Influenza
Conditions
Keywords
GSK Bio's influenza vaccine GSK2340272A, influenza infection
Brief summary
The objective of the study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational 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. Potential subjects in the follow-up phase of a prior investigational study may be enrolled if the investigator's judgment is that it will have no effect on safety, reactogenicity, or immunogenicity endpoints in this study, and that it does not violate the protocol requirements of the prior trial. * 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 tamoxifen 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 |
|---|---|---|
| Number of Seroconverted Subjects for Hemagglutination Inhibition (HI) Antibodies | At Day 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 Seroprotected Subjects for HI Antibodies | At Day 42 | A seroprotected subject was defined as a vaccinated subject with a serum hemagglutination inhibition (HI) titer ≥ 1:40. The flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09). |
| Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | At Day 42 | GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seroprotected Subjects for HI Antibodies | At Days 0 and 21 | A seroprotected subject was defined as a vaccinated subject with a serum hemagglutination inhibition (HI) titer ≥ 1:40. The flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09). |
| Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | At Day 21 | Seroconversion factor (SCF) was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. |
| Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease | At Days 0, 21 and 42 | Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/Neth/602/09. The reference seropositivity cut-off value was ≥ 1:8. |
| Number of Seroconverted Subjects for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 | At Days 21 and 42 | Seroconversion was defined as: For initially seronegative subjects, antibody titer ≥ 1:32 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/Neth/602/09. |
| 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 Subjects With HI Antibody Concentrations Above the Cut-off Value | At Days 0, 21 and 42 | Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The Flu strain assessed was Flu A/CAL/7/09. |
| 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. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = temperature \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. |
| 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. There were no subjects from GSK2340269A Group who reported Temperature. |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Within 21 days after the first vaccination and 63 days after the second vaccination (Day 0 - Day 20 and Day 21 - Day 83) | 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 Adverse Events of Specific 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 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 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. There were no subjects from GSK2340269A Group who reported Redness or Swelling. |
| Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | At Days 0, 21 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 Seroconverted Subjects for HI Antibodies | At Day 21 | Seroconversion was defined as: For initially seronegative subjects (antibody titer \< 1:10 prior to vaccination), antibody titer ≥ 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). |
Countries
Belgium
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, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and 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, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. | 66 |
| Total | 130 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to follow-up (incompl. vaccination) | 1 | 0 |
Baseline characteristics
| Characteristic | GSK2340269A Group | Total | GSK2340272A Group |
|---|---|---|---|
| Age, Continuous | 38.2 Years STANDARD_DEVIATION 14.1 | 38.64 Years STANDARD_DEVIATION 13.78 | 39.1 Years STANDARD_DEVIATION 13.53 |
| Race/Ethnicity, Customized Asian-East Asian heritage | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White-Caucasian/European heritage | 65 Participants | 129 Participants | 64 Participants |
| Sex: Female, Male Female | 39 Participants | 80 Participants | 41 Participants |
| Sex: Female, Male Male | 27 Participants | 50 Participants | 23 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 | 62 / 64 | 48 / 66 |
| serious Total, serious adverse events | 2 / 64 | 1 / 66 |
Outcome results
Primary
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.
Time frame: At Day 42
Population: The analysis was performed on the ATP cohort for immunogenicity, 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 up to 21 days after the second vaccine dose.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK2340272A Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | 72.9 Fold increase |
Primary
Number of Seroconverted Subjects for Hemagglutination Inhibition (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 Day 42
Population: The analysis was performed on the ATP cohort for immunogenicity, 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 up to 21 days after the second vaccine dose.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A Group | Number of Seroconverted Subjects for Hemagglutination Inhibition (HI) Antibodies | 58 Participants |
Primary
Number of Seroprotected Subjects for HI Antibodies
A seroprotected subject was defined as a vaccinated subject with a serum hemagglutination inhibition (HI) titer ≥ 1:40. The flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).
Time frame: At Day 42
Population: The analysis was performed on the ATP cohort for immunogenicity, 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 up to 21 days after the second vaccine dose.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A Group | Number of Seroprotected Subjects for HI Antibodies | 59 Participants |
Secondary
Number of Days With Solicited General Symptoms
The number of days with any solicited general symptoms reported during the solicited post-vaccination period. There were no subjects from GSK2340269A Group who reported Temperature.
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 with the symptom sheet filled in.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| 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 | Fatigue, Overall/dose | 2.0 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 | Headache, post-Dose 2 | 2.0 Days |
| GSK2340272A Group | Number of Days With Solicited General Symptoms | Headache, Overall/dose | 2.0 Days |
| GSK2340272A Group | Number of Days With Solicited General Symptoms | Joint pain, post-Dose 1 | 3.0 Days |
| GSK2340272A Group | Number of Days With Solicited General Symptoms | Joint pain, post-Dose 2 | 1.0 Days |
| GSK2340272A Group | Number of Days With Solicited General Symptoms | Joint pain, Overall/dose | 1.5 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 | Muscle aches, post-Dose 2 | 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 | Sweating, post-Dose 1 | 2.0 Days |
| GSK2340272A Group | Number of Days With Solicited General Symptoms | Sweating, post-Dose 2 | 1.5 Days |
| GSK2340272A Group | Number of Days With Solicited General Symptoms | Sweating, Overall/dose | 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 | Shivering, post-Dose 2 | 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 | Temperature, post-Dose 2 | 2.0 Days |
| GSK2340272A Group | Number of Days With Solicited General Symptoms | Temperature, Overall/dose | 2.0 Days |
| GSK2340272A Group | Number of Days With Solicited General Symptoms | Fatigue, post-Dose 2 | 1.5 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 | Muscle aches, post-Dose 1 | 1.0 Days |
| GSK2340269A Group | Number of Days With Solicited General Symptoms | Fatigue, post-Dose 2 | 3.0 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 | Fatigue, Overall/dose | 2.0 Days |
| GSK2340269A Group | Number of Days With Solicited General Symptoms | Muscle aches, post-Dose 2 | 1.0 Days |
| GSK2340269A Group | Number of Days With Solicited General Symptoms | Headache, post-Dose 1 | 1.0 Days |
| GSK2340269A Group | Number of Days With Solicited General Symptoms | Sweating, Overall/dose | 1.0 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 | Muscle aches, Overall/dose | 1.0 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 | Shivering, post-Dose 2 | 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 | Sweating, post-Dose 1 | 1.0 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 | Shivering, post-Dose 1 | 1.0 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 | Sweating, 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. There were no subjects from GSK2340269A Group who reported Redness or Swelling.
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 with the symptom sheet filled in.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK2340272A Group | Number of Days With Solicited Local Symptoms | Swelling, post-Dose 1 | 2.0 Days |
| GSK2340272A Group | Number of Days With Solicited Local Symptoms | Pain, post-Dose 1 | 3.0 Days |
| GSK2340272A Group | Number of Days With Solicited Local Symptoms | Redness, Overall/dose | 2.5 Days |
| GSK2340272A Group | Number of Days With Solicited Local Symptoms | Swelling, post-Dose 2 | 2.0 Days |
| GSK2340272A Group | Number of Days With Solicited Local Symptoms | Swelling, Overall/dose | 2.0 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 | 2.0 Days |
| GSK2340269A Group | Number of Days With Solicited Local Symptoms | Pain, post-Dose 1 | 1.0 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 | Pain, post-Dose 2 | 2.0 Days |
Secondary
Number of Seroconverted Subjects for HI Antibodies
Seroconversion was defined as: For initially seronegative subjects (antibody titer \< 1:10 prior to vaccination), antibody titer ≥ 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 Day 21
Population: The analysis was performed on the ATP cohort for immunogenicity, 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 up to 21 days after the second vaccine dose.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A Group | Number of Seroconverted Subjects for HI Antibodies | 59 Participants |
| GSK2340269A Group | Number of Seroconverted Subjects for HI Antibodies | 56 Participants |
Secondary
Number of Seroconverted Subjects for HI Antibodies
Seroconversion was defined as: For initially seronegative subjects (antibody titer \< 1:10 prior to vaccination), antibody titer ≥ 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 Day 364
Population: The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A Group | Number of Seroconverted Subjects for HI Antibodies | 41 Participants |
| GSK2340269A Group | Number of Seroconverted Subjects for HI Antibodies | 46 Participants |
Secondary
Number of Seroconverted Subjects for HI Antibodies
Seroconversion was defined as: For initially seronegative subjects (antibody titer \< 1:10 prior to vaccination), antibody titer ≥ 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 Day 182
Population: The analysis was performed on the ATP cohort for persistence at Month 6, which included all evaluable subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 6.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A Group | Number of Seroconverted Subjects for HI Antibodies | 57 Participants |
| GSK2340269A Group | Number of Seroconverted Subjects for HI Antibodies | 47 Participants |
Secondary
Number of Seroconverted Subjects for HI Antibodies
Seroconversion was defined as: For initially seronegative subjects (antibody titer \< 1:10 prior to vaccination), antibody titer ≥ 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 Day 42
Population: The analysis was performed on the ATP cohort for immunogenicity, 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 up to 21 days after the second vaccine dose.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A Group | Number of Seroconverted Subjects for HI Antibodies | 61 Participants |
Secondary
Number of Seroconverted Subjects for Serum Neutralizing Antibodies Against Flu A/Neth/602/09
Seroconversion was defined as: For initially seronegative subjects, antibody titer ≥ 1:32 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/Neth/602/09.
Time frame: At Days 21 and 42
Population: The analysis was performed on the ATP cohort for immunogenicity, 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 up to 21 days after the second vaccine dose.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A Group | Number of Seroconverted Subjects for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 | Flu A/Neth/602/09, Day 21 | 21 Participants |
| GSK2340272A Group | Number of Seroconverted Subjects for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 | Flu A/Neth/602/09, Day 42 | 27 Participants |
| GSK2340269A Group | Number of Seroconverted Subjects for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 | Flu A/Neth/602/09, Day 21 | 22 Participants |
| GSK2340269A Group | Number of Seroconverted Subjects for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 | Flu A/Neth/602/09, Day 42 | 23 Participants |
Secondary
Number of Seroprotected Subjects for HI Antibodies
A seroprotected subject was defined as a vaccinated subject with a serum hemagglutination inhibition (HI) titer ≥ 1:40. The flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).
Time frame: At Day 364
Population: The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A Group | Number of Seroprotected Subjects for HI Antibodies | 46 Participants |
| GSK2340269A Group | Number of Seroprotected Subjects for HI Antibodies | 55 Participants |
Secondary
Number of Seroprotected Subjects for HI Antibodies
A seroprotected subject was defined as a vaccinated subject with a serum hemagglutination inhibition (HI) titer ≥ 1:40. The flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).
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 2 vaccine doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken up to 21 days after the second vaccine dose.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A Group | Number of Seroprotected Subjects for HI Antibodies | Flu A/CAL/7/09, Day 0 | 7 Participants |
| GSK2340272A Group | Number of Seroprotected Subjects for HI Antibodies | Flu A/CAL/7/09, Day 21 | 60 Participants |
| GSK2340269A Group | Number of Seroprotected Subjects for HI Antibodies | Flu A/CAL/7/09, Day 0 | 12 Participants |
| GSK2340269A Group | Number of Seroprotected Subjects for HI Antibodies | Flu A/CAL/7/09, Day 21 | 62 Participants |
Secondary
Number of Seroprotected Subjects for HI Antibodies
A seroprotected subject was defined as a vaccinated subject with a serum hemagglutination inhibition (HI) titer ≥ 1:40. The flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).
Time frame: At Day 182
Population: The analysis was performed on the ATP cohort for persistence at Month 6, which included all evaluable subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 6.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A Group | Number of Seroprotected Subjects for HI Antibodies | 59 Participants |
| GSK2340269A Group | Number of Seroprotected Subjects for HI Antibodies | 52 Participants |
Secondary
Number of Seroprotected Subjects for HI Antibodies
A seroprotected subject was defined as a vaccinated subject with a serum hemagglutination inhibition (HI) titer ≥ 1:40. The flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).
Time frame: At Day 42
Population: The analysis was performed on the ATP cohort for immunogenicity, 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 up to 21 days after the second vaccine dose.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A Group | Number of Seroprotected Subjects for HI Antibodies | 66 Participants |
Secondary
Number of Subjects With Adverse Events of Specific 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 Adverse Events of Specific Interest (AESIs) | 1 Participants |
| GSK2340269A Group | Number of Subjects With Adverse Events of Specific Interest (AESIs) | 1 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 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 | 57 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 | 1 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 | 5 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 | 56 Participants |
| GSK2340272A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 2 Participants |
| GSK2340272A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 3 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 | 9 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 | 61 Participants |
| GSK2340272A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across Doses | 3 Participants |
| GSK2340272A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across Doses | 4 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 | 11 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 | 0 Participants |
| GSK2340269A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 23 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 | 0 Participants |
| GSK2340269A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 0 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 | 0 Participants |
| GSK2340269A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 0 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 | 0 Participants |
| GSK2340269A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 20 Participants |
| GSK2340269A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across Doses | 32 Participants |
| GSK2340269A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 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 | 0 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. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = temperature \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 7-day (Days 0-6) post-vaccination period following 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 | 22 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 0 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 21 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 17 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 | 15 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Dose 1 | 7 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Dose 1 | 0 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Dose 1 | 7 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Dose 1 | 20 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 | 20 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 1 | 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 Shivering, Dose 1 | 6 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Dose 1 | 6 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 | 6 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 0 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 | 0 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 28 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 2 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 27 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 22 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 Headache, Dose 2 | 20 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Dose 2 | 13 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Dose 2 | 0 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Dose 2 | 13 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Dose 2 | 23 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 | 23 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 2 | 11 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 2 | 0 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 2 | 11 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 | 12 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 | 2 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 34 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 2 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 33 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 29 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 3 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 27 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Across doses | 14 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Across doses | 0 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Across doses | 14 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Across doses | 27 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Across doses | 3 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Across doses | 27 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Across doses | 14 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Across doses | 0 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Across doses | 14 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Across doses | 14 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 | 14 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across doses | 2 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 | 12 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 | 6 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 16 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Across doses | 1 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 11 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 2 | 3 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 0 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Across doses | 6 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 8 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 | 4 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Across doses | 9 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 | 3 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Across doses | 0 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Dose 1 | 6 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 | 4 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 | 4 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Across doses | 6 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 1 | 1 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Dose 2 | 6 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 1 | 2 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 | 7 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 | 0 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Across doses | 12 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Dose 1 | 5 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 | 11 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 | 22 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 2 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 | 13 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 3 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 9 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Across doses | 10 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 | 22 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 8 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Across doses | 0 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Dose 2 | 4 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 14 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Dose 2 | 0 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Across doses | 6 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Dose 2 | 4 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 0 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: Within 21 days after the first vaccination and 63 days after the second vaccination (Day 0 - Day 20 and Day 21 - Day 83)
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) | 39 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 7 Participants |
| GSK2340272A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 12 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 38 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 9 Participants |
| GSK2340269A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 7 Participants |
Secondary
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The Flu strain assessed was Flu A/CAL/7/09.
Time frame: At Day 182
Population: The analysis was performed on the ATP cohort for persistence at Month 6, which included all evaluable subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 6.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value | 59 Participants |
| GSK2340269A Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value | 61 Participants |
Secondary
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The Flu strain assessed was Flu A/CAL/7/09.
Time frame: At Days 0, 21 and 42
Population: The analysis was performed on the ATP cohort for immunogenicity, 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 up to 21 days after the second vaccine dose.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2340272A Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value | Flu A/CAL/7/09, Day 0 | 23 Participants |
| GSK2340272A Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value | Flu A/CAL/7/09, Day 21 | 60 Participants |
| GSK2340272A Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value | Flu A/CAL/7/09, Day 42 | 59 Participants |
| GSK2340269A Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value | Flu A/CAL/7/09, Day 0 | 28 Participants |
| GSK2340269A Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value | Flu A/CAL/7/09, Day 21 | 65 Participants |
| GSK2340269A Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value | Flu A/CAL/7/09, Day 42 | 66 Participants |
Secondary
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The Flu strain assessed was Flu A/CAL/09.
Time frame: At Day 364
Population: The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects who met all eligibility criteria and for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2340272A Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value | 59 Participants |
| GSK2340269A Group | Number of Subjects With HI Antibody Concentrations Above the Cut-off Value | 62 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) | 2 Participants |
| GSK2340269A Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |
Secondary
Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
Seroconversion factor (SCF) was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.
Time frame: At Day 364
Population: The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK2340272A Group | Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | 9.7 Fold increase |
| GSK2340269A Group | Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | 8.3 Fold increase |
Secondary
Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
Seroconversion factor (SCF) was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.
Time frame: At Day 21
Population: The analysis was performed on the ATP cohort for immunogenicity, 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 up to 21 days after the second vaccine dose.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK2340272A Group | Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | 38.1 Fold increase |
| GSK2340269A Group | Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | 28.7 Fold increase |
Secondary
Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
Seroconversion factor (SCF) was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.
Time frame: At Day 42
Population: The analysis was performed on the ATP cohort for immunogenicity, 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 up to 21 days after the second vaccine dose.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK2340272A Group | Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | 31.5 Fold increase |
Secondary
Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
Seroconversion factor (SCF) was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.
Time frame: At Day 182
Population: The analysis was performed on the ATP cohort for persistence at Month 6, which included all evaluable subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 6.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK2340272A Group | Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | 22.5 Fold increase |
| GSK2340269A Group | Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | 13.9 Fold increase |
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 Day 364
Population: The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK2340272A Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | 85.8 Titers |
| GSK2340269A Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | 87.6 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 Day 182
Population: The analysis was performed on the ATP cohort for persistence at Month 6, which included all evaluable subjects who met all eligibility criteria and for whom assay results were available for antibodies against the study vaccine antigen component at Month 6.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK2340272A Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | 204.8 Titers |
| GSK2340269A Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | 146.1 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 0, 21 and 42
Population: The analysis was performed on the ATP cohort for immunogenicity, 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 up to 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 | 8.8 Titers |
| GSK2340272A Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 21 | 335.2 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 | 636.3 Titers |
| GSK2340269A Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 0 | 10.8 Titers |
| GSK2340269A Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 21 | 310.2 Titers |
| GSK2340269A Group | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease | Flu A/CAL/7/09, Day 42 | 341.0 Titers |
Secondary
Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease
Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/Neth/602/09. The reference seropositivity cut-off value was ≥ 1:8.
Time frame: At Days 0, 21 and 42
Population: The analysis was performed on the ATP cohort for immunogenicity, 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 up to 21 days after the second vaccine dose.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2340272A Group | Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease | Flu A/Neth/602/09, Day 0 | 6.1 Titers |
| GSK2340272A Group | Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease | Flu A/Neth/602/09, Day 21 | 152.3 Titers |
| GSK2340272A Group | Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease | Flu A/Neth/602/09, Day 42 | 243.8 Titers |
| GSK2340269A Group | Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease | Flu A/Neth/602/09, Day 0 | 9.6 Titers |
| GSK2340269A Group | Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease | Flu A/Neth/602/09, Day 21 | 89.9 Titers |
| GSK2340269A Group | Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease | Flu A/Neth/602/09, Day 42 | 144.9 Titers |