Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.

Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.

Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 post to vaccination], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09). The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was > 40% in subjects 18 to 60 years of age or > 30% for subjects above 60 years of age.

Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 post to vaccination], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09). The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was > 40% in subjects 18 to 60 years of age or > 30% for subjects above 60 years of age.

Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 post to vaccination], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09). The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was > 40% in subjects 18 to 60 years of age or > 30% for subjects above 60 years of age.

Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 post to vaccination], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09). The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was > 40% in subjects 18 to 60 years of age or > 30% for subjects above 60 years of age.

A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was > 70% in subjects 18 to 60 of age or > 60% for subjects above 60 years of age.

A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was > 70% in subjects 18 to 60 of age or > 60% for subjects above 60 years of age.

A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was > 70% in subjects 18 to 60 of age or > 60% for subjects above 60 years of age.

A seroprotected subject was defined as a vaccinated subject with a serum HI titre greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was > 70% in subjects 18 to 60 of age or > 60% for subjects above 60 years of age.

GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. The criterion was fulfilled if the point estimate for GMFR was > 2.5 in subjects 18 to 60 years of age or > 2 for subjects above 60 years of age.

GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. The criterion was fulfilled if the point estimate for GMFR was > 2.5 in subjects 18 to 60 years of age or > 2 for subjects above 60 years of age.

GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. The criterion was fulfilled if the point estimate for GMFR was > 2.5 in subjects 18 to 60 years of age or > 2 for subjects above 60 years of age.

GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. The criterion was fulfilled if the point estimate for GMFR was > 2.5 in subjects 18 to 60 years of age or > 2 for subjects above 60 years of age.

Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/Neth/602/09. The reference seropositivity cut-off value was ≥ 1:8.

Seroconversion was defined as: For initially seronegative subjects, antibody titer ≥ 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/Netherlands/602/09. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was > 40% in subjects 18 to 60 years of age or > 30% for subjects above 60 years of age.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest; prevented normal activities as assessed by inability to attend/do work or school. 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 local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest; prevented normal activities as assessed by inability to attend/do work or school. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest; prevented normal activities as assessed by inability to attend/do work or school. 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. Grade 3 symptom = general symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever = temperature ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

The number of days with any solicited general 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 or their relationship to vaccination. Grade 3 symptom = general symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever = temperature ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

The number of days with any solicited general 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. Grade 3 symptom = general symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever = temperature > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

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

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

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

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

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.

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

Among biochemical and haematological parameters assessed were alanine aminotransferase [ALAT], alkaline phosphatase [AP], aspartate aminotransferase [ASAT], bilirubin [BIL], creatinine [CRE], blood urea nitrogen [BUN]. Levels of haematological/biochemical parameters assessed with respect to normal laboratory values were - unknown, below, within and above in subjects aged 18-60 years and > 6 years old.

Among biochemical and haematological parameters assessed were alanine aminotransferase [ALAT], alkaline phosphatase [AP], aspartate aminotransferase [ASAT], bilirubin [BIL], creatinine [CRE], blood urea nitrogen [BUN]. Levels of haematological/biochemical parameters assessed with respect to normal laboratory values were - unknown, bellow, within and above in subjects aged 18-60 years and > 6 years old.

Among biochemical and haematological parameters assessed were alanine aminotransferase [ALAT], alkaline phosphatase [AP], aspartate aminotransferase [ASAT], bilirubin [BIL], creatinine [CRE], blood urea nitrogen [BUN]. Levels of haematological/biochemical parameters assessed with respect to normal laboratory values were - unknown, bellow, within and above in subjects aged 18-60 years and > 6 years old.

Among biochemical and haematological parameters assessed were alanine aminotransferase [ALAT], alkaline phosphatase [AP], aspartate aminotransferase [ASAT], bilirubin [BIL], creatinine [CRE], blood urea nitrogen [BUN]. Levels of haematological/biochemical parameters assessed with respect to normal laboratory values were - unknown, bellow, within and above in subjects aged 18-60 years and > 6 years old.

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. Note: GSK2340272A 18-60 years (D21) GROUP and GSK2340272A >60 years (D21) GROUP presents results after the 2 vaccine dose; GSK2340272A 18-60 years (M6) GROUP and GSK2340272A >60 years (M6) GROUP presents result after 1 vaccine dose.

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.

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.

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

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

Pooled group for healthy male or female adults, older than 60 years of age (>60), who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21 and at Month 6.

A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was > 70% in subjects 18 to 60 of age or > 60% for subjects above 60 years of age.

The According-To-Protocol (ATP) cohort for immunogenicity at Day 21 included all eligible subjects, for whom 1 dose of study vaccine was administered and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the first vaccine dose.

Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 post to vaccination], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09). The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was > 40% in subjects 18 to 60 years of age or > 30% for subjects above 60 years of age.

The According-To-Protocol (ATP) cohort for immunogenicity at Day 21 included all eligible subjects, for whom 1 dose of study vaccine was administered and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the first vaccine dose.

GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. The criterion was fulfilled if the point estimate for GMFR was > 2.5 in subjects 18 to 60 years of age or > 2 for subjects above 60 years of age.

The According-To-Protocol (ATP) cohort for immunogenicity at Day 21 included all eligible subjects, for whom 1 dose of study vaccine was administered and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the first vaccine dose.

Titres are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.

The ATP cohort for immunogenicity at Day 42 included all eligible subjects, for whom 2 (for D21 Groups)/1 (for M6 Groups) doses of study vaccine were administered and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 (for D21 Groups)/42 (for M6 Groups) days after second/first vaccine dose.

Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.

The ATP cohort for antibody persistence at Day 182 included all eligible subjects, who received at least 1 dose of study vaccine according to their treatment assignment, had not received a vaccine not specified or forbidden in the protocol and for whom assay results were available for the study vaccine antigen component at Month 6.

Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.

The ATP cohort for immunogenicity at Day 203 included all eligible subjects form the GSK2340272A M6 Groups, for whom 2 doses were administrated and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken 21 days after the second dose at Day 182.

Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.

The ATP cohort for persistence at Day 364 included all evaluable subjects, who met all the eligibility criteria, complied with the procedures defined in the protocol during the entire study and with the intervals defined in the protocol for visit at Day 364. This cohort included subjects for whom assay results were available at Day 364.

Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 post to vaccination], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09). The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was > 40% in subjects 18 to 60 years of age or > 30% for subjects above 60 years of age.

The ATP cohort for immunogenicity at Day 42 included all eligible subjects, for whom 2 (for D21 Groups)/1 (for M6 Groups) doses of study vaccine were administered and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 (for D21 Groups)/42 (for M6 Groups) days after second/first vaccine dose.

Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 post to vaccination], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09). The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was > 40% in subjects 18 to 60 years of age or > 30% for subjects above 60 years of age.

The ATP cohort for antibody persistence at Day 182 included all eligible subjects, who received at least 1 dose of study vaccine according to their treatment assignment, had not received a vaccine not specified or forbidden in the protocol and for whom assay results were available for the study vaccine antigen component at Month 6.

Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 post to vaccination], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09). The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was > 40% in subjects 18 to 60 years of age or > 30% for subjects above 60 years of age.

The ATP cohort for immunogenicity at Day 203 included all eligible subjects form the GSK2340272A M6 Groups, for whom 2 doses were administrated and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken 21 days after the second dose at Day 182.

Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 post to vaccination], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09). The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was > 40% in subjects 18 to 60 years of age or > 30% for subjects above 60 years of age.

The ATP cohort for persistence at Day 364 included all evaluable subjects, who met all the eligibility criteria, complied with the procedures defined in the protocol during the entire study and with the intervals defined in the protocol for visit at Day 364. This cohort included subjects for whom assay results were available at Day 364.

A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was > 70% in subjects 18 to 60 of age or > 60% for subjects above 60 years of age.

The ATP cohort for immunogenicity at Day 42 included all eligible subjects, for whom 2 (for D21 Groups)/1 (for M6 Groups) doses of study vaccine was administered and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 (for D21 Groups)/42 (for M6 Groups) days after second/first vaccine dose.

A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was > 70% in subjects 18 to 60 of age or > 60% for subjects above 60 years of age.

The ATP cohort for antibody persistence at Day 182 included all eligible subjects, who received at least 1 dose of study vaccine according to their treatment assignment, had not received a vaccine not specified or forbidden in the protocol and for whom assay results were available for the study vaccine antigen component at Month 6.

A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was > 70% in subjects 18 to 60 of age or > 60% for subjects above 60 years of age.

The ATP cohort for immunogenicity at Day 203 included all eligible subjects form the GSK2340272A M6 Groups, for whom 2 doses were administrated and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken 21 days after the second dose at Day 182.

A seroprotected subject was defined as a vaccinated subject with a serum HI titre greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was > 70% in subjects 18 to 60 of age or > 60% for subjects above 60 years of age.

The ATP cohort for persistence at Day 364 included all evaluable subjects, who met all the eligibility criteria, complied with the procedures defined in the protocol during the entire study and with the intervals defined in the protocol for visit at Day 364. This cohort included subjects for whom assay results were available at Day 364.

GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. The criterion was fulfilled if the point estimate for GMFR was > 2.5 in subjects 18 to 60 years of age or > 2 for subjects above 60 years of age.

The ATP cohort for immunogenicity at Day 42 included all eligible subjects, for whom 2 (for D21 Groups)/1 (for M6 Groups) doses of study vaccine were administered and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 (for D21 Groups)/42 (for M6 Groups) days after second/first vaccine dose.

GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. The criterion was fulfilled if the point estimate for GMFR was > 2.5 in subjects 18 to 60 years of age or > 2 for subjects above 60 years of age.

The ATP cohort for antibody persistence at Day 182 included all eligible subjects, who received at least 1 dose of study vaccine according to their treatment assignment, had not received a vaccine not specified or forbidden in the protocol and for whom assay results were available for the study vaccine antigen component at Month 6.

GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. The criterion was fulfilled if the point estimate for GMFR was > 2.5 in subjects 18 to 60 years of age or > 2 for subjects above 60 years of age.

The ATP cohort for immunogenicity at Day 203 included all eligible subjects form the GSK2340272A M6 Groups, for whom 2 doses were administrated and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken 21 days after the second dose at Day 182.

GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. The criterion was fulfilled if the point estimate for GMFR was > 2.5 in subjects 18 to 60 years of age or > 2 for subjects above 60 years of age.

The ATP cohort for persistence at Day 364 included all evaluable subjects, who met all the eligibility criteria, complied with the procedures defined in the protocol during the entire study and with the intervals defined in the protocol for visit at Day 364. This cohort included subjects for whom assay results were available at Day 364.

Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/Neth/602/09. The reference seropositivity cut-off value was ≥ 1:8.

The ATP cohort for immunogenicity at Day 42 included all eligible subjects, for whom 2 (for D21 Groups)/1 (for M6 Groups) doses of study vaccine were administered and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 (for D21 Groups)/42 (for M6 Groups) days after second/first vaccine dose.

Seroconversion was defined as: For initially seronegative subjects, antibody titer ≥ 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/Netherlands/602/09. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was > 40% in subjects 18 to 60 years of age or > 30% for subjects above 60 years of age.

The ATP cohort for immunogenicity at Day 42 included all eligible subjects, for whom 2 (for D21 Groups)/1 (for M6 Groups) doses of study vaccine were administered and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 (for D21 Groups)/42 (for M6 Groups) days after second/first vaccine dose.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest; prevented normal activities as assessed by inability to attend/do work or school. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented, who filled in their symptom sheets.

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

The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented, who filled in their symptom sheets.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest; prevented normal activities as assessed by inability to attend/do work or school. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

The Total Vaccinated cohort (TVc) included all subjects from the GSK2340272A D21 Groups with at least 1 vaccine administration documented, who filled in their symptom sheets.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest; prevented normal activities as assessed by inability to attend/do work or school. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented, who filled in their symptom sheets.

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

The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented, who filled in their symptom sheets.

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. Grade 3 symptom = general symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever = temperature ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented, who filled in their symptom sheets.

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

The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administrated documented, who filled in their symptom sheets.

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 or their relationship to vaccination. Grade 3 symptom = general symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever = temperature ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

The Total Vaccinated cohort (TVc) included all subjects from the GSK2340272A D21 Groups with at least 1 vaccine administration documented, who filled in their symptom sheets.

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

The Total Vaccinated cohort (TVc) included all subjects from the GSK2340272A D21 Groups with at least 1 vaccine administration documented, who filled in their symptom sheets.

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. Grade 3 symptom = general symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever = temperature > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented, who filled in their symptom sheets.

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

The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented, who filled in their symptom sheets.

An AESI/pIMD 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 Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administrated documented.

An AESI/pIMD 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 Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented.

An AESI/pIMD 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 Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented.

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 Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented.

An AESI/pIMD 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 Total Vaccinated cohort (TVc) included all subjects from the GSK2340272A M6 Groups with at least 1 vaccine administration documented.

Among biochemical and haematological parameters assessed were alanine aminotransferase [ALAT], alkaline phosphatase [AP], aspartate aminotransferase [ASAT], bilirubin [BIL], creatinine [CRE], blood urea nitrogen [BUN]. Levels of haematological/biochemical parameters assessed with respect to normal laboratory values were - unknown, below, within and above in subjects aged 18-60 years and > 6 years old.

The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented and with laboratory results available for the laboratory parameter assessed.

Among biochemical and haematological parameters assessed were alanine aminotransferase [ALAT], alkaline phosphatase [AP], aspartate aminotransferase [ASAT], bilirubin [BIL], creatinine [CRE], blood urea nitrogen [BUN]. Levels of haematological/biochemical parameters assessed with respect to normal laboratory values were - unknown, bellow, within and above in subjects aged 18-60 years and > 6 years old.

The Total Vaccinated cohort (TVc) included all subjects from the GSK2340272A D21 Groups with at least 1 vaccine administration documented and with laboratory results available for the laboratory parameter assessed.

Among biochemical and haematological parameters assessed were alanine aminotransferase [ALAT], alkaline phosphatase [AP], aspartate aminotransferase [ASAT], bilirubin [BIL], creatinine [CRE], blood urea nitrogen [BUN]. Levels of haematological/biochemical parameters assessed with respect to normal laboratory values were - unknown, bellow, within and above in subjects aged 18-60 years and > 6 years old.

The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented and with laboratory results available for the laboratory parameter assessed.

Among biochemical and haematological parameters assessed were alanine aminotransferase [ALAT], alkaline phosphatase [AP], aspartate aminotransferase [ASAT], bilirubin [BIL], creatinine [CRE], blood urea nitrogen [BUN]. Levels of haematological/biochemical parameters assessed with respect to normal laboratory values were - unknown, bellow, within and above in subjects aged 18-60 years and > 6 years old.

The Total Vaccinated cohort (TVc) included all subjects with at least 1 vaccine administration documented and with laboratory results available for the laboratory parameter assessed.