Safety, Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (H1N1) (GSK2340272A)

Seroconversion (SCR) was defined as the percentage of vaccinees that have either a pre-vaccination titer \< 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The strain assessed was Flu A/California/7/2009 (H1N1).

Time frame: At Day 42

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second dose for all subjects.

Seropositivity was defined as H1N1 HI antibody titers greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).

Time frame: At Day 42

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second dose for all subjects.

Seropositivity was defined as H1N1 HI antibody titers greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).

Time frame: At Day 0

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second dose for all subjects.

Seroprotection (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection. The strain assessed was Flu A/California/7/2009 (H1N1).

Time frame: At Day 42

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second dose for all subjects.

Seroconversion factor was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The strain assessed was Flu A/California/7/2009 (H1N1).

Time frame: At Day 42

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second dose for all subjects.

Antibody titers are presented as geometric mean titers (GMTs), with a reference seropositivity cut-off value greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).

Time frame: At Day 42

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second dose for all subjects.

Antibody titers are presented as geometric mean titers (GMTs), with a reference seropositivity cut-off value greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).

Time frame: At Day 0

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjeects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second dose for all subjects.

Seroconversion (SCR) was defined as the percentage of vaccinees that have either a pre-vaccination titer \< 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The strain assessed was Flu A/California/7/2009 (H1N1).

Time frame: At Days 21, 42 and at Month 11-12

Population: The ATP cohort for antibody persistence at Month 11-12 included all evaluable subjects who had received at least one dose of vaccine according to their treatment assignment and for whom data concerning immunogenicity outcome measures and assay results were available for antibodies against the study vaccine component at Month 11-12.

Seropositivity was defined as H1N1 HI antibody titers greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).

Time frame: At Days 0, 21, 42, and at Month 11-12

Population: The ATP cohort for antibody persistence at Month 11-12 included all evaluable subjects who had received at least one dose of vaccine according to their treatment assignment and for whom data concerning immunogenicity outcome measures and assay results were available for antibodies against the study vaccine component at Month 11-12.

Seroprotection (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection. The strain assessed was Flu A/California/7/2009 (H1N1).

Time frame: At Days 0, 21, 42 and at Month 11-12

Population: The ATP cohort for antibody persistence at Month 11-12 included all evaluable subjects who had received at least one dose of vaccine according to their treatment assignment and for whom data concerning immunogenicity outcome measures and assay results were available for antibodies against the study vaccine component at Month 11-12.

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. Potential immune-mediated diseases (pIMDs) are 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.

Time frame: During the entire study period (Day 0 up to Month 11-12)

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

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.

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

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

Assessed solicited general symptoms were drowsiness, irritability, loss of appetite 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 relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 loss of appetite= not eating at all. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

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

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

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.

Time frame: During a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84)

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

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.

Time frame: During the entire study period (Day 0 up to Month 7 and Day 0 up to Month 11-12)

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

Among biochemical parameters assessed were: alanine aminotrasferase \[ALAT\], aspartate aminotransferase \[ASAT\], bilirubin total \[BIL/T\], bilirubin direct \[BIL/D\], creatinine \[CREA\] and blood urea nitrogen \[BUN\]. Levels of biochemical parameters assessed with respect to normal laboratory values were - unknown, below, within and above.

Time frame: At Days 0, 21 and 42

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

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.

Time frame: During the entire study period (Day 0 up to Month 11-12)

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

Vaccine response rate was defined as the percentage of vaccinees with a minimum 4-fold increase in titer at post-vaccination for neutralising antibody response. For initially seronegative subjects, antibody titer ≥ 1:32 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The strain assessed was Flu A/Neth/602/2009.

Time frame: At Days 21, 42 and at Month 11-12

Population: The ATP cohort for antibody persistence at Month 11-12 included all evaluable subjects who had received at least one dose of vaccine according to their treatment assignment and for whom data concerning immunogenicity outcome measures and assay results were available for antibodies against the study vaccine component at Month 11-12.

Vaccine response rate was defined as the percentage of vaccinees with a minimum 4-fold increase in titer at post-vaccination for neutralising antibody response. For initially seronegative subjects, antibody titer ≥ 1:32 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The strain assessed was Flu A/Neth/602/2009.

Time frame: At Days 21 and 42

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second dose for all subjects.

Seroconversion factor was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The strain assessed was Flu A/California/7/2009 (H1N1).

Time frame: At Days 21, 42 and at Month 11-12

Population: The ATP cohort for antibody persistence at Month 11-12 included all evaluable subjects who had received at least one dose of vaccine according to their treatment assignment and for whom data concerning immunogenicity outcome measures and assay results were available for antibodies against the study vaccine component at Month 11-12.

Antibody titers are presented as geometric mean titers (GMTs), with a reference seropositivity cut-off value greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).

Time frame: At Days 0, 21, 42 and at Month 11-12

Population: The ATP cohort for antibody persistence at Month 11-12 included all evaluable subjects who had received at least one dose of vaccine according to their treatment assignment and for whom data concerning immunogenicity outcome measures and assay results were available for antibodies against the study vaccine component at Month 11-12.

Antibody titers are presented as geometric mean titers (GMTs), with a reference seropositivity cut-off value greater than or equal to (≥) 1:8. The strain assessed was Flu A/Neth/602/09.

Time frame: At Days 0, 21, 42 and at Month 11-12

Population: The ATP cohort for antibody persistence at Month 11-12 included all evaluable subjects who had received at least one dose of vaccine according to their treatment assignment and for whom data concerning immunogenicity outcome measures and assay results were available for antibodies against the study vaccine component at Month 11-12.

Antibody titers are presented as geometric mean titers (GMTs), with a reference seropositivity cut-off value greater than or equal to (≥) 1:8. The strain assessed was Flu A/Neth/602/09.

Time frame: At Days 0, 21 and 42

Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second dose for all subjects.