Influenza
Conditions
Keywords
Influenza, Influenza vaccine
Brief summary
The purpose of this study is to evaluate the immune response and safety of influenza vaccine candidate with or without adjuvant compared to Fluarix™ administered intramuscularly in elderly aged 60 years old and above.
Detailed description
Subjects will be randomized into 3 groups and will be followed for 6 months with 4 scheduled contacts per subjects. The immune response will be evaluated at days 0, 21 and 180 after vaccination. The safety evaluation will involve follow-up of solicited local and general signs and symptoms, unsolicited adverse events and serious adverse events. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Interventions
BIOLOGICALCandidate Influenza Vaccine GSK1247446A - 2 different formulations
Single dose, Intramuscular injection
BIOLOGICALFluarixTM
Single dose, Intramuscular injection
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
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 hypersensivity to a previous dose of influenza vaccine. * Previous vaccination against influenza within the 9 months prior to enrollment. * 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 Virus | At Days 0 and 21 post-vaccination | Titers are presented as geometric mean titers (GMTs). The 3 flu strains assessed were A/New Caledonia, A/New York and B/Malaysia. The reference seropositivity cut-off value was ≥ 1:10. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus | At Day 180 post-vaccination. | Titers are presented as geometric mean titers (GMTs). The 3 flu strains assessed were A/New Caledonia, A/New York and B/Malaysia. The reference seropositivity cut-off value was ≥ 1:10. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | During the 7-day (Days 0-6) follow-up period after vaccination | Assessed solicited local symptoms were ecchymosis, pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 ecchymosis/redness/swelling = ecchymosis/redness/swelling spreading beyond 50 millimeters (mm) of injection site. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | During the 7-day (Days 0-6) follow up period after vaccination | Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as oral temperature equal to or above 37.5 degrees Celsius (°C)\], headache, muscle aches, shivering. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. |
| Number of Subjects With Unsolicited Adverse Events (AEs). | During the 30-day (Days 0-29) follow-up period after vaccination | 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 Any and Related Serious Adverse Events (SAEs) | During the entire study period (Day 0 to Day 180) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Any = occurrence of any SAE regardless of intensity grade or relation to vaccination. Related = SAE assessed by the investigator as related to the vaccination. |
Countries
Finland, Greece
Participant flow
Recruitment details
A total of 1220 subjects were enrolled in the study. Study duration was of approximately 6 months (180 days) for all subjects.
Participants by arm
| Arm | Count |
|---|---|
| GSK1247446A-AS03 Group Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | 407 |
| GSK1247446A Group Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | 406 |
| Fluarix Group Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | 407 |
| Total | 1,220 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 | 1 |
| Overall Study | Other | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | GSK1247446A-AS03 Group | GSK1247446A Group | Fluarix Group | Total |
|---|---|---|---|---|
| Age, Continuous | 64.0 Years STANDARD_DEVIATION 5.12 | 64.1 Years STANDARD_DEVIATION 4.95 | 64.2 Years STANDARD_DEVIATION 5.38 | 64.1 Years STANDARD_DEVIATION 5.15 |
| Sex: Female, Male Female | 209 Participants | 205 Participants | 208 Participants | 622 Participants |
| Sex: Female, Male Male | 198 Participants | 201 Participants | 199 Participants | 598 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 302 / 407 | 143 / 406 | 181 / 407 |
| serious Total, serious adverse events | 8 / 407 | 13 / 406 | 13 / 407 |
Outcome results
Primary
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus
Titers are presented as geometric mean titers (GMTs). The 3 flu strains assessed were A/New Caledonia, A/New York and B/Malaysia. The reference seropositivity cut-off value was ≥ 1:10.
Time frame: At Days 0 and 21 post-vaccination
Population: The analysis was based on the ATP cohort for immunogenicity at Day 21 including subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination at this time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1247446A-AS03 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus | A/New Caledonia, Day 0 [N=395,393,389] | 13.4 titer |
| GSK1247446A-AS03 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus | A/New York, Day 0 [N=395,393,389] | 10.8 titer |
| GSK1247446A-AS03 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus | B/Malaysia, Day 0 [N=395,393,389] | 17.8 titer |
| GSK1247446A-AS03 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus | A/New Caledonia, Day 21 [N=395,393,389] | 168.0 titer |
| GSK1247446A-AS03 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus | A/New York, Day 21 [N=395,393,389] | 179.8 titer |
| GSK1247446A-AS03 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus | B/Malaysia, Day 21 [N=394,390,389] | 341.2 titer |
| GSK1247446A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus | B/Malaysia, Day 21 [N=394,390,389] | 175.4 titer |
| GSK1247446A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus | A/New Caledonia, Day 0 [N=395,393,389] | 13.9 titer |
| GSK1247446A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus | A/New Caledonia, Day 21 [N=395,393,389] | 97.7 titer |
| GSK1247446A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus | A/New York, Day 21 [N=395,393,389] | 70.4 titer |
| GSK1247446A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus | A/New York, Day 0 [N=395,393,389] | 11.9 titer |
| GSK1247446A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus | B/Malaysia, Day 0 [N=395,393,389] | 16.0 titer |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus | A/New York, Day 0 [N=395,393,389] | 11.5 titer |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus | B/Malaysia, Day 0 [N=395,393,389] | 15.6 titer |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus | B/Malaysia, Day 21 [N=394,390,389] | 292.0 titer |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus | A/New Caledonia, Day 21 [N=395,393,389] | 202.4 titer |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus | A/New Caledonia, Day 0 [N=395,393,389] | 14.2 titer |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus | A/New York, Day 21 [N=395,393,389] | 104.3 titer |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Assessed solicited local symptoms were ecchymosis, pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 ecchymosis/redness/swelling = ecchymosis/redness/swelling spreading beyond 50 millimeters (mm) of injection site.
Time frame: During the 7-day (Days 0-6) follow-up period after vaccination
Population: The analysis was based on the Total Vaccinated Cohort that included all vaccinated subjects with the symptom sheet completed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1247446A-AS03 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Swelling | 84 Subjects |
| GSK1247446A-AS03 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Ecchymosis > 50mm | 1 Subjects |
| GSK1247446A-AS03 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Redness > 50mm | 22 Subjects |
| GSK1247446A-AS03 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Swelling > 50mm | 19 Subjects |
| GSK1247446A-AS03 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain | 12 Subjects |
| GSK1247446A-AS03 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Ecchymosis | 28 Subjects |
| GSK1247446A-AS03 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Redness | 95 Subjects |
| GSK1247446A-AS03 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Pain | 246 Subjects |
| GSK1247446A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Ecchymosis > 50mm | 0 Subjects |
| GSK1247446A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Pain | 32 Subjects |
| GSK1247446A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Swelling > 50mm | 0 Subjects |
| GSK1247446A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Ecchymosis | 20 Subjects |
| GSK1247446A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Swelling | 8 Subjects |
| GSK1247446A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain | 0 Subjects |
| GSK1247446A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Redness > 50mm | 1 Subjects |
| GSK1247446A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Redness | 50 Subjects |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Redness | 65 Subjects |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Swelling | 50 Subjects |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Swelling > 50mm | 4 Subjects |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Pain | 86 Subjects |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Redness > 50mm | 6 Subjects |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain | 1 Subjects |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Ecchymosis | 19 Subjects |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Ecchymosis > 50mm | 1 Subjects |
Secondary
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 or result in disability/incapacity. Any = occurrence of any SAE regardless of intensity grade or relation to vaccination. Related = SAE assessed by the investigator as related to the vaccination.
Time frame: During the entire study period (Day 0 to Day 180)
Population: The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1247446A-AS03 Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Subjects with any SAE(s) | 8 Subjects |
| GSK1247446A-AS03 Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Subjects with related SAE(s) | 2 Subjects |
| GSK1247446A Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Subjects with any SAE(s) | 13 Subjects |
| GSK1247446A Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Subjects with related SAE(s) | 1 Subjects |
| Fluarix Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Subjects with any SAE(s) | 13 Subjects |
| Fluarix Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Subjects with related SAE(s) | 0 Subjects |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as oral temperature equal to or above 37.5 degrees Celsius (°C)\], headache, muscle aches, shivering. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 7-day (Days 0-6) follow up period after vaccination
Population: The analysis was based on the Total vaccinated Cohort which included all vaccinated subjects with the symptom sheet completed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1247446A-AS03 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever (oral) ≥37.5°C | 21 Subjects |
| GSK1247446A-AS03 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue | 149 Subjects |
| GSK1247446A-AS03 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Shivering | 94 Subjects |
| GSK1247446A-AS03 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fever | 21 Subjects |
| GSK1247446A-AS03 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Arthralgia | 73 Subjects |
| GSK1247446A-AS03 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Arthralgia | 80 Subjects |
| GSK1247446A-AS03 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Arthralgia | 6 Subjects |
| GSK1247446A-AS03 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Muscle aches | 129 Subjects |
| GSK1247446A-AS03 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Headache | 104 Subjects |
| GSK1247446A-AS03 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue | 6 Subjects |
| GSK1247446A-AS03 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Headache | 100 Subjects |
| GSK1247446A-AS03 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Muscle aches | 6 Subjects |
| GSK1247446A-AS03 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache | 5 Subjects |
| GSK1247446A-AS03 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Muscle aches | 125 Subjects |
| GSK1247446A-AS03 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Shivering | 10 Subjects |
| GSK1247446A-AS03 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever (oral) ≥39.0°C | 0 Subjects |
| GSK1247446A-AS03 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Shivering | 95 Subjects |
| GSK1247446A-AS03 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue | 148 Subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fever | 2 Subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue | 1 Subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Muscle aches | 31 Subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Muscle aches | 28 Subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Shivering | 19 Subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Shivering | 17 Subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Arthralgia | 17 Subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Arthralgia | 0 Subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Arthralgia | 14 Subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue | 42 Subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue | 36 Subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever (oral) ≥37.5°C | 4 Subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever (oral) ≥39.0°C | 0 Subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Headache | 51 Subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache | 0 Subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Headache | 45 Subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Muscle aches | 0 Subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Shivering | 1 Subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Shivering | 26 Subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Muscle aches | 38 Subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever (oral) ≥37.5°C | 2 Subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Muscle aches | 36 Subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue | 0 Subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever (oral) ≥39.0°C | 0 Subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Headache | 46 Subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Arthralgia | 21 Subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Headache | 53 Subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Arthralgia | 1 Subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Shivering | 22 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. | Related Arthralgia | 18 Subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Shivering | 1 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 Fatigue | 47 Subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache | 1 Subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue | 42 Subjects |
Secondary
Number of Subjects With Unsolicited Adverse Events (AEs).
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time frame: During the 30-day (Days 0-29) follow-up period after vaccination
Population: The analysis was based on the Total Vaccinated Cohort which included all vaccinated subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1247446A-AS03 Group | Number of Subjects With Unsolicited Adverse Events (AEs). | Subjects with related AEs | 43 Subjects |
| GSK1247446A-AS03 Group | Number of Subjects With Unsolicited Adverse Events (AEs). | Subjects with Grade 3 AEs | 13 Subjects |
| GSK1247446A-AS03 Group | Number of Subjects With Unsolicited Adverse Events (AEs). | Subjects with any AEs | 114 Subjects |
| GSK1247446A Group | Number of Subjects With Unsolicited Adverse Events (AEs). | Subjects with any AEs | 82 Subjects |
| GSK1247446A Group | Number of Subjects With Unsolicited Adverse Events (AEs). | Subjects with Grade 3 AEs | 11 Subjects |
| GSK1247446A Group | Number of Subjects With Unsolicited Adverse Events (AEs). | Subjects with related AEs | 19 Subjects |
| Fluarix Group | Number of Subjects With Unsolicited Adverse Events (AEs). | Subjects with related AEs | 19 Subjects |
| Fluarix Group | Number of Subjects With Unsolicited Adverse Events (AEs). | Subjects with any AEs | 95 Subjects |
| Fluarix Group | Number of Subjects With Unsolicited Adverse Events (AEs). | Subjects with Grade 3 AEs | 16 Subjects |
Secondary
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus
Titers are presented as geometric mean titers (GMTs). The 3 flu strains assessed were A/New Caledonia, A/New York and B/Malaysia. The reference seropositivity cut-off value was ≥ 1:10.
Time frame: At Day 180 post-vaccination.
Population: The analysis was based on the ATP cohort for immunogenicity at Day 180 including subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination at this time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1247446A-AS03 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus | A/New York at Day180 | 56.8 titer |
| GSK1247446A-AS03 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus | A/New Caledonia at Day180 | 64.3 titer |
| GSK1247446A-AS03 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus | B/Malaysia at Day180 | 88.6 titer |
| GSK1247446A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus | A/New Caledonia at Day180 | 54.3 titer |
| GSK1247446A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus | A/New York at Day180 | 35.8 titer |
| GSK1247446A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus | B/Malaysia at Day180 | 65.2 titer |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus | A/New Caledonia at Day180 | 84.4 titer |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus | B/Malaysia at Day180 | 90.9 titer |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus | A/New York at Day180 | 42.4 titer |