Trial Outcomes & Findings for Clinical Study of the Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2186877A in People Aged 65 Years or Older (NCT NCT00765076)

NCT ID: NCT00765076

Last Updated: 2018-07-31

Results Overview

The markers assessed were Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α), interferon-gamma (IFN-γ)

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 192 participants
• Primary outcome timeframe: Day 21
• Results posted on: 2018-07-31

Participant Flow

Participant milestones

Measure	New Generation Influenza Vaccine GSK2186877A Group Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0	Fluarix Elderly Group Subjects aged \>= 65 years receiving 1 dose of Fluarix vaccine at Day 0	Fluarix Young Group Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
Overall Study STARTED	69	73	50
Overall Study COMPLETED	68	73	49
Overall Study NOT COMPLETED	1	0	1

Reasons for withdrawal

Measure	New Generation Influenza Vaccine GSK2186877A Group Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0	Fluarix Elderly Group Subjects aged \>= 65 years receiving 1 dose of Fluarix vaccine at Day 0	Fluarix Young Group Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
Overall Study Adverse Event	1	0	0
Overall Study Withdrawal by Subject	0	0	1

Baseline Characteristics

Clinical Study of the Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2186877A in People Aged 65 Years or Older

Baseline characteristics by cohort

Measure	New Generation Influenza Vaccine GSK2186877A Group n=69 Participants Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0	Fluarix Elderly Group n=73 Participants Subjects aged \>= 65 years receiving 1 dose of Fluarix vaccine at Day 0	Fluarix Young Group n=50 Participants Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0	Total n=192 Participants Total of all reporting groups
Age, Continuous	71.5 Years STANDARD_DEVIATION 5.44 • n=5 Participants	71.5 Years STANDARD_DEVIATION 5.32 • n=7 Participants	26.0 Years STANDARD_DEVIATION 4.91 • n=5 Participants	59.7 Years STANDARD_DEVIATION 20.69 • n=4 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	29 Participants n=7 Participants	27 Participants n=5 Participants	92 Participants n=4 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	44 Participants n=7 Participants	23 Participants n=5 Participants	100 Participants n=4 Participants

PRIMARY outcome

Timeframe: Day 21

Population: Analysis was performed on According-to-Protocol (ATP) Immunogenicity cohort. This cohort included all evaluable subjects for whom data concerning immunogenicity were available. Analysis was only performed for New generation influenza vaccine GSK2186877A Group and Fluarix elderly Group.

The markers assessed were Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α), interferon-gamma (IFN-γ)

Outcome measures

Measure	New Generation Influenza Vaccine GSK2186877A Group n=62 Participants Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0	Fluarix Elderly Group n=61 Participants Subjects aged \>= 65 years receiving 1 dose of Fluarix vaccine at Day 0	Fluarix Young Group Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
The Geometric Mean (GM) Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains Which Are Producing at Least Two Different Markers	3371.11 cells per million CD4+ Tcells Standard Deviation 3602.15	2108.10 cells per million CD4+ Tcells Standard Deviation 1728.38	—

SECONDARY outcome

Timeframe: At Day 0, 21, 42 and 180

Population: Analysis was performed on According-to-Protocol (ATP) Immunogenicity cohort. This cohort included all evaluable subjects for whom data concerning immunogenicity were available.

The markers assessed were CD40L, IL-2, TNF-α, IFN-γ. The separate vaccine strains tested included A/Brisbane, A/Uruguay, B/Brisbane antigens.

Outcome measures

Measure	New Generation Influenza Vaccine GSK2186877A Group n=62 Participants Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0	Fluarix Elderly Group n=64 Participants Subjects aged \>= 65 years receiving 1 dose of Fluarix vaccine at Day 0	Fluarix Young Group n=44 Participants Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Which Were Producing at Least Two Different Markers pooled vaccine strain Day 0	1269.34 cells per million CD4+ Tcells Standard Deviation 1032.60	1309.30 cells per million CD4+ Tcells Standard Deviation 2098.97	2026.14 cells per million CD4+ Tcells Standard Deviation 1004.93
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Which Were Producing at Least Two Different Markers pooled vaccine strain Day 21	3371.11 cells per million CD4+ Tcells Standard Deviation 3602.15	2108.10 cells per million CD4+ Tcells Standard Deviation 1728.38	3228.91 cells per million CD4+ Tcells Standard Deviation 1714.91
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Which Were Producing at Least Two Different Markers pooled vaccine strain Day 42	2657.07 cells per million CD4+ Tcells Standard Deviation 1903.38	1540.08 cells per million CD4+ Tcells Standard Deviation 1138.94	2669.41 cells per million CD4+ Tcells Standard Deviation 1391.70
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Which Were Producing at Least Two Different Markers pooled vaccine strain Day 180	2105.66 cells per million CD4+ Tcells Standard Deviation 1232.80	1484.11 cells per million CD4+ Tcells Standard Deviation 1024.53	2746.76 cells per million CD4+ Tcells Standard Deviation 1232.90
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Which Were Producing at Least Two Different Markers A/Brisbane vaccine strain Day 0	402.28 cells per million CD4+ Tcells Standard Deviation 421.64	340.57 cells per million CD4+ Tcells Standard Deviation 352.55	793.58 cells per million CD4+ Tcells Standard Deviation 452.84
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Which Were Producing at Least Two Different Markers A/Brisbane vaccine strain Day 21	1062.79 cells per million CD4+ Tcells Standard Deviation 1049.87	462.34 cells per million CD4+ Tcells Standard Deviation 712.32	982.18 cells per million CD4+ Tcells Standard Deviation 727.70
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Which Were Producing at Least Two Different Markers A/Brisbane vaccine strain Day 42	822.07 cells per million CD4+ Tcells Standard Deviation 667.91	392.04 cells per million CD4+ Tcells Standard Deviation 498.81	874.34 cells per million CD4+ Tcells Standard Deviation 544.91
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Which Were Producing at Least Two Different Markers A/Brisbane vaccine strain Day 180	669.67 cells per million CD4+ Tcells Standard Deviation 579.75	463.94 cells per million CD4+ Tcells Standard Deviation 458.04	973.29 cells per million CD4+ Tcells Standard Deviation 555.34
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Which Were Producing at Least Two Different Markers A/Uruguay vaccine strain Day 0	342.58 cells per million CD4+ Tcells Standard Deviation 340.83	274.47 cells per million CD4+ Tcells Standard Deviation 282.29	437.07 cells per million CD4+ Tcells Standard Deviation 410.66
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Which Were Producing at Least Two Different Markers A/Uruguay vaccine strain Day 21	930.98 cells per million CD4+ Tcells Standard Deviation 1262.81	497.49 cells per million CD4+ Tcells Standard Deviation 479.98	667.38 cells per million CD4+ Tcells Standard Deviation 465.08
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Which Were Producing at Least Two Different Markers A/Uruguay vaccine strain Day 42	678.88 cells per million CD4+ Tcells Standard Deviation 669.99	331.62 cells per million CD4+ Tcells Standard Deviation 365.40	473.17 cells per million CD4+ Tcells Standard Deviation 500.92
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Which Were Producing at Least Two Different Markers A/Uruguay vaccine strain Day 180	640.97 cells per million CD4+ Tcells Standard Deviation 567.70	331.02 cells per million CD4+ Tcells Standard Deviation 324.69	654.30 cells per million CD4+ Tcells Standard Deviation 503.69
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Which Were Producing at Least Two Different Markers B/Brisbane vaccine strain Day 0	672.58 cells per million CD4+ Tcells Standard Deviation 615.67	504.36 cells per million CD4+ Tcells Standard Deviation 588.82	1183.48 cells per million CD4+ Tcells Standard Deviation 582.67
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Which Were Producing at Least Two Different Markers B/Brisbane vaccine strain Day 21	1755.55 cells per million CD4+ Tcells Standard Deviation 1961.87	1149.98 cells per million CD4+ Tcells Standard Deviation 1032.36	1861.66 cells per million CD4+ Tcells Standard Deviation 884.81
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Which Were Producing at Least Two Different Markers B/Brisbane vaccine strain Day 42	1325.35 cells per million CD4+ Tcells Standard Deviation 1094.01	807.46 cells per million CD4+ Tcells Standard Deviation 639.01	1572.47 cells per million CD4+ Tcells Standard Deviation 719.96
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Which Were Producing at Least Two Different Markers B/Brisbane vaccine strain Day 180	1034.78 cells per million CD4+ Tcells Standard Deviation 725.84	778.13 cells per million CD4+ Tcells Standard Deviation 630.32	1640.71 cells per million CD4+ Tcells Standard Deviation 897.14

SECONDARY outcome

Timeframe: At Day 0, 21, 42 and 180

Population: The analysis was based on According-to-Protocol (ATP) Immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity data were available.

The markers assessed were CD40L, IL-2, TNF-α, IFN-γ. The separate vaccine strains tested included A/Brisbane, A/Uruguay, B/Brisbane antigens.

Outcome measures

Measure	New Generation Influenza Vaccine GSK2186877A Group n=62 Participants Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0	Fluarix Elderly Group n=64 Participants Subjects aged \>= 65 years receiving 1 dose of Fluarix vaccine at Day 0	Fluarix Young Group n=44 Participants Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker pooled strain[CD4-CD40L] D 0	1104.24 cells per million CD4+ Tcells Standard Deviation 987.15	1211.72 cells per million CD4+ Tcells Standard Deviation 1086.88	1879.85 cells per million CD4+ Tcells Standard Deviation 963.74
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker pooled strain[CD4-CD40L] D 21	2817.50 cells per million CD4+ Tcells Standard Deviation 3166.07	1935.66 cells per million CD4+ Tcells Standard Deviation 1597.56	2929.86 cells per million CD4+ Tcells Standard Deviation 1644.61
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker pooled strain[CD4-CD40L] D 42	2447.37 cells per million CD4+ Tcells Standard Deviation 1766.85	1425.02 cells per million CD4+ Tcells Standard Deviation 1082.35	2436.43 cells per million CD4+ Tcells Standard Deviation 1365.81
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker pooled strain[CD4-CD40L] D 180	2036.70 cells per million CD4+ Tcells Standard Deviation 1170.14	1416.78 cells per million CD4+ Tcells Standard Deviation 973.63	2619.74 cells per million CD4+ Tcells Standard Deviation 1167.44
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker pooled strain[CD4- IFN-γ] D 0	832.47 cells per million CD4+ Tcells Standard Deviation 798.10	835.22 cells per million CD4+ Tcells Standard Deviation 1598.81	1403.57 cells per million CD4+ Tcells Standard Deviation 777.81
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker pooled strain[CD4- IFN-γ] D 21	2305.58 cells per million CD4+ Tcells Standard Deviation 2712.79	1341.17 cells per million CD4+ Tcells Standard Deviation 1195.01	2258.27 cells per million CD4+ Tcells Standard Deviation 1307.01
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker pooled strain[CD4- IFN-γ] D 42	1775.61 cells per million CD4+ Tcells Standard Deviation 1464.84	997.25 cells per million CD4+ Tcells Standard Deviation 818.08	1849.44 cells per million CD4+ Tcells Standard Deviation 1124.86
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker pooled strain[CD4- IFN-γ] D 180	1495.36 cells per million CD4+ Tcells Standard Deviation 1031.14	1019.64 cells per million CD4+ Tcells Standard Deviation 790.42	2102.93 cells per million CD4+ Tcells Standard Deviation 1074.53
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker pooled strain[CD4-IL-2] D 0	1085.32 cells per million CD4+ Tcells Standard Deviation 930.22	1119.34 cells per million CD4+ Tcells Standard Deviation 1002.46	1717.41 cells per million CD4+ Tcells Standard Deviation 852.57
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker pooled strain[CD4-IL-2] D 21	2534.86 cells per million CD4+ Tcells Standard Deviation 3188.65	1779.41 cells per million CD4+ Tcells Standard Deviation 1595.66	2690.36 cells per million CD4+ Tcells Standard Deviation 1583.12
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker pooled strain[CD4-IL-2] D42	2205.91 cells per million CD4+ Tcells Standard Deviation 1754.74	1310.05 cells per million CD4+ Tcells Standard Deviation 1062.08	2199.18 cells per million CD4+ Tcells Standard Deviation 1251.48
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker pooled strain[CD4-IL-2] D 180	1837.60 cells per million CD4+ Tcells Standard Deviation 1093.26	1285.14 cells per million CD4+ Tcells Standard Deviation 955.76	2302.51 cells per million CD4+ Tcells Standard Deviation 1042.85
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker pooled strain[CD4-TNF-α] D 0	874.43 cells per million CD4+ Tcells Standard Deviation 812.98	928.86 cells per million CD4+ Tcells Standard Deviation 1924.68	1425.50 cells per million CD4+ Tcells Standard Deviation 768.88
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker pooled strain[CD4-TNF-α] D 21	2114.47 cells per million CD4+ Tcells Standard Deviation 2448.22	1284.20 cells per million CD4+ Tcells Standard Deviation 1080.26	1999.07 cells per million CD4+ Tcells Standard Deviation 1010.68
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker pooled strain[CD4-TNF-α] D 42	1741.65 cells per million CD4+ Tcells Standard Deviation 1350.73	1012.42 cells per million CD4+ Tcells Standard Deviation 805.86	1752.99 cells per million CD4+ Tcells Standard Deviation 933.90
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker pooled strain[CD4-TNF-α] D 180	1413.29 cells per million CD4+ Tcells Standard Deviation 865.27	1015.29 cells per million CD4+ Tcells Standard Deviation 830.38	1821.04 cells per million CD4+ Tcells Standard Deviation 880.59
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker A/Brisbane strain[CD4-CD40L] D 0	387.76 cells per million CD4+ Tcells Standard Deviation 400.63	320.29 cells per million CD4+ Tcells Standard Deviation 338.91	750.57 cells per million CD4+ Tcells Standard Deviation 435.67
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker A/Brisbane strain[CD4-CD40L] D 21	980.10 cells per million CD4+ Tcells Standard Deviation 937.63	462.64 cells per million CD4+ Tcells Standard Deviation 676.17	919.30 cells per million CD4+ Tcells Standard Deviation 679.26
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker A/Brisbane strain[CD4-CD40L] D 42	771.49 cells per million CD4+ Tcells Standard Deviation 616.20	365.94 cells per million CD4+ Tcells Standard Deviation 474.72	818.54 cells per million CD4+ Tcells Standard Deviation 522.72
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker A/Brisbane strain[CD4-CD40L] D 180	653.13 cells per million CD4+ Tcells Standard Deviation 547.36	466.55 cells per million CD4+ Tcells Standard Deviation 429.28	922.06 cells per million CD4+ Tcells Standard Deviation 511.19
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker A/Uruguay strain[CD4-CD40L] D 0	308.73 cells per million CD4+ Tcells Standard Deviation 316.94	227.76 cells per million CD4+ Tcells Standard Deviation 266.35	384.02 cells per million CD4+ Tcells Standard Deviation 397.54
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker A/Uruguay strain[CD4-CD40L] D 21	805.56 cells per million CD4+ Tcells Standard Deviation 1066.84	451.52 cells per million CD4+ Tcells Standard Deviation 459.24	602.51 cells per million CD4+ Tcells Standard Deviation 431.82
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker A/Uruguay strain[CD4-CD40L] D 42	592.88 cells per million CD4+ Tcells Standard Deviation 579.07	286.06 cells per million CD4+ Tcells Standard Deviation 333.05	417.15 cells per million CD4+ Tcells Standard Deviation 468.52
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker A/Uruguay strain[CD4-CD40L] D 180	609.34 cells per million CD4+ Tcells Standard Deviation 524.50	298.70 cells per million CD4+ Tcells Standard Deviation 295.58	584.68 cells per million CD4+ Tcells Standard Deviation 446.49
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker B/Brisbane strain[CD4-CD40L] D 0	647.94 cells per million CD4+ Tcells Standard Deviation 581.98	515.89 cells per million CD4+ Tcells Standard Deviation 566.11	1129.44 cells per million CD4+ Tcells Standard Deviation 573.40
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker B/Brisbane strain[CD4-CD40L] D 21	1607.98 cells per million CD4+ Tcells Standard Deviation 1806.43	1077.12 cells per million CD4+ Tcells Standard Deviation 990.77	1737.45 cells per million CD4+ Tcells Standard Deviation 842.62
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker B/Brisbane strain[CD4-CD40L] D 42	1246.10 cells per million CD4+ Tcells Standard Deviation 1033.85	763.04 cells per million CD4+ Tcells Standard Deviation 606.04	1472.48 cells per million CD4+ Tcells Standard Deviation 725.44
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker B/Brisbane strain[CD4-CD40L] D 180	1011.39 cells per million CD4+ Tcells Standard Deviation 682.07	757.17 cells per million CD4+ Tcells Standard Deviation 611.01	1570.98 cells per million CD4+ Tcells Standard Deviation 843.76
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker A/Brisbane strain[CD4- IFN-γ] D 0	279.24 cells per million CD4+ Tcells Standard Deviation 337.13	258.94 cells per million CD4+ Tcells Standard Deviation 258.55	563.26 cells per million CD4+ Tcells Standard Deviation 323.39
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker A/Brisbane strain[CD4- IFN-γ] D 21	725.55 cells per million CD4+ Tcells Standard Deviation 752.84	344.39 cells per million CD4+ Tcells Standard Deviation 447.19	680.40 cells per million CD4+ Tcells Standard Deviation 543.42
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker A/Brisbane strain[CD4- IFN-γ] D 42	572.87 cells per million CD4+ Tcells Standard Deviation 520.31	326.66 cells per million CD4+ Tcells Standard Deviation 322.73	623.21 cells per million CD4+ Tcells Standard Deviation 409.74
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker A/Brisbane strain[CD4- IFN-γ] D 180	586.26 cells per million CD4+ Tcells Standard Deviation 474.54	363.03 cells per million CD4+ Tcells Standard Deviation 361.43	773.40 cells per million CD4+ Tcells Standard Deviation 486.08
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker A/Uruguay strain[CD4- IFN-γ] D 0	214.92 cells per million CD4+ Tcells Standard Deviation 245.84	164.78 cells per million CD4+ Tcells Standard Deviation 199.00	283.81 cells per million CD4+ Tcells Standard Deviation 267.71
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker A/Uruguay strain[CD4- IFN-γ] D 21	641.94 cells per million CD4+ Tcells Standard Deviation 944.37	314.63 cells per million CD4+ Tcells Standard Deviation 311.72	403.00 cells per million CD4+ Tcells Standard Deviation 355.57
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker A/Uruguay strain[CD4- IFN-γ] D 42	458.72 cells per million CD4+ Tcells Standard Deviation 501.32	246.18 cells per million CD4+ Tcells Standard Deviation 227.80	331.47 cells per million CD4+ Tcells Standard Deviation 356.93
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker A/Uruguay strain[CD4- IFN-γ] D 180	426.59 cells per million CD4+ Tcells Standard Deviation 418.38	228.06 cells per million CD4+ Tcells Standard Deviation 215.33	451.90 cells per million CD4+ Tcells Standard Deviation 400.61
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker B/Brisbane strain[CD4- IFN-γ] D 0	342.59 cells per million CD4+ Tcells Standard Deviation 532.27	319.38 cells per million CD4+ Tcells Standard Deviation 507.10	824.76 cells per million CD4+ Tcells Standard Deviation 496.44
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker B/Brisbane strain[CD4- IFN-γ] D 21	1219.72 cells per million CD4+ Tcells Standard Deviation 1581.26	721.43 cells per million CD4+ Tcells Standard Deviation 849.49	1361.31 cells per million CD4+ Tcells Standard Deviation 712.84
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker B/Brisbane strain[CD4- IFN-γ] D 42	903.71 cells per million CD4+ Tcells Standard Deviation 918.49	517.83 cells per million CD4+ Tcells Standard Deviation 501.51	1095.12 cells per million CD4+ Tcells Standard Deviation 676.34
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker B/Brisbane strain[CD4- IFN-γ] D 180	697.03 cells per million CD4+ Tcells Standard Deviation 635.80	510.37 cells per million CD4+ Tcells Standard Deviation 539.79	1253.33 cells per million CD4+ Tcells Standard Deviation 862.51
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker A/Brisbane strain[CD4-IL2] D 0	346.00 cells per million CD4+ Tcells Standard Deviation 369.76	319.16 cells per million CD4+ Tcells Standard Deviation 331.16	677.11 cells per million CD4+ Tcells Standard Deviation 397.23
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker A/Brisbane strain[CD4-IL2] D 21	872.32 cells per million CD4+ Tcells Standard Deviation 897.70	427.26 cells per million CD4+ Tcells Standard Deviation 664.07	816.95 cells per million CD4+ Tcells Standard Deviation 655.93
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker A/Brisbane strain[CD4-IL2] D 42	696.36 cells per million CD4+ Tcells Standard Deviation 598.29	393.67 cells per million CD4+ Tcells Standard Deviation 460.81	720.28 cells per million CD4+ Tcells Standard Deviation 468.43
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker A/Brisbane strain[CD4-IL2] D 180	570.30 cells per million CD4+ Tcells Standard Deviation 503.83	387.63 cells per million CD4+ Tcells Standard Deviation 429.61	817.80 cells per million CD4+ Tcells Standard Deviation 470.25
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker A/Uruguay strain[CD4-IL2] D 0	278.66 cells per million CD4+ Tcells Standard Deviation 306.46	240.26 cells per million CD4+ Tcells Standard Deviation 261.18	369.77 cells per million CD4+ Tcells Standard Deviation 322.49
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker A/Uruguay strain[CD4-IL2] D 21	680.16 cells per million CD4+ Tcells Standard Deviation 1060.47	391.84 cells per million CD4+ Tcells Standard Deviation 425.96	510.88 cells per million CD4+ Tcells Standard Deviation 385.11
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker A/Uruguay strain[CD4-IL2] D 42	534.07 cells per million CD4+ Tcells Standard Deviation 579.96	295.90 cells per million CD4+ Tcells Standard Deviation 322.75	438.09 cells per million CD4+ Tcells Standard Deviation 401.87
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker A/Uruguay strain[CD4-IL2] D 180	526.12 cells per million CD4+ Tcells Standard Deviation 483.57	299.67 cells per million CD4+ Tcells Standard Deviation 274.20	514.55 cells per million CD4+ Tcells Standard Deviation 404.73
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker B/Brisbane strain[CD4-IL2] D 0	587.16 cells per million CD4+ Tcells Standard Deviation 566.46	451.89 cells per million CD4+ Tcells Standard Deviation 549.60	1019.08 cells per million CD4+ Tcells Standard Deviation 512.69
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker B/Brisbane strain[CD4-IL2] D 21	1496.41 cells per million CD4+ Tcells Standard Deviation 1826.01	1004.17 cells per million CD4+ Tcells Standard Deviation 966.20	1592.61 cells per million CD4+ Tcells Standard Deviation 810.35
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker B/Brisbane strain[CD4-IL2] D 42	1144.72 cells per million CD4+ Tcells Standard Deviation 1021.68	724.10 cells per million CD4+ Tcells Standard Deviation 593.13	1322.64 cells per million CD4+ Tcells Standard Deviation 664.52
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker B/Brisbane strain[CD4-IL2] D 180	933.06 cells per million CD4+ Tcells Standard Deviation 660.87	704.18 cells per million CD4+ Tcells Standard Deviation 602.50	1439.92 cells per million CD4+ Tcells Standard Deviation 753.90
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker A/Brisbane strain[CD4-TNF-α] D 0	262.44 cells per million CD4+ Tcells Standard Deviation 349.53	247.22 cells per million CD4+ Tcells Standard Deviation 274.83	536.34 cells per million CD4+ Tcells Standard Deviation 369.21
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker A/Brisbane strain[CD4-TNF-α] D 21	621.35 cells per million CD4+ Tcells Standard Deviation 746.04	289.38 cells per million CD4+ Tcells Standard Deviation 376.07	497.77 cells per million CD4+ Tcells Standard Deviation 499.72
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker A/Brisbane strain[CD4-TNF-α] D 42	500.13 cells per million CD4+ Tcells Standard Deviation 518.12	238.28 cells per million CD4+ Tcells Standard Deviation 329.62	564.91 cells per million CD4+ Tcells Standard Deviation 395.51
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker A/Brisbane strain[CD4-TNF-α] D 180	462.60 cells per million CD4+ Tcells Standard Deviation 402.23	308.96 cells per million CD4+ Tcells Standard Deviation 347.12	616.75 cells per million CD4+ Tcells Standard Deviation 383.70
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker A/Uruguay strain[CD4-TNF-α] D 0	223.83 cells per million CD4+ Tcells Standard Deviation 292.61	191.52 cells per million CD4+ Tcells Standard Deviation 234.42	284.69 cells per million CD4+ Tcells Standard Deviation 317.94
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker A/Uruguay strain[CD4-TNF-α] D 21	600.99 cells per million CD4+ Tcells Standard Deviation 932.13	320.59 cells per million CD4+ Tcells Standard Deviation 308.63	411.24 cells per million CD4+ Tcells Standard Deviation 333.50
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker A/Uruguay strain[CD4-TNF-α] D 42	452.35 cells per million CD4+ Tcells Standard Deviation 515.50	211.12 cells per million CD4+ Tcells Standard Deviation 267.39	333.52 cells per million CD4+ Tcells Standard Deviation 375.97
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker A/Uruguay strain[CD4-TNF-α] D 180	370.86 cells per million CD4+ Tcells Standard Deviation 415.54	230.70 cells per million CD4+ Tcells Standard Deviation 241.03	477.18 cells per million CD4+ Tcells Standard Deviation 355.92
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker B/Brisbane strain[CD4-TNF-α] D 0	414.10 cells per million CD4+ Tcells Standard Deviation 472.20	305.51 cells per million CD4+ Tcells Standard Deviation 516.15	773.44 cells per million CD4+ Tcells Standard Deviation 420.89
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker B/Brisbane strain[CD4-TNF-α] D 21	967.79 cells per million CD4+ Tcells Standard Deviation 1226.62	639.74 cells per million CD4+ Tcells Standard Deviation 663.66	1057.83 cells per million CD4+ Tcells Standard Deviation 507.15
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker B/Brisbane strain[CD4-TNF-α] D 42	775.92 cells per million CD4+ Tcells Standard Deviation 756.63	413.38 cells per million CD4+ Tcells Standard Deviation 490.41	953.30 cells per million CD4+ Tcells Standard Deviation 491.50
The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker B/Brisbane strain[CD4-TNF-α] D 180	642.05 cells per million CD4+ Tcells Standard Deviation 520.83	475.44 cells per million CD4+ Tcells Standard Deviation 511.57	1051.51 cells per million CD4+ Tcells Standard Deviation 664.61

SECONDARY outcome

Timeframe: At Day 0, 21, 42 and 180

Population: The analysis of immunogenicity was performed on According-to-Protocol (ATP) Immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity data were available.

Antibody titers were expressed as Geometric mean titers (GMTs) calculated after invitro stimulation with separate vaccine strains.

Outcome measures

Measure	New Generation Influenza Vaccine GSK2186877A Group n=62 Participants Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0	Fluarix Elderly Group n=66 Participants Subjects aged \>= 65 years receiving 1 dose of Fluarix vaccine at Day 0	Fluarix Young Group n=44 Participants Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
Haemagglutinin Inhibition (HI) Antibody Titers A/Brisbane strain at Day 0	16.5 titer Interval 12.7 to 21.5	14.3 titer Interval 10.9 to 18.7	20.5 titer Interval 13.0 to 32.3
Haemagglutinin Inhibition (HI) Antibody Titers A/Brisbane strain at Day 21	105.1 titer Interval 80.3 to 137.6	67.2 titer Interval 49.6 to 91.2	220.8 titer Interval 163.3 to 298.7
Haemagglutinin Inhibition (HI) Antibody Titers A/Brisbane strain at Day 42	82.3 titer Interval 64.5 to 105.0	56.8 titer Interval 42.0 to 77.0	181.4 titer Interval 133.5 to 246.6
Haemagglutinin Inhibition (HI) Antibody Titers A/Brisbane strain at Day 180	38.4 titer Interval 30.3 to 48.7	32.1 titer Interval 24.0 to 42.8	90.3 titer Interval 60.7 to 134.2
Haemagglutinin Inhibition (HI) Antibody Titers A/Uruguay strain at Day 0	21.4 titer Interval 15.0 to 30.4	17.5 titer Interval 13.2 to 23.3	16.4 titer Interval 11.0 to 24.5
Haemagglutinin Inhibition (HI) Antibody Titers A/Uruguay strain at Day 21	330.9 titer Interval 239.8 to 456.7	164.2 titer Interval 113.3 to 238.0	179.0 titer Interval 115.1 to 278.4
Haemagglutinin Inhibition (HI) Antibody Titers A/Uruguay strain at Day 42	254.8 titer Interval 182.1 to 356.5	110.1 titer Interval 77.4 to 156.6	130.3 titer Interval 86.6 to 196.1
Haemagglutinin Inhibition (HI) Antibody Titers A/Uruguay strain at Day 180	117.0 titer Interval 83.0 to 164.9	59.9 titer Interval 41.8 to 85.9	74.4 titer Interval 47.6 to 116.2
Haemagglutinin Inhibition (HI) Antibody Titers B/Brisbane strain at Day 0	92.0 titer Interval 66.2 to 127.8	97.0 titer Interval 72.9 to 129.2	169.0 titer Interval 108.2 to 263.9
Haemagglutinin Inhibition (HI) Antibody Titers B/Brisbane strain at Day 21	699.9 titer Interval 538.4 to 909.8	502.6 titer Interval 388.6 to 650.0	1229.4 titer Interval 972.8 to 1553.8
Haemagglutinin Inhibition (HI) Antibody Titers B/Brisbane strain at Day 42	487.2 titer Interval 372.2 to 637.8	393.9 titer Interval 310.3 to 500.0	971.6 titer Interval 778.0 to 1213.3
Haemagglutinin Inhibition (HI) Antibody Titers B/Brisbane strain at Day 180	254.5 titer Interval 195.3 to 331.6	238.4 titer Interval 188.4 to 301.6	677.2 titer Interval 513.7 to 892.7

SECONDARY outcome

Timeframe: At Day 0, 21, 42 and 180

Population: The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity data were available.

Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10

Outcome measures

Measure	New Generation Influenza Vaccine GSK2186877A Group n=62 Participants Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0	Fluarix Elderly Group n=66 Participants Subjects aged \>= 65 years receiving 1 dose of Fluarix vaccine at Day 0	Fluarix Young Group n=44 Participants Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
The Number of Subjects Seropositive to HI Antibodies Calculated After in Vitro Stimulation With Separate Vaccine Strains. B/Brisbane strain at Day 0	59 Participants	65 Participants	42 Participants
The Number of Subjects Seropositive to HI Antibodies Calculated After in Vitro Stimulation With Separate Vaccine Strains. A/Brisbane strain at Day 0	43 Participants	40 Participants	25 Participants
The Number of Subjects Seropositive to HI Antibodies Calculated After in Vitro Stimulation With Separate Vaccine Strains. A/Brisbane strain at Day 21	61 Participants	62 Participants	43 Participants
The Number of Subjects Seropositive to HI Antibodies Calculated After in Vitro Stimulation With Separate Vaccine Strains. A/Brisbane strain at Day 42	60 Participants	62 Participants	44 Participants
The Number of Subjects Seropositive to HI Antibodies Calculated After in Vitro Stimulation With Separate Vaccine Strains. A/Brisbane strain at Day 180	57 Participants	57 Participants	40 Participants
The Number of Subjects Seropositive to HI Antibodies Calculated After in Vitro Stimulation With Separate Vaccine Strains. A/Uruguay strain at Day 0	41 Participants	45 Participants	24 Participants
The Number of Subjects Seropositive to HI Antibodies Calculated After in Vitro Stimulation With Separate Vaccine Strains. A/Uruguay strain at Day 21	62 Participants	63 Participants	41 Participants
The Number of Subjects Seropositive to HI Antibodies Calculated After in Vitro Stimulation With Separate Vaccine Strains. A/Uruguay strain at Day 42	60 Participants	62 Participants	42 Participants
The Number of Subjects Seropositive to HI Antibodies Calculated After in Vitro Stimulation With Separate Vaccine Strains. A/Uruguay strain at Day 180	61 Participants	59 Participants	39 Participants
The Number of Subjects Seropositive to HI Antibodies Calculated After in Vitro Stimulation With Separate Vaccine Strains. B/Brisbane strain at Day 21	62 Participants	66 Participants	43 Participants
The Number of Subjects Seropositive to HI Antibodies Calculated After in Vitro Stimulation With Separate Vaccine Strains. B/Brisbane strain at Day 42	61 Participants	65 Participants	44 Participants
The Number of Subjects Seropositive to HI Antibodies Calculated After in Vitro Stimulation With Separate Vaccine Strains. B/Brisbane strain at Day 180	62 Participants	66 Participants	43 Participants

SECONDARY outcome

Timeframe: At Day 21, 42 and 180

Population: The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity data were available.

Seroconversion was defined as the number of vaccinees who had either a prevaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.

Outcome measures

Measure	New Generation Influenza Vaccine GSK2186877A Group n=62 Participants Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0	Fluarix Elderly Group n=66 Participants Subjects aged \>= 65 years receiving 1 dose of Fluarix vaccine at Day 0	Fluarix Young Group n=44 Participants Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
The Number of Subjects Seroconverted to HI Antibodies A/Brisbane strain at Day 21	36 Participants	32 Participants	29 Participants
The Number of Subjects Seroconverted to HI Antibodies A/Brisbane strain at Day 42	33 Participants	25 Participants	29 Participants
The Number of Subjects Seroconverted to HI Antibodies A/Brisbane strain at Day 180	16 Participants	16 Participants	23 Participants
The Number of Subjects Seroconverted to HI Antibodies A/Uruguay strain at Day 21	52 Participants	50 Participants	33 Participants
The Number of Subjects Seroconverted to HI Antibodies A/Uruguay strain at Day 42	48 Participants	44 Participants	30 Participants
The Number of Subjects Seroconverted to HI Antibodies A/Uruguay strain at Day 180	36 Participants	28 Participants	20 Participants
The Number of Subjects Seroconverted to HI Antibodies B/Brisbane strain at Day 21	44 Participants	38 Participants	29 Participants
The Number of Subjects Seroconverted to HI Antibodies B/Brisbane strain at Day 42	38 Participants	35 Participants	25 Participants
The Number of Subjects Seroconverted to HI Antibodies B/Brisbane strain at Day 180	22 Participants	22 Participants	20 Participants

SECONDARY outcome

Timeframe: At Day 21, 42 and 180

Population: The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity data were available.

Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.

Outcome measures

Measure	New Generation Influenza Vaccine GSK2186877A Group n=62 Participants Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0	Fluarix Elderly Group n=66 Participants Subjects aged \>= 65 years receiving 1 dose of Fluarix vaccine at Day 0	Fluarix Young Group n=44 Participants Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
HI Antibody Seroconversion Factors A/Brisbane strain at Day 21	6.4 fold increase Interval 4.5 to 9.0	4.7 fold increase Interval 3.4 to 6.6	10.6 fold increase Interval 6.3 to 17.9
HI Antibody Seroconversion Factors A/Brisbane strain at Day 42	5.1 fold increase Interval 3.7 to 7.0	3.9 fold increase Interval 2.8 to 5.4	8.9 fold increase Interval 5.3 to 14.7
HI Antibody Seroconversion Factors A/Brisbane strain at Day 180	2.3 fold increase Interval 1.8 to 3.0	2.2 fold increase Interval 1.7 to 3.0	4.6 fold increase Interval 2.9 to 7.2
HI Antibody Seroconversion Factors A/Uruguay strain at Day 21	15.5 fold increase Interval 10.8 to 22.2	9.4 fold increase Interval 6.6 to 13.2	11.3 fold increase Interval 7.2 to 17.8
HI Antibody Seroconversion Factors A/Uruguay strain at Day 42	12.2 fold increase Interval 8.5 to 17.4	6.4 fold increase Interval 4.7 to 8.6	7.9 fold increase Interval 5.3 to 11.9
HI Antibody Seroconversion Factors A/Uruguay strain at Day 180	5.5 fold increase Interval 4.1 to 7.3	3.4 fold increase Interval 2.5 to 4.6	4.5 fold increase Interval 3.0 to 6.9
HI Antibody Seroconversion Factors B/Brisbane strain at Day 21	7.6 fold increase Interval 5.6 to 10.3	5.2 fold increase Interval 3.8 to 7.1	7.4 fold increase Interval 4.7 to 11.6
HI Antibody Seroconversion Factors B/Brisbane strain at Day 42	5.4 fold increase Interval 4.0 to 7.2	4.1 fold increase Interval 3.1 to 5.4	5.8 fold increase Interval 3.7 to 8.9
HI Antibody Seroconversion Factors B/Brisbane strain at Day 180	2.8 fold increase Interval 2.2 to 3.4	2.5 fold increase Interval 1.9 to 3.1	4.0 fold increase Interval 2.8 to 5.8

SECONDARY outcome

Timeframe: At Day 0, 21, 42 and 180

Population: The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity data were available.

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

Outcome measures

Measure	New Generation Influenza Vaccine GSK2186877A Group n=62 Participants Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0	Fluarix Elderly Group n=66 Participants Subjects aged \>= 65 years receiving 1 dose of Fluarix vaccine at Day 0	Fluarix Young Group n=44 Participants Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
The Number of Subjects Seroprotected to HI Antibodies A/Brisbane strain at Day 0	20 Participants	16 Participants	18 Participants
The Number of Subjects Seroprotected to HI Antibodies A/Brisbane strain at Day 21	57 Participants	53 Participants	42 Participants
The Number of Subjects Seroprotected to HI Antibodies A/Brisbane strain at Day 42	56 Participants	47 Participants	42 Participants
The Number of Subjects Seroprotected to HI Antibodies A/Brisbane strain at Day 180	39 Participants	34 Participants	36 Participants
The Number of Subjects Seroprotected to HI Antibodies A/Uruguay strain at Day 0	26 Participants	24 Participants	16 Participants
The Number of Subjects Seroprotected to HI Antibodies A/Uruguay strain at Day 21	61 Participants	57 Participants	39 Participants
The Number of Subjects Seroprotected to HI Antibodies A/Uruguay strain at Day 42	59 Participants	53 Participants	39 Participants
The Number of Subjects Seroprotected to HI Antibodies A/Uruguay strain at Day 180	53 Participants	48 Participants	33 Participants
The Number of Subjects Seroprotected to HI Antibodies B/Brisbane strain at Day 0	51 Participants	57 Participants	39 Participants
The Number of Subjects Seroprotected to HI Antibodies B/Brisbane strain at Day 21	62 Participants	65 Participants	43 Participants
The Number of Subjects Seroprotected to HI Antibodies B/Brisbane strain at Day 42	61 Participants	64 Participants	44 Participants
The Number of Subjects Seroprotected to HI Antibodies B/Brisbane strain at Day 180	60 Participants	65 Participants	42 Participants

SECONDARY outcome

Timeframe: Day 0 -6

Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.

Grade 3 ecchymosis, redness and swelling was >100mm and grade 3 pain was considerable pain at rest, that prevented normal everyday activity.

Outcome measures

Measure	New Generation Influenza Vaccine GSK2186877A Group n=69 Participants Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0	Fluarix Elderly Group n=73 Participants Subjects aged \>= 65 years receiving 1 dose of Fluarix vaccine at Day 0	Fluarix Young Group n=50 Participants Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Any ecchymosis	2 Participants	1 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Grade 3 ecchymosis	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Any pain	43 Participants	15 Participants	35 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Grade 3 pain	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Any redness	5 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Grade 3 redness	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Any swelling	8 Participants	1 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Grade 3 swelling	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 0 -6

Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented on subjects who experienced the symptom.

Duration was defined as the number of days with any grade of local symptoms.

Outcome measures

Measure	New Generation Influenza Vaccine GSK2186877A Group n=43 Participants Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0	Fluarix Elderly Group n=15 Participants Subjects aged \>= 65 years receiving 1 dose of Fluarix vaccine at Day 0	Fluarix Young Group n=35 Participants Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
Duration of Solicited Local AEs Ecchymosis	3.5 Days Interval 3.0 to 4.0	5.0 Days Interval 5.0 to 5.0	—
Duration of Solicited Local AEs Pain	2.0 Days Interval 1.0 to 6.0	1.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 4.0
Duration of Solicited Local AEs Redness	2.0 Days Interval 1.0 to 5.0	—	—
Duration of Solicited Local AEs Swelling	4.0 Days Interval 1.0 to 6.0	5.0 Days Interval 5.0 to 5.0	—

SECONDARY outcome

Timeframe: Day 0 -6

Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.

Any fever was defined as oral temperature ≥ 38.0 degree centigrade (°C), grade 3 fever was defined as oral temperature ≥ 39.0°C. For other symptoms grade 3 was defined as general symptom that prevented normal activity and related was general symptom assessed by the investigator as causally related to the study vaccination.

Outcome measures

Measure	New Generation Influenza Vaccine GSK2186877A Group n=69 Participants Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0	Fluarix Elderly Group n=73 Participants Subjects aged \>= 65 years receiving 1 dose of Fluarix vaccine at Day 0	Fluarix Young Group n=50 Participants Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Any arthralgia	14 Participants	3 Participants	4 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Grade 3 arthralgia	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Related arthralgia	12 Participants	1 Participants	3 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Any fatigue	22 Participants	12 Participants	21 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Grade 3 fatigue	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Related fatigue	21 Participants	8 Participants	11 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Any gastrointestinal symptoms	6 Participants	4 Participants	6 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Grade 3 gastrointestinal symptoms	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Related gastrointestinal symptoms	5 Participants	1 Participants	4 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Any headache	22 Participants	7 Participants	14 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Grade 3 headache	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Related headache	17 Participants	2 Participants	7 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Any myalgia	17 Participants	8 Participants	11 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Grade 3 myalgia	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Related myalgia	16 Participants	7 Participants	9 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Any shivering	11 Participants	0 Participants	2 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Grade 3 shivering	0 Participants	0 Participants	1 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Related shivering	8 Participants	0 Participants	1 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Any fever	2 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Grade 3 fever	1 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Related fever	2 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 0 -6

Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented on subjects who experienced the symptom.

Duration was defined as number of days with any grade of general symptoms.

Outcome measures

Measure	New Generation Influenza Vaccine GSK2186877A Group n=22 Participants Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0	Fluarix Elderly Group n=12 Participants Subjects aged \>= 65 years receiving 1 dose of Fluarix vaccine at Day 0	Fluarix Young Group n=21 Participants Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
Duration of Solicited General AEs Arthralgia	2.0 Days Interval 1.0 to 6.0	2.0 Days Interval 1.0 to 3.0	1.5 Days Interval 1.0 to 6.0
Duration of Solicited General AEs Fatigue	2.0 Days Interval 1.0 to 7.0	2.5 Days Interval 1.0 to 7.0	2.0 Days Interval 1.0 to 7.0
Duration of Solicited General AEs Gastrointestinal symptoms	1.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.0	1.0 Days Interval 1.0 to 2.0
Duration of Solicited General AEs Headache	1.0 Days Interval 1.0 to 5.0	2.0 Days Interval 1.0 to 4.0	1.5 Days Interval 1.0 to 4.0
Duration of Solicited General AEs Myalgia	2.0 Days Interval 1.0 to 6.0	1.5 Days Interval 1.0 to 3.0	1.0 Days Interval 1.0 to 2.0
Duration of Solicited General AEs Shivering	1.0 Days Interval 1.0 to 7.0	—	2.5 Days Interval 2.0 to 3.0
Duration of Solicited General AEs Fever	2.0 Days Interval 1.0 to 3.0	—	—

SECONDARY outcome

Timeframe: Day 0-20

Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.

Unsolicited AE covers any AE 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 occurrence of any unsolicited symptom, regardless of intensity or relation to vaccination, grade 3 was unsolicited symptom that prevented normal activity and related was event assessed by investigator as causally related to the study vaccination.

Outcome measures

Measure	New Generation Influenza Vaccine GSK2186877A Group n=69 Participants Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0	Fluarix Elderly Group n=73 Participants Subjects aged \>= 65 years receiving 1 dose of Fluarix vaccine at Day 0	Fluarix Young Group n=50 Participants Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs Any AE(s)	13 Participants	21 Participants	15 Participants
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs Related AE(s)	3 Participants	2 Participants	1 Participants
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs Grade 3 AE(s)	2 Participants	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Day 0-179

Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.

For each solicited and unsolicited AE the subject experienced, the subject was asked if they received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom, regardless of intensity or relation to vaccination, grade 3 was defined as symptom that prevented normal activity and related was event assessed by investigator as causally related to the study vaccination.

Outcome measures

Measure	New Generation Influenza Vaccine GSK2186877A Group n=69 Participants Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0	Fluarix Elderly Group n=73 Participants Subjects aged \>= 65 years receiving 1 dose of Fluarix vaccine at Day 0	Fluarix Young Group n=50 Participants Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) Any MAE(s)	24 Participants	21 Participants	13 Participants
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) Grade 3 MAE(s)	4 Participants	9 Participants	3 Participants
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) Related MAE(s)	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 0-364

Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.

AESI for safety monitoring are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any was defined as occurrence of any symptom, regardless of intensity or relation to vaccination.

Outcome measures

Measure	New Generation Influenza Vaccine GSK2186877A Group n=69 Participants Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0	Fluarix Elderly Group n=73 Participants Subjects aged \>= 65 years receiving 1 dose of Fluarix vaccine at Day 0	Fluarix Young Group n=50 Participants Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
Number of Subjects Reporting Any AEs of Specific Interest (AESI)	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 0-364

Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom, regardless of intensity or relation to vaccination and related was event assessed by investigator as causally related to the study vaccination.

Outcome measures

Measure	New Generation Influenza Vaccine GSK2186877A Group n=69 Participants Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0	Fluarix Elderly Group n=73 Participants Subjects aged \>= 65 years receiving 1 dose of Fluarix vaccine at Day 0	Fluarix Young Group n=50 Participants Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)	5 Participants	11 Participants	1 Participants

Adverse Events

New Generation Influenza Vaccine GSK2186877A Group

Serious events: 5 serious events

Other events: 53 other events

Deaths: 0 deaths

Fluarix Elderly Group

Serious events: 11 serious events

Other events: 27 other events

Deaths: 0 deaths

Fluarix Young Group

Serious events: 1 serious events

Other events: 43 other events

Deaths: 0 deaths

Serious adverse events

Measure	New Generation Influenza Vaccine GSK2186877A Group n=69 participants at risk Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0	Fluarix Elderly Group n=73 participants at risk Subjects aged \>= 65 years receiving 1 dose of Fluarix vaccine at Day 0	Fluarix Young Group n=50 participants at risk Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
Gastrointestinal disorders Abdominal hernia	1.4% 1/69 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	0.00% 0/73 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	0.00% 0/50 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.
Nervous system disorders Amnesia	0.00% 0/69 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	1.4% 1/73 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	0.00% 0/50 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.
Blood and lymphatic system disorders Anaemia	1.4% 1/69 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	0.00% 0/73 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	0.00% 0/50 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.
Cardiac disorders Arrhythmia	0.00% 0/69 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	1.4% 1/73 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	0.00% 0/50 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.
Cardiac disorders Atrial flutter	1.4% 1/69 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	0.00% 0/73 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	0.00% 0/50 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm	0.00% 0/69 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	1.4% 1/73 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	0.00% 0/50 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/69 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	1.4% 1/73 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	0.00% 0/50 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.
Immune system disorders Hypersensitivity	0.00% 0/69 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	0.00% 0/73 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	2.0% 1/50 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.
Injury, poisoning and procedural complications Ligament rupture	0.00% 0/69 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	1.4% 1/73 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	0.00% 0/50 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.00% 0/69 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	1.4% 1/73 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	0.00% 0/50 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	1.4% 1/69 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	0.00% 0/73 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	0.00% 0/50 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.00% 0/69 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	1.4% 1/73 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	0.00% 0/50 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.
Cardiac disorders Myocardial infarction	1.4% 1/69 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	0.00% 0/73 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	0.00% 0/50 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.
Renal and urinary disorders Nephritis	0.00% 0/69 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	1.4% 1/73 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	0.00% 0/50 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.
General disorders Non-cardiac chest pain	0.00% 0/69 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	1.4% 1/73 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	0.00% 0/50 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.
Gastrointestinal disorders Rectal haemorrhage	1.4% 1/69 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	0.00% 0/73 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	0.00% 0/50 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/69 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	1.4% 1/73 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	0.00% 0/50 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.
Nervous system disorders Syncope	0.00% 0/69 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	1.4% 1/73 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	0.00% 0/50 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Urinary tract neoplasm	0.00% 0/69 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	1.4% 1/73 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	0.00% 0/50 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.00% 0/69 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	1.4% 1/73 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	0.00% 0/50 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.
Ear and labyrinth disorders Vertigo	1.4% 1/69 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	0.00% 0/73 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	0.00% 0/50 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.

Other adverse events

Measure	New Generation Influenza Vaccine GSK2186877A Group n=69 participants at risk Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0	Fluarix Elderly Group n=73 participants at risk Subjects aged \>= 65 years receiving 1 dose of Fluarix vaccine at Day 0	Fluarix Young Group n=50 participants at risk Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
Infections and infestations Nasopharyngitis	2.9% 2/69 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	2.7% 2/73 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	8.0% 4/50 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.
General disorders Pain	62.3% 43/69 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	20.5% 15/73 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	70.0% 35/50 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.
General disorders Redness	7.2% 5/69 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	0.00% 0/73 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	0.00% 0/50 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.
General disorders Swelling	11.6% 8/69 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	1.4% 1/73 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	0.00% 0/50 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.
General disorders Arthralgia	20.3% 14/69 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	4.1% 3/73 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	8.0% 4/50 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.
General disorders Fatigue	31.9% 22/69 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	16.4% 12/73 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	42.0% 21/50 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.
General disorders Gastrointestinal symptoms	8.7% 6/69 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	5.5% 4/73 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	12.0% 6/50 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.
General disorders Headache	31.9% 22/69 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	9.6% 7/73 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	28.0% 14/50 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.
General disorders Myalgia	24.6% 17/69 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	11.0% 8/73 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	22.0% 11/50 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.
General disorders Shivering	15.9% 11/69 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	0.00% 0/73 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.	4.0% 2/50 • Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period.

Additional Information

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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.
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Restriction type: OTHER