Influenza
Conditions
Keywords
Influenza, Influenza vaccine
Brief summary
The purpose of this phase IIb study is to demonstrate the consistency of three lots of an adjuvanted influenza vaccine candidate and to evaluate the safety of this vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years old and above.
Detailed description
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Interventions
BIOLOGICALCandidate Influenza Vaccine GSK1247446A - 3 different formulations
Single dose, Intramuscular injection
BIOLOGICALFluarix TM
Single dose, Intramuscular injection
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* A male or female age 60 years or older at the time of the vaccination. * Subjects who the investigator believes can and will comply with the requirements of the protocol * Written informed consent obtained from the subject. * Free of an acute aggravation of the health status as established by clinical examination before entering into the study.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period. * Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination * Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period. * Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 30 days after vaccination. * History of hypersensitivity to a previous dose of influenza vaccine. * History of confirmed influenza infection within the last 12 months. * History of allergy or reactions likely to be exacerbated by any component of the vaccine(s) * Acute disease at the time of enrolment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | At Days 0 and 21 | Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/New Caledonia, A/New York and B/Malaysia. The seropositivity cut-off assay was 1:10. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables. |
| Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | At Day 21 | A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \<1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 assessed influenza strains were A/New Caledonia, A/New York and B/Malaysia. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables. |
| Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | At Days 0 and 21 | A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 assessed influenza strains were A/New Caledonia, A/New York and B/Malaysia. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables. |
| Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | At Day 21 | The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 assessed influenza strains were A/New Caledonia, A/New York and B/Malaysia. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables. |
| Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | During the 7-day (Days 0-6) post vaccination period | Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site. All solicited local symptoms were assessed by the investigator as being related to study vaccination. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | During the 7-day (Days 0-6) post vaccination period | Assessed solicited general symptoms were arthralgia, fatigue, fever \[oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], headache, muscle aches and shivering. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0°C. Related = symptom considered by the investigator to have a causal relationship to study vaccination. |
| Number of Subjects With New Onset of Chronic Diseases (NOCDs). | From Day 0 to Day 180 | NOCDs include conditions such as diabetes, autoimmune disease, asthma, allergies etc. This table includes rare events, defined as events with an occurrence rate of 0.1 % and belonging to the NOCDs. |
| Number of Subjects With Medically Significant Conditions (MSCs). | From Day 0 to Day 180 | MSCs were defined as conditions prompting emergency room visits or physician visits that were not related to common diseases or routine visits. This table includes rare events, defined as events with an occurrence rate of 0.1 % and belonging to the MSCs. |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | During the 30-day (Days 0-29) post-vaccination period | Unsolicited AE covers any AE 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 = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal activity Related = unsolicited AE assessed by the investigator as related to the vaccination. This table includes rare events, defined as events with an occurrence rate of 0.1 % and belonging to the AEs. |
| Number of Subjects With Any and Related Serious Adverse Events (SAEs). | During the entire study period (Days 0-180) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any = any SAE regardless of intensity or relationship to vaccination. Related (REL) = SAE assessed by the investigator as related to the vaccination. |
Countries
Estonia, France, Germany, Greece, Norway, Russia, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GSK1247446A Lot 1 Group Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. | 850 |
| GSK1247446A Lot 2 Group Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. | 850 |
| GSK1247446A Lot 3 Group Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. | 854 |
| Fluarix Group Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm. | 570 |
| Total | 3,124 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 0 | 1 |
| Overall Study | Lost to Follow-up | 3 | 1 | 5 | 4 |
| Overall Study | Withdrawal by Subject | 2 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | GSK1247446A Lot 1 Group | GSK1247446A Lot 2 Group | GSK1247446A Lot 3 Group | Fluarix Group | Total |
|---|---|---|---|---|---|
| Age, Continuous | 68.4 Years STANDARD_DEVIATION 6.17 | 68.8 Years STANDARD_DEVIATION 6.43 | 68.7 Years STANDARD_DEVIATION 6.54 | 68.3 Years STANDARD_DEVIATION 6.15 | 68.6 Years STANDARD_DEVIATION 6.33 |
| Sex: Female, Male Female | 475 Participants | 451 Participants | 479 Participants | 340 Participants | 1745 Participants |
| Sex: Female, Male Male | 375 Participants | 399 Participants | 375 Participants | 230 Participants | 1379 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 653 / 850 | 636 / 850 | 634 / 854 | 1,923 / 2,554 | 321 / 570 |
| serious Total, serious adverse events | 30 / 850 | 24 / 850 | 23 / 854 | 77 / 2,554 | 21 / 570 |
Outcome results
Primary
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \<1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 assessed influenza strains were A/New Caledonia, A/New York and B/Malaysia. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables.
Time frame: At Day 21
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1247446A Lot 1 Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | A/New Caledonia, Day 21 | 214 subjects |
| GSK1247446A Lot 1 Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | A/New York, Day 21 | 308 subjects |
| GSK1247446A Lot 1 Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | B/Malaysia, Day 21 | 333 subjects |
| GSK1247446A Lot 2 Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | A/New Caledonia, Day 21 | 205 subjects |
| GSK1247446A Lot 2 Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | A/New York, Day 21 | 309 subjects |
| GSK1247446A Lot 2 Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | B/Malaysia, Day 21 | 317 subjects |
| GSK1247446A Lot 3 Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | A/New York, Day 21 | 313 subjects |
| GSK1247446A Lot 3 Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | B/Malaysia, Day 21 | 326 subjects |
| GSK1247446A Lot 3 Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | A/New Caledonia, Day 21 | 233 subjects |
| GSK1247446A Pooled Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | A/New Caledonia, Day 21 | 652 subjects |
| GSK1247446A Pooled Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | A/New York, Day 21 | 930 subjects |
| GSK1247446A Pooled Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | B/Malaysia, Day 21 | 976 subjects |
| Fluarix Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | A/New York, Day 21 | 49 subjects |
| Fluarix Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | A/New Caledonia, Day 21 | 47 subjects |
| Fluarix Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | B/Malaysia, Day 21 | 59 subjects |
Primary
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 assessed influenza strains were A/New Caledonia, A/New York and B/Malaysia. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables.
Time frame: At Days 0 and 21
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1247446A Lot 1 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A/New York, Day 0 [N=494;494;499;1487;106] | 197 subjects |
| GSK1247446A Lot 1 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A/New York, Day 21 [N=491;487;492;1470;106] | 451 subjects |
| GSK1247446A Lot 1 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A/New Caledonia, Day 21 [N=491;487;492;1470;106] | 439 subjects |
| GSK1247446A Lot 1 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | B/Malaysia, Day 21 [N=491;487;492;1470;106] | 474 subjects |
| GSK1247446A Lot 1 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A/New Caledonia, Day 0 [N=494;494;499;1487;106] | 221 subjects |
| GSK1247446A Lot 1 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | B/Malaysia, Day 0 [N=494;494;499;1487;106] | 240 subjects |
| GSK1247446A Lot 2 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A/New Caledonia, Day 0 [N=494;494;499;1487;106] | 220 subjects |
| GSK1247446A Lot 2 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A/New York, Day 0 [N=494;494;499;1487;106] | 201 subjects |
| GSK1247446A Lot 2 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A/New Caledonia, Day 21 [N=491;487;492;1470;106] | 433 subjects |
| GSK1247446A Lot 2 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A/New York, Day 21 [N=491;487;492;1470;106] | 447 subjects |
| GSK1247446A Lot 2 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | B/Malaysia, Day 21 [N=491;487;492;1470;106] | 475 subjects |
| GSK1247446A Lot 2 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | B/Malaysia, Day 0 [N=494;494;499;1487;106] | 230 subjects |
| GSK1247446A Lot 3 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A/New York, Day 21 [N=491;487;492;1470;106] | 454 subjects |
| GSK1247446A Lot 3 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | B/Malaysia, Day 21 [N=491;487;492;1470;106] | 481 subjects |
| GSK1247446A Lot 3 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | B/Malaysia, Day 0 [N=494;494;499;1487;106] | 236 subjects |
| GSK1247446A Lot 3 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A/New Caledonia, Day 21 [N=491;487;492;1470;106] | 454 subjects |
| GSK1247446A Lot 3 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A/New Caledonia, Day 0 [N=494;494;499;1487;106] | 229 subjects |
| GSK1247446A Lot 3 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A/New York, Day 0 [N=494;494;499;1487;106] | 200 subjects |
| GSK1247446A Pooled Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | B/Malaysia, Day 21 [N=491;487;492;1470;106] | 1430 subjects |
| GSK1247446A Pooled Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A/New York, Day 0 [N=494;494;499;1487;106] | 598 subjects |
| GSK1247446A Pooled Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A/New York, Day 21 [N=491;487;492;1470;106] | 1352 subjects |
| GSK1247446A Pooled Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | B/Malaysia, Day 0 [N=494;494;499;1487;106] | 706 subjects |
| GSK1247446A Pooled Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A/New Caledonia, Day 21 [N=491;487;492;1470;106] | 1326 subjects |
| GSK1247446A Pooled Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A/New Caledonia, Day 0 [N=494;494;499;1487;106] | 670 subjects |
| Fluarix Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | B/Malaysia, Day 21 [N=491;487;492;1470;106] | 97 subjects |
| Fluarix Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A/New Caledonia, Day 21 [N=491;487;492;1470;106] | 94 subjects |
| Fluarix Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A/New York, Day 21 [N=491;487;492;1470;106] | 89 subjects |
| Fluarix Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | B/Malaysia, Day 0 [N=494;494;499;1487;106] | 52 subjects |
| Fluarix Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A/New York, Day 0 [N=494;494;499;1487;106] | 47 subjects |
| Fluarix Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A/New Caledonia, Day 0 [N=494;494;499;1487;106] | 46 subjects |
Primary
Number of Subjects With Any and Related Serious Adverse Events (SAEs).
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any = any SAE regardless of intensity or relationship to vaccination. Related (REL) = SAE assessed by the investigator as related to the vaccination.
Time frame: During the entire study period (Days 0-180)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1247446A Lot 1 Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs). | Any SAE(s), Days 0-29 [N=850;850;854;2554;570] | 4 subjects |
| GSK1247446A Lot 1 Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs). | REL SAE(s), Days 0-29 [N=850;850;854;2554;570] | 0 subjects |
| GSK1247446A Lot 1 Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs). | Any SAE(s), Days 30-180 [N=844;848;848;2540;565] | 26 subjects |
| GSK1247446A Lot 1 Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs). | REL SAE(s), Days 30-180 [N=844;848;848;2540;565] | 0 subjects |
| GSK1247446A Lot 2 Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs). | Any SAE(s), Days 0-29 [N=850;850;854;2554;570] | 4 subjects |
| GSK1247446A Lot 2 Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs). | REL SAE(s), Days 30-180 [N=844;848;848;2540;565] | 1 subjects |
| GSK1247446A Lot 2 Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs). | REL SAE(s), Days 0-29 [N=850;850;854;2554;570] | 0 subjects |
| GSK1247446A Lot 2 Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs). | Any SAE(s), Days 30-180 [N=844;848;848;2540;565] | 20 subjects |
| GSK1247446A Lot 3 Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs). | REL SAE(s), Days 30-180 [N=844;848;848;2540;565] | 0 subjects |
| GSK1247446A Lot 3 Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs). | REL SAE(s), Days 0-29 [N=850;850;854;2554;570] | 0 subjects |
| GSK1247446A Lot 3 Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs). | Any SAE(s), Days 30-180 [N=844;848;848;2540;565] | 20 subjects |
| GSK1247446A Lot 3 Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs). | Any SAE(s), Days 0-29 [N=850;850;854;2554;570] | 3 subjects |
| GSK1247446A Pooled Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs). | Any SAE(s), Days 0-29 [N=850;850;854;2554;570] | 11 subjects |
| GSK1247446A Pooled Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs). | REL SAE(s), Days 0-29 [N=850;850;854;2554;570] | 0 subjects |
| GSK1247446A Pooled Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs). | REL SAE(s), Days 30-180 [N=844;848;848;2540;565] | 1 subjects |
| GSK1247446A Pooled Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs). | Any SAE(s), Days 30-180 [N=844;848;848;2540;565] | 66 subjects |
| Fluarix Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs). | REL SAE(s), Days 30-180 [N=844;848;848;2540;565] | 0 subjects |
| Fluarix Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs). | Any SAE(s), Days 30-180 [N=844;848;848;2540;565] | 17 subjects |
| Fluarix Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs). | REL SAE(s), Days 0-29 [N=850;850;854;2554;570] | 0 subjects |
| Fluarix Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs). | Any SAE(s), Days 0-29 [N=850;850;854;2554;570] | 4 subjects |
Primary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Assessed solicited general symptoms were arthralgia, fatigue, fever \[oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], headache, muscle aches and shivering. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0°C. Related = symptom considered by the investigator to have a causal relationship to study vaccination.
Time frame: During the 7-day (Days 0-6) post vaccination period
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with a documented dose and with symptom sheets completed .
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1247446A Lot 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Arthralgia | 9 subjects |
| GSK1247446A Lot 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Headache | 100 subjects |
| GSK1247446A Lot 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache | 8 subjects |
| GSK1247446A Lot 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Headache | 182 subjects |
| GSK1247446A Lot 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue | 156 subjects |
| GSK1247446A Lot 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Shivering | 8 subjects |
| GSK1247446A Lot 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever > 39.0°C | 0 subjects |
| GSK1247446A Lot 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Arthralgia | 69 subjects |
| GSK1247446A Lot 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fever | 35 subjects |
| GSK1247446A Lot 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Shivering | 51 subjects |
| GSK1247446A Lot 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Arthralgia | 130 subjects |
| GSK1247446A Lot 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Shivering | 92 subjects |
| GSK1247446A Lot 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue | 251 subjects |
| GSK1247446A Lot 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever ≥ 37.5°C | 45 subjects |
| GSK1247446A Lot 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Muscle aches | 159 subjects |
| GSK1247446A Lot 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Muscle aches | 8 subjects |
| GSK1247446A Lot 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Muscle aches | 254 subjects |
| GSK1247446A Lot 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue | 13 subjects |
| GSK1247446A Lot 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Shivering | 93 subjects |
| GSK1247446A Lot 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Arthralgia | 133 subjects |
| GSK1247446A Lot 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Arthralgia | 10 subjects |
| GSK1247446A Lot 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Arthralgia | 90 subjects |
| GSK1247446A Lot 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue | 210 subjects |
| GSK1247446A Lot 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue | 17 subjects |
| GSK1247446A Lot 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue | 143 subjects |
| GSK1247446A Lot 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever ≥ 37.5°C | 54 subjects |
| GSK1247446A Lot 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever > 39.0°C | 3 subjects |
| GSK1247446A Lot 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Headache | 167 subjects |
| GSK1247446A Lot 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache | 11 subjects |
| GSK1247446A Lot 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Headache | 109 subjects |
| GSK1247446A Lot 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Muscle aches | 234 subjects |
| GSK1247446A Lot 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Muscle aches | 13 subjects |
| GSK1247446A Lot 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Muscle aches | 160 subjects |
| GSK1247446A Lot 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Shivering | 11 subjects |
| GSK1247446A Lot 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Shivering | 62 subjects |
| GSK1247446A Lot 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fever | 34 subjects |
| GSK1247446A Lot 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Muscle aches | 245 subjects |
| GSK1247446A Lot 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever > 39.0°C | 1 subjects |
| GSK1247446A Lot 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Shivering | 9 subjects |
| GSK1247446A Lot 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever ≥ 37.5°C | 44 subjects |
| GSK1247446A Lot 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Shivering | 90 subjects |
| GSK1247446A Lot 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Muscle aches | 17 subjects |
| GSK1247446A Lot 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache | 8 subjects |
| GSK1247446A Lot 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue | 233 subjects |
| GSK1247446A Lot 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Muscle aches | 156 subjects |
| GSK1247446A Lot 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Headache | 182 subjects |
| GSK1247446A Lot 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Arthralgia | 12 subjects |
| GSK1247446A Lot 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue | 11 subjects |
| GSK1247446A Lot 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fever | 28 subjects |
| GSK1247446A Lot 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Headache | 111 subjects |
| GSK1247446A Lot 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue | 144 subjects |
| GSK1247446A Lot 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Shivering | 45 subjects |
| GSK1247446A Lot 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Arthralgia | 85 subjects |
| GSK1247446A Lot 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Arthralgia | 133 subjects |
| GSK1247446A Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Arthralgia | 396 subjects |
| GSK1247446A Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Headache | 531 subjects |
| GSK1247446A Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue | 41 subjects |
| GSK1247446A Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache | 27 subjects |
| GSK1247446A Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fever | 97 subjects |
| GSK1247446A Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Headache | 320 subjects |
| GSK1247446A Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Muscle aches | 733 subjects |
| GSK1247446A Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue | 694 subjects |
| GSK1247446A Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Muscle aches | 38 subjects |
| GSK1247446A Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Muscle aches | 475 subjects |
| GSK1247446A Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Arthralgia | 244 subjects |
| GSK1247446A Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Shivering | 275 subjects |
| GSK1247446A Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Shivering | 28 subjects |
| GSK1247446A Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Shivering | 158 subjects |
| GSK1247446A Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue | 443 subjects |
| GSK1247446A Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Arthralgia | 31 subjects |
| GSK1247446A Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever ≥ 37.5°C | 143 subjects |
| GSK1247446A Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever > 39.0°C | 4 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Shivering | 0 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue | 101 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Shivering | 28 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Headache | 38 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Arthralgia | 2 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Shivering | 13 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache | 3 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue | 53 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue | 4 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Muscle aches | 0 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Arthralgia | 47 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Muscle aches | 46 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Arthralgia | 29 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever > 39.0°C | 0 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever ≥ 37.5°C | 2 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fever | 1 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Muscle aches | 79 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Headache | 77 subjects |
Primary
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.
Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site. All solicited local symptoms were assessed by the investigator as being related to study vaccination.
Time frame: During the 7-day (Days 0-6) post vaccination period
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with a documented dose and with symptom sheets completed .
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1247446A Lot 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Swelling > 50 mm | 54 subjects |
| GSK1247446A Lot 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Redness > 50 mm | 103 subjects |
| GSK1247446A Lot 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Any Redness | 324 subjects |
| GSK1247446A Lot 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Any Ecchymosis | 22 subjects |
| GSK1247446A Lot 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Ecchymosis > 50 mm | 1 subjects |
| GSK1247446A Lot 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Any Pain | 470 subjects |
| GSK1247446A Lot 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Any Swelling | 241 subjects |
| GSK1247446A Lot 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Grade 3 Pain | 9 subjects |
| GSK1247446A Lot 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Redness > 50 mm | 80 subjects |
| GSK1247446A Lot 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Any Pain | 449 subjects |
| GSK1247446A Lot 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Swelling > 50 mm | 46 subjects |
| GSK1247446A Lot 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Any Redness | 297 subjects |
| GSK1247446A Lot 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Any Swelling | 208 subjects |
| GSK1247446A Lot 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Grade 3 Pain | 13 subjects |
| GSK1247446A Lot 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Ecchymosis > 50 mm | 2 subjects |
| GSK1247446A Lot 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Any Ecchymosis | 34 subjects |
| GSK1247446A Lot 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Any Redness | 338 subjects |
| GSK1247446A Lot 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Any Ecchymosis | 30 subjects |
| GSK1247446A Lot 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Ecchymosis > 50 mm | 3 subjects |
| GSK1247446A Lot 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Any Pain | 456 subjects |
| GSK1247446A Lot 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Grade 3 Pain | 13 subjects |
| GSK1247446A Lot 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Redness > 50 mm | 115 subjects |
| GSK1247446A Lot 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Any Swelling | 238 subjects |
| GSK1247446A Lot 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Swelling > 50 mm | 59 subjects |
| GSK1247446A Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Redness > 50 mm | 298 subjects |
| GSK1247446A Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Any Pain | 1375 subjects |
| GSK1247446A Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Any Ecchymosis | 86 subjects |
| GSK1247446A Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Ecchymosis > 50 mm | 6 subjects |
| GSK1247446A Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Swelling > 50 mm | 159 subjects |
| GSK1247446A Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Any Redness | 959 subjects |
| GSK1247446A Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Any Swelling | 687 subjects |
| GSK1247446A Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Grade 3 Pain | 35 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Grade 3 Pain | 3 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Swelling > 50 mm | 5 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Redness > 50 mm | 17 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Any Pain | 170 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Any Swelling | 87 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Any Ecchymosis | 17 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Ecchymosis > 50 mm | 0 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Any Redness | 162 subjects |
Primary
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Unsolicited AE covers any AE 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 = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal activity Related = unsolicited AE assessed by the investigator as related to the vaccination. This table includes rare events, defined as events with an occurrence rate of 0.1 % and belonging to the AEs.
Time frame: During the 30-day (Days 0-29) post-vaccination period
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1247446A Lot 1 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with any related AE(s) | 47 subjects |
| GSK1247446A Lot 1 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with any Grade 3 AE(s) | 11 subjects |
| GSK1247446A Lot 1 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with any AE(s) | 133 subjects |
| GSK1247446A Lot 2 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with any AE(s) | 150 subjects |
| GSK1247446A Lot 2 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with any related AE(s) | 57 subjects |
| GSK1247446A Lot 2 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with any Grade 3 AE(s) | 14 subjects |
| GSK1247446A Lot 3 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with any Grade 3 AE(s) | 15 subjects |
| GSK1247446A Lot 3 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with any related AE(s) | 65 subjects |
| GSK1247446A Lot 3 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with any AE(s) | 162 subjects |
| GSK1247446A Pooled Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with any Grade 3 AE(s) | 40 subjects |
| GSK1247446A Pooled Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with any AE(s) | 445 subjects |
| GSK1247446A Pooled Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with any related AE(s) | 169 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with any related AE(s) | 16 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with any Grade 3 AE(s) | 10 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with any AE(s) | 109 subjects |
Primary
Number of Subjects With Medically Significant Conditions (MSCs).
MSCs were defined as conditions prompting emergency room visits or physician visits that were not related to common diseases or routine visits. This table includes rare events, defined as events with an occurrence rate of 0.1 % and belonging to the MSCs.
Time frame: From Day 0 to Day 180
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK1247446A Lot 1 Group | Number of Subjects With Medically Significant Conditions (MSCs). | 70 subjects |
| GSK1247446A Lot 2 Group | Number of Subjects With Medically Significant Conditions (MSCs). | 69 subjects |
| GSK1247446A Lot 3 Group | Number of Subjects With Medically Significant Conditions (MSCs). | 72 subjects |
| GSK1247446A Pooled Group | Number of Subjects With Medically Significant Conditions (MSCs). | 211 subjects |
| Fluarix Group | Number of Subjects With Medically Significant Conditions (MSCs). | 52 subjects |
Primary
Number of Subjects With New Onset of Chronic Diseases (NOCDs).
NOCDs include conditions such as diabetes, autoimmune disease, asthma, allergies etc. This table includes rare events, defined as events with an occurrence rate of 0.1 % and belonging to the NOCDs.
Time frame: From Day 0 to Day 180
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK1247446A Lot 1 Group | Number of Subjects With New Onset of Chronic Diseases (NOCDs). | 3 subjects |
| GSK1247446A Lot 2 Group | Number of Subjects With New Onset of Chronic Diseases (NOCDs). | 3 subjects |
| GSK1247446A Lot 3 Group | Number of Subjects With New Onset of Chronic Diseases (NOCDs). | 2 subjects |
| GSK1247446A Pooled Group | Number of Subjects With New Onset of Chronic Diseases (NOCDs). | 8 subjects |
| Fluarix Group | Number of Subjects With New Onset of Chronic Diseases (NOCDs). | 1 subjects |
Primary
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 assessed influenza strains were A/New Caledonia, A/New York and B/Malaysia. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables.
Time frame: At Day 21
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1247446A Lot 1 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/New Caledonia, Day 21 | 4.6 fold increase |
| GSK1247446A Lot 1 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/New York, Day 21 | 7.9 fold increase |
| GSK1247446A Lot 1 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | B/Malaysia, Day 21 | 8.2 fold increase |
| GSK1247446A Lot 2 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/New York, Day 21 | 7.9 fold increase |
| GSK1247446A Lot 2 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | B/Malaysia, Day 21 | 7.6 fold increase |
| GSK1247446A Lot 2 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/New Caledonia, Day 21 | 4.2 fold increase |
| GSK1247446A Lot 3 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/New Caledonia, Day 21 | 4.7 fold increase |
| GSK1247446A Lot 3 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | B/Malaysia, Day 21 | 7.6 fold increase |
| GSK1247446A Lot 3 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/New York, Day 21 | 7.7 fold increase |
| GSK1247446A Pooled Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/New York, Day 21 | 7.8 fold increase |
| GSK1247446A Pooled Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | B/Malaysia, Day 21 | 7.8 fold increase |
| GSK1247446A Pooled Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/New Caledonia, Day 21 | 4.5 fold increase |
| Fluarix Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/New York, Day 21 | 4.2 fold increase |
| Fluarix Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/New Caledonia, Day 21 | 5.1 fold increase |
| Fluarix Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | B/Malaysia, Day 21 | 6.0 fold increase |
Primary
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/New Caledonia, A/New York and B/Malaysia. The seropositivity cut-off assay was 1:10. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables.
Time frame: At Days 0 and 21
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1247446A Lot 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | B/Malaysia, Day 21 [N=492;488;492;1472;106] | 243.0 titers |
| GSK1247446A Lot 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/New Caledonia, Day 21 [N=492;488;492;1472;106] | 121.4 titers |
| GSK1247446A Lot 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/New York, Day 0 [N=494;494;499;1487;106] | 24.2 titers |
| GSK1247446A Lot 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/New York, Day 21 [N=492;488;492;1472;106] | 189.3 titers |
| GSK1247446A Lot 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | B/Malaysia, Day 0 [N=494;494;499;1487;106] | 29.6 titers |
| GSK1247446A Lot 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/New Caledonia, Day 0 [N=494;494;499;1487;106] | 26.7 titers |
| GSK1247446A Lot 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | B/Malaysia, Day 21 [N=492;488;492;1472;106] | 229.9 titers |
| GSK1247446A Lot 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/New York, Day 0 [N=494;494;499;1487;106] | 23.9 titers |
| GSK1247446A Lot 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/New Caledonia, Day 21 [N=492;488;492;1472;106] | 119.1 titers |
| GSK1247446A Lot 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/New Caledonia, Day 0 [N=494;494;499;1487;106] | 28.5 titers |
| GSK1247446A Lot 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | B/Malaysia, Day 0 [N=494;494;499;1487;106] | 29.7 titers |
| GSK1247446A Lot 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/New York, Day 21 [N=492;488;492;1472;106] | 192.3 titers |
| GSK1247446A Lot 3 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | B/Malaysia, Day 0 [N=494;494;499;1487;106] | 31.8 titers |
| GSK1247446A Lot 3 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | B/Malaysia, Day 21 [N=492;488;492;1472;106] | 238.7 titers |
| GSK1247446A Lot 3 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/New York, Day 21 [N=492;488;492;1472;106] | 187.3 titers |
| GSK1247446A Lot 3 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/New York, Day 0 [N=494;494;499;1487;106] | 24.3 titers |
| GSK1247446A Lot 3 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/New Caledonia, Day 0 [N=494;494;499;1487;106] | 28.6 titers |
| GSK1247446A Lot 3 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/New Caledonia, Day 21 [N=492;488;492;1472;106] | 133.8 titers |
| GSK1247446A Pooled Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/New Caledonia, Day 0 [N=494;494;499;1487;106] | 27.9 titers |
| GSK1247446A Pooled Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/New York, Day 0 [N=494;494;499;1487;106] | 24.1 titers |
| GSK1247446A Pooled Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/New York, Day 21 [N=492;488;492;1472;106] | 189.6 titers |
| GSK1247446A Pooled Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | B/Malaysia, Day 0 [N=494;494;499;1487;106] | 30.3 titers |
| GSK1247446A Pooled Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | B/Malaysia, Day 21 [N=492;488;492;1472;106] | 237.1 titers |
| GSK1247446A Pooled Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/New Caledonia, Day 21 [N=492;488;492;1472;106] | 124.6 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | B/Malaysia, Day 21 [N=492;488;492;1472;106] | 167.0 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | B/Malaysia, Day 0 [N=494;494;499;1487;106] | 27.7 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/New York, Day 21 [N=492;488;492;1472;106] | 110.9 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/New York, Day 0 [N=494;494;499;1487;106] | 26.2 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/New Caledonia, Day 21 [N=492;488;492;1472;106] | 130.6 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/New Caledonia, Day 0 [N=494;494;499;1487;106] | 25.7 titers |