Influenza
Conditions
Keywords
Elderly, Vaccine, Influenza
Brief summary
The purpose of this observer-blind clinical trial is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in the elderly. Subjects were previously vaccinated (NCT00529516).
Interventions
BIOLOGICALInfluenza vaccine GSK2186877A
One intramuscularly injection at Day 0
BIOLOGICALGSK Biologicals' Fluarix™
One intramuscularly injection at Day 0
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* A male or female subject previously enrolled in study 109821 (NCT 00529516) in the \>= 65 years and 18-41 years of age groups and having received the study vaccine. * Subjects of whom the investigator believes that they can and will comply with the requirements of the protocol. Specific attention should be given to the compliance potential of subjects with suspected or known drug or alcohol abuse. * Written informed consent obtained from the subject. * Free of an acute aggravation of the health status as established by medical history and clinical examination before entering into the study * If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
Exclusion criteria
* 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. * Planned administration of an influenza vaccine other than the study vaccines during the entire study period. * Any vaccination against influenza since January 2008 with any seasonal influenza vaccine. * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * History of hypersensitivity to a previous dose of influenza vaccine. * History of allergy or reactions likely to be exacerbated by any component of the vaccines. * Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or pre-existing laboratory screening tests. * Acute disease at the time of enrolment. * Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned administration during the study period. * Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days prior to vaccination, or planned use during the study period. * Any medical conditions in which intramuscular injections are contraindicated. * Pregnant or lactating females. * Female planning to become pregnant or planning to discontinue contraceptive precautions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 0 to Day 20 | Day 0-20 | 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 was defined as occurrence of any symptom regardless of intensity grade and related was an event assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Day 0-6 | Grade 3 ecchymosis, redness and swelling were ≥ 100 millimeters (mm) and grade 3 pain was considerable pain at rest that prevented normal everyday activities. Any was \>20 mm for ecchymosis, redness and swelling. |
| Duration of Solicited Local AEs | Day 0-6 | Duration was defined as number of days with any grade of local symptoms. |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Day 0-6 | Any fever was defined as oral temperature ≥38.0 degree centigrade (°C), grade 3 fever was oral temperature ≥ 39.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relationship to the study vaccination, grade 3 was defined as a general symptom that prevented normal activity. Related arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever were defined as general symptoms assessed by the investigator as causally related to the study vaccination. |
| Duration of Solicited General AEs | Day 0-6 | Duration was defined as number of days with any grade of general symptoms. |
| Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs | Day 0-20 | 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 was defined as occurrence of any unsolicited symptom regardless of intensity grade. Grade 3 was defined as an unsolicited symptom that prevented normal activity. Related was an event assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) During Day 0 to Day 20 | Day 0-20 | For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as a symptom that prevented normal activity and related was a general symptom assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Diseases From Day 0 to Day 20 | Day 0-20 | AESI for safety monitoring are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any was defined as occurrence of any symptom regardless of intensity grade. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) Between Day 21 and Day 179 | Day 21-179 | For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as a symptom that prevented normal activity and related was a general symptom assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Diseases Between Day 21 and Day 364 | Day 21-364. | AESI for safety monitoring are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as a symptom that prevented normal activity and related was a general symptom assessed by the investigator as causally related to the study vaccination. |
| Haemagglutination Inhibition (HI) Antibody Titers | Day 0-21 | Antibody titers were expressed as Geometric mean titres (GMTs) per separate vaccine strain. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens. |
| The Number of Subjects Seropositive to HI Antibodies | Day 0-21 | A seropositive subject was defined as a subject with antibody titer greater than or equal to the cut-off value i.e ≥ 1:10. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens. |
| The Number of Subjects Seroprotected by HI Antibodies | Day 0-21 | A seroprotected subject was defined as a subject with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens. |
| The Number of Subjects Seroconverted to HI Antibodies | At Day 21 | A seroconverted subject was defined as a 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 4-fold increase in post-vaccination titer. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens. |
| HI Antibody Seroconversion Factors (SCF) | At Day 21 | SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens. |
| Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 21 to Day 364 | Day 21-364 | 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 was defined as occurrence of any symptom regardless of intensity grade and related was an event assessed by the investigator as causally related to the study vaccination. |
Countries
Belgium, Germany, Norway, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| New Generation Influenza Vaccine GSK2186877A Group Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A. | 375 |
| Fluarix Elderly Group Subjects aged ≥66 years received one dose of Fluarix vaccine. | 393 |
| Fluarix Young Group Subjects aged 19-43 years received one dose of Fluarix vaccine. | 203 |
| Total | 971 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 7 | 4 | 0 |
| Overall Study | Lost to Follow-up | 6 | 6 | 7 |
| Overall Study | Withdrawal by Subject | 9 | 8 | 9 |
Baseline characteristics
| Characteristic | New Generation Influenza Vaccine GSK2186877A Group | Fluarix Elderly Group | Fluarix Young Group | Total |
|---|---|---|---|---|
| Age, Continuous | 74.4 Years STANDARD_DEVIATION 5.23 | 74.7 Years STANDARD_DEVIATION 5.74 | 32.4 Years STANDARD_DEVIATION 6.78 | 65.7 Years STANDARD_DEVIATION 18.1 |
| Sex: Female, Male Female | 190 Participants | 203 Participants | 118 Participants | 511 Participants |
| Sex: Female, Male Male | 185 Participants | 190 Participants | 85 Participants | 460 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 | 218 / 375 | 109 / 393 | 133 / 203 |
| serious Total, serious adverse events | 40 / 375 | 43 / 393 | 4 / 203 |
Outcome results
Primary
Duration of Solicited General AEs
Duration was defined as number of days with any grade of general symptoms.
Time frame: Day 0-6
Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| New Generation Influenza Vaccine GSK2186877A Group | Duration of Solicited General AEs | Myalgia | 2.0 Days |
| New Generation Influenza Vaccine GSK2186877A Group | Duration of Solicited General AEs | Shivering | 1.0 Days |
| New Generation Influenza Vaccine GSK2186877A Group | Duration of Solicited General AEs | Fever | 1.0 Days |
| New Generation Influenza Vaccine GSK2186877A Group | Duration of Solicited General AEs | Fatigue | 2.0 Days |
| New Generation Influenza Vaccine GSK2186877A Group | Duration of Solicited General AEs | Gastrointestinal symptoms | 2.0 Days |
| New Generation Influenza Vaccine GSK2186877A Group | Duration of Solicited General AEs | Arthralgia | 2.0 Days |
| New Generation Influenza Vaccine GSK2186877A Group | Duration of Solicited General AEs | Headache | 1.0 Days |
| Fluarix Elderly Group | Duration of Solicited General AEs | Headache | 2.0 Days |
| Fluarix Elderly Group | Duration of Solicited General AEs | Gastrointestinal symptoms | 2.0 Days |
| Fluarix Elderly Group | Duration of Solicited General AEs | Shivering | 1.5 Days |
| Fluarix Elderly Group | Duration of Solicited General AEs | Fatigue | 2.0 Days |
| Fluarix Elderly Group | Duration of Solicited General AEs | Arthralgia | 3.0 Days |
| Fluarix Elderly Group | Duration of Solicited General AEs | Fever | 1.0 Days |
| Fluarix Elderly Group | Duration of Solicited General AEs | Myalgia | 3.0 Days |
| Fluarix Young Group | Duration of Solicited General AEs | Fever | 3.0 Days |
| Fluarix Young Group | Duration of Solicited General AEs | Arthralgia | 2.0 Days |
| Fluarix Young Group | Duration of Solicited General AEs | Gastrointestinal symptoms | 2.0 Days |
| Fluarix Young Group | Duration of Solicited General AEs | Headache | 1.0 Days |
| Fluarix Young Group | Duration of Solicited General AEs | Myalgia | 2.0 Days |
| Fluarix Young Group | Duration of Solicited General AEs | Shivering | 2.0 Days |
| Fluarix Young Group | Duration of Solicited General AEs | Fatigue | 2.0 Days |
Primary
Duration of Solicited Local AEs
Duration was defined as number of days with any grade of local symptoms.
Time frame: Day 0-6
Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| New Generation Influenza Vaccine GSK2186877A Group | Duration of Solicited Local AEs | Ecchymosis | 6.5 Days |
| New Generation Influenza Vaccine GSK2186877A Group | Duration of Solicited Local AEs | Pain | 2.0 Days |
| New Generation Influenza Vaccine GSK2186877A Group | Duration of Solicited Local AEs | Redness | 3.0 Days |
| New Generation Influenza Vaccine GSK2186877A Group | Duration of Solicited Local AEs | Swelling | 2.0 Days |
| Fluarix Elderly Group | Duration of Solicited Local AEs | Pain | 2.0 Days |
| Fluarix Elderly Group | Duration of Solicited Local AEs | Redness | 2.0 Days |
| Fluarix Elderly Group | Duration of Solicited Local AEs | Ecchymosis | 5.0 Days |
| Fluarix Elderly Group | Duration of Solicited Local AEs | Swelling | 1.5 Days |
| Fluarix Young Group | Duration of Solicited Local AEs | Redness | 1.0 Days |
| Fluarix Young Group | Duration of Solicited Local AEs | Pain | 2.0 Days |
| Fluarix Young Group | Duration of Solicited Local AEs | Swelling | 1.0 Days |
| Fluarix Young Group | Duration of Solicited Local AEs | Ecchymosis | 2.0 Days |
Primary
Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Diseases From Day 0 to Day 20
AESI for safety monitoring are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any was defined as occurrence of any symptom regardless of intensity grade.
Time frame: Day 0-20
Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| New Generation Influenza Vaccine GSK2186877A Group | Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Diseases From Day 0 to Day 20 | 0 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Diseases From Day 0 to Day 20 | 0 Participants |
| Fluarix Young Group | Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Diseases From Day 0 to Day 20 | 0 Participants |
Primary
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Grade 3 ecchymosis, redness and swelling were ≥ 100 millimeters (mm) and grade 3 pain was considerable pain at rest that prevented normal everyday activities. Any was \>20 mm for ecchymosis, redness and swelling.
Time frame: Day 0-6
Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| New Generation Influenza Vaccine GSK2186877A Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any ecchymosis | 2 Participants |
| New Generation Influenza Vaccine GSK2186877A Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 ecchymosis | 0 Participants |
| New Generation Influenza Vaccine GSK2186877A Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any pain | 159 Participants |
| New Generation Influenza Vaccine GSK2186877A Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 pain | 0 Participants |
| New Generation Influenza Vaccine GSK2186877A Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any redness | 57 Participants |
| New Generation Influenza Vaccine GSK2186877A Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 redness | 3 Participants |
| New Generation Influenza Vaccine GSK2186877A Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any swelling | 23 Participants |
| New Generation Influenza Vaccine GSK2186877A Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 swelling | 0 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any pain | 49 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any swelling | 6 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 pain | 0 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any redness | 10 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 redness | 0 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any ecchymosis | 3 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 ecchymosis | 0 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 swelling | 0 Participants |
| Fluarix Young Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any pain | 122 Participants |
| Fluarix Young Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 ecchymosis | 0 Participants |
| Fluarix Young Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any ecchymosis | 1 Participants |
| Fluarix Young Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 pain | 0 Participants |
| Fluarix Young Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any swelling | 7 Participants |
| Fluarix Young Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 redness | 0 Participants |
| Fluarix Young Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any redness | 9 Participants |
| Fluarix Young Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 swelling | 0 Participants |
Primary
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 0 to Day 20
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 was defined as occurrence of any symptom regardless of intensity grade and related was an event assessed by the investigator as causally related to the study vaccination.
Time frame: Day 0-20
Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| New Generation Influenza Vaccine GSK2186877A Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 0 to Day 20 | Any SAEs | 3 Participants |
| New Generation Influenza Vaccine GSK2186877A Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 0 to Day 20 | Related SAEs | 0 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 0 to Day 20 | Any SAEs | 4 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 0 to Day 20 | Related SAEs | 0 Participants |
| Fluarix Young Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 0 to Day 20 | Any SAEs | 0 Participants |
| Fluarix Young Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 0 to Day 20 | Related SAEs | 0 Participants |
Primary
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) During Day 0 to Day 20
For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as a symptom that prevented normal activity and related was a general symptom assessed by the investigator as causally related to the study vaccination.
Time frame: Day 0-20
Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| New Generation Influenza Vaccine GSK2186877A Group | Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) During Day 0 to Day 20 | Grade 3 MAE(s) | 3 Participants |
| New Generation Influenza Vaccine GSK2186877A Group | Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) During Day 0 to Day 20 | Any MAE(s) | 17 Participants |
| New Generation Influenza Vaccine GSK2186877A Group | Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) During Day 0 to Day 20 | Related MAE(s) | 0 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) During Day 0 to Day 20 | Grade 3 MAE(s) | 6 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) During Day 0 to Day 20 | Any MAE(s) | 22 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) During Day 0 to Day 20 | Related MAE(s) | 0 Participants |
| Fluarix Young Group | Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) During Day 0 to Day 20 | Any MAE(s) | 9 Participants |
| Fluarix Young Group | Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) During Day 0 to Day 20 | Related MAE(s) | 1 Participants |
| Fluarix Young Group | Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) During Day 0 to Day 20 | Grade 3 MAE(s) | 1 Participants |
Primary
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Any fever was defined as oral temperature ≥38.0 degree centigrade (°C), grade 3 fever was oral temperature ≥ 39.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relationship to the study vaccination, grade 3 was defined as a general symptom that prevented normal activity. Related arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever were defined as general symptoms assessed by the investigator as causally related to the study vaccination.
Time frame: Day 0-6
Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| New Generation Influenza Vaccine GSK2186877A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 gastrointestinal symptoms | 1 Participants |
| New Generation Influenza Vaccine GSK2186877A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any arthralgia | 44 Participants |
| New Generation Influenza Vaccine GSK2186877A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related myalgia | 44 Participants |
| New Generation Influenza Vaccine GSK2186877A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related gastrointestinal symptoms | 11 Participants |
| New Generation Influenza Vaccine GSK2186877A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any fatigue | 72 Participants |
| New Generation Influenza Vaccine GSK2186877A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 myalgia | 0 Participants |
| New Generation Influenza Vaccine GSK2186877A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any headache | 54 Participants |
| New Generation Influenza Vaccine GSK2186877A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related fever | 3 Participants |
| New Generation Influenza Vaccine GSK2186877A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any myalgia | 68 Participants |
| New Generation Influenza Vaccine GSK2186877A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 headache | 2 Participants |
| New Generation Influenza Vaccine GSK2186877A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any fever | 3 Participants |
| New Generation Influenza Vaccine GSK2186877A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related headache | 33 Participants |
| New Generation Influenza Vaccine GSK2186877A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 fatigue | 1 Participants |
| New Generation Influenza Vaccine GSK2186877A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 fever | 0 Participants |
| New Generation Influenza Vaccine GSK2186877A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related shivering | 21 Participants |
| New Generation Influenza Vaccine GSK2186877A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related fatigue | 40 Participants |
| New Generation Influenza Vaccine GSK2186877A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related arthralgia | 25 Participants |
| New Generation Influenza Vaccine GSK2186877A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 shivering | 1 Participants |
| New Generation Influenza Vaccine GSK2186877A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any gastrointestinal symptoms | 26 Participants |
| New Generation Influenza Vaccine GSK2186877A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 arthralgia | 0 Participants |
| New Generation Influenza Vaccine GSK2186877A Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any shivering | 32 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any fever | 1 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any arthralgia | 20 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 arthralgia | 0 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related arthralgia | 8 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any fatigue | 37 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 fatigue | 2 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related fatigue | 17 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any gastrointestinal symptoms | 18 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 gastrointestinal symptoms | 1 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related gastrointestinal symptoms | 10 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any headache | 38 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 headache | 2 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related headache | 18 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any myalgia | 33 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 myalgia | 1 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related myalgia | 16 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any shivering | 16 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 shivering | 2 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related shivering | 8 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 fever | 0 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related fever | 0 Participants |
| Fluarix Young Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 gastrointestinal symptoms | 0 Participants |
| Fluarix Young Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 arthralgia | 1 Participants |
| Fluarix Young Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related myalgia | 26 Participants |
| Fluarix Young Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any gastrointestinal symptoms | 9 Participants |
| Fluarix Young Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related fever | 2 Participants |
| Fluarix Young Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any shivering | 10 Participants |
| Fluarix Young Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related fatigue | 28 Participants |
| Fluarix Young Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 fever | 0 Participants |
| Fluarix Young Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 shivering | 0 Participants |
| Fluarix Young Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 fatigue | 2 Participants |
| Fluarix Young Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any arthralgia | 11 Participants |
| Fluarix Young Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related shivering | 10 Participants |
| Fluarix Young Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 headache | 0 Participants |
| Fluarix Young Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any fatigue | 39 Participants |
| Fluarix Young Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related headache | 21 Participants |
| Fluarix Young Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any headache | 31 Participants |
| Fluarix Young Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related arthralgia | 9 Participants |
| Fluarix Young Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any myalgia | 36 Participants |
| Fluarix Young Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related gastrointestinal symptoms | 7 Participants |
| Fluarix Young Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any fever | 2 Participants |
| Fluarix Young Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 myalgia | 1 Participants |
Primary
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited 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 was defined as occurrence of any unsolicited symptom regardless of intensity grade. Grade 3 was defined as an unsolicited symptom that prevented normal activity. Related was an event assessed by the investigator as causally related to the study vaccination.
Time frame: Day 0-20
Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| New Generation Influenza Vaccine GSK2186877A Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs | Grade 3 AE(s) | 3 Participants |
| New Generation Influenza Vaccine GSK2186877A Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs | Any AE(s) | 45 Participants |
| New Generation Influenza Vaccine GSK2186877A Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs | Related AE(s) | 8 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs | Grade 3 AE(s) | 8 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs | Any AE(s) | 47 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs | Related AE(s) | 5 Participants |
| Fluarix Young Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs | Any AE(s) | 38 Participants |
| Fluarix Young Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs | Related AE(s) | 3 Participants |
| Fluarix Young Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs | Grade 3 AE(s) | 1 Participants |
Secondary
Haemagglutination Inhibition (HI) Antibody Titers
Antibody titers were expressed as Geometric mean titres (GMTs) per separate vaccine strain. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
Time frame: Day 0-21
Population: Analysis was performed on According-to-Protocol (ATP) Immunogenicity cohort. This cohort included all evaluable subjects for whom data concerning immunogenicity were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| New Generation Influenza Vaccine GSK2186877A Group | Haemagglutination Inhibition (HI) Antibody Titers | A/Brisbane strain at Day 0 | 28.5 titer |
| New Generation Influenza Vaccine GSK2186877A Group | Haemagglutination Inhibition (HI) Antibody Titers | A/Brisbane strain at Day 21 | 70.8 titer |
| New Generation Influenza Vaccine GSK2186877A Group | Haemagglutination Inhibition (HI) Antibody Titers | A/Uruguay strain at Day 0 | 48.9 titer |
| New Generation Influenza Vaccine GSK2186877A Group | Haemagglutination Inhibition (HI) Antibody Titers | A/Uruguay strain at Day 21 | 331.3 titer |
| New Generation Influenza Vaccine GSK2186877A Group | Haemagglutination Inhibition (HI) Antibody Titers | B/Brisbane strain at Day 0 | 169.1 titer |
| New Generation Influenza Vaccine GSK2186877A Group | Haemagglutination Inhibition (HI) Antibody Titers | B/Brisbane strain at Day 21 | 576.5 titer |
| Fluarix Elderly Group | Haemagglutination Inhibition (HI) Antibody Titers | B/Brisbane strain at Day 21 | 463.5 titer |
| Fluarix Elderly Group | Haemagglutination Inhibition (HI) Antibody Titers | A/Brisbane strain at Day 0 | 22.9 titer |
| Fluarix Elderly Group | Haemagglutination Inhibition (HI) Antibody Titers | A/Uruguay strain at Day 21 | 149.2 titer |
| Fluarix Elderly Group | Haemagglutination Inhibition (HI) Antibody Titers | B/Brisbane strain at Day 0 | 157.4 titer |
| Fluarix Elderly Group | Haemagglutination Inhibition (HI) Antibody Titers | A/Brisbane strain at Day 21 | 51.9 titer |
| Fluarix Elderly Group | Haemagglutination Inhibition (HI) Antibody Titers | A/Uruguay strain at Day 0 | 29.2 titer |
| Fluarix Young Group | Haemagglutination Inhibition (HI) Antibody Titers | A/Brisbane strain at Day 21 | 112.5 titer |
| Fluarix Young Group | Haemagglutination Inhibition (HI) Antibody Titers | A/Uruguay strain at Day 0 | 29.2 titer |
| Fluarix Young Group | Haemagglutination Inhibition (HI) Antibody Titers | B/Brisbane strain at Day 21 | 765.2 titer |
| Fluarix Young Group | Haemagglutination Inhibition (HI) Antibody Titers | A/Uruguay strain at Day 21 | 161.7 titer |
| Fluarix Young Group | Haemagglutination Inhibition (HI) Antibody Titers | A/Brisbane strain at Day 0 | 52.8 titer |
| Fluarix Young Group | Haemagglutination Inhibition (HI) Antibody Titers | B/Brisbane strain at Day 0 | 196.4 titer |
Secondary
HI Antibody Seroconversion Factors (SCF)
SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
Time frame: At Day 21
Population: Analysis was performed on According-to-Protocol (ATP) immunogenicity cohort . The cohort included all evaluable subjects for whom data concerning immunogenicity at were available.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| New Generation Influenza Vaccine GSK2186877A Group | HI Antibody Seroconversion Factors (SCF) | B/Brisbane strain | 3.4 fold increase |
| New Generation Influenza Vaccine GSK2186877A Group | HI Antibody Seroconversion Factors (SCF) | A/Uruguay strain | 6.8 fold increase |
| New Generation Influenza Vaccine GSK2186877A Group | HI Antibody Seroconversion Factors (SCF) | A/Brisbane strain | 2.5 fold increase |
| Fluarix Elderly Group | HI Antibody Seroconversion Factors (SCF) | A/Uruguay strain | 5.1 fold increase |
| Fluarix Elderly Group | HI Antibody Seroconversion Factors (SCF) | A/Brisbane strain | 2.3 fold increase |
| Fluarix Elderly Group | HI Antibody Seroconversion Factors (SCF) | B/Brisbane strain | 2.9 fold increase |
| Fluarix Young Group | HI Antibody Seroconversion Factors (SCF) | A/Brisbane strain | 2.1 fold increase |
| Fluarix Young Group | HI Antibody Seroconversion Factors (SCF) | B/Brisbane strain | 3.9 fold increase |
| Fluarix Young Group | HI Antibody Seroconversion Factors (SCF) | A/Uruguay strain | 5.5 fold increase |
Secondary
Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Diseases Between Day 21 and Day 364
AESI for safety monitoring are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as a symptom that prevented normal activity and related was a general symptom assessed by the investigator as causally related to the study vaccination.
Time frame: Day 21-364.
Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| New Generation Influenza Vaccine GSK2186877A Group | Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Diseases Between Day 21 and Day 364 | Grade 3 AESI | 0 Participants |
| New Generation Influenza Vaccine GSK2186877A Group | Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Diseases Between Day 21 and Day 364 | Any AESI | 2 Participants |
| New Generation Influenza Vaccine GSK2186877A Group | Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Diseases Between Day 21 and Day 364 | Related AESI | 0 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Diseases Between Day 21 and Day 364 | Grade 3 AESI | 0 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Diseases Between Day 21 and Day 364 | Any AESI | 0 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Diseases Between Day 21 and Day 364 | Related AESI | 0 Participants |
| Fluarix Young Group | Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Diseases Between Day 21 and Day 364 | Any AESI | 0 Participants |
| Fluarix Young Group | Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Diseases Between Day 21 and Day 364 | Related AESI | 0 Participants |
| Fluarix Young Group | Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Diseases Between Day 21 and Day 364 | Grade 3 AESI | 0 Participants |
Secondary
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 21 to Day 364
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 was defined as occurrence of any symptom regardless of intensity grade and related was an event assessed by the investigator as causally related to the study vaccination.
Time frame: Day 21-364
Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| New Generation Influenza Vaccine GSK2186877A Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 21 to Day 364 | Any SAE(s) | 40 Participants |
| New Generation Influenza Vaccine GSK2186877A Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 21 to Day 364 | Related SAE(s) | 0 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 21 to Day 364 | Any SAE(s) | 43 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 21 to Day 364 | Related SAE(s) | 0 Participants |
| Fluarix Young Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 21 to Day 364 | Any SAE(s) | 4 Participants |
| Fluarix Young Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 21 to Day 364 | Related SAE(s) | 0 Participants |
Secondary
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) Between Day 21 and Day 179
For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as a symptom that prevented normal activity and related was a general symptom assessed by the investigator as causally related to the study vaccination.
Time frame: Day 21-179
Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| New Generation Influenza Vaccine GSK2186877A Group | Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) Between Day 21 and Day 179 | Grade 3 MAE(s) | 22 Participants |
| New Generation Influenza Vaccine GSK2186877A Group | Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) Between Day 21 and Day 179 | Any MAE(s) | 89 Participants |
| New Generation Influenza Vaccine GSK2186877A Group | Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) Between Day 21 and Day 179 | Related MAE(s) | 0 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) Between Day 21 and Day 179 | Grade 3 MAE(s) | 26 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) Between Day 21 and Day 179 | Any MAE(s) | 111 Participants |
| Fluarix Elderly Group | Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) Between Day 21 and Day 179 | Related MAE(s) | 0 Participants |
| Fluarix Young Group | Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) Between Day 21 and Day 179 | Any MAE(s) | 55 Participants |
| Fluarix Young Group | Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) Between Day 21 and Day 179 | Related MAE(s) | 0 Participants |
| Fluarix Young Group | Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) Between Day 21 and Day 179 | Grade 3 MAE(s) | 14 Participants |
Secondary
The Number of Subjects Seroconverted to HI Antibodies
A seroconverted subject was defined as a 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 4-fold increase in post-vaccination titer. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
Time frame: At Day 21
Population: Analysis was performed on According-to-Protocol (ATP) Immunogenicity cohort. This cohort included all evaluable subjects for whom data concerning immunogenicity were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| New Generation Influenza Vaccine GSK2186877A Group | The Number of Subjects Seroconverted to HI Antibodies | A/Uruguay strain | 285 Participants |
| New Generation Influenza Vaccine GSK2186877A Group | The Number of Subjects Seroconverted to HI Antibodies | A/Brisbane strain | 107 Participants |
| New Generation Influenza Vaccine GSK2186877A Group | The Number of Subjects Seroconverted to HI Antibodies | B/Brisbane strain | 168 Participants |
| Fluarix Elderly Group | The Number of Subjects Seroconverted to HI Antibodies | A/Uruguay strain | 228 Participants |
| Fluarix Elderly Group | The Number of Subjects Seroconverted to HI Antibodies | A/Brisbane strain | 94 Participants |
| Fluarix Elderly Group | The Number of Subjects Seroconverted to HI Antibodies | B/Brisbane strain | 140 Participants |
| Fluarix Young Group | The Number of Subjects Seroconverted to HI Antibodies | A/Brisbane strain | 54 Participants |
| Fluarix Young Group | The Number of Subjects Seroconverted to HI Antibodies | B/Brisbane strain | 104 Participants |
| Fluarix Young Group | The Number of Subjects Seroconverted to HI Antibodies | A/Uruguay strain | 124 Participants |
Secondary
The Number of Subjects Seropositive to HI Antibodies
A seropositive subject was defined as a subject with antibody titer greater than or equal to the cut-off value i.e ≥ 1:10. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
Time frame: Day 0-21
Population: Analysis was performed on According-to-Protocol (ATP) Immunogenicity cohort. This cohort included all evaluable subjects for whom data concerning immunogenicity were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| New Generation Influenza Vaccine GSK2186877A Group | The Number of Subjects Seropositive to HI Antibodies | A/Brisbane strain at Day 0 | 336 Participants |
| New Generation Influenza Vaccine GSK2186877A Group | The Number of Subjects Seropositive to HI Antibodies | A/Brisbane strain at Day 21 | 364 Participants |
| New Generation Influenza Vaccine GSK2186877A Group | The Number of Subjects Seropositive to HI Antibodies | A/Uruguay strain at Day 0 | 344 Participants |
| New Generation Influenza Vaccine GSK2186877A Group | The Number of Subjects Seropositive to HI Antibodies | A/Uruguay strain at Day 21 | 368 Participants |
| New Generation Influenza Vaccine GSK2186877A Group | The Number of Subjects Seropositive to HI Antibodies | B/Brisbane strain at Day 0 | 366 Participants |
| New Generation Influenza Vaccine GSK2186877A Group | The Number of Subjects Seropositive to HI Antibodies | B/Brisbane strain at Day 21 | 368 Participants |
| Fluarix Elderly Group | The Number of Subjects Seropositive to HI Antibodies | B/Brisbane strain at Day 21 | 375 Participants |
| Fluarix Elderly Group | The Number of Subjects Seropositive to HI Antibodies | A/Brisbane strain at Day 0 | 315 Participants |
| Fluarix Elderly Group | The Number of Subjects Seropositive to HI Antibodies | A/Uruguay strain at Day 21 | 368 Participants |
| Fluarix Elderly Group | The Number of Subjects Seropositive to HI Antibodies | B/Brisbane strain at Day 0 | 374 Participants |
| Fluarix Elderly Group | The Number of Subjects Seropositive to HI Antibodies | A/Brisbane strain at Day 21 | 366 Participants |
| Fluarix Elderly Group | The Number of Subjects Seropositive to HI Antibodies | A/Uruguay strain at Day 0 | 320 Participants |
| Fluarix Young Group | The Number of Subjects Seropositive to HI Antibodies | A/Brisbane strain at Day 21 | 193 Participants |
| Fluarix Young Group | The Number of Subjects Seropositive to HI Antibodies | A/Uruguay strain at Day 0 | 167 Participants |
| Fluarix Young Group | The Number of Subjects Seropositive to HI Antibodies | B/Brisbane strain at Day 21 | 194 Participants |
| Fluarix Young Group | The Number of Subjects Seropositive to HI Antibodies | A/Uruguay strain at Day 21 | 191 Participants |
| Fluarix Young Group | The Number of Subjects Seropositive to HI Antibodies | A/Brisbane strain at Day 0 | 186 Participants |
| Fluarix Young Group | The Number of Subjects Seropositive to HI Antibodies | B/Brisbane strain at Day 0 | 192 Participants |
Secondary
The Number of Subjects Seroprotected by HI Antibodies
A seroprotected subject was defined as a subject with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
Time frame: Day 0-21
Population: Analysis was performed on According-to-Protocol (ATP) Immunogenicity cohort. This cohort included all evaluable subjects for whom data concerning immunogenicity were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| New Generation Influenza Vaccine GSK2186877A Group | The Number of Subjects Seroprotected by HI Antibodies | A/Brisbane strain at Day 0 | 171 Participants |
| New Generation Influenza Vaccine GSK2186877A Group | The Number of Subjects Seroprotected by HI Antibodies | A/Brisbane strain at Day 21 | 314 Participants |
| New Generation Influenza Vaccine GSK2186877A Group | The Number of Subjects Seroprotected by HI Antibodies | A/Uruguay strain at Day 0 | 247 Participants |
| New Generation Influenza Vaccine GSK2186877A Group | The Number of Subjects Seroprotected by HI Antibodies | A/Uruguay strain at Day 21 | 361 Participants |
| New Generation Influenza Vaccine GSK2186877A Group | The Number of Subjects Seroprotected by HI Antibodies | B/Brisbane strain at Day 0 | 359 Participants |
| New Generation Influenza Vaccine GSK2186877A Group | The Number of Subjects Seroprotected by HI Antibodies | B/Brisbane strain at Day 21 | 368 Participants |
| Fluarix Elderly Group | The Number of Subjects Seroprotected by HI Antibodies | B/Brisbane strain at Day 21 | 375 Participants |
| Fluarix Elderly Group | The Number of Subjects Seroprotected by HI Antibodies | A/Brisbane strain at Day 0 | 142 Participants |
| Fluarix Elderly Group | The Number of Subjects Seroprotected by HI Antibodies | A/Uruguay strain at Day 21 | 341 Participants |
| Fluarix Elderly Group | The Number of Subjects Seroprotected by HI Antibodies | B/Brisbane strain at Day 0 | 363 Participants |
| Fluarix Elderly Group | The Number of Subjects Seroprotected by HI Antibodies | A/Brisbane strain at Day 21 | 276 Participants |
| Fluarix Elderly Group | The Number of Subjects Seroprotected by HI Antibodies | A/Uruguay strain at Day 0 | 178 Participants |
| Fluarix Young Group | The Number of Subjects Seroprotected by HI Antibodies | A/Brisbane strain at Day 21 | 179 Participants |
| Fluarix Young Group | The Number of Subjects Seroprotected by HI Antibodies | A/Uruguay strain at Day 0 | 102 Participants |
| Fluarix Young Group | The Number of Subjects Seroprotected by HI Antibodies | B/Brisbane strain at Day 21 | 194 Participants |
| Fluarix Young Group | The Number of Subjects Seroprotected by HI Antibodies | A/Uruguay strain at Day 21 | 181 Participants |
| Fluarix Young Group | The Number of Subjects Seroprotected by HI Antibodies | A/Brisbane strain at Day 0 | 137 Participants |
| Fluarix Young Group | The Number of Subjects Seroprotected by HI Antibodies | B/Brisbane strain at Day 0 | 186 Participants |