Influenza
Conditions
Keywords
Influenza vaccine
Brief summary
A study to investigate the incidence of influenza and influenza-related complications, in adults between 50-64 years and elderly adults 65 years and over vaccinated with Fluarix™
Interventions
BIOLOGICALFluarix™
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* A male or female age 50 years or older at the time of the first vaccination. * non-childbearing female * Availability to follow up by phone * Subjects with residence status allowing free mixing with general community
Exclusion criteria
* Use of non-registered products * Pregnancy * Hypersensitivity to a previous dose of influenza vaccine * Acute disease at the time of enrolment/vaccination. * History of allergy or reactions likely to be exacerbated by any component of the vaccine * Any contra-indication to intramuscular administration of Fluarix™ * For subjects enrolled in the immunogenicity subset only: administration of immune-modifying drugs within 7 days prior to the vaccination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With at Least One Influenza-like-infection (ILI) Episode | From Month 0 to Month 6 | Analysis included all non-confirmed or lab confirmed ILI episodes (at least 1 episode, 1 episode, 2 episodes or more than (\>) 2 episodes) reported. |
| Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B | From Month 0 to Month 6 | Lab confirmed ILI episodes were assessed by means of viral culture (VC) infection (nasal and throat swabs) determination and/or using the Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) assay. |
| Number of Subjects With Hospitalization, Emergency Room Visits, or Unscheduled Medical Office Visits Due to ILI | From Month 0 to Month 6 | ILI which led to subject hospitalization, emergency room visits and unplanned medical office visits were recorded by number (at least 1, 1, or above 1), as part of the ILI surveillance. |
| Number of Subjects With Hospitalizations, Emergency Room Visits or Unscheduled Medical Office Visits, Due to Laboratory Confirmed Influenza | From Month 0 to Month 6 | Laboratory confirmed (LC) ILI which led to subject hospitalization, emergency room visits and unplanned medical office visits were recorded by number (at least 1, 1, or above 1), as part of the ILI surveillance. |
| Number of Subjects With Hospitalization or Emergency Room Visit for Any Cause | From Month 0 to Month 6 | As part of ILI surveillance any reasons, or other reasons than those mentioned which led to subject hospitalization, emergency room visits and unplanned medical office visits were recorded by number (at least 1, 1, or above 1). |
| Number of Subjects With Emergency Room Visits, or Unscheduled Medical Office Visits Due to Influenza-related Complications | From Month 0 to Month 6 | ILI complications which led to subject hospitalization, emergency room visits and unplanned medical office visits were recorded by number (at least 1, 1, or above 1) as part of the ILI surveillance, which included: pneumonia, ischemic heart disease, congestive failure, acute cerebrovascular disease chronic obstructive pulmonary disease (COPD) exacerbation. |
| Number of Subjects With Influenza-related Complications | From Month 0 to Month 6 | ILI complications refer to episodes of pneumonia, ischemic heart disease \[HD\] (unstable angina or myocardial infarction), congestive heart failure \[HF\], acute cerebrovascular disease \[ACD\] (stroke or transient ischemic attack \[IA\]), COPD exacerbation and all illnesses (pooled episode of each illness). ILI complications were recorded by number of episodes (at least 1 episode, 1 episode and above 1 episode). |
| Number of Subjects With Fatal Outcomes Due to Laboratory Confirmed Influenza Infection | From Month 0 to Month 6 | Death due to lab confirmed influenza infection was recorded during the influeza period only. |
| Number of Subjects With Fatal Outcomes | From Month 0 to Month 6 | Number of deaths caused by laboratory non-confirmed ILI or other reasons were recorded during the influenza |
| Number of Subjects With Laboratory-confirmed Respiratory Syncytial Virus Infection (RSV) | From Month 0 to Month 6 | RSV infection was determined by the RT-PCR assay. |
| Number of Subjects With Serious Adverse Events (SAEs) | From Month 0 to Month 6 | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or 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 or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination. |
| Number of Seroconverted Subjects for Each Influenza Strain | At Day 21 | A seroconverted subject was defined as a subject having either a pre-vaccination hemagglutinin inhibition (HI) titer lower than (\<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥1:10 and a minimum four-fold increase in the post-vaccination titer. Assessed influenza strains were A/New Caledonia, A/Wisconsin and B/Malaysia. |
| Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | At Day 21 | The seroconversion factor (SCF) was defined as the fold increase in serum HI geometric mean titer (GMT) post vaccination on Day 21 compared to Day 0. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia. |
| Number of Seroprotected Subjects Against the 3 Influenza Strains | At Day 0 (PRE) | A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥1:40. |
| Number of Seropositive Subjects for Each Influenza Strain | At Day 0 (PRE) | A seropositive subject was defined as a vaccinated subject with antibody titer ≥1:10. |
| Serum HI Antibody Titers for Each Influenza Strain | At Day 0 (PRE) | Serum HI antibody titers were expressed as Geometric Mean Titers (GMTs). |
Countries
Germany, Netherlands, Poland, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fluarix 50-64 Years Group Adult subjects aged between and including 50-64 years who received a single dose of Fluarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm, were enrolled for investigation of influenza and influenza-related complications. | 1,047 |
| Fluarix 65+ Years Group Elderly subjects aged 65 and over who received a single dose of Fluarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm, were enrolled for investigation of influenza and influenza-related complications. | 2,007 |
| Total | 3,054 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 9 |
| Overall Study | Lost to Follow-up | 18 | 16 |
| Overall Study | Other | 0 | 3 |
| Overall Study | Protocol Violation | 2 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 5 |
Baseline characteristics
| Characteristic | Fluarix 50-64 Years Group | Fluarix 65+ Years Group | Total |
|---|---|---|---|
| Age, Continuous | 57.6 Years STANDARD_DEVIATION 4.11 | 70.3 Years STANDARD_DEVIATION 4.42 | 65.92 Years STANDARD_DEVIATION 7.4 |
| Sex: Female, Male Female | 599 Participants | 1094 Participants | 1693 Participants |
| Sex: Female, Male Male | 448 Participants | 913 Participants | 1361 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 1,047 | 10 / 2,007 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 23 / 1,047 | 105 / 2,007 |
Outcome results
Primary
Number of Seroconverted Subjects for Each Influenza Strain
A seroconverted subject was defined as a subject having either a pre-vaccination hemagglutinin inhibition (HI) titer lower than (\<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥1:10 and a minimum four-fold increase in the post-vaccination titer. Assessed influenza strains were A/New Caledonia, A/Wisconsin and B/Malaysia.
Time frame: At Day 21
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluarix 50-64 Years Group | Number of Seroconverted Subjects for Each Influenza Strain | A/Wisconsin | 167 Participants |
| Fluarix 50-64 Years Group | Number of Seroconverted Subjects for Each Influenza Strain | A/New Caledonia | 171 Participants |
| Fluarix 50-64 Years Group | Number of Seroconverted Subjects for Each Influenza Strain | B/Malaysia | 168 Participants |
| Fluarix 65+ Years Group | Number of Seroconverted Subjects for Each Influenza Strain | A/Wisconsin | 304 Participants |
| Fluarix 65+ Years Group | Number of Seroconverted Subjects for Each Influenza Strain | A/New Caledonia | 306 Participants |
| Fluarix 65+ Years Group | Number of Seroconverted Subjects for Each Influenza Strain | B/Malaysia | 306 Participants |
| Fluarix 50+ Years Group | Number of Seroconverted Subjects for Each Influenza Strain | A/New Caledonia | 477 Participants |
| Fluarix 50+ Years Group | Number of Seroconverted Subjects for Each Influenza Strain | B/Malaysia | 474 Participants |
| Fluarix 50+ Years Group | Number of Seroconverted Subjects for Each Influenza Strain | A/Wisconsin | 471 Participants |
Primary
Number of Seropositive Subjects for Each Influenza Strain
A seropositive subject was defined as a vaccinated subject with an antibody titer ≥1:10.
Time frame: At Day 21
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluarix 50-64 Years Group | Number of Seropositive Subjects for Each Influenza Strain | A/New Caledonia, Day 21 | 171 Participants |
| Fluarix 50-64 Years Group | Number of Seropositive Subjects for Each Influenza Strain | B/Malaysia, Day 21 | 168 Participants |
| Fluarix 50-64 Years Group | Number of Seropositive Subjects for Each Influenza Strain | A/Wisconsin, Day 21 | 167 Participants |
| Fluarix 65+ Years Group | Number of Seropositive Subjects for Each Influenza Strain | B/Malaysia, Day 21 | 306 Participants |
| Fluarix 65+ Years Group | Number of Seropositive Subjects for Each Influenza Strain | A/Wisconsin, Day 21 | 304 Participants |
| Fluarix 65+ Years Group | Number of Seropositive Subjects for Each Influenza Strain | A/New Caledonia, Day 21 | 306 Participants |
| Fluarix 50+ Years Group | Number of Seropositive Subjects for Each Influenza Strain | B/Malaysia, Day 21 | 474 Participants |
| Fluarix 50+ Years Group | Number of Seropositive Subjects for Each Influenza Strain | A/Wisconsin, Day 21 | 471 Participants |
| Fluarix 50+ Years Group | Number of Seropositive Subjects for Each Influenza Strain | A/New Caledonia, Day 21 | 477 Participants |
Primary
Number of Seropositive Subjects for Each Influenza Strain
A seropositive subject was defined as a vaccinated subject with antibody titer ≥1:10.
Time frame: At Day 0 (PRE)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluarix 50-64 Years Group | Number of Seropositive Subjects for Each Influenza Strain | A/New Caledonia, PRE | 162 Participants |
| Fluarix 50-64 Years Group | Number of Seropositive Subjects for Each Influenza Strain | B/Malaysia, PRE | 132 Participants |
| Fluarix 50-64 Years Group | Number of Seropositive Subjects for Each Influenza Strain | A/Wisconsin, PRE | 102 Participants |
| Fluarix 65+ Years Group | Number of Seropositive Subjects for Each Influenza Strain | A/New Caledonia, PRE | 294 Participants |
| Fluarix 65+ Years Group | Number of Seropositive Subjects for Each Influenza Strain | B/Malaysia, PRE | 277 Participants |
| Fluarix 65+ Years Group | Number of Seropositive Subjects for Each Influenza Strain | A/Wisconsin, PRE | 209 Participants |
| Fluarix 50+ Years Group | Number of Seropositive Subjects for Each Influenza Strain | B/Malaysia, PRE | 409 Participants |
| Fluarix 50+ Years Group | Number of Seropositive Subjects for Each Influenza Strain | A/Wisconsin, PRE | 311 Participants |
| Fluarix 50+ Years Group | Number of Seropositive Subjects for Each Influenza Strain | A/New Caledonia, PRE | 456 Participants |
Primary
Number of Seroprotected Subjects Against the 3 Influenza Strains
A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥1:40.
Time frame: At Day 21
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluarix 50-64 Years Group | Number of Seroprotected Subjects Against the 3 Influenza Strains | A/Wisconsin, Day 21 | 144 Participants |
| Fluarix 50-64 Years Group | Number of Seroprotected Subjects Against the 3 Influenza Strains | A/New Caledonia, Day 21 | 161 Participants |
| Fluarix 50-64 Years Group | Number of Seroprotected Subjects Against the 3 Influenza Strains | B/Malaysia, Day 21 | 155 Participants |
| Fluarix 65+ Years Group | Number of Seroprotected Subjects Against the 3 Influenza Strains | A/Wisconsin, Day 21 | 280 Participants |
| Fluarix 65+ Years Group | Number of Seroprotected Subjects Against the 3 Influenza Strains | A/New Caledonia, Day 21 | 294 Participants |
| Fluarix 65+ Years Group | Number of Seroprotected Subjects Against the 3 Influenza Strains | B/Malaysia, Day 21 | 290 Participants |
| Fluarix 50+ Years Group | Number of Seroprotected Subjects Against the 3 Influenza Strains | A/New Caledonia, Day 21 | 455 Participants |
| Fluarix 50+ Years Group | Number of Seroprotected Subjects Against the 3 Influenza Strains | B/Malaysia, Day 21 | 445 Participants |
| Fluarix 50+ Years Group | Number of Seroprotected Subjects Against the 3 Influenza Strains | A/Wisconsin, Day 21 | 424 Participants |
Primary
Number of Seroprotected Subjects Against the 3 Influenza Strains
A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥1:40.
Time frame: At Day 0 (PRE)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluarix 50-64 Years Group | Number of Seroprotected Subjects Against the 3 Influenza Strains | A/Wisconsin, PRE | 48 Participants |
| Fluarix 50-64 Years Group | Number of Seroprotected Subjects Against the 3 Influenza Strains | A/New Caledonia, PRE | 91 Participants |
| Fluarix 50-64 Years Group | Number of Seroprotected Subjects Against the 3 Influenza Strains | B/Malaysia, PRE | 63 Participants |
| Fluarix 65+ Years Group | Number of Seroprotected Subjects Against the 3 Influenza Strains | A/Wisconsin, PRE | 106 Participants |
| Fluarix 65+ Years Group | Number of Seroprotected Subjects Against the 3 Influenza Strains | A/New Caledonia, PRE | 184 Participants |
| Fluarix 65+ Years Group | Number of Seroprotected Subjects Against the 3 Influenza Strains | B/Malaysia, PRE | 173 Participants |
| Fluarix 50+ Years Group | Number of Seroprotected Subjects Against the 3 Influenza Strains | A/New Caledonia, PRE | 275 Participants |
| Fluarix 50+ Years Group | Number of Seroprotected Subjects Against the 3 Influenza Strains | B/Malaysia, PRE | 236 Participants |
| Fluarix 50+ Years Group | Number of Seroprotected Subjects Against the 3 Influenza Strains | A/Wisconsin, PRE | 154 Participants |
Primary
Number of Subjects With at Least One Influenza-like-infection (ILI) Episode
Analysis included all non-confirmed or lab confirmed ILI episodes (at least 1 episode, 1 episode, 2 episodes or more than (\>) 2 episodes) reported.
Time frame: From Month 0 to Month 6
Population: The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluarix 50-64 Years Group | Number of Subjects With at Least One Influenza-like-infection (ILI) Episode | 1 ILI episode | 125 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With at Least One Influenza-like-infection (ILI) Episode | At least 1 ILI episode | 133 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With at Least One Influenza-like-infection (ILI) Episode | 2 ILI episodes | 8 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With at Least One Influenza-like-infection (ILI) Episode | >2 ILI episodes | 0 Participants |
| Fluarix 65+ Years Group | Number of Subjects With at Least One Influenza-like-infection (ILI) Episode | >2 ILI episodes | 0 Participants |
| Fluarix 65+ Years Group | Number of Subjects With at Least One Influenza-like-infection (ILI) Episode | 2 ILI episodes | 12 Participants |
| Fluarix 65+ Years Group | Number of Subjects With at Least One Influenza-like-infection (ILI) Episode | At least 1 ILI episode | 243 Participants |
| Fluarix 65+ Years Group | Number of Subjects With at Least One Influenza-like-infection (ILI) Episode | 1 ILI episode | 231 Participants |
| Fluarix 50+ Years Group | Number of Subjects With at Least One Influenza-like-infection (ILI) Episode | At least 1 ILI episode | 376 Participants |
| Fluarix 50+ Years Group | Number of Subjects With at Least One Influenza-like-infection (ILI) Episode | 1 ILI episode | 356 Participants |
| Fluarix 50+ Years Group | Number of Subjects With at Least One Influenza-like-infection (ILI) Episode | 2 ILI episodes | 20 Participants |
| Fluarix 50+ Years Group | Number of Subjects With at Least One Influenza-like-infection (ILI) Episode | >2 ILI episodes | 0 Participants |
Primary
Number of Subjects With Emergency Room Visits, or Unscheduled Medical Office Visits Due to Influenza-related Complications
ILI complications which led to subject hospitalization, emergency room visits and unplanned medical office visits were recorded by number (at least 1, 1, or above 1) as part of the ILI surveillance, which included: pneumonia, ischemic heart disease, congestive failure, acute cerebrovascular disease chronic obstructive pulmonary disease (COPD) exacerbation.
Time frame: From Month 0 to Month 6
Population: The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluarix 50-64 Years Group | Number of Subjects With Emergency Room Visits, or Unscheduled Medical Office Visits Due to Influenza-related Complications | 1 ILI complication | 4 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Emergency Room Visits, or Unscheduled Medical Office Visits Due to Influenza-related Complications | At least 1 ILI complication | 4 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Emergency Room Visits, or Unscheduled Medical Office Visits Due to Influenza-related Complications | Above 1 ILI complication | 0 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Emergency Room Visits, or Unscheduled Medical Office Visits Due to Influenza-related Complications | 1 ILI complication | 14 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Emergency Room Visits, or Unscheduled Medical Office Visits Due to Influenza-related Complications | At least 1 ILI complication | 16 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Emergency Room Visits, or Unscheduled Medical Office Visits Due to Influenza-related Complications | Above 1 ILI complication | 2 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Emergency Room Visits, or Unscheduled Medical Office Visits Due to Influenza-related Complications | At least 1 ILI complication | 20 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Emergency Room Visits, or Unscheduled Medical Office Visits Due to Influenza-related Complications | Above 1 ILI complication | 2 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Emergency Room Visits, or Unscheduled Medical Office Visits Due to Influenza-related Complications | 1 ILI complication | 18 Participants |
Primary
Number of Subjects With Fatal Outcomes
Number of deaths caused by laboratory non-confirmed ILI or other reasons were recorded during the influenza
Time frame: From Month 0 to Month 6
Population: The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluarix 50-64 Years Group | Number of Subjects With Fatal Outcomes | ILI not confirmed | 0 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Fatal Outcomes | Other | 1 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Fatal Outcomes | ILI not confirmed | 0 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Fatal Outcomes | Other | 6 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Fatal Outcomes | ILI not confirmed | 0 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Fatal Outcomes | Other | 7 Participants |
Primary
Number of Subjects With Fatal Outcomes Due to Laboratory Confirmed Influenza Infection
Death due to lab confirmed influenza infection was recorded during the influeza period only.
Time frame: From Month 0 to Month 6
Population: The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fluarix 50-64 Years Group | Number of Subjects With Fatal Outcomes Due to Laboratory Confirmed Influenza Infection | 0 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Fatal Outcomes Due to Laboratory Confirmed Influenza Infection | 0 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Fatal Outcomes Due to Laboratory Confirmed Influenza Infection | 0 Participants |
Primary
Number of Subjects With Hospitalization, Emergency Room Visits, or Unscheduled Medical Office Visits Due to ILI
ILI which led to subject hospitalization, emergency room visits and unplanned medical office visits were recorded by number (at least 1, 1, or above 1), as part of the ILI surveillance.
Time frame: From Month 0 to Month 6
Population: The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluarix 50-64 Years Group | Number of Subjects With Hospitalization, Emergency Room Visits, or Unscheduled Medical Office Visits Due to ILI | 1 ILI | 31 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Hospitalization, Emergency Room Visits, or Unscheduled Medical Office Visits Due to ILI | At least 1 ILI | 31 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Hospitalization, Emergency Room Visits, or Unscheduled Medical Office Visits Due to ILI | Above 1 ILI | 0 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Hospitalization, Emergency Room Visits, or Unscheduled Medical Office Visits Due to ILI | 1 ILI | 49 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Hospitalization, Emergency Room Visits, or Unscheduled Medical Office Visits Due to ILI | At least 1 ILI | 51 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Hospitalization, Emergency Room Visits, or Unscheduled Medical Office Visits Due to ILI | Above 1 ILI | 2 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Hospitalization, Emergency Room Visits, or Unscheduled Medical Office Visits Due to ILI | At least 1 ILI | 82 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Hospitalization, Emergency Room Visits, or Unscheduled Medical Office Visits Due to ILI | Above 1 ILI | 2 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Hospitalization, Emergency Room Visits, or Unscheduled Medical Office Visits Due to ILI | 1 ILI | 80 Participants |
Primary
Number of Subjects With Hospitalization or Emergency Room Visit for Any Cause
As part of ILI surveillance any reasons, or other reasons than those mentioned which led to subject hospitalization, emergency room visits and unplanned medical office visits were recorded by number (at least 1, 1, or above 1).
Time frame: From Month 0 to Month 6
Population: The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluarix 50-64 Years Group | Number of Subjects With Hospitalization or Emergency Room Visit for Any Cause | Any reason - at least 1 | 47 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Hospitalization or Emergency Room Visit for Any Cause | Other reason - at least 1 | 13 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Hospitalization or Emergency Room Visit for Any Cause | Other reason - above 1 | 3 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Hospitalization or Emergency Room Visit for Any Cause | Other reason - one | 10 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Hospitalization or Emergency Room Visit for Any Cause | Any reason - one | 43 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Hospitalization or Emergency Room Visit for Any Cause | Any reason - above one | 4 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Hospitalization or Emergency Room Visit for Any Cause | Other reason - one | 69 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Hospitalization or Emergency Room Visit for Any Cause | Any reason - above one | 17 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Hospitalization or Emergency Room Visit for Any Cause | Any reason - at least 1 | 124 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Hospitalization or Emergency Room Visit for Any Cause | Any reason - one | 107 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Hospitalization or Emergency Room Visit for Any Cause | Other reason - above 1 | 3 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Hospitalization or Emergency Room Visit for Any Cause | Other reason - at least 1 | 72 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Hospitalization or Emergency Room Visit for Any Cause | Other reason - above 1 | 6 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Hospitalization or Emergency Room Visit for Any Cause | Other reason - at least 1 | 85 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Hospitalization or Emergency Room Visit for Any Cause | Any reason - at least 1 | 171 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Hospitalization or Emergency Room Visit for Any Cause | Any reason - one | 150 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Hospitalization or Emergency Room Visit for Any Cause | Any reason - above one | 21 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Hospitalization or Emergency Room Visit for Any Cause | Other reason - one | 79 Participants |
Primary
Number of Subjects With Hospitalizations, Emergency Room Visits or Unscheduled Medical Office Visits, Due to Laboratory Confirmed Influenza
Laboratory confirmed (LC) ILI which led to subject hospitalization, emergency room visits and unplanned medical office visits were recorded by number (at least 1, 1, or above 1), as part of the ILI surveillance.
Time frame: From Month 0 to Month 6
Population: The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluarix 50-64 Years Group | Number of Subjects With Hospitalizations, Emergency Room Visits or Unscheduled Medical Office Visits, Due to Laboratory Confirmed Influenza | 1 LC ILI | 2 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Hospitalizations, Emergency Room Visits or Unscheduled Medical Office Visits, Due to Laboratory Confirmed Influenza | At lesat 1 LC ILI | 2 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Hospitalizations, Emergency Room Visits or Unscheduled Medical Office Visits, Due to Laboratory Confirmed Influenza | Above 1 LC ILI | 0 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Hospitalizations, Emergency Room Visits or Unscheduled Medical Office Visits, Due to Laboratory Confirmed Influenza | 1 LC ILI | 6 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Hospitalizations, Emergency Room Visits or Unscheduled Medical Office Visits, Due to Laboratory Confirmed Influenza | At lesat 1 LC ILI | 6 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Hospitalizations, Emergency Room Visits or Unscheduled Medical Office Visits, Due to Laboratory Confirmed Influenza | Above 1 LC ILI | 0 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Hospitalizations, Emergency Room Visits or Unscheduled Medical Office Visits, Due to Laboratory Confirmed Influenza | At lesat 1 LC ILI | 8 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Hospitalizations, Emergency Room Visits or Unscheduled Medical Office Visits, Due to Laboratory Confirmed Influenza | Above 1 LC ILI | 0 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Hospitalizations, Emergency Room Visits or Unscheduled Medical Office Visits, Due to Laboratory Confirmed Influenza | 1 LC ILI | 8 Participants |
Primary
Number of Subjects With Influenza-related Complications
ILI complications refer to episodes of pneumonia, ischemic heart disease \[HD\] (unstable angina or myocardial infarction), congestive heart failure \[HF\], acute cerebrovascular disease \[ACD\] (stroke or transient ischemic attack \[IA\]), COPD exacerbation and all illnesses (pooled episode of each illness). ILI complications were recorded by number of episodes (at least 1 episode, 1 episode and above 1 episode).
Time frame: From Month 0 to Month 6
Population: The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluarix 50-64 Years Group | Number of Subjects With Influenza-related Complications | Myocardial infarction at least 1 episode | 2 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Influenza-related Complications | Stroke 1 episode | 0 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Influenza-related Complications | Transient IA above 1 episode | 0 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Influenza-related Complications | COPD exacerbation above 1 episode | 0 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Influenza-related Complications | Pneumonia at least 1 episode | 2 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Influenza-related Complications | Pneumonia 1 episode | 2 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Influenza-related Complications | Pneumonia above 1 episode | 0 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Influenza-related Complications | Ischemic HD at least 1 episode | 2 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Influenza-related Complications | Ischemic HD 1 episode | 2 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Influenza-related Complications | Ischemic HD above 1 episode | 0 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Influenza-related Complications | Unstable angina at least 1 episode | 0 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Influenza-related Complications | Unstable angina 1 episode | 0 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Influenza-related Complications | Unstable angina above 1 episode | 0 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Influenza-related Complications | Myocardial infarction 1 episode | 2 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Influenza-related Complications | Myocardial infarction above 1 episode | 0 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Influenza-related Complications | Congestive HF at least 1 episode | 0 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Influenza-related Complications | Congestive HF 1 episode | 0 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Influenza-related Complications | Congestive HF above 1 episode | 0 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Influenza-related Complications | ACD at least 1 episode | 0 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Influenza-related Complications | ACD 1 episode | 0 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Influenza-related Complications | ACD above 1 episode | 0 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Influenza-related Complications | Stroke at least 1 episode | 0 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Influenza-related Complications | Stroke above 1 episode | 0 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Influenza-related Complications | Transient IA at least 1 episode | 0 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Influenza-related Complications | Transient IA 1 episode | 0 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Influenza-related Complications | COPD exacerbation at least 1 episode | 1 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Influenza-related Complications | COPD exacerbation 1 episode | 1 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Influenza-related Complications | Any illness at least 1 episode | 5 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Influenza-related Complications | Any illness 1 episode | 5 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Influenza-related Complications | Any illness above 1 episode | 0 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Influenza-related Complications | Unstable angina at least 1 episode | 0 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Influenza-related Complications | Transient IA 1 episode | 0 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Influenza-related Complications | Unstable angina 1 episode | 0 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Influenza-related Complications | Unstable angina above 1 episode | 0 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Influenza-related Complications | Any illness 1 episode | 15 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Influenza-related Complications | COPD exacerbation at least 1 episode | 3 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Influenza-related Complications | Myocardial infarction above 1 episode | 0 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Influenza-related Complications | Congestive HF at least 1 episode | 2 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Influenza-related Complications | Congestive HF 1 episode | 2 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Influenza-related Complications | COPD exacerbation 1 episode | 2 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Influenza-related Complications | Congestive HF above 1 episode | 0 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Influenza-related Complications | ACD at least 1 episode | 1 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Influenza-related Complications | COPD exacerbation above 1 episode | 1 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Influenza-related Complications | ACD 1 episode | 1 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Influenza-related Complications | ACD above 1 episode | 0 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Influenza-related Complications | Stroke at least 1 episode | 1 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Influenza-related Complications | Myocardial infarction at least 1 episode | 3 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Influenza-related Complications | Myocardial infarction 1 episode | 3 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Influenza-related Complications | Stroke 1 episode | 1 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Influenza-related Complications | Transient IA above 1 episode | 0 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Influenza-related Complications | Any illness at least 1 episode | 17 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Influenza-related Complications | Pneumonia at least 1 episode | 9 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Influenza-related Complications | Stroke above 1 episode | 0 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Influenza-related Complications | Pneumonia 1 episode | 9 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Influenza-related Complications | Pneumonia above 1 episode | 0 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Influenza-related Complications | Ischemic HD at least 1 episode | 3 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Influenza-related Complications | Transient IA at least 1 episode | 0 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Influenza-related Complications | Ischemic HD 1 episode | 3 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Influenza-related Complications | Ischemic HD above 1 episode | 0 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Influenza-related Complications | Any illness above 1 episode | 2 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Influenza-related Complications | Pneumonia 1 episode | 11 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Influenza-related Complications | Stroke above 1 episode | 0 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Influenza-related Complications | Myocardial infarction at least 1 episode | 5 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Influenza-related Complications | Unstable angina 1 episode | 0 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Influenza-related Complications | Transient IA above 1 episode | 0 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Influenza-related Complications | Ischemic HD 1 episode | 5 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Influenza-related Complications | Unstable angina above 1 episode | 0 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Influenza-related Complications | Myocardial infarction 1 episode | 5 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Influenza-related Complications | Stroke at least 1 episode | 1 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Influenza-related Complications | Transient IA 1 episode | 0 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Influenza-related Complications | Myocardial infarction above 1 episode | 0 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Influenza-related Complications | COPD exacerbation at least 1 episode | 4 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Influenza-related Complications | Pneumonia above 1 episode | 0 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Influenza-related Complications | Congestive HF at least 1 episode | 2 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Influenza-related Complications | Any illness 1 episode | 20 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Influenza-related Complications | Any illness at least 1 episode | 22 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Influenza-related Complications | Congestive HF 1 episode | 2 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Influenza-related Complications | Stroke 1 episode | 1 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Influenza-related Complications | Transient IA at least 1 episode | 0 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Influenza-related Complications | Congestive HF above 1 episode | 0 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Influenza-related Complications | COPD exacerbation 1 episode | 3 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Influenza-related Complications | Ischemic HD at least 1 episode | 5 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Influenza-related Complications | ACD at least 1 episode | 1 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Influenza-related Complications | Pneumonia at least 1 episode | 11 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Influenza-related Complications | Unstable angina at least 1 episode | 0 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Influenza-related Complications | ACD 1 episode | 1 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Influenza-related Complications | COPD exacerbation above 1 episode | 1 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Influenza-related Complications | Ischemic HD above 1 episode | 0 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Influenza-related Complications | ACD above 1 episode | 0 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Influenza-related Complications | Any illness above 1 episode | 2 Participants |
Primary
Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B
Lab confirmed ILI episodes were assessed by means of viral culture (VC) infection (nasal and throat swabs) determination and/or using the Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) assay.
Time frame: From Month 0 to Month 6
Population: The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluarix 50-64 Years Group | Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B | VC and/or RT-PCR Influenza A | 13 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B | RT-PCR Influenza B | 0 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B | VC Influenza B | 0 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B | VC and/or RT-PCR Influenza A and/or B | 13 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B | RT-PCR Influenza A | 13 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B | VC Influenza A and B | 0 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B | VC and RT-PCR Influenza A | 12 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B | RT-PCR Influenza A and/or B | 13 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B | VC and/or RT-PCR Influenza B | 0 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B | VC and RT-PCR Influenza A and B | 0 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B | VC and RT-PCR Influenza A and/or B | 12 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B | VC and/or RT-PCR Influenza A and B | 0 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B | VC Influenza A and/or B | 12 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B | VC and RT-PCR Influenza B | 0 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B | RT-PCR Influenza A and B | 0 Participants |
| Fluarix 50-64 Years Group | Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B | VC Influenza A | 12 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B | VC and/or RT-PCR Influenza A | 15 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B | VC and/or RT-PCR Influenza A and/or B | 15 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B | VC and/or RT-PCR Influenza A and B | 0 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B | VC and/or RT-PCR Influenza B | 0 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B | VC Influenza A and/or B | 9 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B | VC Influenza A | 9 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B | VC Influenza B | 0 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B | VC Influenza A and B | 0 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B | RT-PCR Influenza A and/or B | 15 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B | RT-PCR Influenza A | 15 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B | RT-PCR Influenza B | 0 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B | RT-PCR Influenza A and B | 0 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B | VC and RT-PCR Influenza A and/or B | 9 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B | VC and RT-PCR Influenza A | 9 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B | VC and RT-PCR Influenza B | 0 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B | VC and RT-PCR Influenza A and B | 0 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B | RT-PCR Influenza B | 0 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B | VC Influenza A and/or B | 21 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B | VC and RT-PCR Influenza A and B | 0 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B | RT-PCR Influenza A and B | 0 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B | VC and/or RT-PCR Influenza B | 0 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B | VC and RT-PCR Influenza B | 0 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B | VC and RT-PCR Influenza A and/or B | 21 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B | VC and/or RT-PCR Influenza A | 28 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B | VC Influenza A and B | 0 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B | VC and/or RT-PCR Influenza A and B | 0 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B | RT-PCR Influenza A and/or B | 28 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B | VC Influenza B | 0 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B | VC and RT-PCR Influenza A | 21 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B | RT-PCR Influenza A | 28 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B | VC Influenza A | 21 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B | VC and/or RT-PCR Influenza A and/or B | 28 Participants |
Primary
Number of Subjects With Laboratory-confirmed Respiratory Syncytial Virus Infection (RSV)
RSV infection was determined by the RT-PCR assay.
Time frame: From Month 0 to Month 6
Population: The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fluarix 50-64 Years Group | Number of Subjects With Laboratory-confirmed Respiratory Syncytial Virus Infection (RSV) | 16 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Laboratory-confirmed Respiratory Syncytial Virus Infection (RSV) | 27 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Laboratory-confirmed Respiratory Syncytial Virus Infection (RSV) | 43 Participants |
Primary
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity 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 or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Time frame: From Month 0 to Month 6
Population: The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fluarix 50-64 Years Group | Number of Subjects With Serious Adverse Events (SAEs) | 23 Participants |
| Fluarix 65+ Years Group | Number of Subjects With Serious Adverse Events (SAEs) | 105 Participants |
| Fluarix 50+ Years Group | Number of Subjects With Serious Adverse Events (SAEs) | 128 Participants |
Primary
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease
The seroconversion factor (SCF) was defined as the fold increase in serum HI geometric mean titer (GMT) post vaccination on Day 21 compared to Day 0. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
Time frame: At Day 21
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluarix 50-64 Years Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/Wisconsin | 156.7 Titer |
| Fluarix 50-64 Years Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New Caledonia | 216.4 Titer |
| Fluarix 50-64 Years Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | B/Malaysia | 149.9 Titer |
| Fluarix 65+ Years Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/Wisconsin | 179.1 Titer |
| Fluarix 65+ Years Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New Caledonia | 142.9 Titer |
| Fluarix 65+ Years Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | B/Malaysia | 184.0 Titer |
| Fluarix 50+ Years Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New Caledonia | 165.8 Titer |
| Fluarix 50+ Years Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | B/Malaysia | 171.0 Titer |
| Fluarix 50+ Years Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/Wisconsin | 170.8 Titer |
Primary
Serum HI Antibody Titers for Each Influenza Strain
Serum HI antibody titers were expressed as Geometric Mean Titers (GMTs).
Time frame: At Day 0 (PRE)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluarix 50-64 Years Group | Serum HI Antibody Titers for Each Influenza Strain | B/Malaysia, PRE | 21.4 Titer |
| Fluarix 50-64 Years Group | Serum HI Antibody Titers for Each Influenza Strain | A/Wisconsin, PRE | 16.9 Titer |
| Fluarix 50-64 Years Group | Serum HI Antibody Titers for Each Influenza Strain | A/New Caledonia, PRE | 40.5 Titer |
| Fluarix 65+ Years Group | Serum HI Antibody Titers for Each Influenza Strain | B/Malaysia, PRE | 38.8 Titer |
| Fluarix 65+ Years Group | Serum HI Antibody Titers for Each Influenza Strain | A/Wisconsin, PRE | 21.5 Titer |
| Fluarix 65+ Years Group | Serum HI Antibody Titers for Each Influenza Strain | A/New Caledonia, PRE | 43.2 Titer |
| Fluarix 50+ Years Group | Serum HI Antibody Titers for Each Influenza Strain | A/Wisconsin, PRE | 19.8 Titer |
| Fluarix 50+ Years Group | Serum HI Antibody Titers for Each Influenza Strain | A/New Caledonia, PRE | 42.2 Titer |
| Fluarix 50+ Years Group | Serum HI Antibody Titers for Each Influenza Strain | B/Malaysia, PRE | 31.3 Titer |
Primary
Serum HI Antibody Titers for Each Influenza Strain
Serum HI antibody titers were expressed as Geometric Mean Titers (GMTs).
Time frame: At Day 21
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluarix 50-64 Years Group | Serum HI Antibody Titers for Each Influenza Strain | A/Wisconsin, Day 21 | 156.7 Titer |
| Fluarix 50-64 Years Group | Serum HI Antibody Titers for Each Influenza Strain | A/New Caledonia, Day 21 | 216.4 Titer |
| Fluarix 50-64 Years Group | Serum HI Antibody Titers for Each Influenza Strain | B/Malaysia, Day 21 | 149.9 Titer |
| Fluarix 65+ Years Group | Serum HI Antibody Titers for Each Influenza Strain | A/Wisconsin, Day 21 | 179.1 Titer |
| Fluarix 65+ Years Group | Serum HI Antibody Titers for Each Influenza Strain | A/New Caledonia, Day 21 | 142.9 Titer |
| Fluarix 65+ Years Group | Serum HI Antibody Titers for Each Influenza Strain | B/Malaysia, Day 21 | 184.0 Titer |
| Fluarix 50+ Years Group | Serum HI Antibody Titers for Each Influenza Strain | A/New Caledonia, Day 21 | 165.8 Titer |
| Fluarix 50+ Years Group | Serum HI Antibody Titers for Each Influenza Strain | B/Malaysia, Day 21 | 171.0 Titer |
| Fluarix 50+ Years Group | Serum HI Antibody Titers for Each Influenza Strain | A/Wisconsin, Day 21 | 170.8 Titer |