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

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00979602
• Collaborator: (none)
• Enrollment: 4,048
• Locations: 38
• Arms: 2
• Actual Duration (Months): 14.8
• Patients Per Site: 106.5
• Patients Per Site Per Month: 7.2

Study Details

Study Description

Brief Summary

The purpose of this study is to characterize the safety, immunogenicity, and relative efficacy of the H1N1 (swine) flu vaccines GSK2340273A and GSK2340274A in adults 18 years of age or older.

Condition or Disease	Intervention/Treatment	Phase
Influenza	Biological: GSK2340274A; Biological: GSK2340273A	Phase 3

Detailed Description

Collaborators: United States Department of Health and Human Services, Office of Biomedical Advanced Research and Development Authority

Study Design

• Study Type: Interventional
• Actual Enrollment: 4048 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: A Study to Evaluate the Safety, Immunogenicity, and Relative Efficacy of A/California/7/2009 (H1N1)V-like Vaccines GSK2340274A and GSK2340273A in Adults Aged 18 Years and Older
• Actual Study Start Date: Nov 9, 2009
• Actual Primary Completion Date: Jan 10, 2011
• Actual Study Completion Date: Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GSK2340274A Group Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Biological: GSK2340274A; One intramuscular injection
Experimental: GSK2340273A Group Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Biological: GSK2340273A; One intramuscular injection

Outcome Measures

Primary Outcome Measures

1. Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain [At Day 21]

   A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer higher than or equal to (≥)1:40 or at least a 4-fold increase of the pre-vaccination titer of ≥ 1:10. The Flu strain assessed was A/California/7/09 (H1N1)v-like (Flu A/CAL/7/09) in subjects of 18-60 years and older and 18-64 years and older, following the Committee for Medicinal Products for Human Use (CHMP) and the Center for Biologics Evaluation and Research (CBER) guidance.

2. Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain [At Day 0]

   A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) antibody titer ≥ 1:40 against the tested virus. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.

3. Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain [At Day 21]

   A seroprotected subject was defined as a vaccinated subject with serum HI antibody titer ≥ 1:40. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.

4. Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain [At Day 21]

   SCF was defined as the fold increase in serum HI geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus, in subjects 18-60 years and older and 18-64 years and older, following the CHMP guidance.

5. Number of A/California/7/2009 (H1N1)V-like Illness (ILI) Cases [From Day 14 post-vaccination up to study end (at Day 385)]

   The analysis focused on Quantitative Reverse Transcription Polymerase Chain Reaction Assay (RT-qPCR)-confirmed A/California/7/2009 (H1N1)v-like illness (ILI) cases.

Secondary Outcome Measures

1. Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain [At Days 0 and 21]

   Cut-off values assessed were greater than or equal to (≥) 1:10 in the sera of subjects seronegative before vaccination. The Flu strains assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.

2. Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain [At Days 0 and 21]

   Titers were presented as geometric mean titers (GMTs). The flu strain assessed was /California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.

3. Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain [At Day 42]

   Cut-off values assessed were greater than or equal to (≥) 1:10 in the sera of subjects seronegative before vaccination. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.

4. Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain [At Day 42]

   Titers were presented as geometric mean titers (GMTs). The flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.

5. Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain [At Day 182]

   Cut-off values assessed were greater than or equal to ≥ 1:10 in the sera of subjects seronegative before vaccination. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.

6. Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain [At Day 182]

   Titers were presented as geometric mean titers (GMTs). The flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.

7. Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain [At Day 42]

   A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥1:40 and at least a 4-fold increase of the pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) (Flu A/CAL/7/09) in subjects of 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.

8. Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain [At Day 182]

   A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥1:40 and at least a 4-fold increase of the pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) (Flu A/CAL/7/09) in subjects of 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.

9. Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain [At Day 42]

   A seroprotected subject was defined as a vaccinated subject with serum HI antibody titer ≥ 1:40. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.

10. Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain [At Day 182]

    A seroprotected subject was defined as a vaccinated subject with serum HI antibody titer ≥ 1:40. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.

11. Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain [At Day 42]

    SCF was defined as the fold increase in serum HI geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus, in subjects 18-60 years and older and 18-64 years and older, following the CHMP.

12. Seroconversion Factor (SCF) for HI Antibodies Against A/CAL/7/09 H1N1 Virus Strain [At Day 182]

    SCF was defined as the fold increase in serum HI geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus, in subjects 18-60 years and older and 18-64 years and older, following the CHMP.

13. Number of A/California Influenza Related Cases [From Day 0 up to the end of ILI surveillance (Day 385)]

    Influenza related cases included: A/California/7/2009 (H1N1)v-like influenza illness (ILI) cases, pneumonia cases, RT-qPCR confirmed influenza, culture confirmed influenza and RT-qPCR confirmed influenza with pneumonia.

14. Number of ILI Symptoms in All Reported ILI Cases [From Day 0 up to the end of ILI surveillance (Day 385)]

    Assessed ILI symptoms were fever [defined as oral temperature equal to or above (≥) 38.5 degrees Celsius (°C)], myalgia (muscle aches all over the body), cough, sore throat, runny/stuffy nose, short of breath, headache, vomiting, diarrhea, chills, fatigue.

15. Number of ILI Symptoms in All Reported ILI Cases [From Day 14 post-vaccination through the end of ILI surveillance (Day 385)]

    Assessed ILI symptoms were fever [defined as oral temperature equal to or above (≥) 38.5 degrees Celsius (°C)], myalgia (muscle aches all over the body), cough, sore throat, runny/stuffy nose, short of breath, headache, vomiting, diarrhea, chills, fatigue.

16. Number of Subjects With Any and Grade 3 Solicited Local Symptoms [During the 7-day (Days 0-6) post-vaccination period]

    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y).

17. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [During the 7-day (Days 0-6) post-vaccination period]

    Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above (≥) 38.0 degrees Celsius (°C)], headache, joint pain at other location, muscle aches, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y).

18. Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels [At Days 7 and 21]

    Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], alkaline phosphatase [AP], aspartate aminotransferase [AST], basophils [BAS], total bilirubin [T/BIL], bilirubin direct [BIL/D], creatinine [CREA], eosinophils [EOS], hematocrit [HEM], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC], blood urea nitrogen [BUN] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed with respect to normal laboratory values were - unknown, below, within and above for subjects aged 18-64 years (18-64y) and >64 years old (>64y).

19. Number of Subjects With Any Medically-attended Adverse Events (MAEs) [Throughout the entire study period (Day 0 - Day 385)]

    MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y).

20. Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) [Throughout the entire study period (Day 0 - Day 385)]

    Potential immune-mediated diseases (pIMDs) represent a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y).

21. Number of Subjects With Any Unsolicited Adverse Events (AEs) [Within the 42-day (Days 0-41) post-vaccination period]

    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y).

22. Number of Subjects With Serious Adverse Events (SAEs) [Throughout the entire study period (Day 0 - Day 385)]

    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Subjects who the investigator believes can and will comply with the requirements of the protocol.

• Written informed consent obtained from the subject.

• Male and female adults, >= 18 years of age at the time of the first vaccination.

• Satisfactory baseline medical assessment by history and physical examination.

• Safety laboratory test results within the parameters specified in the protocol.

• Comprehension of the study requirements, ability to comprehend and comply with procedures for collection of safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits as demonstrated by signature on the informed consent document.

• Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line, or mobile, but NOT a pay phone or other multiple-user device.

• Female subjects of non-childbearing potential may be enrolled in the study.

• Female subjects of childbearing potential may be enrolled in the study, if the subject:

• has practiced adequate contraception for 30 days prior to vaccination; and

• has a negative pregnancy test on the day of first vaccination; and

• has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion Criteria:

• Medical history of physician-confirmed infection with an A/California/7/2009 (H1N1)v-like virus.

• Previous vaccination at any time with an A/California/7/2009 (H1N1)v-like virus vaccine.

• With the exception of seasonal influenza vaccination, administration of any vaccine(s) within 30 days before study vaccination on Day 0. Seasonal influenza vaccine may be administered up to 14 days prior to study vaccination on Day 0.

• Planned administration of any vaccine other than the study vaccines between Day 0 and the phlebotomy 21 days after vaccination.

• Planned administration of any monovalent pandemic (H1N1)v-like vaccine other than the study vaccines during the whole study (Day 0 - Day 385).

• Previous vaccination with an H1N1v-like virus vaccine or a medical history of physician-confirmed infection with an H1N1v-like virus.

• Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.

• Presence of a temperature >= 38.0ºC (>= 100.4 ºF), oral temperature assessment preferred, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.

• Diagnosed with cancer, or treatment for cancer, within 3 years.

• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.

• Receipt of systemic glucocorticoids within 1month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. Topical, intra-articularly injected, or inhaled glucocorticoids, topical calcineurin inhibitors, or imiquimod are allowed.

• Receipt of any immunoglobulins and/or any blood products within 3 months of study enrollment or planned administration of any of these products during the study period.

• Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin are eligible if no such doses are given in the 24 hours before a study vaccination. Persons receiving prophylactic antiplatelet medications, e.g., low-dose acetylsalicylic acid, and without a clinically-apparent bleeding tendency, are eligible.

• History of an acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 weeks of receipt of seasonal influenza vaccine.

• With the exception of seasonal influenza vaccination, administration of any vaccines within 30 days before study vaccination on Day 0. Seasonal influenza vaccine may be administered up to 14 days prior to study vaccination on Day 0.

• Planned administration of any vaccine other than the study vaccine between Day 0 and the phlebotomy 21 days after the second study vaccine dose.

• Use of any investigational or non-registered product within 30 days preceding the first dose of study vaccine, or planned use during the study period.

• Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.

• Known pregnancy or a positive urine beta-human chorionic gonadotropin test result prior to vaccination.

• Lactating or nursing women.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Mesa	Arizona	United States	85213
2	GSK Investigational Site	Phoenix	Arizona	United States	85020
3	GSK Investigational Site	Phoenix	Arizona	United States	85028
4	GSK Investigational Site	Los Angeles	California	United States	90057
5	GSK Investigational Site	Clearwater	Florida	United States	33761
6	GSK Investigational Site	DeLand	Florida	United States	32720
7	GSK Investigational Site	Delray Beach	Florida	United States	33484
8	GSK Investigational Site	Jacksonville	Florida	United States	32205
9	GSK Investigational Site	Chicago	Illinois	United States	60610
10	GSK Investigational Site	Wichita	Kansas	United States	67207
11	GSK Investigational Site	Lexington	Kentucky	United States	40509
12	GSK Investigational Site	Columbia	Maryland	United States	21045
13	GSK Investigational Site	Rockville	Maryland	United States	20850
14	GSK Investigational Site	Milford	Massachusetts	United States	01757
15	GSK Investigational Site	Kansas City	Missouri	United States	64114
16	GSK Investigational Site	Somers Point	New Jersey	United States	08244
17	GSK Investigational Site	Binghamton	New York	United States	13901
18	GSK Investigational Site	Camillus	New York	United States	13031
19	GSK Investigational Site	Winston-Salem	North Carolina	United States	27103
20	GSK Investigational Site	Willoughby Hills	Ohio	United States	44094
21	GSK Investigational Site	Erie	Pennsylvania	United States	16506
22	GSK Investigational Site	Warwick	Rhode Island	United States	02886
23	GSK Investigational Site	Spartanburg	South Carolina	United States	29303
24	GSK Investigational Site	Nashville	Tennessee	United States	37203
25	GSK Investigational Site	Wenatchee	Washington	United States	98801
26	GSK Investigational Site	Coquitlam	British Columbia	Canada	V3K 3P4
27	GSK Investigational Site	Bay Roberts	Newfoundland and Labrador	Canada	A0A 1G0
28	GSK Investigational Site	Saint John's	Newfoundland and Labrador	Canada	A1A 3R5
29	GSK Investigational Site	Brampton	Ontario	Canada	L6T 3T1
30	GSK Investigational Site	London	Ontario	Canada	N5W 6A2
31	GSK Investigational Site	Ottawa	Ontario	Canada	K1Y 4G2
32	GSK Investigational Site	Sudbury	Ontario	Canada	P3E 1H5
33	GSK Investigational Site	Toronto	Ontario	Canada	M3H 5S4
34	GSK Investigational Site	Gatineau	Quebec	Canada	J8Y 6S8
35	GSK Investigational Site	Quebec City	Quebec	Canada	G1E 7G9
36	GSK Investigational Site	Sherbrooke	Quebec	Canada	J1H 1Z1
37	GSK Investigational Site	St-Romulad	Quebec	Canada	G6W 5M6
38	GSK Investigational Site	Quebec		Canada	G1W 4R4

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00979602
• Other Study ID Numbers: 113480
• First Posted: Sep 18, 2009
• Last Update Posted: Mar 21, 2018
• Last Verified: Mar 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by GlaxoSmithKline: GSK Bio's influenza vaccine GSK2340274A; Influenza Vaccines; GSK Bio's influenza vaccine GSK2340273A; influenza infection
• Additional relevant MeSH terms: Influenza, Human

Study Results

Participant Flow

Arm/Group Title	GSK2340274A Group	GSK2340273A Group
Arm/Group Description	Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Period Title: Overall Study
STARTED	2025	2023
COMPLETED	1880	1890
NOT COMPLETED	145	133

Baseline Characteristics

Arm/Group Title	GSK2340274A Group	GSK2340273A Group	Total
Arm/Group Description	Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Total of all reporting groups
Overall Participants	2025	2023	4048
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	45.5 (18.6)	45.4 (18.3)	45.5 (18.4)
Sex: Female, Male (Count of Participants)
Female	1185 58.5%	1185 58.6%	2370 58.5%
Male	840 41.5%	838 41.4%	1678 41.5%
Race/Ethnicity, Customized (Count of Participants)
African Heritage/African American	118 5.8%	113 5.6%	231 5.7%
American Indian or Alaskan native	14 0.7%	11 0.5%	25 0.6%
Asian - Central/South Asian Heritage	35 1.7%	42 2.1%	77 1.9%
Asian - East Asian Heritage	13 0.6%	8 0.4%	21 0.5%
Asian - Japanese Heritage	4 0.2%	4 0.2%	8 0.2%
Asian - South East Asian Heritage	8 0.4%	7 0.3%	15 0.4%
Native Hawaiian or other Pacific Islander	1 0%	2 0.1%	3 0.1%
White - Arabic/North African Heritage	19 0.9%	24 1.2%	43 1.1%
White - Caucasian/European Heritage	1787 88.2%	1790 88.5%	3577 88.4%
Other	26 1.3%	22 1.1%	48 1.2%

Outcome Measures

1. Primary Outcome

Title	Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
Description	A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer higher than or equal to (≥)1:40 or at least a 4-fold increase of the pre-vaccination titer of ≥ 1:10. The Flu strain assessed was A/California/7/09 (H1N1)v-like (Flu A/CAL/7/09) in subjects of 18-60 years and older and 18-64 years and older, following the Committee for Medicinal Products for Human Use (CHMP) and the Center for Biologics Evaluation and Research (CBER) guidance.
Time Frame	At Day 21

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 21 were available.

Arm/Group Title	GSK2340274A (18-60 y) Group	GSK2340274A (>60 y) Group	GSK2340273A (18-60 y) Group	GSK2340273A (>60 y) Group	GSK2340274A (18-64 y) Group	GSK2340274A (>64 y) Group	GSK2340273A (18-64 y) Group	GSK2340273A (>64 y) Group
Arm/Group Description	Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Measure Participants	1345	535	1338	531	1426	454	1414	455
Count of Participants [Participants]	1210 59.8%	411 20.3%	1012 25%	301 NaN	1279 NaN	342 NaN	1055 NaN	258 NaN

2. Primary Outcome

Title	Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain
Description	A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) antibody titer ≥ 1:40 against the tested virus. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
Time Frame	At Day 0

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 21 were available.

Arm/Group Title	GSK2340274A (18-60 y) Group	GSK2340274A (>60 y) Group	GSK2340273A (18-60 y) Group	GSK2340273A (>60 y) Group	GSK2340274A (18-64 y) Group	GSK2340274A (>64 y) Group	GSK2340273A (18-64 y) Group	GSK2340273A (>64 y) Group
Arm/Group Description	Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Measure Participants	1347	535	1344	532	1428	454	1420	456
Count of Participants [Participants]	337 16.6%	74 3.7%	332 8.2%	92 NaN	350 NaN	61 NaN	346 NaN	78 NaN

3. Primary Outcome

Title	Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain
Description	A seroprotected subject was defined as a vaccinated subject with serum HI antibody titer ≥ 1:40. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
Time Frame	At Day 21

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 21 were available.

Arm/Group Title	GSK2340274A (18-60 y) Group	GSK2340274A (>60 y) Group	GSK2340273A (18-60 y) Group	GSK2340273A (>60 y) Group	GSK2340274A (18-64 y) Group	GSK2340274A (>64 y) Group	GSK2340273A (18-64 y) Group	GSK2340273A (>64 y) Group
Arm/Group Description	Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Measure Participants	1350	539	1347	533	1432	457	1424	456
Count of Participants [Participants]	1326 65.5%	470 23.2%	1246 30.8%	371 NaN	1403 NaN	393 NaN	1302 NaN	315 NaN

4. Primary Outcome

Title	Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
Description	SCF was defined as the fold increase in serum HI geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus, in subjects 18-60 years and older and 18-64 years and older, following the CHMP guidance.
Time Frame	At Day 21

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 21 were available.

Arm/Group Title	GSK2340274A (18-60 y) Group	GSK2340274A (>60 y) Group	GSK2340273A (18-60 y) Group	GSK2340273A (>60 y) Group	GSK2340274A (18-64 y) Group	GSK2340274A (>64 y) Group	GSK2340273A (18-64 y) Group	GSK2340273A (>64 y) Group
Arm/Group Description	Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Measure Participants	1345	535	1338	531	1426	454	1414	455
Geometric Mean (95% Confidence Interval) [Fold increase]	27.7	12.5	15.5	6.4	26.9	11.9	14.8	6.3

5. Primary Outcome

Title	Number of A/California/7/2009 (H1N1)V-like Illness (ILI) Cases
Description	The analysis focused on Quantitative Reverse Transcription Polymerase Chain Reaction Assay (RT-qPCR)-confirmed A/California/7/2009 (H1N1)v-like illness (ILI) cases.
Time Frame	From Day 14 post-vaccination up to study end (at Day 385)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for efficacy, which included all eligible subjects who received the study vaccine according to their treatment assignment and who were successfully contacted at least once during the active influenza surveillance period after completing the Day 21 study visit.

Arm/Group Title	GSK2340274A Group	GSK2340273A Group
Arm/Group Description	Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Measure Participants	1949	1958
Number [Events]	1	2

6. Secondary Outcome

Title	Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
Description	Cut-off values assessed were greater than or equal to (≥) 1:10 in the sera of subjects seronegative before vaccination. The Flu strains assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
Time Frame	At Days 0 and 21

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 21 were available.

Arm/Group Title	GSK2340274A (18-60 y) Group	GSK2340274A (>60 y) Group	GSK2340273A (18-60 y) Group	GSK2340273A (>60 y) Group	GSK2340274A (18-64 y) Group	GSK2340274A (>64 y) Group	GSK2340273A (18-64 y) Group	GSK2340273A (>64 y) Group
Arm/Group Description	Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Measure Participants	1350	539	1347	533	1432	457	1424	456
Flu A/CAL/7/09, Day 0	754 37.2%	293 14.5%	731 18.1%	312 NaN	803 NaN	244 NaN	775 NaN	268 NaN
Flu A/CAL/7/09, Day 21	1348 66.6%	534 26.4%	1335 33%	512 NaN	1430 NaN	452 NaN	1410 NaN	437 NaN

7. Secondary Outcome

Title	Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
Description	Titers were presented as geometric mean titers (GMTs). The flu strain assessed was /California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
Time Frame	At Days 0 and 21

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 21 were available.

Arm/Group Title	GSK2340274A (18-60 y) Group	GSK2340274A (>60 y) Group	GSK2340273A (18-60 y) Group	GSK2340273A (>60 y) Group	GSK2340274A (18-64 y) Group	GSK2340274A (>64 y) Group	GSK2340273A (18-64 y) Group	GSK2340273A (>64 y) Group
Arm/Group Description	Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Measure Participants	1350	539	1347	533	1432	457	1424	456
Flu A/CAL/7/09, Day 0	14.9	11.0	14.8	12.2	14.7	10.9	14.7	12.0
Flu A/CAL/7/09, Day 21	415.0	135.9	228.7	77.3	396.2	128.6	217.6	75.2

8. Secondary Outcome

Title	Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
Description	Cut-off values assessed were greater than or equal to (≥) 1:10 in the sera of subjects seronegative before vaccination. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
Time Frame	At Day 42

Outcome Measure Data

Analysis Population Description

The analysis was performed on a subset from the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 42 were available.

Arm/Group Title	GSK2340274A (18-60 y) Group	GSK2340274A (>60 y) Group	GSK2340273A (18-60 y) Group	GSK2340273A (>60 y) Group	GSK2340274A (18-64 y) Group	GSK2340274A (>64 y) Group	GSK2340273A (18-64 y) Group	GSK2340273A (>64 y) Group
Arm/Group Description	Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Measure Participants	50	50	44	48	52	48	46	46
Count of Participants [Participants]	50 2.5%	50 2.5%	44 1.1%	45 NaN	52 NaN	48 NaN	46 NaN	43 NaN

9. Secondary Outcome

Title	Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
Description	Titers were presented as geometric mean titers (GMTs). The flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
Time Frame	At Day 42

Outcome Measure Data

Analysis Population Description

The analysis was performed on a subset from the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 42 were available.

Arm/Group Title	GSK2340274A (18-60 y) Group	GSK2340274A (>60 y) Group	GSK2340273A (18-60 y) Group	GSK2340273A (>60 y) Group	GSK2340274A (18-64 y) Group	GSK2340274A (>64 y) Group	GSK2340273A (18-64 y) Group	GSK2340273A (>64 y) Group
Arm/Group Description	Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Measure Participants	50	50	44	48	52	48	46	46
Geometric Mean (95% Confidence Interval) [Titers]	288.5	105.4	177.2	47.9	276.5	105.9	170.0	47.2

10. Secondary Outcome

Title	Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
Description	Cut-off values assessed were greater than or equal to ≥ 1:10 in the sera of subjects seronegative before vaccination. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
Time Frame	At Day 182

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 182 were available.

Arm/Group Title	GSK2340274A (18-60 y) Group	GSK2340274A (>60 y) Group	GSK2340273A (18-60 y) Group	GSK2340273A (>60 y) Group	GSK2340274A (18-64 y) Group	GSK2340274A (>64 y) Group	GSK2340273A (18-64 y) Group	GSK2340273A (>64 y) Group
Arm/Group Description	Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Measure Participants	1306	543	1314	536	1388	461	1391	459
Count of Participants [Participants]	1282 63.3%	501 24.8%	1257 31.1%	449 NaN	1361 NaN	422 NaN	1324 NaN	382 NaN

11. Secondary Outcome

Title	Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
Description	Titers were presented as geometric mean titers (GMTs). The flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
Time Frame	At Day 182

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 182 were available.

Arm/Group Title	GSK2340274A (18-60 y) Group	GSK2340274A (>60 y) Group	GSK2340273A (18-60 y) Group	GSK2340273A (>60 y) Group	GSK2340274A (18-64 y) Group	GSK2340274A (>64 y) Group	GSK2340273A (18-64 y) Group	GSK2340273A (>64 y) Group
Arm/Group Description	Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Measure Participants	1306	543	1314	536	1388	461	1391	459
Geometric Mean (95% Confidence Interval) [Titers]	115.5	38.4	87.6	30.1	109.5	37.1	83.3	29.2

12. Secondary Outcome

Title	Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
Description	A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥1:40 and at least a 4-fold increase of the pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) (Flu A/CAL/7/09) in subjects of 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
Time Frame	At Day 42

Outcome Measure Data

Analysis Population Description

The analysis was performed on a subset from the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 42 were available.

Arm/Group Title	GSK2340274A (18-60 y) Group	GSK2340274A (>60 y) Group	GSK2340273A (18-60 y) Group	GSK2340273A (>60 y) Group	GSK2340274A (18-64 y) Group	GSK2340274A (>64 y) Group	GSK2340273A (18-64 y) Group	GSK2340273A (>64 y) Group
Arm/Group Description	Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Measure Participants	50	50	44	48	52	48	46	46
Count of Participants [Participants]	49 2.4%	36 1.8%	35 0.9%	20 NaN	51 NaN	34 NaN	36 NaN	19 NaN

13. Secondary Outcome

Title	Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
Description	A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥1:40 and at least a 4-fold increase of the pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) (Flu A/CAL/7/09) in subjects of 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
Time Frame	At Day 182

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 182 were available.

Arm/Group Title	GSK2340274A (18-60 y) Group	GSK2340274A (>60 y) Group	GSK2340273A (18-60 y) Group	GSK2340273A (>60 y) Group	GSK2340274A (18-64 y) Group	GSK2340274A (>64 y) Group	GSK2340273A (18-64 y) Group	GSK2340273A (>64 y) Group
Arm/Group Description	Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Measure Participants	1302	539	1304	534	1383	458	1380	458
Count of Participants [Participants]	823 40.6%	198 9.8%	717 17.7%	146 NaN	861 NaN	160 NaN	741 NaN	122 NaN

14. Secondary Outcome

Title	Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain
Description	A seroprotected subject was defined as a vaccinated subject with serum HI antibody titer ≥ 1:40. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
Time Frame	At Day 42

Outcome Measure Data

Analysis Population Description

The analysis was performed on a subset from the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 42 were available.

Arm/Group Title	GSK2340274A (18-60 y) Group	GSK2340274A (>60 y) Group	GSK2340273A (18-60 y) Group	GSK2340273A (>60 y) Group	GSK2340274A (18-64 y) Group	GSK2340274A (>64 y) Group	GSK2340273A (18-64 y) Group	GSK2340273A (>64 y) Group
Arm/Group Description	Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Measure Participants	50	50	44	48	52	48	46	46
Count of Participants [Participants]	49 2.4%	38 1.9%	41 1%	29 NaN	51 NaN	36 NaN	43 NaN	27 NaN

15. Secondary Outcome

Title	Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain
Description	A seroprotected subject was defined as a vaccinated subject with serum HI antibody titer ≥ 1:40. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
Time Frame	At Day 182

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 182 were available.

Arm/Group Title	GSK2340274A (18-60 y) Group	GSK2340274A (>60 y) Group	GSK2340273A (18-60 y) Group	GSK2340273A (>60 y) Group	GSK2340274A (18-64 y) Group	GSK2340274A (>64 y) Group	GSK2340273A (18-64 y) Group	GSK2340273A (>64 y) Group
Arm/Group Description	Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Measure Participants	1306	543	1314	536	1388	461	1391	459
Count of Participants [Participants]	1091 53.9%	286 14.1%	1009 24.9%	236 NaN	1140 NaN	237 NaN	1047 NaN	198 NaN

16. Secondary Outcome

Title	Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
Description	SCF was defined as the fold increase in serum HI geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus, in subjects 18-60 years and older and 18-64 years and older, following the CHMP.
Time Frame	At Day 42

Outcome Measure Data

Analysis Population Description

The analysis was performed on a subset from the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 42 were available.

Arm/Group Title	GSK2340274A (18-60 y) Group	GSK2340274A (>60 y) Group	GSK2340273A (18-60 y) Group	GSK2340273A (>60 y) Group	GSK2340274A (18-64 y) Group	GSK2340274A (>64 y) Group	GSK2340273A (18-64 y) Group	GSK2340273A (>64 y) Group
Arm/Group Description	Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Measure Participants	50	50	44	48	52	48	46	46
Geometric Mean (95% Confidence Interval) [Fold increase]	26.8	11.1	13.7	4.0	26.1	11.0	13.2	3.9

17. Secondary Outcome

Title	Seroconversion Factor (SCF) for HI Antibodies Against A/CAL/7/09 H1N1 Virus Strain
Description	SCF was defined as the fold increase in serum HI geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus, in subjects 18-60 years and older and 18-64 years and older, following the CHMP.
Time Frame	At Day 182

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 182 were available.

Arm/Group Title	GSK2340274A (18-60 y) Group	GSK2340274A (>60 y) Group	GSK2340273A (18-60 y) Group	GSK2340273A (>60 y) Group	GSK2340274A (18-64 y) Group	GSK2340274A (>64 y) Group	GSK2340273A (18-64 y) Group	GSK2340273A (>64 y) Group
Arm/Group Description	Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Measure Participants	1302	539	1304	534	1383	458	1380	458
Geometric Mean (95% Confidence Interval) [Fold increase]	7.7	3.5	5.9	2.5	7.5	3.4	5.6	2.5

18. Secondary Outcome

Title	Number of A/California Influenza Related Cases
Description	Influenza related cases included: A/California/7/2009 (H1N1)v-like influenza illness (ILI) cases, pneumonia cases, RT-qPCR confirmed influenza, culture confirmed influenza and RT-qPCR confirmed influenza with pneumonia.
Time Frame	From Day 0 up to the end of ILI surveillance (Day 385)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for efficacy, which included all eligible subjects who received the study vaccine according to their treatment assignment and who were successfully contacted at least once during the active influenza surveillance period after completing the Day 21 study visit.

Arm/Group Title	GSK2340274A Group	GSK2340273A Group
Arm/Group Description	Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Measure Participants	1949	1958
ILI cases	195	234
Pneumonia cases	8	21
RT-qPCR confirmed influenza	1	2
Culture confirmed influenza	1	2
RT-qPCR confirmed influenza with pneumonia	0	0

19. Secondary Outcome

Title	Number of ILI Symptoms in All Reported ILI Cases
Description	Assessed ILI symptoms were fever [defined as oral temperature equal to or above (≥) 38.5 degrees Celsius (°C)], myalgia (muscle aches all over the body), cough, sore throat, runny/stuffy nose, short of breath, headache, vomiting, diarrhea, chills, fatigue.
Time Frame	From Day 0 up to the end of ILI surveillance (Day 385)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for efficacy, which included all eligible subjects who received the study vaccine according to their treatment assignment and who were successfully contacted at least once during the active influenza surveillance period after completing the Day 21 study visit.

Arm/Group Title	GSK2340274A Group	GSK2340273A Group
Arm/Group Description	Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Measure Participants	1949	1958
Fever	47	58
Myalgia	109	140
Cough	104	138
Sore throat	98	140
Runny or stuffy nose	103	132
Short of breath	48	54
Headache	97	134
Vomiting	23	20
Diarrhea	30	35
Chills	80	104
Fatigue	106	146

20. Secondary Outcome

Title	Number of ILI Symptoms in All Reported ILI Cases
Description	Assessed ILI symptoms were fever [defined as oral temperature equal to or above (≥) 38.5 degrees Celsius (°C)], myalgia (muscle aches all over the body), cough, sore throat, runny/stuffy nose, short of breath, headache, vomiting, diarrhea, chills, fatigue.
Time Frame	From Day 14 post-vaccination through the end of ILI surveillance (Day 385)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for efficacy, which included all eligible subjects who received the study vaccine according to their treatment assignment and who were successfully contacted at least once during the active influenza surveillance period after completing the Day 21 study visit.

Arm/Group Title	GSK2340274A Group	GSK2340273A Group
Arm/Group Description	Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Measure Participants	1949	1958
Fever	45	51
Myalgia	104	128
Cough	99	127
Sore throat	93	129
Runny or stuffy nose	99	119
Short of breath	46	50
Headache	93	122
Vomiting	21	16
Diarrhea	28	32
Chills	76	96
Fatigue	102	132

21. Secondary Outcome

Title	Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Description	Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y).
Time Frame	During the 7-day (Days 0-6) post-vaccination period

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who filled in their symptom sheets.

Arm/Group Title	GSK2340274A (18-64 y) Group	GSK2340274A (>64 y) Group	GSK2340273A (18-64 y) Group	GSK2340273A (>64 y) Group
Arm/Group Description	Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Measure Participants	1529	480	1531	479
Any Pain	1256 62%	272 13.4%	458 11.3%	45 NaN
Grade 3 Pain	55 2.7%	2 0.1%	4 0.1%	0 NaN
Any Redness	89 4.4%	25 1.2%	11 0.3%	6 NaN
Grade 3 Redness	0 0%	2 0.1%	0 0%	0 NaN
Any Swelling	137 6.8%	28 1.4%	10 0.2%	3 NaN
Grade 3 Swelling	1 0%	0 0%	0 0%	0 NaN

22. Secondary Outcome

Title	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Description	Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above (≥) 38.0 degrees Celsius (°C)], headache, joint pain at other location, muscle aches, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y).
Time Frame	During the 7-day (Days 0-6) post-vaccination period

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who filled in their symptom sheets.

Arm/Group Title	GSK2340274A (18-64 y) Group	GSK2340274A (>64 y) Group	GSK2340273A (18-64 y) Group	GSK2340273A (>64 y) Group
Arm/Group Description	Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Measure Participants	1529	480	1531	479
Any Fatigue	473 23.4%	84 4.2%	361 8.9%	59 NaN
Grade 3 Fatigue	23 1.1%	3 0.1%	18 0.4%	0 NaN
Related Fatigue	382 18.9%	63 3.1%	298 7.4%	48 NaN
Any Headache	452 22.3%	73 3.6%	421 10.4%	55 NaN
Grade 3 Headache	24 1.2%	1 0%	14 0.3%	1 NaN
Related Headache	359 17.7%	53 2.6%	312 7.7%	43 NaN
Any Joint pain	242 12%	52 2.6%	135 3.3%	27 NaN
Grade 3 Joint pain	16 0.8%	3 0.1%	6 0.1%	2 NaN
Related Joint pain	205 10.1%	43 2.1%	112 2.8%	23 NaN
Any Muscle aches	600 29.6%	93 4.6%	281 6.9%	35 NaN
Grade 3 Muscle aches	25 1.2%	4 0.2%	9 0.2%	1 NaN
Related Muscle aches	531 26.2%	79 3.9%	240 5.9%	26 NaN
Any Shivering	157 7.8%	23 1.1%	94 2.3%	17 NaN
Grade 3 Shivering	12 0.6%	1 0%	7 0.2%	0 NaN
Related Shivering	130 6.4%	17 0.8%	76 1.9%	14 NaN
Any Sweating	106 5.2%	10 0.5%	76 1.9%	6 NaN
Grade 3 Sweating	4 0.2%	0 0%	3 0.1%	0 NaN
Related Sweating	81 4%	7 0.3%	59 1.5%	5 NaN
Any Temperature	19 0.9%	4 0.2%	16 0.4%	2 NaN
Grade 3 Temperature	1 0%	0 0%	0 0%	0 NaN
Related Temperature	7 0.3%	3 0.1%	7 0.2%	0 NaN

23. Secondary Outcome

Title	Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels
Description	Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], alkaline phosphatase [AP], aspartate aminotransferase [AST], basophils [BAS], total bilirubin [T/BIL], bilirubin direct [BIL/D], creatinine [CREA], eosinophils [EOS], hematocrit [HEM], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC], blood urea nitrogen [BUN] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed with respect to normal laboratory values were - unknown, below, within and above for subjects aged 18-64 years (18-64y) and >64 years old (>64y).
Time Frame	At Days 7 and 21

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

Arm/Group Title	GSK2340274A (18-64 y) Group	GSK2340274A (>64 y) Group	GSK2340273A (18-64 y) Group	GSK2340273A (>64 y) Group
Arm/Group Description	Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Measure Participants	1527	479	1524	478
Unknown	3 0.1%	1 0%	5 0.1%	3 NaN
Below	0 0%	0 0%	0 0%	0 NaN
Within	1497 73.9%	471 23.3%	1482 36.6%	472 NaN
Above	27 1.3%	7 0.3%	37 0.9%	3 NaN
Unknown	9 0.4%	0 0%	4 0.1%	1 NaN
Below	0 0%	0 0%	0 0%	0 NaN
Within	1455 71.9%	469 23.2%	1437 35.5%	469 NaN
Above	29 1.4%	4 0.2%	51 1.3%	4 NaN
Unknown	3 0.1%	1 0%	5 0.1%	3 NaN
Below	1 0%	0 0%	0 0%	0 NaN
Within	1497 73.9%	463 22.9%	1495 36.9%	468 NaN
Above	26 1.3%	15 0.7%	23 0.6%	7 NaN
Unknown	9 0.4%	0 0%	4 0.1%	1 NaN
Below	2 0.1%	0 0%	0 0%	0 NaN
Within	1461 72.1%	463 22.9%	1469 36.3%	464 NaN
Above	21 1%	10 0.5%	19 0.5%	9 NaN
Unknown	12 0.6%	3 0.1%	14 0.3%	4 NaN
Below	0 0%	0 0%	0 0%	0 NaN
Within	1505 74.3%	475 23.5%	1493 36.9%	473 NaN
Above	10 0.5%	1 0%	17 0.4%	1 NaN
Unknown	14 0.7%	0 0%	6 0.1%	4 NaN
Below	0 0%	0 0%	0 0%	0 NaN
Within	1466 72.4%	472 23.3%	1459 36%	468 NaN
Above	13 0.6%	1 0%	27 0.7%	2 NaN
Unknown	15 0.7%	8 0.4%	8 0.2%	1 NaN
Below	0 0%	0 0%	0 0%	0 NaN
Within	1511 74.6%	471 23.3%	1515 37.4%	477 NaN
Above	0 0%	0 0%	0 0%	0 NaN
Unknown	35 1.7%	10 0.5%	32 0.8%	8 NaN
Below	0 0%	0 0%	0 0%	0 NaN
Within	1458 72%	463 22.9%	1460 36.1%	466 NaN
Above	0 0%	0 0%	0 0%	0 NaN
Unknown	3 0.1%	1 0%	5 0.1%	3 NaN
Below	0 0%	0 0%	0 0%	0 NaN
Within	1511 74.6%	475 23.5%	1500 37.1%	472 NaN
Above	13 0.6%	3 0.1%	19 0.5%	3 NaN
Unknown	9 0.4%	0 0%	4 0.1%	1 NaN
Below	0 0%	0 0%	0 0%	0 NaN
Within	1467 72.4%	468 23.1%	1466 36.2%	467 NaN
Above	17 0.8%	5 0.2%	22 0.5%	6 NaN
Unknown	3 0.1%	1 0%	5 0.1%	3 NaN
Below	0 0%	0 0%	0 0%	0 NaN
Within	1524 75.3%	478 23.6%	1518 37.5%	475 NaN
Above	0 0%	0 0%	1 0%	0 NaN
Unknown	9 0.4%	0 0%	4 0.1%	1 NaN
Below	0 0%	0 0%	0 0%	0 NaN
Within	1484 73.3%	473 23.4%	1488 36.8%	473 NaN
Above	0 0%	0 0%	0 0%	0 NaN
Unknown	3 0.1%	1 0%	5 0.1%	3 NaN
Below	149 7.4%	35 1.7%	144 3.6%	30 NaN
Within	1365 67.4%	443 21.9%	1363 33.7%	443 NaN
Above	10 0.5%	0 0%	11 0.3%	2 NaN
Unknown	9 0.4%	0 0%	3 0.1%	1 NaN
Below	150 7.4%	37 1.8%	136 3.4%	32 NaN
Within	1324 65.4%	431 21.3%	1345 33.2%	438 NaN
Above	10 0.5%	5 0.2%	8 0.2%	3 NaN
Unknown	15 0.7%	8 0.4%	8 0.2%	1 NaN
Below	64 3.2%	12 0.6%	66 1.6%	10 NaN
Within	1411 69.7%	437 21.6%	1414 34.9%	449 NaN
Above	36 1.8%	22 1.1%	35 0.9%	18 NaN
Unknown	35 1.7%	10 0.5%	32 0.8%	8 NaN
Below	63 3.1%	20 1%	60 1.5%	16 NaN
Within	1345 66.4%	427 21.1%	1361 33.6%	437 NaN
Above	50 2.5%	16 0.8%	39 1%	13 NaN
Unknown	13 0.6%	6 0.3%	8 0.2%	1 NaN
Below	72 3.6%	7 0.3%	82 2%	6 NaN
Within	1429 70.6%	463 22.9%	1416 35%	467 NaN
Above	12 0.6%	3 0.1%	17 0.4%	4 NaN
Unknown	29 1.4%	9 0.4%	29 0.7%	8 NaN
Below	88 4.3%	10 0.5%	91 2.2%	9 NaN
Within	1368 67.6%	451 22.3%	1362 33.6%	453 NaN
Above	8 0.4%	3 0.1%	10 0.2%	4 NaN
Unknown	13 0.6%	6 0.3%	8 0.2%	1 NaN
Below	47 2.3%	4 0.2%	65 1.6%	3 NaN
Within	1455 71.9%	465 23%	1436 35.5%	470 NaN
Above	11 0.5%	4 0.2%	14 0.3%	4 NaN
Unknown	29 1.4%	9 0.4%	28 0.7%	8 NaN
Below	58 2.9%	3 0.1%	68 1.7%	6 NaN
Within	1399 69.1%	460 22.7%	1385 34.2%	456 NaN
Above	7 0.3%	1 0%	11 0.3%	4 NaN
Unknown	15 0.7%	8 0.4%	8 0.2%	1 NaN
Below	5 0.2%	5 0.2%	7 0.2%	7 NaN
Within	1494 73.8%	466 23%	1500 37.1%	468 NaN
Above	12 0.6%	0 0%	8 0.2%	2 NaN
Unknown	35 1.7%	10 0.5%	32 0.8%	8 NaN
Below	7 0.3%	7 0.3%	2 0%	8 NaN
Within	1445 71.4%	454 22.4%	1444 35.7%	452 NaN
Above	6 0.3%	2 0.1%	14 0.3%	6 NaN
Unknown	15 0.7%	8 0.4%	8 0.2%	1 NaN
Below	306 15.1%	54 2.7%	290 7.2%	52 NaN
Within	1205 59.5%	417 20.6%	1224 30.2%	423 NaN
Above	0 0%	0 0%	1 0%	2 NaN
Unknown	35 1.7%	10 0.5%	32 0.8%	8 NaN
Below	309 15.3%	58 2.9%	304 7.5%	64 NaN
Within	1149 56.7%	404 20%	1155 28.5%	402 NaN
Above	0 0%	1 0%	1 0%	0 NaN
Unknown	15 0.7%	8 0.4%	8 0.2%	1 NaN
Below	42 2.1%	9 0.4%	39 1%	11 NaN
Within	1449 71.6%	454 22.4%	1448 35.8%	459 NaN
Above	16 0.8%	6 0.3%	27 0.7%	4 NaN
Unknown	35 1.7%	10 0.5%	32 0.8%	8 NaN
Below	48 2.4%	18 0.9%	53 1.3%	12 NaN
Within	1392 68.7%	440 21.7%	1392 34.4%	448 NaN
Above	18 0.9%	5 0.2%	15 0.4%	6 NaN
Unknown	15 0.7%	8 0.4%	8 0.2%	2 NaN
Below	6 0.3%	5 0.2%	8 0.2%	7 NaN
Within	1498 74%	465 23%	1501 37.1%	467 NaN
Above	7 0.3%	1 0%	6 0.1%	2 NaN
Unknown	30 1.5%	11 0.5%	29 0.7%	10 NaN
Below	7 0.3%	5 0.2%	11 0.3%	6 NaN
Within	1454 71.8%	456 22.5%	1448 35.8%	456 NaN
Above	2 0.1%	1 0%	4 0.1%	2 NaN
Unknown	13 0.6%	6 0.3%	8 0.2%	1 NaN
Below	97 4.8%	6 0.3%	102 2.5%	6 NaN
Within	1411 69.7%	463 22.9%	1402 34.6%	469 NaN
Above	5 0.2%	4 0.2%	11 0.3%	2 NaN
Unknown	29 1.4%	9 0.4%	29 0.7%	8 NaN
Below	95 4.7%	8 0.4%	90 2.2%	8 NaN
Within	1368 67.6%	455 22.5%	1367 33.8%	458 NaN
Above	1 0%	1 0%	6 0.1%	0 NaN
Unknown	3 0.1%	1 0%	5 0.1%	3 NaN
Below	5 0.2%	0 0%	9 0.2%	0 NaN
Within	1509 74.5%	471 23.3%	1500 37.1%	466 NaN
Above	10 0.5%	7 0.3%	9 0.2%	9 NaN
Unknown	9 0.4%	0 0%	4 0.1%	1 NaN
Below	9 0.4%	0 0%	5 0.1%	0 NaN
Within	1462 72.2%	467 23.1%	1467 36.2%	469 NaN
Above	13 0.6%	6 0.3%	16 0.4%	4 NaN
Unknown	15 0.7%	8 0.4%	8 0.2%	1 NaN
Below	27 1.3%	10 0.5%	30 0.7%	12 NaN
Within	1457 72%	455 22.5%	1440 35.6%	458 NaN
Above	27 1.3%	6 0.3%	45 1.1%	7 NaN
Unknown	35 1.7%	10 0.5%	32 0.8%	8 NaN
Below	31 1.5%	11 0.5%	30 0.7%	10 NaN
Within	1406 69.4%	448 22.1%	1398 34.5%	444 NaN
Above	21 1%	4 0.2%	32 0.8%	12 NaN

24. Secondary Outcome

Title	Number of Subjects With Any Medically-attended Adverse Events (MAEs)
Description	MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y).
Time Frame	Throughout the entire study period (Day 0 - Day 385)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

Arm/Group Title	GSK2340274A (18-64 y) Group	GSK2340274A (>64 y) Group	GSK2340273A (18-64 y) Group	GSK2340273A (>64 y) Group
Arm/Group Description	Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Measure Participants	1544	481	1543	480
Count of Participants [Participants]	615 30.4%	247 12.2%	614 15.2%	265 NaN

25. Secondary Outcome

Title	Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)
Description	Potential immune-mediated diseases (pIMDs) represent a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y).
Time Frame	Throughout the entire study period (Day 0 - Day 385)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

Arm/Group Title	GSK2340274A (18-64 y) Group	GSK2340274A (>64 y) Group	GSK2340273A (18-64 y) Group	GSK2340273A (>64 y) Group
Arm/Group Description	Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Measure Participants	1544	481	1543	480
Count of Participants [Participants]	2 0.1%	3 0.1%	4 0.1%	3 NaN

26. Secondary Outcome

Title	Number of Subjects With Any Unsolicited Adverse Events (AEs)
Description	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y).
Time Frame	Within the 42-day (Days 0-41) post-vaccination period

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

Arm/Group Title	GSK2340274A (18-64 y) Group	GSK2340274A (>64 y) Group	GSK2340273A (18-64 y) Group	GSK2340273A (>64 y) Group
Arm/Group Description	Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Measure Participants	1544	481	1543	480
Count of Participants [Participants]	495 24.4%	119 5.9%	522 12.9%	139 NaN

27. Secondary Outcome

Title	Number of Subjects With Serious Adverse Events (SAEs)
Description	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y).
Time Frame	Throughout the entire study period (Day 0 - Day 385)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

Arm/Group Title	GSK2340274A (18-64 y) Group	GSK2340274A (>64 y) Group	GSK2340273A (18-64 y) Group	GSK2340273A (>64 y) Group
Arm/Group Description	Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.	Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Measure Participants	1544	481	1543	480
Count of Participants [Participants]	45 2.2%	39 1.9%	32 0.8%	41 NaN

Adverse Events

Time Frame	Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 42-day (Days 0-41) post-vaccination period. Serious adverse events (SAE): during the entire study period (Day 0 to Day 385).
Arm/Group Title	GSK2340274A Group		GSK2340273A Group
Arm/Group Description	Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.		Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
All Cause Mortality
	GSK2340274A Group		GSK2340273A Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/2025 (0.3%)		1/2023 (0%)
Serious Adverse Events
	GSK2340274A Group		GSK2340273A Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	84/2025 (4.1%)		73/2023 (3.6%)
Blood and lymphatic system disorders
Pancytopenia	0/2025 (0%)	0	1/2023 (0%)	1
Splenic vein thrombosis	0/2025 (0%)	0	1/2023 (0%)	1
Cardiac disorders
Acute coronary syndrome	2/2025 (0.1%)	2	0/2023 (0%)	0
Atrial fibrillation	2/2025 (0.1%)	2	4/2023 (0.2%)	4
Bradycardia	1/2025 (0%)	1	0/2023 (0%)	0
Cardiac failure congestive	0/2025 (0%)	0	1/2023 (0%)	1
Coronary artery disease	0/2025 (0%)	0	4/2023 (0.2%)	4
Coronary artery stenosis	0/2025 (0%)	0	1/2023 (0%)	1
Myocardial infarction	2/2025 (0.1%)	2	2/2023 (0.1%)	2
Sick sinus syndrome	1/2025 (0%)	1	0/2023 (0%)	0
Ear and labyrinth disorders
Vertigo	1/2025 (0%)	1	0/2023 (0%)	0
Vertigo positional	0/2025 (0%)	0	1/2023 (0%)	1
Gastrointestinal disorders
Abdominal hernia	1/2025 (0%)	1	0/2023 (0%)	0
Abdominal pain lower	0/2025 (0%)	0	1/2023 (0%)	1
Abdominal pain upper	1/2025 (0%)	1	0/2023 (0%)	0
Colitis ulcerative	1/2025 (0%)	1	0/2023 (0%)	0
Gastric fistula	1/2025 (0%)	1	0/2023 (0%)	0
Gastritis	1/2025 (0%)	1	0/2023 (0%)	0
Hiatus hernia	1/2025 (0%)	1	0/2023 (0%)	0
Intestinal obstruction	2/2025 (0.1%)	2	0/2023 (0%)	0
Mesenteric vein thrombosis	0/2025 (0%)	0	1/2023 (0%)	1
Nausea	0/2025 (0%)	0	1/2023 (0%)	1
Pancreatitis	2/2025 (0.1%)	2	3/2023 (0.1%)	3
Pancreatitis acute	1/2025 (0%)	1	1/2023 (0%)	1
Peritonitis	1/2025 (0%)	1	0/2023 (0%)	0
Rectal haemorrhage	0/2025 (0%)	0	1/2023 (0%)	1
Retroperitoneal haematoma	1/2025 (0%)	1	0/2023 (0%)	0
Vomiting	1/2025 (0%)	1	1/2023 (0%)	1
General disorders
Chest discomfort	1/2025 (0%)	1	0/2023 (0%)	0
Chest pain	2/2025 (0.1%)	2	4/2023 (0.2%)	4
Influenza like illness	0/2025 (0%)	0	1/2023 (0%)	1
Non-cardiac chest pain	2/2025 (0.1%)	2	0/2023 (0%)	0
Pyrexia	0/2025 (0%)	0	1/2023 (0%)	1
Hepatobiliary disorders
Biliary dyskinesia	1/2025 (0%)	1	0/2023 (0%)	0
Cholecystitis	1/2025 (0%)	1	2/2023 (0.1%)	2
Liver disorder	1/2025 (0%)	1	0/2023 (0%)	0
Portal vein thrombosis	0/2025 (0%)	0	1/2023 (0%)	1
Infections and infestations
Abscess	1/2025 (0%)	1	0/2023 (0%)	0
Appendicitis	1/2025 (0%)	1	0/2023 (0%)	0
Bronchitis	1/2025 (0%)	1	1/2023 (0%)	1
Cellulitis	2/2025 (0.1%)	2	1/2023 (0%)	1
Clostridial infection	1/2025 (0%)	1	0/2023 (0%)	0
Enterocolitis bacterial	0/2025 (0%)	0	1/2023 (0%)	1
Gangrene	0/2025 (0%)	0	1/2023 (0%)	2
Gastroenteritis	0/2025 (0%)	0	2/2023 (0.1%)	2
Herpes virus infection	0/2025 (0%)	0	1/2023 (0%)	1
Histoplasmosis	1/2025 (0%)	1	0/2023 (0%)	0
Infectious mononucleosis	0/2025 (0%)	0	1/2023 (0%)	1
Kidney infection	0/2025 (0%)	0	1/2023 (0%)	3
Lobar pneumonia	0/2025 (0%)	0	1/2023 (0%)	1
Localised infection	1/2025 (0%)	1	0/2023 (0%)	0
Osteomyelitis	0/2025 (0%)	0	1/2023 (0%)	1
Pneumonia	1/2025 (0%)	1	6/2023 (0.3%)	6
Pneumonia primary atypical	1/2025 (0%)	1	0/2023 (0%)	0
Pneumonia staphylococcal	1/2025 (0%)	1	0/2023 (0%)	0
Postoperative wound infection	0/2025 (0%)	0	1/2023 (0%)	1
Pyelonephritis	1/2025 (0%)	1	0/2023 (0%)	0
Septic shock	0/2025 (0%)	0	1/2023 (0%)	1
Skin infection	1/2025 (0%)	1	0/2023 (0%)	0
Subcutaneous abscess	0/2025 (0%)	0	1/2023 (0%)	1
Injury, poisoning and procedural complications
Alcohol poisoning	1/2025 (0%)	1	0/2023 (0%)	0
Ankle fracture	1/2025 (0%)	1	1/2023 (0%)	1
Clavicle fracture	1/2025 (0%)	1	0/2023 (0%)	0
Drug toxicity	1/2025 (0%)	1	0/2023 (0%)	0
Foot fracture	1/2025 (0%)	1	0/2023 (0%)	0
Hip fracture	0/2025 (0%)	0	1/2023 (0%)	1
Humerus fracture	0/2025 (0%)	0	2/2023 (0.1%)	2
Lower limb fracture	0/2025 (0%)	0	1/2023 (0%)	1
Multiple fractures	1/2025 (0%)	1	0/2023 (0%)	0
Pelvic fracture	1/2025 (0%)	1	0/2023 (0%)	0
Radius fracture	0/2025 (0%)	0	1/2023 (0%)	1
Skin laceration	0/2025 (0%)	0	1/2023 (0%)	1
Subdural haematoma	0/2025 (0%)	0	1/2023 (0%)	1
Ulna fracture	0/2025 (0%)	0	2/2023 (0.1%)	2
Wrist fracture	0/2025 (0%)	0	1/2023 (0%)	1
Investigations
Blood potassium decreased	0/2025 (0%)	0	1/2023 (0%)	1
Brain natriuretic peptide increased	0/2025 (0%)	0	1/2023 (0%)	1
Electrocardiogram st segment elevation	1/2025 (0%)	1	0/2023 (0%)	0
Enzyme activity decreased	0/2025 (0%)	0	1/2023 (0%)	1
Metabolism and nutrition disorders
Hyperglycaemia	1/2025 (0%)	1	0/2023 (0%)	0
Hypokalaemia	1/2025 (0%)	1	0/2023 (0%)	0
Hyponatraemia	1/2025 (0%)	1	0/2023 (0%)	0
Type 2 diabetes mellitus	1/2025 (0%)	1	0/2023 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	2/2025 (0.1%)	2	1/2023 (0%)	1
Arthritis	2/2025 (0.1%)	3	0/2023 (0%)	0
Intervertebral disc protrusion	1/2025 (0%)	1	0/2023 (0%)	0
Musculoskeletal chest pain	1/2025 (0%)	1	0/2023 (0%)	0
Rhabdomyolysis	1/2025 (0%)	1	0/2023 (0%)	0
Spinal column stenosis	1/2025 (0%)	1	0/2023 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma	0/2025 (0%)	0	1/2023 (0%)	1
Breast cancer	2/2025 (0.1%)	2	1/2023 (0%)	1
Bronchioloalveolar carcinoma	0/2025 (0%)	0	1/2023 (0%)	1
Colon cancer	2/2025 (0.1%)	2	1/2023 (0%)	1
Colorectal cancer	0/2025 (0%)	0	1/2023 (0%)	1
Endometrial cancer	1/2025 (0%)	1	0/2023 (0%)	0
Follicle centre lymphoma, follicular grade i, ii, iii stage iii	0/2025 (0%)	0	1/2023 (0%)	1
Glioblastoma multiforme	0/2025 (0%)	0	1/2023 (0%)	1
Malignant melanoma	1/2025 (0%)	2	0/2023 (0%)	0
Neoplasm malignant	1/2025 (0%)	1	0/2023 (0%)	0
Paget's disease of the breast	0/2025 (0%)	0	1/2023 (0%)	1
Prostate cancer	1/2025 (0%)	1	0/2023 (0%)	0
Rectal cancer	1/2025 (0%)	1	0/2023 (0%)	0
Thymoma	1/2025 (0%)	1	0/2023 (0%)	0
Thyroid cancer	1/2025 (0%)	1	1/2023 (0%)	1
Uterine cancer	1/2025 (0%)	1	0/2023 (0%)	0
Nervous system disorders
Ataxia	0/2025 (0%)	0	1/2023 (0%)	1
Carotid artery stenosis	0/2025 (0%)	0	1/2023 (0%)	1
Cerebrovascular accident	2/2025 (0.1%)	2	1/2023 (0%)	1
Cognitive disorder	0/2025 (0%)	0	1/2023 (0%)	1
Convulsion	0/2025 (0%)	0	1/2023 (0%)	1
Dizziness	1/2025 (0%)	1	0/2023 (0%)	0
Grand mal convulsion	1/2025 (0%)	1	0/2023 (0%)	0
Hypoaesthesia	0/2025 (0%)	0	1/2023 (0%)	1
Multiple sclerosis	0/2025 (0%)	0	1/2023 (0%)	1
Nerve compression	0/2025 (0%)	0	1/2023 (0%)	1
Syncope	1/2025 (0%)	1	1/2023 (0%)	1
Transient ischaemic attack	1/2025 (0%)	1	2/2023 (0.1%)	2
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous complete	0/2025 (0%)	0	1/2023 (0%)	1
Pre-eclampsia	0/2025 (0%)	0	1/2023 (0%)	1
Small for dates baby	0/2025 (0%)	0	1/2023 (0%)	1
Psychiatric disorders
Completed suicide	1/2025 (0%)	1	0/2023 (0%)	0
Major depression	0/2025 (0%)	0	1/2023 (0%)	1
Psychotic disorder	1/2025 (0%)	1	1/2023 (0%)	1
Suicide attempt	1/2025 (0%)	1	1/2023 (0%)	1
Renal and urinary disorders
Calculus bladder	0/2025 (0%)	0	1/2023 (0%)	1
Calculus ureteric	1/2025 (0%)	1	0/2023 (0%)	0
Hydronephrosis	1/2025 (0%)	1	0/2023 (0%)	0
Nephrolithiasis	2/2025 (0.1%)	2	0/2023 (0%)	0
Renal failure acute	1/2025 (0%)	1	2/2023 (0.1%)	2
Renal tubular necrosis	1/2025 (0%)	1	0/2023 (0%)	0
Urethral perforation	1/2025 (0%)	1	0/2023 (0%)	0
Urethral stenosis	0/2025 (0%)	0	1/2023 (0%)	1
Urinary incontinence	0/2025 (0%)	0	1/2023 (0%)	1
Reproductive system and breast disorders
Benign prostatic hyperplasia	0/2025 (0%)	0	1/2023 (0%)	1
Cystocele	1/2025 (0%)	1	0/2023 (0%)	0
Prostatitis	1/2025 (0%)	1	0/2023 (0%)	0
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	2/2025 (0.1%)	2	1/2023 (0%)	1
Dyspnoea	0/2025 (0%)	0	1/2023 (0%)	1
Haemoptysis	1/2025 (0%)	1	0/2023 (0%)	0
Pneumonia aspiration	0/2025 (0%)	0	2/2023 (0.1%)	2
Pneumonitis	1/2025 (0%)	1	0/2023 (0%)	0
Pneumothorax	0/2025 (0%)	0	1/2023 (0%)	1
Pulmonary embolism	3/2025 (0.1%)	3	0/2023 (0%)	0
Skin and subcutaneous tissue disorders
Stevens-johnson syndrome	0/2025 (0%)	0	1/2023 (0%)	1
Vascular disorders
Arteriosclerosis	1/2025 (0%)	1	0/2023 (0%)	0
Deep vein thrombosis	1/2025 (0%)	1	0/2023 (0%)	0
Hypertension	1/2025 (0%)	1	0/2023 (0%)	0
Hypertensive crisis	0/2025 (0%)	0	1/2023 (0%)	1
Other (Not Including Serious) Adverse Events
	GSK2340274A Group		GSK2340273A Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1680/2025 (83%)		1063/2023 (52.5%)
General disorders
Chills	181/2025 (8.9%)	183	116/2023 (5.7%)	116
Fatigue	564/2025 (27.9%)	573	428/2023 (21.2%)	435
Pain	1530/2025 (75.6%)	1533	508/2023 (25.1%)	509
Swelling	165/2025 (8.1%)	165	14/2023 (0.7%)	14
Musculoskeletal and connective tissue disorders
Arthralgia	299/2025 (14.8%)	302	165/2023 (8.2%)	167
Myalgia	698/2025 (34.5%)	709	326/2023 (16.1%)	329
Nervous system disorders
Headache	547/2025 (27%)	570	510/2023 (25.2%)	530
Respiratory, thoracic and mediastinal disorders
Cough	78/2025 (3.9%)	82	110/2023 (5.4%)	112
Oropharyngeal pain	122/2025 (6%)	124	126/2023 (6.2%)	131
Skin and subcutaneous tissue disorders
Erythema	114/2025 (5.6%)	114	18/2023 (0.9%)	18
Hyperhidrosis	116/2025 (5.7%)	116	83/2023 (4.1%)	83

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.