Influenza
Conditions
Keywords
influenza infection, GSK Bio's influenza vaccine GSK2186877A
Brief summary
The objective of the study is to evaluate immunogenicity between different formulations of GSK Biologicals' investigational vaccine GSK2186877A.
Interventions
BIOLOGICALGSK investigational FluNG vaccine GSK2186877A, aged lot
Single dose, intramuscular injection
BIOLOGICALGSK investigational FluNG vaccine GSK2186877A, fresh lot
Single dose, intramuscular injection
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. Specific attention should be given to the compliance potential of subjects with suspected or known drug or alcohol abuse. * A man or woman 65 years of age or older at the time of vaccination. * Written informed consent obtained from the subject. * Free of an acute aggravation of the health status as established by clinical evaluation before entering into the study.
Exclusion criteria
* Any confirmed or suspected influenza illness within the last 6 months. * Previous vaccination against influenza with any seasonal vaccine since December 2008. * Planned administration of an influenza vaccine other than the study vaccines during the entire study period. * Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use 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 Visit 2. * Administration of immunoglobulins and/or any blood products within the 3 months preceding the dose of study vaccine or planned administration during the study period. * Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. For corticosteroids, this will mean prednisone \>= 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s) including egg and chicken protein, included history of hypersensitivity to a previous dose of influenza vaccine. * Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. * Acute disease and/or fever at the time of enrolment. * Fever is defined as temperature \>= 37.5°C on oral setting. * Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator. * Any medical conditions in which intramuscular injections are contraindicated.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Haemagglutination-Inhibition (HI) Antibody Titers Against the 3 Vaccine Strains | At Days 0 and 21 | Titers are presented as Geometric Mean Titers. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Seropositive Against the 3 Vaccine Strains | At Days 0 and 21 | A seropositive subject was defined as a subject with a serum HI titer greater than or equal to 1:10. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane. |
| Number of Subjects Seroconverted for the 3 Vaccine Strains | At Day 21 | A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a four-fold increase in post-vaccination titer. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane. |
| Seroconversion Factor for the 3 Vaccine Strains | At Day 21 | Seroconversion factor 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. |
| Number of Subjects Seroprotected for the 3 Vaccine Strains | At Days 0 and 21 | A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. |
| Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | During the 7-day post-vaccination period | Local symptoms assessed include ecchymosis, pain, redness and swelling. General symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, muscle aches, shivering and fever \[oral temperature greater than or equal to 38 degrees Celsius (°C)\]. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter. Grade 3 fever: oral temperature greater than or equal to 39°C. Related: general symptom assessed by the investigator as causally related to the study vaccination. |
| Duration of Solicited Local and General Symptoms | During the 7-day post-vaccination period | Local symptoms assessed include ecchymosis, pain, redness and swelling. General symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, muscle aches, shivering and fever. Duration is expressed as median number of days the specific symptom was experienced. |
| Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | During the 21-day 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. |
| Number of Subjects Reporting Adverse Events of Specific Interest (AESI) | During the 21-day post-vaccination period | AESIs for safety monitoring included autoimmune diseases and other immune mediated inflammatory disorders. |
| Number of Subjects Reporting Serious Adverse Events (SAEs) | During the entire study period (up to Day 21) | 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. |
Countries
Estonia, Slovakia
Participant flow
Pre-assignment details
Two subjects enrolled in the study did not receive any vaccination, and as such are not accounted for as started.
Participants by arm
| Arm | Count |
|---|---|
| FluNG Aged Group Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A). | 362 |
| FluNG Fresh Group Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A). | 362 |
| Total | 724 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lost to Follow-up | 2 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | FluNG Aged Group | FluNG Fresh Group | Total |
|---|---|---|---|
| Age, Continuous | 73.3 Years STANDARD_DEVIATION 6.09 | 73.5 Years STANDARD_DEVIATION 6.36 | 73.4 Years STANDARD_DEVIATION 6.22 |
| Sex: Female, Male Female | 239 Participants | 243 Participants | 482 Participants |
| Sex: Female, Male Male | 123 Participants | 119 Participants | 242 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 242 / 362 | 252 / 362 |
| serious Total, serious adverse events | 1 / 362 | 1 / 362 |
Outcome results
Primary
Serum Haemagglutination-Inhibition (HI) Antibody Titers Against the 3 Vaccine Strains
Titers are presented as Geometric Mean Titers. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane.
Time frame: At Days 0 and 21
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom data concerning immunogenicity outcome variable measures were available for the specific time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| FluNG Aged Group | Serum Haemagglutination-Inhibition (HI) Antibody Titers Against the 3 Vaccine Strains | A/Brisbane [Day 0] | 14.1 Titer |
| FluNG Aged Group | Serum Haemagglutination-Inhibition (HI) Antibody Titers Against the 3 Vaccine Strains | A/Brisbane [Day 21] | 108.4 Titer |
| FluNG Aged Group | Serum Haemagglutination-Inhibition (HI) Antibody Titers Against the 3 Vaccine Strains | A/Uruguay [Day 0] | 18.5 Titer |
| FluNG Aged Group | Serum Haemagglutination-Inhibition (HI) Antibody Titers Against the 3 Vaccine Strains | A/Uruguay [Day 21] | 291.5 Titer |
| FluNG Aged Group | Serum Haemagglutination-Inhibition (HI) Antibody Titers Against the 3 Vaccine Strains | B/Brisbane [Day 0] | 68.2 Titer |
| FluNG Aged Group | Serum Haemagglutination-Inhibition (HI) Antibody Titers Against the 3 Vaccine Strains | B/Brisbane [Day 21] | 537.9 Titer |
| FluNG Fresh Group | Serum Haemagglutination-Inhibition (HI) Antibody Titers Against the 3 Vaccine Strains | B/Brisbane [Day 0] | 62.3 Titer |
| FluNG Fresh Group | Serum Haemagglutination-Inhibition (HI) Antibody Titers Against the 3 Vaccine Strains | A/Brisbane [Day 0] | 13.4 Titer |
| FluNG Fresh Group | Serum Haemagglutination-Inhibition (HI) Antibody Titers Against the 3 Vaccine Strains | A/Uruguay [Day 21] | 282.7 Titer |
| FluNG Fresh Group | Serum Haemagglutination-Inhibition (HI) Antibody Titers Against the 3 Vaccine Strains | A/Brisbane [Day 21] | 108.7 Titer |
| FluNG Fresh Group | Serum Haemagglutination-Inhibition (HI) Antibody Titers Against the 3 Vaccine Strains | B/Brisbane [Day 21] | 534.2 Titer |
| FluNG Fresh Group | Serum Haemagglutination-Inhibition (HI) Antibody Titers Against the 3 Vaccine Strains | A/Uruguay [Day 0] | 19.1 Titer |
Secondary
Duration of Solicited Local and General Symptoms
Local symptoms assessed include ecchymosis, pain, redness and swelling. General symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, muscle aches, shivering and fever. Duration is expressed as median number of days the specific symptom was experienced.
Time frame: During the 7-day post-vaccination period
Population: The analysis was performed on the Total Vaccinated Cohort, on those subjects reporting the specific symptom only.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FluNG Aged Group | Duration of Solicited Local and General Symptoms | Ecchymosis | 4.0 Days |
| FluNG Aged Group | Duration of Solicited Local and General Symptoms | Pain | 2.0 Days |
| FluNG Aged Group | Duration of Solicited Local and General Symptoms | Redness | 3.0 Days |
| FluNG Aged Group | Duration of Solicited Local and General Symptoms | Swelling | 3.0 Days |
| FluNG Aged Group | Duration of Solicited Local and General Symptoms | Arthralgia | 4.0 Days |
| FluNG Aged Group | Duration of Solicited Local and General Symptoms | Fatigue | 2.5 Days |
| FluNG Aged Group | Duration of Solicited Local and General Symptoms | Gastrointestinal symptoms | 2.0 Days |
| FluNG Aged Group | Duration of Solicited Local and General Symptoms | Headache | 2.0 Days |
| FluNG Aged Group | Duration of Solicited Local and General Symptoms | Muscle aches | 3.0 Days |
| FluNG Aged Group | Duration of Solicited Local and General Symptoms | Shivering | 1.0 Days |
| FluNG Aged Group | Duration of Solicited Local and General Symptoms | Fever | 1.0 Days |
| FluNG Fresh Group | Duration of Solicited Local and General Symptoms | Fever | 1.0 Days |
| FluNG Fresh Group | Duration of Solicited Local and General Symptoms | Ecchymosis | 4.0 Days |
| FluNG Fresh Group | Duration of Solicited Local and General Symptoms | Gastrointestinal symptoms | 2.0 Days |
| FluNG Fresh Group | Duration of Solicited Local and General Symptoms | Shivering | 1.5 Days |
| FluNG Fresh Group | Duration of Solicited Local and General Symptoms | Redness | 3.0 Days |
| FluNG Fresh Group | Duration of Solicited Local and General Symptoms | Headache | 2.0 Days |
| FluNG Fresh Group | Duration of Solicited Local and General Symptoms | Swelling | 3.0 Days |
| FluNG Fresh Group | Duration of Solicited Local and General Symptoms | Pain | 3.0 Days |
| FluNG Fresh Group | Duration of Solicited Local and General Symptoms | Arthralgia | 3.0 Days |
| FluNG Fresh Group | Duration of Solicited Local and General Symptoms | Muscle aches | 2.0 Days |
| FluNG Fresh Group | Duration of Solicited Local and General Symptoms | Fatigue | 2.0 Days |
Secondary
Number of Subjects Reporting Adverse Events of Specific Interest (AESI)
AESIs for safety monitoring included autoimmune diseases and other immune mediated inflammatory disorders.
Time frame: During the 21-day post-vaccination period
Population: The analysis was performed on the Total Vaccinated Cohort including all vaccinated subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FluNG Aged Group | Number of Subjects Reporting Adverse Events of Specific Interest (AESI) | 0 Participants |
| FluNG Fresh Group | Number of Subjects Reporting Adverse Events of Specific Interest (AESI) | 0 Participants |
Secondary
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms
Local symptoms assessed include ecchymosis, pain, redness and swelling. General symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, muscle aches, shivering and fever \[oral temperature greater than or equal to 38 degrees Celsius (°C)\]. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter. Grade 3 fever: oral temperature greater than or equal to 39°C. Related: general symptom assessed by the investigator as causally related to the study vaccination.
Time frame: During the 7-day post-vaccination period
Population: The analysis was performed on the Total Vaccinated Cohort including all vaccinated subjects with their symptom sheet completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FluNG Aged Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches | 47 Participants |
| FluNG Aged Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering | 2 Participants |
| FluNG Aged Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Related Shivering | 20 Participants |
| FluNG Aged Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 1 Participants |
| FluNG Aged Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 4 Participants |
| FluNG Aged Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches | 2 Participants |
| FluNG Aged Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 6 Participants |
| FluNG Aged Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Any Shivering | 28 Participants |
| FluNG Aged Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Any Ecchymosis | 9 Participants |
| FluNG Aged Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Ecchymosis | 0 Participants |
| FluNG Aged Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Any Pain | 180 Participants |
| FluNG Aged Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Pain | 0 Participants |
| FluNG Aged Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Any Redness | 99 Participants |
| FluNG Aged Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Redness | 0 Participants |
| FluNG Aged Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Any Swelling | 45 Participants |
| FluNG Aged Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Swelling | 0 Participants |
| FluNG Aged Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia | 49 Participants |
| FluNG Aged Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia | 2 Participants |
| FluNG Aged Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia | 28 Participants |
| FluNG Aged Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 86 Participants |
| FluNG Aged Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 1 Participants |
| FluNG Aged Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 68 Participants |
| FluNG Aged Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms | 29 Participants |
| FluNG Aged Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms | 0 Participants |
| FluNG Aged Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms | 17 Participants |
| FluNG Aged Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 66 Participants |
| FluNG Aged Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 0 Participants |
| FluNG Aged Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 47 Participants |
| FluNG Aged Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches | 60 Participants |
| FluNG Fresh Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Swelling | 2 Participants |
| FluNG Fresh Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Any Shivering | 26 Participants |
| FluNG Fresh Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms | 1 Participants |
| FluNG Fresh Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering | 0 Participants |
| FluNG Fresh Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia | 63 Participants |
| FluNG Fresh Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Related Shivering | 23 Participants |
| FluNG Fresh Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 9 Participants |
| FluNG Fresh Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 62 Participants |
| FluNG Fresh Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 1 Participants |
| FluNG Fresh Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia | 0 Participants |
| FluNG Fresh Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 9 Participants |
| FluNG Fresh Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms | 15 Participants |
| FluNG Fresh Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia | 44 Participants |
| FluNG Fresh Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches | 49 Participants |
| FluNG Fresh Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 98 Participants |
| FluNG Fresh Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Any Ecchymosis | 11 Participants |
| FluNG Fresh Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 82 Participants |
| FluNG Fresh Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Ecchymosis | 0 Participants |
| FluNG Fresh Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 1 Participants |
| FluNG Fresh Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Any Pain | 190 Participants |
| FluNG Fresh Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches | 62 Participants |
| FluNG Fresh Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Pain | 2 Participants |
| FluNG Fresh Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 80 Participants |
| FluNG Fresh Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Any Redness | 106 Participants |
| FluNG Fresh Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 0 Participants |
| FluNG Fresh Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Redness | 2 Participants |
| FluNG Fresh Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms | 29 Participants |
| FluNG Fresh Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Any Swelling | 69 Participants |
| FluNG Fresh Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches | 1 Participants |
Secondary
Number of Subjects Reporting 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.
Time frame: During the 21-day post-vaccination period
Population: The analysis was performed on the Total Vaccinated Cohort including all vaccinated subjects.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FluNG Aged Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AEs | 13 Participants |
| FluNG Aged Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AEs | 1 Participants |
| FluNG Aged Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AEs | 5 Participants |
| FluNG Fresh Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AEs | 24 Participants |
| FluNG Fresh Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AEs | 1 Participants |
| FluNG Fresh Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AEs | 12 Participants |
Secondary
Number of Subjects Reporting 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.
Time frame: During the entire study period (up to Day 21)
Population: The analysis was performed on the Total Vaccinated Cohort including all vaccinated subjects.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FluNG Aged Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | Any SAEs | 1 Participants |
| FluNG Aged Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | Related SAEs | 0 Participants |
| FluNG Fresh Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | Any SAEs | 1 Participants |
| FluNG Fresh Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | Related SAEs | 0 Participants |
Secondary
Number of Subjects Seroconverted for the 3 Vaccine Strains
A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a four-fold increase in post-vaccination titer. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane.
Time frame: At Day 21
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom data concerning immunogenicity outcome variable measures were available for the specific time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FluNG Aged Group | Number of Subjects Seroconverted for the 3 Vaccine Strains | A/Brisbane | 228 Participants |
| FluNG Aged Group | Number of Subjects Seroconverted for the 3 Vaccine Strains | A/Uruguay | 292 Participants |
| FluNG Aged Group | Number of Subjects Seroconverted for the 3 Vaccine Strains | B/Brisbane | 224 Participants |
| FluNG Fresh Group | Number of Subjects Seroconverted for the 3 Vaccine Strains | A/Brisbane | 227 Participants |
| FluNG Fresh Group | Number of Subjects Seroconverted for the 3 Vaccine Strains | A/Uruguay | 292 Participants |
| FluNG Fresh Group | Number of Subjects Seroconverted for the 3 Vaccine Strains | B/Brisbane | 247 Participants |
Secondary
Number of Subjects Seropositive Against the 3 Vaccine Strains
A seropositive subject was defined as a subject with a serum HI titer greater than or equal to 1:10. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane.
Time frame: At Days 0 and 21
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom data concerning immunogenicity outcome variable measures were available for the specific time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FluNG Aged Group | Number of Subjects Seropositive Against the 3 Vaccine Strains | A/Brisbane [Day 0] | 224 Participants |
| FluNG Aged Group | Number of Subjects Seropositive Against the 3 Vaccine Strains | A/Brisbane [Day 21] | 353 Participants |
| FluNG Aged Group | Number of Subjects Seropositive Against the 3 Vaccine Strains | A/Uruguay [Day 0] | 231 Participants |
| FluNG Aged Group | Number of Subjects Seropositive Against the 3 Vaccine Strains | A/Uruguay [Day 21] | 353 Participants |
| FluNG Aged Group | Number of Subjects Seropositive Against the 3 Vaccine Strains | B/Brisbane [Day 0] | 326 Participants |
| FluNG Aged Group | Number of Subjects Seropositive Against the 3 Vaccine Strains | B/Brisbane [Day 21] | 357 Participants |
| FluNG Fresh Group | Number of Subjects Seropositive Against the 3 Vaccine Strains | B/Brisbane [Day 0] | 335 Participants |
| FluNG Fresh Group | Number of Subjects Seropositive Against the 3 Vaccine Strains | A/Brisbane [Day 0] | 220 Participants |
| FluNG Fresh Group | Number of Subjects Seropositive Against the 3 Vaccine Strains | A/Uruguay [Day 21] | 353 Participants |
| FluNG Fresh Group | Number of Subjects Seropositive Against the 3 Vaccine Strains | A/Brisbane [Day 21] | 349 Participants |
| FluNG Fresh Group | Number of Subjects Seropositive Against the 3 Vaccine Strains | B/Brisbane [Day 21] | 355 Participants |
| FluNG Fresh Group | Number of Subjects Seropositive Against the 3 Vaccine Strains | A/Uruguay [Day 0] | 236 Participants |
Secondary
Number of Subjects Seroprotected for the 3 Vaccine Strains
A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.
Time frame: At Days 0 and 21
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom data concerning immunogenicity outcome variable measures were available for the specific time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FluNG Aged Group | Number of Subjects Seroprotected for the 3 Vaccine Strains | A/Uruguay [Day 0] | 120 Participants |
| FluNG Aged Group | Number of Subjects Seroprotected for the 3 Vaccine Strains | A/Uruguay [Day 21] | 338 Participants |
| FluNG Aged Group | Number of Subjects Seroprotected for the 3 Vaccine Strains | B/Brisbane [Day 0] | 261 Participants |
| FluNG Aged Group | Number of Subjects Seroprotected for the 3 Vaccine Strains | A/Brisbane [Day 21] | 318 Participants |
| FluNG Aged Group | Number of Subjects Seroprotected for the 3 Vaccine Strains | B/Brisbane [Day 21] | 357 Participants |
| FluNG Aged Group | Number of Subjects Seroprotected for the 3 Vaccine Strains | A/Brisbane [Day 0] | 87 Participants |
| FluNG Fresh Group | Number of Subjects Seroprotected for the 3 Vaccine Strains | B/Brisbane [Day 21] | 355 Participants |
| FluNG Fresh Group | Number of Subjects Seroprotected for the 3 Vaccine Strains | A/Brisbane [Day 0] | 85 Participants |
| FluNG Fresh Group | Number of Subjects Seroprotected for the 3 Vaccine Strains | A/Brisbane [Day 21] | 308 Participants |
| FluNG Fresh Group | Number of Subjects Seroprotected for the 3 Vaccine Strains | A/Uruguay [Day 21] | 337 Participants |
| FluNG Fresh Group | Number of Subjects Seroprotected for the 3 Vaccine Strains | B/Brisbane [Day 0] | 260 Participants |
| FluNG Fresh Group | Number of Subjects Seroprotected for the 3 Vaccine Strains | A/Uruguay [Day 0] | 131 Participants |
Secondary
Seroconversion Factor for the 3 Vaccine Strains
Seroconversion factor 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.
Time frame: At Day 21
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom data concerning immunogenicity outcome variable measures were available for the specific time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| FluNG Aged Group | Seroconversion Factor for the 3 Vaccine Strains | A/Brisbane | 7.7 Fold Increase |
| FluNG Aged Group | Seroconversion Factor for the 3 Vaccine Strains | A/Uruguay | 15.8 Fold Increase |
| FluNG Aged Group | Seroconversion Factor for the 3 Vaccine Strains | B/Brisbane | 7.9 Fold Increase |
| FluNG Fresh Group | Seroconversion Factor for the 3 Vaccine Strains | A/Brisbane | 8.1 Fold Increase |
| FluNG Fresh Group | Seroconversion Factor for the 3 Vaccine Strains | A/Uruguay | 14.8 Fold Increase |
| FluNG Fresh Group | Seroconversion Factor for the 3 Vaccine Strains | B/Brisbane | 8.6 Fold Increase |