Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.

Seroconversion (SCR) was defined as follows: for initially seronegative subjects, antibody titer equal to or above (≥) 1:40 after vaccination; for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.

Seroconversion (SCR) was defined as follows: for initially seronegative subjects, antibody titer equal to or above (≥) 1:40 after vaccination; for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.

Seroconversion (SCR) was defined as follows: for initially seronegative subjects, antibody titer equal to or above (≥) 1:40 after vaccination; for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.

A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.

A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.

A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.

SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.

SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.

SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.

SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.

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.

The number of days with any solicited local symptoms reported during the solicited post-vaccination period.

Assessed solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptom that prevented normal everyday activities. Grade 3 fever = fever above (>) 40.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.

The number of days with any solicited general symptoms reported during the solicited 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. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

Total of all reporting groups

Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.

Seroconversion (SCR) was defined as follows: for initially seronegative subjects, antibody titer equal to or above (≥) 1:40 after vaccination; for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old. The primary endpoint results consist in those presented for GSK2340272A Group.

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received two doses of vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken 14 days (Day 35) after the second vaccine dose.

A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old. The primary endpoint results consist in those presented for GSK2340272A Group.

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received two doses of vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken 14 days (Day 35) after the second vaccine dose.

GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old. The primary endpoint results consist in those presented for GSK2340272A Group.

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received two doses of vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken 14 days (Day 35) after the second vaccine dose.

Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received two doses of vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood samples taken at Day 0 and Day 21.

Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.

The analysis was performed on the ATP cohort for persistence (Month 6), which included all evaluable subjects who received at least one dose of the vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken at Month 6.

Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.

The analysis was performed on the ATP cohort for persistence (Month 12), which included all evaluable subjects who received at least one dose of the vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken at Month 12.

Seroconversion (SCR) was defined as follows: for initially seronegative subjects, antibody titer equal to or above (≥) 1:40 after vaccination; for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received two doses of vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken at Day 21.

Seroconversion (SCR) was defined as follows: for initially seronegative subjects, antibody titer equal to or above (≥) 1:40 after vaccination; for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.

The analysis was performed on the ATP cohort for persistence (Month 6), which included all evaluable subjects who received at least one dose of the vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken at Month 6.

Seroconversion (SCR) was defined as follows: for initially seronegative subjects, antibody titer equal to or above (≥) 1:40 after vaccination; for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.

The analysis was performed on the ATP cohort for persistence (Month 12), which included all evaluable subjects who received at least one dose of the vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken at Month 12.

A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received two doses of vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken at Day 0 and Day 21.

A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.

The analysis was performed on the ATP cohort for persistence (Month 6), which included all evaluable subjects who received at least one dose of the vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken at Month 6.

A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.

The analysis was performed on the ATP cohort for persistence (Month 12), which included all evaluable subjects who received at least one dose of the vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken at Month 12.

SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received two doses of vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken at Day 21.

SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received two doses of vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken 14 days (Day 35) after the second vaccine dose.

SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.

The analysis was performed on the ATP cohort for persistence (Month 6), which included all evaluable subjects who received at least one dose of the vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken at Month 6.

SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.

The analysis was performed on the ATP cohort for persistence (Month 12), which included all evaluable subjects who received at least one dose of the vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken at Month 12.

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.

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet filled in.

The number of days with any solicited local symptoms reported during the solicited post-vaccination period.

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

Assessed solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptom that prevented normal everyday activities. Grade 3 fever = fever above (>) 40.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet filled in.

The number of days with any solicited general symptoms reported during the solicited post-vaccination period.

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

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

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

SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

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

An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.

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

Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.

This solicited local symptom was only collected from subjects with their symptom sheet completed.

This solicited local symptom was only collected from subjects with their symptom sheet completed.

This solicited local symptom was only collected from subjects with their symptom sheet completed.

This solicited general symptom was only collected from subjects with their symptom sheet completed.

This solicited general symptom was only collected from subjects with their symptom sheet completed.

This solicited general symptom was only collected from subjects with their symptom sheet completed.

This solicited general symptom was only collected from subjects with their symptom sheet completed.

This solicited general symptom was only collected from subjects with their symptom sheet completed.

This solicited general symptom was only collected from subjects with their symptom sheet completed.