders Renal failure	0.00% 0/38 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	1.4% 1/73 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/149 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/150 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/38 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/73 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/149 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.67% 1/150 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/38 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/73 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/149 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.67% 1/150 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).
Vascular disorders Haematoma	0.00% 0/38 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	1.4% 1/73 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/149 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/150 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).

Other adverse events

Measure	Placebo Group n=38 participants at risk Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 3 Group n=73 participants at risk Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 2 Group n=149 participants at risk Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.	GSK1437173A Formulation 1 Group n=150 participants at risk Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
General disorders Chills	0.00% 0/38 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/73 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	2.0% 3/149 • Number of events 4 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	5.3% 8/150 • Number of events 10 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).
Skin and subcutaneous tissue disorders Erythema	0.00% 0/38 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	4.1% 3/73 • Number of events 3 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	18.1% 27/149 • Number of events 36 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	31.3% 47/150 • Number of events 66 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).
General disorders Fatigue	18.4% 7/38 • Number of events 8 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	21.9% 16/73 • Number of events 20 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	34.9% 52/149 • Number of events 73 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	48.7% 73/150 • Number of events 101 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).
Gastrointestinal disorders Gastrointestinal disorder	7.9% 3/38 • Number of events 3 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	6.8% 5/73 • Number of events 5 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	12.1% 18/149 • Number of events 22 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	11.3% 17/150 • Number of events 20 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).
Nervous system disorders Headache	13.2% 5/38 • Number of events 6 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	15.1% 11/73 • Number of events 14 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	24.8% 37/149 • Number of events 50 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	38.0% 57/150 • Number of events 76 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).
Musculoskeletal and connective tissue disorders Myalgia	5.3% 2/38 • Number of events 3 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	16.4% 12/73 • Number of events 16 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	32.9% 49/149 • Number of events 69 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	42.0% 63/150 • Number of events 93 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).
General disorders Pain	7.9% 3/38 • Number of events 3 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	19.2% 14/73 • Number of events 17 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	69.8% 104/149 • Number of events 171 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	84.0% 126/150 • Number of events 220 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).
General disorders Pyrexia	2.6% 1/38 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	0.00% 0/73 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	12.1% 18/149 • Number of events 21 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	17.3% 26/150 • Number of events 33 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).
General disorders Swelling	0.00% 0/38 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	4.1% 3/73 • Number of events 3 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	16.8% 25/149 • Number of events 29 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).	16.0% 24/150 • Number of events 27 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 14).

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER