Influenza
Conditions
Keywords
influenza infection, GSK Biologicals' influenza vaccine GSK2340272A and GSK2340274A
Brief summary
The primary purpose of the study is to assess the equivalence of the immune response elicited by two GSK Biologicals' adjuvanted influenza investigational vaccines (GSK2340272A and GSK2340274A) in adults aged 18 to 60 years. The second purpose of the study is to evaluate the safety and reactogenicity of these two vaccines.
Detailed description
This Protocol Posting has been updated following Protocol Amendment 4, July 2010, leading to removal of one of the secondary outcome measures.
Interventions
BIOLOGICALInfluenza vaccine GSK2340272A
Two intramuscular injections at Day 0 and Day 21
BIOLOGICALInfluenza vaccine GSK2340274A
Two intramuscular injections at Day 0 and Day 21
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female aged 18 to 60 years inclusive, at the time of the first vaccination. * Subjects who the investigator believes that they can and will comply with the requirements of the protocol. * Written informed consent obtained from the subject. * Satisfactory baseline medical assessment by history and physical examination. * 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 multiple-user device * Females of non-childbearing potential may be enrolled in the study. * Female of childbearing potential may be enrolled in the study, if she: * has practiced adequate contraception for 30 days prior to vaccination, and * has a negative pregnancy test on the day of 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
* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period. * 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 an axillary temperature \>= 37.5°C (99.5°F), or acute symptoms greater than mild severity on the scheduled date of first vaccination. NOTE: The subject may be vaccinated at a later date, provided symptoms have resolved, vaccination occurs within the window specified by the protocol, and all other eligibility criteria continue to be satisfied. * Clinically or virologically confirmed influenza infection within 6 months preceding the study start. * Diagnosed with cancer, or treatment for cancer, within 3 years. * Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection. * Clinically or virologically confirmed influenza infection within 6 months preceding the study start. * Chronic administration of immunosuppressants or other immune modifying drugs within 6 months of study enrolment or planned administration during the study period. * Receipt of any immunoglobulins and/or any blood products within 3 months of study enrolment or planned administration of any of these products during the study period. * Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. * An acute evolving neurological disorder or history of Guillain-Barré syndrome. * Administration of any vaccines within 30 days before vaccination. * 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. * Pregnant or lactating female * Female planning to become pregnant or planning to discontinue contraceptive precautions. * Any conditions which, in the opinion of the investigator, prevents the subjects from participating in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | At Day 21 | 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 greater than or equal to (≥) 1:10. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of SCR Subjects for HI Antibodies | At Days 182 and 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). |
| Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | At Days 0 and 42 | 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. |
| Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | At Days 0, 21 and 42 | 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. |
| Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | At Days 21 and 42 | GMFR 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. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses | 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. |
| Number of Days With Solicited Local Symptoms | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses | The number of days with any solicited local symptoms reported during the solicited post-vaccination period. |
| Number of Seroconverted (SCR) Subjects for HI Antibodies | At Days 21 and 42 | Seroconversion was defined as: For initially seronegative subjects \[antibody titer below (\<) 1:10 prior to vaccination\], 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). |
| Number of Days With Solicited General Symptoms | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses | The number of days with any solicited general symptoms reported during the solicited post-vaccination period. |
| Number of Subjects With Potential Immune-mediated Diseases (pIMDs) | From Day 0 up to Day 42 | A 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. |
| Number of Subjects With pIMDs | During the entire study period (from Day 0 up to Day 364) | A 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. |
| Number of Subjects With Any Adverse Event of Special Interest (AESIs) | During the entire study period (from Day 0 up to Day 364) | 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. |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Within 21 days after the first vaccination (Days 0 - 20) and 63 days after the second vaccination (up to Day 84) | 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. |
| Number of Subjects With Serious Adverse Events (SAEs) | During the entire study period (from Day 0 up to Day 364) | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses | 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 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 and ≤ 40°C. Related = symptom assessed by the investigator as related to the vaccination. |
Countries
France, Germany
Participant flow
Pre-assignment details
Out of 336 subjects enrolled in the study, 2 subjects did not receive any vaccination.
Participants by arm
| Arm | Count |
|---|---|
| GSK2340272A GROUP Healthy male or female adults, between and including 18 to 60 years of age, 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. | 167 |
| GSK2340274A GROUP Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | 167 |
| Total | 334 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 3 |
| Overall Study | Withdrawal by Subject | 3 | 4 |
Baseline characteristics
| Characteristic | GSK2340272A GROUP | GSK2340274A GROUP | Total |
|---|---|---|---|
| Age, Continuous | 40.1 Years STANDARD_DEVIATION 11.65 | 39.7 Years STANDARD_DEVIATION 11.98 | 39.90 Years STANDARD_DEVIATION 11.8 |
| Race/Ethnicity, Customized Geographic ancestry African heritage / african american | 2 Participants | 3 Participants | 5 Participants |
| Race/Ethnicity, Customized Geographic ancestry White - arabic / north african heritage | 0 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized Geographic ancestry White - caucasian / european heritage | 165 Participants | 161 Participants | 326 Participants |
| Sex: Female, Male Female | 87 Participants | 77 Participants | 164 Participants |
| Sex: Female, Male Male | 80 Participants | 90 Participants | 170 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 167 | 0 / 167 |
| other Total, other adverse events | 157 / 167 | 159 / 167 |
| serious Total, serious adverse events | 9 / 167 | 11 / 167 |
Outcome results
Primary
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
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 greater than or equal to (≥) 1:10.
Time frame: At Day 21
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who received 1 vaccine dose and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the first vaccine dose.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK2340272A GROUP | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | 383.6 Titers |
| GSK2340274A GROUP | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | 339.1 Titers |
Secondary
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
GMFR 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.
Time frame: At Days 182 and 364
Population: The ATP cohort for persistence at Day 182 and 364 included all evaluable subjects who had received at least 1 dose of study/control vaccine, according to their treatment assignment during the primary vaccination course, and for whom assay results were available for antibodies against the study vaccine antigen component at Days 182 and 364.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2340272A GROUP | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 182 | 22.0 Fold increase |
| GSK2340272A GROUP | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 364 | 11.0 Fold increase |
| GSK2340274A GROUP | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 182 | 21.7 Fold increase |
| GSK2340274A GROUP | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 364 | 11.0 Fold increase |
Secondary
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
GMFR 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.
Time frame: At Days 21 and 42
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects who received 2 vaccine doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the first and second vaccine dose.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2340272A GROUP | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 21 | 40.3 Fold increase |
| GSK2340272A GROUP | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 42 | 63.0 Fold increase |
| GSK2340274A GROUP | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 21 | 31.6 Fold increase |
| GSK2340274A GROUP | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 42 | 63.2 Fold increase |
Secondary
Number of Days With Solicited General Symptoms
The number of days with any solicited general symptoms reported during the solicited post-vaccination period.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK2340272A GROUP | Number of Days With Solicited General Symptoms | Muscle aches, Post-Dose 2 | 2.0 Days |
| GSK2340272A GROUP | Number of Days With Solicited General Symptoms | Headache, Overall/dose | 1.0 Days |
| GSK2340272A GROUP | Number of Days With Solicited General Symptoms | Muscle aches, Overall/dose | 2.0 Days |
| GSK2340272A GROUP | Number of Days With Solicited General Symptoms | Fatigue, Post-Dose 2 | 1.0 Days |
| GSK2340272A GROUP | Number of Days With Solicited General Symptoms | Sweating, Post-Dose 1 | 1.0 Days |
| GSK2340272A GROUP | Number of Days With Solicited General Symptoms | Joint pain, Post-Dose 1 | 2.0 Days |
| GSK2340272A GROUP | Number of Days With Solicited General Symptoms | Sweating, Post-Dose 2 | 1.0 Days |
| GSK2340272A GROUP | Number of Days With Solicited General Symptoms | Headache, Post-Dose 1 | 1.0 Days |
| GSK2340272A GROUP | Number of Days With Solicited General Symptoms | Sweating, Overall/dose | 1.0 Days |
| GSK2340272A GROUP | Number of Days With Solicited General Symptoms | Joint pain, Post-Dose 2 | 2.0 Days |
| GSK2340272A GROUP | Number of Days With Solicited General Symptoms | Shivering, Post-Dose 1 | 1.0 Days |
| GSK2340272A GROUP | Number of Days With Solicited General Symptoms | Fatigue, Post-Dose 1 | 2.0 Days |
| GSK2340272A GROUP | Number of Days With Solicited General Symptoms | Shivering, Post-Dose 2 | 1.0 Days |
| GSK2340272A GROUP | Number of Days With Solicited General Symptoms | Joint pain, Overall/dose | 2.0 Days |
| GSK2340272A GROUP | Number of Days With Solicited General Symptoms | Shivering, Overall/dose | 1.0 Days |
| GSK2340272A GROUP | Number of Days With Solicited General Symptoms | Headache, Post-Dose 2 | 1.0 Days |
| GSK2340272A GROUP | Number of Days With Solicited General Symptoms | Temperature, Post-Dose 1 | 3.0 Days |
| GSK2340272A GROUP | Number of Days With Solicited General Symptoms | Muscle aches, Post-Dose 1 | 2.0 Days |
| GSK2340272A GROUP | Number of Days With Solicited General Symptoms | Temperature, Post-Dose 2 | 1.0 Days |
| GSK2340272A GROUP | Number of Days With Solicited General Symptoms | Fatigue, Overall/dose | 2.0 Days |
| GSK2340272A GROUP | Number of Days With Solicited General Symptoms | Temperature, Overall/dose | 1.0 Days |
| GSK2340274A GROUP | Number of Days With Solicited General Symptoms | Sweating, Post-Dose 1 | 1.0 Days |
| GSK2340274A GROUP | Number of Days With Solicited General Symptoms | Fatigue, Post-Dose 1 | 2.0 Days |
| GSK2340274A GROUP | Number of Days With Solicited General Symptoms | Fatigue, Post-Dose 2 | 2.0 Days |
| GSK2340274A GROUP | Number of Days With Solicited General Symptoms | Fatigue, Overall/dose | 2.0 Days |
| GSK2340274A GROUP | Number of Days With Solicited General Symptoms | Headache, Post-Dose 1 | 2.0 Days |
| GSK2340274A GROUP | Number of Days With Solicited General Symptoms | Headache, Post-Dose 2 | 2.0 Days |
| GSK2340274A GROUP | Number of Days With Solicited General Symptoms | Headache, Overall/dose | 2.0 Days |
| GSK2340274A GROUP | Number of Days With Solicited General Symptoms | Joint pain, Post-Dose 1 | 2.0 Days |
| GSK2340274A GROUP | Number of Days With Solicited General Symptoms | Joint pain, Post-Dose 2 | 2.0 Days |
| GSK2340274A GROUP | Number of Days With Solicited General Symptoms | Joint pain, Overall/dose | 2.0 Days |
| GSK2340274A GROUP | Number of Days With Solicited General Symptoms | Muscle aches, Post-Dose 1 | 2.0 Days |
| GSK2340274A GROUP | Number of Days With Solicited General Symptoms | Muscle aches, Post-Dose 2 | 2.0 Days |
| GSK2340274A GROUP | Number of Days With Solicited General Symptoms | Muscle aches, Overall/dose | 2.0 Days |
| GSK2340274A GROUP | Number of Days With Solicited General Symptoms | Temperature, Overall/dose | 1.0 Days |
| GSK2340274A GROUP | Number of Days With Solicited General Symptoms | Sweating, Post-Dose 2 | 1.0 Days |
| GSK2340274A GROUP | Number of Days With Solicited General Symptoms | Sweating, Overall/dose | 1.0 Days |
| GSK2340274A GROUP | Number of Days With Solicited General Symptoms | Shivering, Post-Dose 1 | 1.0 Days |
| GSK2340274A GROUP | Number of Days With Solicited General Symptoms | Shivering, Post-Dose 2 | 1.0 Days |
| GSK2340274A GROUP | Number of Days With Solicited General Symptoms | Shivering, Overall/dose | 1.0 Days |
| GSK2340274A GROUP | Number of Days With Solicited General Symptoms | Temperature, Post-Dose 1 | 1.0 Days |
| GSK2340274A GROUP | Number of Days With Solicited General Symptoms | Temperature, Post-Dose 2 | 2.0 Days |
Secondary
Number of Days With Solicited Local Symptoms
The number of days with any solicited local symptoms reported during the solicited post-vaccination period.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK2340272A GROUP | Number of Days With Solicited Local Symptoms | Swelling, Overall/dose | 3.0 Days |
| GSK2340272A GROUP | Number of Days With Solicited Local Symptoms | Pain, Post-Dose 2 | 3.0 Days |
| GSK2340272A GROUP | Number of Days With Solicited Local Symptoms | Pain, Overall/dose | 3.0 Days |
| GSK2340272A GROUP | Number of Days With Solicited Local Symptoms | Redness, Post-Dose 1 | 3.0 Days |
| GSK2340272A GROUP | Number of Days With Solicited Local Symptoms | Redness, Post-Dose 2 | 3.0 Days |
| GSK2340272A GROUP | Number of Days With Solicited Local Symptoms | Redness, Overall/dose | 3.0 Days |
| GSK2340272A GROUP | Number of Days With Solicited Local Symptoms | Swelling, Post-Dose 1 | 3.0 Days |
| GSK2340272A GROUP | Number of Days With Solicited Local Symptoms | Swelling, Post-Dose 2 | 3.0 Days |
| GSK2340272A GROUP | Number of Days With Solicited Local Symptoms | Pain, Post-Dose 1 | 3.0 Days |
| GSK2340274A GROUP | Number of Days With Solicited Local Symptoms | Swelling, Post-Dose 2 | 2.0 Days |
| GSK2340274A GROUP | Number of Days With Solicited Local Symptoms | Swelling, Overall/dose | 2.0 Days |
| GSK2340274A GROUP | Number of Days With Solicited Local Symptoms | Pain, Post-Dose 1 | 3.0 Days |
| GSK2340274A GROUP | Number of Days With Solicited Local Symptoms | Redness, Post-Dose 2 | 2.0 Days |
| GSK2340274A GROUP | Number of Days With Solicited Local Symptoms | Pain, Post-Dose 2 | 3.0 Days |
| GSK2340274A GROUP | Number of Days With Solicited Local Symptoms | Swelling, Post-Dose 1 | 2.0 Days |
| GSK2340274A GROUP | Number of Days With Solicited Local Symptoms | Pain, Overall/dose | 3.0 Days |
| GSK2340274A GROUP | Number of Days With Solicited Local Symptoms | Redness, Overall/dose | 3.0 Days |
| GSK2340274A GROUP | Number of Days With Solicited Local Symptoms | Redness, Post-Dose 1 | 3.0 Days |
Secondary
Number of SCR Subjects for HI Antibodies
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).
Time frame: At Days 182 and 364
Population: The ATP cohort for persistence at Day 182 and 364 included all evaluable subjects who had received at least 1 dose of study/control vaccine, according to their treatment assignment during the primary vaccination course, and for whom assay results were available for antibodies against the study vaccine antigen component at Days 182 and 364.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A GROUP | Number of SCR Subjects for HI Antibodies | Flu A/CAL/7/09, Day 182 | 144 Participants |
| GSK2340272A GROUP | Number of SCR Subjects for HI Antibodies | Flu A/CAL/7/09, Day 364 | 109 Participants |
| GSK2340274A GROUP | Number of SCR Subjects for HI Antibodies | Flu A/CAL/7/09, Day 182 | 141 Participants |
| GSK2340274A GROUP | Number of SCR Subjects for HI Antibodies | Flu A/CAL/7/09, Day 364 | 106 Participants |
Secondary
Number of Seroconverted (SCR) Subjects for HI Antibodies
Seroconversion was defined as: For initially seronegative subjects \[antibody titer below (\<) 1:10 prior to vaccination\], 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).
Time frame: At Days 21 and 42
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the first and second vaccine dose.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A GROUP | Number of Seroconverted (SCR) Subjects for HI Antibodies | Flu A/CAL/7/09, Day 21 | 151 Participants |
| GSK2340272A GROUP | Number of Seroconverted (SCR) Subjects for HI Antibodies | Flu A/CAL/7/09, Day 42 | 154 Participants |
| GSK2340274A GROUP | Number of Seroconverted (SCR) Subjects for HI Antibodies | Flu A/CAL/7/09, Day 21 | 145 Participants |
| GSK2340274A GROUP | Number of Seroconverted (SCR) Subjects for HI Antibodies | Flu A/CAL/7/09, Day 42 | 153 Participants |
Secondary
Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
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.
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 who received 2 vaccine doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the first and second vaccine dose.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A GROUP | Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | Flu A/CAL/7/09, Day 0 | 19 Participants |
| GSK2340272A GROUP | Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | Flu A/CAL/7/09, Day 21 | 155 Participants |
| GSK2340272A GROUP | Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | Flu A/CAL/7/09, Day 42 | 155 Participants |
| GSK2340274A GROUP | Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | Flu A/CAL/7/09, Day 0 | 22 Participants |
| GSK2340274A GROUP | Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | Flu A/CAL/7/09, Day 21 | 151 Participants |
| GSK2340274A GROUP | Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | Flu A/CAL/7/09, Day 42 | 155 Participants |
Secondary
Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
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.
Time frame: At Days 182 and 364
Population: The ATP cohort for persistence at Day 182 and 364 included all evaluable subjects who had received at least 1 dose of study/control vaccine, according to their treatment assignment during the primary vaccination course, and for whom assay results were available for antibodies against the study vaccine antigen component at Days 182 and 364.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A GROUP | Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | Flu A/CAL/7/09, Day 182 | 151 Participants |
| GSK2340272A GROUP | Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | Flu A/CAL/7/09, Day 364 | 121 Participants |
| GSK2340274A GROUP | Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | Flu A/CAL/7/09, Day 182 | 150 Participants |
| GSK2340274A GROUP | Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain | Flu A/CAL/7/09, Day 364 | 121 Participants |
Secondary
Number of Subjects With Any Adverse Event of Special Interest (AESIs)
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.
Time frame: During the entire study period (from Day 0 up to Day 364)
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A GROUP | Number of Subjects With Any Adverse Event of Special Interest (AESIs) | 0 Participants |
| GSK2340274A GROUP | Number of Subjects With Any Adverse Event of Special Interest (AESIs) | 0 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
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.
Time frame: During the 7-day (Days 0-6) post-vaccination period following 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 32 Participants |
| GSK2340272A GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| GSK2340272A GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 6 Participants |
| GSK2340272A GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 17 Participants |
| GSK2340272A GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 2 Participants |
| GSK2340272A GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 1 Participants |
| GSK2340272A GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 148 Participants |
| GSK2340272A GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 139 Participants |
| GSK2340272A GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 153 Participants |
| GSK2340272A GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 35 Participants |
| GSK2340272A GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 8 Participants |
| GSK2340272A GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| GSK2340272A GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 0 Participants |
| GSK2340272A GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 5 Participants |
| GSK2340272A GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 36 Participants |
| GSK2340272A GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 25 Participants |
| GSK2340272A GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 2 Participants |
| GSK2340272A GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 18 Participants |
| GSK2340274A GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 0 Participants |
| GSK2340274A GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 144 Participants |
| GSK2340274A GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 19 Participants |
| GSK2340274A GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| GSK2340274A GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 29 Participants |
| GSK2340274A GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| GSK2340274A GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 137 Participants |
| GSK2340274A GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 4 Participants |
| GSK2340274A GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 17 Participants |
| GSK2340274A GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| GSK2340274A GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 21 Participants |
| GSK2340274A GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 28 Participants |
| GSK2340274A GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| GSK2340274A GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 151 Participants |
| GSK2340274A GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 6 Participants |
| GSK2340274A GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 0 Participants |
| GSK2340274A GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 36 Participants |
| GSK2340274A GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 4 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
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 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 and ≤ 40°C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 7-day (Days 0-6) post-vaccination period following 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 57 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Dose 2 | 63 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Dose 1 | 1 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 2 | 37 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Dose 1 | 33 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 2 | 5 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Dose 1 | 12 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 2 | 37 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 3 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Dose 2 | 24 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 1 | 2 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Dose 2 | 4 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Dose 1 | 57 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Dose 2 | 23 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 1 | 1 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 2 | 11 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 46 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 2 | 2 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 1 | 2 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 2 | 11 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Dose 1 | 3 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 92 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 61 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 6 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 55 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 87 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 3 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 83 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Dose 1 | 55 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 6 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 59 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 74 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Dose 1 | 37 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Across doses | 53 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 1 | 34 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Across doses | 5 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 2 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Across doses | 49 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 54 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Across doses | 85 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 53 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Across doses | 6 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 1 | 0 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Across doses | 83 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Dose 2 | 34 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Across doses | 57 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Dose 1 | 1 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Across doses | 5 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Dose 2 | 5 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Across doses | 56 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 1 | 32 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Across doses | 28 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Dose 2 | 33 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Across doses | 5 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 4 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Across doses | 27 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Dose 2 | 64 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Across doses | 12 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Dose 1 | 13 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Across doses | 3 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Dose 2 | 4 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Across doses | 12 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 60 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Across doses | 11 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 55 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 2 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 54 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 48 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 2 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 44 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Dose 1 | 38 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Dose 1 | 2 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Dose 1 | 37 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Dose 1 | 81 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Dose 1 | 4 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Dose 1 | 79 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 1 | 24 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 1 | 2 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 1 | 24 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Dose 1 | 14 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Dose 1 | 1 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Dose 1 | 14 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 1 | 5 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 1 | 2 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 1 | 5 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 60 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 4 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 59 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 51 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 3 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 46 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Dose 2 | 47 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Dose 2 | 4 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Dose 2 | 45 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Dose 2 | 71 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Dose 2 | 2 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Dose 2 | 70 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 2 | 35 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 2 | 4 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 2 | 32 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Dose 2 | 16 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Dose 2 | 2 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Dose 2 | 15 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 2 | 8 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 2 | 3 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 2 | 8 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 79 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 5 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 78 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 73 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 5 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 69 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Across doses | 66 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Across doses | 5 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Across doses | 64 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Across doses | 104 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Across doses | 5 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Across doses | 102 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Across doses | 47 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Across doses | 6 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Across doses | 45 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Across doses | 28 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Across doses | 3 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Across doses | 27 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Across doses | 11 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Across doses | 5 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
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: Within 21 days after the first vaccination (Days 0 - 20) and 63 days after the second vaccination (up to Day 84)
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s), Days 0-20 | 37 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s), Days 0-20 | 3 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s), Days 0-20 | 17 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s), up to Day 84 | 68 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s), up to Day 84 | 16 Participants |
| GSK2340272A GROUP | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s), up to Day 84 | 20 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s), up to Day 84 | 8 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s), Days 0-20 | 31 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s), up to Day 84 | 71 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s), Days 0-20 | 1 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s), up to Day 84 | 20 Participants |
| GSK2340274A GROUP | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s), Days 0-20 | 11 Participants |
Secondary
Number of Subjects With pIMDs
A 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.
Time frame: During the entire study period (from Day 0 up to Day 364)
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A GROUP | Number of Subjects With pIMDs | 1 Participants |
| GSK2340274A GROUP | Number of Subjects With pIMDs | 0 Participants |
Secondary
Number of Subjects With Potential Immune-mediated Diseases (pIMDs)
A 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.
Time frame: From Day 0 up to Day 42
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A GROUP | Number of Subjects With Potential Immune-mediated Diseases (pIMDs) | 0 Participants |
| GSK2340274A GROUP | Number of Subjects With Potential Immune-mediated Diseases (pIMDs) | 0 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
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 (from Day 0 up to Day 364)
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A GROUP | Number of Subjects With Serious Adverse Events (SAEs) | 9 Participants |
| GSK2340274A GROUP | Number of Subjects With Serious Adverse Events (SAEs) | 11 Participants |
Secondary
Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
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.
Time frame: At Days 0 and 42
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2340272A GROUP | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 0 | 9.5 Titers |
| GSK2340272A GROUP | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 42 | 599.8 Titers |
| GSK2340274A GROUP | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 0 | 10.7 Titers |
| GSK2340274A GROUP | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 42 | 678.3 Titers |
Secondary
Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
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.
Time frame: At Days 182 and 364
Population: The ATP cohort for persistence at Day 182 and 364 included all evaluable subjects who had received at least 1 dose of study/control vaccine, according to their treatment assignment during the primary vaccination course, and for whom assay results were available for antibodies against the study vaccine antigen component at Days 182 and 364.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2340272A GROUP | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 182 | 202.5 Titers |
| GSK2340272A GROUP | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 364 | 96.7 Titers |
| GSK2340274A GROUP | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 182 | 233.0 Titers |
| GSK2340274A GROUP | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 364 | 107.6 Titers |