Influenza
Conditions
Keywords
influenza infection, GSK Bio's influenza vaccine GSK2340272A
Brief summary
The purpose of the study is to evaluate the safety and immunogenicity of GSK Biologicals' influenza vaccine GSK2340272A.
Interventions
BIOLOGICALGSK investigational vaccine GSK2340272A
Two intramuscular injections
BIOLOGICALGSK investigational vaccine GSK2340269A
Two intramuscular injections
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* A male or female aged 18 to 60 years 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. Stable health status is defined as the absence of health event satisfying the definition of a serious adverse event, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within one month prior to enrollment. * 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. * Female subjects of non-childbearing potential may be enrolled in the study. * Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause. * Female subjects of childbearing potential may be enrolled in the study, if the subject: * has practiced adequate contraception for 30 days prior to vaccination, and * has a negative pregnancy test on the day of 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, 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. * Diagnosed with cancer, or treatment for cancer, within the past 3 years. * Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible. * Persons with a history of histological-confirmed basal cell carcinoma of the skin successfully treated with local excisions only are excepted and may enroll within 3 years of diagnosis, but other histological types of skin cancer require a 3-year untreated and disease-free window as above. * Women who are disease free 3 years or more after the treatment for breast cancer and receiving long-term prophylactic are excepted and may enroll. * 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. Persons receiving individual doses of low molecular weight heparin outside of 24 hours prior to vaccination are eligible. Persons receiving prophylactic antiplatelet medications, e.g., low-dose aspirin, and without a clinically-apparent bleeding tendency, are eligible. * 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/California/7/2009 Strain of Influenza Disease | At Day 35 | Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old. The primary endpoint results consist in those presented for GSK2340272A Group. |
| Number of Seroconverted Subjects for HI Antibodies | At Day 35 | Seroconversion (SCR) was defined as follows: for initially seronegative subjects, antibody titer equal to or above (≥) 1:40 after vaccination; for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old. The primary endpoint results consist in those presented for GSK2340272A Group. |
| Number of Seroprotected Subjects for HI Antibodies | At Day 35 | A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old. The primary endpoint results consist in those presented for GSK2340272A Group. |
| Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease | At Day 35 | GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old. The primary endpoint results consist in those presented for GSK2340272A Group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Seroconversion Factor (SCF) for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease | At Day 21 | SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old. |
| SCF for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease | At Day 35 | SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | During the 7-day (Days 0-6) follow-up period after 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) follow-up period after each dose and overall | The number of days with any solicited local symptoms reported during the solicited post-vaccination period. |
| Titers for Serum HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease | At Days 0 and 21 | Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old. |
| Number of Days With Solicited General Symptoms | During the 7-day (Days 0-6) follow-up period after each dose and overall | The number of days with any solicited general symptoms reported during the solicited post-vaccination period. |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | During the 21-day (Days 0-20) follow-up after the first vaccination and during the 63-day (Days 21-83) follow-up after the second vaccination (From Day 0 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) follow-up period after 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 and relationship to vaccination. Grade 3 symptom = symptom that prevented normal everyday activities. Grade 3 fever = fever above (\>) 40.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination. |
| Number of Seroconverted Subjects for HI Antibodies | At Day 21 | Seroconversion (SCR) was defined as follows: for initially seronegative subjects, antibody titer equal to or above (≥) 1:40 after vaccination; for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old. |
| Number of Seroprotected Subjects for HI Antibodies | At Days 0 and 21 | A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old. |
| Number of Subjects With Adverse Events of Specific Interest (AESI) | 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. |
Countries
Germany
Participant flow
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. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21. | 64 |
| GSK2340269A Group Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21. | 66 |
| Total | 130 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Other | 3 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | GSK2340272A Group | GSK2340269A Group | Total |
|---|---|---|---|
| Age, Continuous | 39.90 Years STANDARD_DEVIATION 11.72 | 39.30 Years STANDARD_DEVIATION 13.16 | 39.60 Years STANDARD_DEVIATION 12.43 |
| Race/Ethnicity, Customized White-Caucasian/European heritage | 64 Participants | 66 Participants | 130 Participants |
| Sex: Female, Male Female | 27 Participants | 31 Participants | 58 Participants |
| Sex: Female, Male Male | 37 Participants | 35 Participants | 72 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 64 | 0 / 66 |
| other Total, other adverse events | 61 / 64 | 49 / 66 |
| serious Total, serious adverse events | 0 / 64 | 3 / 66 |
Outcome results
Primary
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease
GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old. The primary endpoint results consist in those presented for GSK2340272A Group.
Time frame: At Day 35
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received two doses of vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken 14 days (Day 35) after the second vaccine dose.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK2340272A Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease | 73.9 Fold change |
| GSK2340269A Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease | 45.6 Fold change |
Primary
Number of Seroconverted Subjects for HI Antibodies
Seroconversion (SCR) was defined as follows: for initially seronegative subjects, antibody titer equal to or above (≥) 1:40 after vaccination; for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old. The primary endpoint results consist in those presented for GSK2340272A Group.
Time frame: At Day 35
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received two doses of vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken 14 days (Day 35) after the second vaccine dose.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A Group | Number of Seroconverted Subjects for HI Antibodies | 56 Participants |
| GSK2340269A Group | Number of Seroconverted Subjects for HI Antibodies | 60 Participants |
Primary
Number of Seroprotected Subjects for HI Antibodies
A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old. The primary endpoint results consist in those presented for GSK2340272A Group.
Time frame: At Day 35
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received two doses of vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken 14 days (Day 35) after the second vaccine dose.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A Group | Number of Seroprotected Subjects for HI Antibodies | 56 Participants |
| GSK2340269A Group | Number of Seroprotected Subjects for HI Antibodies | 61 Participants |
Primary
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease
Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old. The primary endpoint results consist in those presented for GSK2340272A Group.
Time frame: At Day 35
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who received two doses of vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken 14 days (Day 35) after the second vaccine dose.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK2340272A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease | 780.2 Titers |
| GSK2340269A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease | 533.6 Titers |
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) follow-up period after each dose and overall
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 | Headache, Overall/dose | 2.0 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 | 2.0 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 | 2.0 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 | 1.0 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 | 2.0 Days |
| GSK2340272A Group | Number of Days With Solicited General Symptoms | Fever, post-Dose 1 | NA 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 | Fever, post-Dose 2 | 1.0 Days |
| GSK2340272A Group | Number of Days With Solicited General Symptoms | Fatigue, Overall/dose | 1.0 Days |
| GSK2340272A Group | Number of Days With Solicited General Symptoms | Fever, Overall/dose | 1.0 Days |
| GSK2340272A Group | Number of Days With Solicited General Symptoms | Muscle aches, post-Dose 2 | 2.0 Days |
| GSK2340269A Group | Number of Days With Solicited General Symptoms | Fever, Overall/dose | NA Days |
| GSK2340269A Group | Number of Days With Solicited General Symptoms | Fatigue, post-Dose 1 | 2.0 Days |
| GSK2340269A Group | Number of Days With Solicited General Symptoms | Fatigue, post-Dose 2 | 2.0 Days |
| GSK2340269A Group | Number of Days With Solicited General Symptoms | Fatigue, Overall/dose | 2.0 Days |
| GSK2340269A Group | Number of Days With Solicited General Symptoms | Headache, post-Dose 1 | 1.5 Days |
| GSK2340269A Group | Number of Days With Solicited General Symptoms | Headache, post-Dose 2 | 2.0 Days |
| GSK2340269A Group | Number of Days With Solicited General Symptoms | Headache, Overall/dose | 2.0 Days |
| GSK2340269A Group | Number of Days With Solicited General Symptoms | Joint pain, post-Dose 1 | 2.0 Days |
| GSK2340269A Group | Number of Days With Solicited General Symptoms | Joint pain, post-Dose 2 | 2.0 Days |
| GSK2340269A Group | Number of Days With Solicited General Symptoms | Joint pain, Overall/dose | 2.0 Days |
| GSK2340269A Group | Number of Days With Solicited General Symptoms | Muscle aches, post-Dose 1 | 1.5 Days |
| GSK2340269A Group | Number of Days With Solicited General Symptoms | Muscle aches, post-Dose 2 | 3.0 Days |
| GSK2340269A Group | Number of Days With Solicited General Symptoms | Muscle aches, Overall/dose | 2.0 Days |
| GSK2340269A Group | Number of Days With Solicited General Symptoms | Sweating, post-Dose 1 | 2.0 Days |
| GSK2340269A Group | Number of Days With Solicited General Symptoms | Sweating, post-Dose 2 | 2.0 Days |
| GSK2340269A Group | Number of Days With Solicited General Symptoms | Sweating, Overall/dose | 2.0 Days |
| GSK2340269A Group | Number of Days With Solicited General Symptoms | Shivering, post-Dose 1 | 1.0 Days |
| GSK2340269A Group | Number of Days With Solicited General Symptoms | Shivering, post-Dose 2 | 2.0 Days |
| GSK2340269A Group | Number of Days With Solicited General Symptoms | Shivering, Overall/dose | 1.0 Days |
| GSK2340269A Group | Number of Days With Solicited General Symptoms | Fever, post-Dose 1 | NA Days |
| GSK2340269A Group | Number of Days With Solicited General Symptoms | Fever, post-Dose 2 | NA 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) follow-up period after each dose and overall
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 | Redness, Post-Dose 2 | 2.0 Days |
| GSK2340272A Group | Number of Days With Solicited Local Symptoms | Redness, Overall/dose | 2.0 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 | Swelling, Post-Dose 1 | 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 | Swelling, Post-Dose 2 | 3.0 Days |
| GSK2340272A Group | Number of Days With Solicited Local Symptoms | Redness, Post-Dose 1 | 2.0 Days |
| 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 1 | 3.0 Days |
| GSK2340269A Group | Number of Days With Solicited Local Symptoms | Swelling, Overall/dose | 2.5 Days |
| GSK2340269A Group | Number of Days With Solicited Local Symptoms | Pain, Post-Dose 1 | 2.0 Days |
| GSK2340269A Group | Number of Days With Solicited Local Symptoms | Pain, Post-Dose 2 | 2.0 Days |
| GSK2340269A Group | Number of Days With Solicited Local Symptoms | Pain, Overall/dose | 2.0 Days |
| GSK2340269A Group | Number of Days With Solicited Local Symptoms | Redness, Post-Dose 1 | 4.0 Days |
| GSK2340269A Group | Number of Days With Solicited Local Symptoms | Redness, Overall/dose | 2.0 Days |
| GSK2340269A Group | Number of Days With Solicited Local Symptoms | Swelling, Post-Dose 1 | 4.0 Days |
| GSK2340269A Group | Number of Days With Solicited Local Symptoms | Swelling, Post-Dose 2 | 1.0 Days |
| GSK2340269A Group | Number of Days With Solicited Local Symptoms | Redness, Post-Dose 2 | 1.5 Days |
Secondary
Number of Seroconverted Subjects for HI Antibodies
Seroconversion (SCR) was defined as follows: for initially seronegative subjects, antibody titer equal to or above (≥) 1:40 after vaccination; for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.
Time frame: At Day 182
Population: The analysis was performed on the ATP cohort for persistence (Month 6), which included all evaluable subjects who received at least one dose of the vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken at Month 6.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A Group | Number of Seroconverted Subjects for HI Antibodies | 53 Participants |
| GSK2340269A Group | Number of Seroconverted Subjects for HI Antibodies | 49 Participants |
Secondary
Number of Seroconverted Subjects for HI Antibodies
Seroconversion (SCR) was defined as follows: for initially seronegative subjects, antibody titer equal to or above (≥) 1:40 after vaccination; for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.
Time frame: At Day 21
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received two doses of vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken at Day 21.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A Group | Number of Seroconverted Subjects for HI Antibodies | 55 Participants |
| GSK2340269A Group | Number of Seroconverted Subjects for HI Antibodies | 58 Participants |
Secondary
Number of Seroconverted Subjects for HI Antibodies
Seroconversion (SCR) was defined as follows: for initially seronegative subjects, antibody titer equal to or above (≥) 1:40 after vaccination; for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.
Time frame: At Day 364
Population: The analysis was performed on the ATP cohort for persistence (Month 12), which included all evaluable subjects who received at least one dose of the vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken at Month 12.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A Group | Number of Seroconverted Subjects for HI Antibodies | 38 Participants |
| GSK2340269A Group | Number of Seroconverted Subjects for HI Antibodies | 41 Participants |
Secondary
Number of Seroprotected Subjects for HI Antibodies
A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.
Time frame: At Day 364
Population: The analysis was performed on the ATP cohort for persistence (Month 12), which included all evaluable subjects who received at least one dose of the vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken at Month 12.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A Group | Number of Seroprotected Subjects for HI Antibodies | 48 Participants |
| GSK2340269A Group | Number of Seroprotected Subjects for HI Antibodies | 51 Participants |
Secondary
Number of Seroprotected Subjects for HI Antibodies
A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.
Time frame: At Days 0 and 21
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received two doses of vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken at Day 0 and Day 21.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A Group | Number of Seroprotected Subjects for HI Antibodies | Flu A/California/7/2009, Day 0 | 7 Participants |
| GSK2340272A Group | Number of Seroprotected Subjects for HI Antibodies | Flu A/California/7/2009, Day 21 | 55 Participants |
| GSK2340269A Group | Number of Seroprotected Subjects for HI Antibodies | Flu A/California/7/2009, Day 0 | 8 Participants |
| GSK2340269A Group | Number of Seroprotected Subjects for HI Antibodies | Flu A/California/7/2009, Day 21 | 60 Participants |
Secondary
Number of Seroprotected Subjects for HI Antibodies
A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.
Time frame: At Day 182
Population: The analysis was performed on the ATP cohort for persistence (Month 6), which included all evaluable subjects who received at least one dose of the vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken at Month 6.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A Group | Number of Seroprotected Subjects for HI Antibodies | 56 Participants |
| GSK2340269A Group | Number of Seroprotected Subjects for HI Antibodies | 56 Participants |
Secondary
Number of Subjects With Adverse Events of Specific Interest (AESI)
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 Adverse Events of Specific Interest (AESI) | 0 Participants |
| GSK2340269A Group | Number of Subjects With Adverse Events of Specific Interest (AESI) | 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) follow-up period after each dose and across doses
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 56 Participants |
| GSK2340272A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 1 Participants |
| GSK2340272A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 20 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 | Any Swelling, Dose 1 | 20 Participants |
| GSK2340272A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| GSK2340272A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 53 Participants |
| GSK2340272A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| GSK2340272A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 16 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 | Any Swelling, Dose 2 | 12 Participants |
| GSK2340272A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| GSK2340272A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 57 Participants |
| GSK2340272A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 1 Participants |
| GSK2340272A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 24 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 | Any Swelling, Across doses | 21 Participants |
| GSK2340272A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 0 Participants |
| GSK2340269A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 1 Participants |
| GSK2340269A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 39 Participants |
| GSK2340269A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| GSK2340269A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| GSK2340269A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 0 Participants |
| GSK2340269A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 3 Participants |
| GSK2340269A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 1 Participants |
| GSK2340269A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| GSK2340269A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 3 Participants |
| GSK2340269A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 1 Participants |
| GSK2340269A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| GSK2340269A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| GSK2340269A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 2 Participants |
| GSK2340269A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 33 Participants |
| GSK2340269A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 41 Participants |
| GSK2340269A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 1 Participants |
| GSK2340269A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 0 Participants |
| GSK2340269A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 2 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 and relationship to vaccination. Grade 3 symptom = symptom that prevented normal everyday activities. Grade 3 fever = fever above (\>) 40.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.
Time frame: During the 7-day (Days 0-6) follow-up period after each dose and across doses
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 26 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 2 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 10 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 19 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 1 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 9 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint Pain, Dose 1 | 15 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 | Related Joint Pain, Dose 1 | 9 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle Aches, Dose 1 | 22 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle Aches, Dose 1 | 1 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle Aches, Dose 1 | 10 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 1 | 7 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 Shivering, Dose 1 | 2 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Dose 1 | 9 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Dose 1 | 0 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Dose 1 | 4 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 1 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1 | 0 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1 | 1 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 29 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 | Related Fatigue, Dose 2 | 16 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 19 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 3 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 11 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint Pain, Dose 2 | 23 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint Pain, Dose 2 | 2 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint Pain, Dose 2 | 15 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle Aches, Dose 2 | 30 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle Aches, Dose 2 | 2 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle Aches, Dose 2 | 17 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 2 | 12 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 2 | 1 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 2 | 10 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Dose 2 | 12 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Dose 2 | 1 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Dose 2 | 8 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 2 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2 | 0 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2 | 1 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 35 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 5 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 20 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 30 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 4 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 17 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint Pain, Across doses | 27 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint Pain, Across doses | 2 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint Pain, Across doses | 18 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle Aches, Across doses | 35 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle Aches, Across doses | 2 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle Aches, Across doses | 18 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Across doses | 16 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Across doses | 1 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Across doses | 10 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Across doses | 17 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Across doses | 1 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Across doses | 11 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across doses | 3 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Across doses | 0 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Across doses | 2 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle Aches, Dose 2 | 0 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 18 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 8 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 1 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle Aches, Dose 2 | 2 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 7 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Across doses | 0 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 10 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 2 | 4 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 1 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint Pain, Across doses | 10 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 5 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 2 | 0 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint Pain, Dose 1 | 5 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Across doses | 4 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint Pain, Dose 1 | 0 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 2 | 2 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint Pain, Dose 1 | 2 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint Pain, Across doses | 1 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle Aches, Dose 1 | 12 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Dose 2 | 7 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle Aches, Dose 1 | 0 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Across doses | 4 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle Aches, Dose 1 | 3 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Dose 2 | 0 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 1 | 7 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint Pain, Across doses | 5 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 1 | 0 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Dose 2 | 1 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 1 | 3 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Across doses | 0 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Dose 1 | 11 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 0 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Dose 1 | 1 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle Aches, Across doses | 14 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Dose 1 | 3 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2 | 0 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 0 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Across doses | 14 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1 | 0 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2 | 0 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1 | 0 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle Aches, Across doses | 0 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 13 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 23 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 0 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across doses | 0 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 7 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 1 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 12 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle Aches, Across doses | 5 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 0 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 11 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 5 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Across doses | 1 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint Pain, Dose 2 | 7 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 18 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint Pain, Dose 2 | 1 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Across doses | 10 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint Pain, Dose 2 | 3 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 1 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle Aches, Dose 2 | 7 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Across doses | 0 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: During the 21-day (Days 0-20) follow-up after the first vaccination and during the 63-day (Days 21-83) follow-up after the second vaccination (From Day 0 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) | 22 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 1 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 5 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 27 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 4 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 6 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) | 0 Participants |
| GSK2340269A Group | Number of Subjects With Serious Adverse Events (SAEs) | 3 Participants |
Secondary
SCF for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease
SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.
Time frame: At Day 35
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received two doses of vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken 14 days (Day 35) after the second vaccine dose.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK2340272A Group | SCF for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease | 45.6 Fold change |
Secondary
SCF for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease
SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.
Time frame: At Day 182
Population: The analysis was performed on the ATP cohort for persistence (Month 6), which included all evaluable subjects who received at least one dose of the vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken at Month 6.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK2340272A Group | SCF for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease | 15.3 Fold change |
| GSK2340269A Group | SCF for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease | 11.7 Fold change |
Secondary
SCF for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease
SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.
Time frame: At Day 364
Population: The analysis was performed on the ATP cohort for persistence (Month 12), which included all evaluable subjects who received at least one dose of the vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken at Month 12.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK2340272A Group | SCF for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease | 8.4 Fold change |
| GSK2340269A Group | SCF for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease | 7.6 Fold change |
Secondary
Seroconversion Factor (SCF) for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease
SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.
Time frame: At Day 21
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received two doses of vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken at Day 21.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK2340272A Group | Seroconversion Factor (SCF) for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease | 51.3 Fold change |
| GSK2340269A Group | Seroconversion Factor (SCF) for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease | 45.3 Fold change |
Secondary
Titers for Serum HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease
Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.
Time frame: At Day 182
Population: The analysis was performed on the ATP cohort for persistence (Month 6), which included all evaluable subjects who received at least one dose of the vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken at Month 6.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK2340272A Group | Titers for Serum HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease | 161.9 Titers |
| GSK2340269A Group | Titers for Serum HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease | 149.7 Titers |
Secondary
Titers for Serum HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease
Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.
Time frame: At Day 364
Population: The analysis was performed on the ATP cohort for persistence (Month 12), which included all evaluable subjects who received at least one dose of the vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood sample taken at Month 12.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK2340272A Group | Titers for Serum HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease | 90.1 Titers |
| GSK2340269A Group | Titers for Serum HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease | 96.0 Titers |
Secondary
Titers for Serum HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease
Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old.
Time frame: At Days 0 and 21
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received two doses of vaccine and for whom assay results were available for antibodies against H1N1 antigen for blood samples taken at Day 0 and Day 21.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2340272A Group | Titers for Serum HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease | Flu A/California/7/2009, Day 0 | 10.6 Titers |
| GSK2340272A Group | Titers for Serum HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease | Flu A/California/7/2009, Day 21 | 541.7 Titers |
| GSK2340269A Group | Titers for Serum HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease | Flu A/California/7/2009, Day 0 | 11.7 Titers |
| GSK2340269A Group | Titers for Serum HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease | Flu A/California/7/2009, Day 21 | 530.5 Titers |