Trial Outcomes & Findings for Study on the Incidence of Influenza and Its Complications, in Subjects Aged 50 Years and Over Vaccinated With Fluarix™ (NCT NCT00377611)
NCT ID: NCT00377611
Last Updated: 2018-10-09
Results Overview
Analysis included all non-confirmed or lab confirmed ILI episodes (at least 1 episode, 1 episode, 2 episodes or more than (\>) 2 episodes) reported.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
3054 participants
Primary outcome timeframe
From Month 0 to Month 6
Results posted on
2018-10-09
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
1047
|
2007
|
|
Overall Study
COMPLETED
|
1025
|
1974
|
|
Overall Study
NOT COMPLETED
|
22
|
33
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
9
|
|
Overall Study
Protocol Violation
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
5
|
|
Overall Study
Lost to Follow-up
|
18
|
16
|
|
Overall Study
Other
|
0
|
3
|
Baseline Characteristics
Study on the Incidence of Influenza and Its Complications, in Subjects Aged 50 Years and Over Vaccinated With Fluarix™
Baseline characteristics by cohort
| Measure |
Fluarix 50-64 Years Group
n=1047 Participants
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.
|
Fluarix 65+ Years Group
n=2007 Participants
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.
|
Total
n=3054 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.6 Years
STANDARD_DEVIATION 4.11 • n=5 Participants
|
70.3 Years
STANDARD_DEVIATION 4.42 • n=7 Participants
|
65.92 Years
STANDARD_DEVIATION 7.40 • n=5 Participants
|
|
Sex: Female, Male
Female
|
599 Participants
n=5 Participants
|
1094 Participants
n=7 Participants
|
1693 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
448 Participants
n=5 Participants
|
913 Participants
n=7 Participants
|
1361 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Month 0 to Month 6Population: The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.
Analysis included all non-confirmed or lab confirmed ILI episodes (at least 1 episode, 1 episode, 2 episodes or more than (\>) 2 episodes) reported.
Outcome measures
| Measure |
Fluarix 50-64 Years Group
n=297 Participants
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.
|
Fluarix 65+ Years Group
n=697 Participants
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.
|
Fluarix 50+ Years Group
n=994 Participants
Adult subjects aged 50 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.
|
|---|---|---|---|
|
Number of Subjects With at Least One Influenza-like-infection (ILI) Episode
At least 1 ILI episode
|
133 Participants
|
243 Participants
|
376 Participants
|
|
Number of Subjects With at Least One Influenza-like-infection (ILI) Episode
>2 ILI episodes
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With at Least One Influenza-like-infection (ILI) Episode
1 ILI episode
|
125 Participants
|
231 Participants
|
356 Participants
|
|
Number of Subjects With at Least One Influenza-like-infection (ILI) Episode
2 ILI episodes
|
8 Participants
|
12 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: From Month 0 to Month 6Population: The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available
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.
Outcome measures
| Measure |
Fluarix 50-64 Years Group
n=297 Participants
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.
|
Fluarix 65+ Years Group
n=697 Participants
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.
|
Fluarix 50+ Years Group
n=994 Participants
Adult subjects aged 50 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.
|
|---|---|---|---|
|
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
|
15 Participants
|
28 Participants
|
|
Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B
VC Influenza A and/or B
|
12 Participants
|
9 Participants
|
21 Participants
|
|
Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B
VC Influenza A
|
12 Participants
|
9 Participants
|
21 Participants
|
|
Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B
VC Influenza B
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
9 Participants
|
21 Participants
|
|
Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B
VC and RT-PCR Influenza A
|
12 Participants
|
9 Participants
|
21 Participants
|
|
Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B
VC and RT-PCR Influenza A and B
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B
VC and/or RT-PCR Influenza A
|
13 Participants
|
15 Participants
|
28 Participants
|
|
Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B
VC and/or RT-PCR Influenza B
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B
VC Influenza A and B
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B
RT-PCR Influenza A and/or B
|
13 Participants
|
15 Participants
|
28 Participants
|
|
Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B
RT-PCR Influenza A
|
13 Participants
|
15 Participants
|
28 Participants
|
|
Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B
RT-PCR Influenza B
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B
RT-PCR Influenza A and B
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B
VC and RT-PCR Influenza B
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Month 0 to Month 6Population: The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.
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.
Outcome measures
| Measure |
Fluarix 50-64 Years Group
n=297 Participants
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.
|
Fluarix 65+ Years Group
n=697 Participants
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.
|
Fluarix 50+ Years Group
n=994 Participants
Adult subjects aged 50 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.
|
|---|---|---|---|
|
Number of Subjects With Hospitalization, Emergency Room Visits, or Unscheduled Medical Office Visits Due to ILI
Above 1 ILI
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Hospitalization, Emergency Room Visits, or Unscheduled Medical Office Visits Due to ILI
At least 1 ILI
|
31 Participants
|
51 Participants
|
82 Participants
|
|
Number of Subjects With Hospitalization, Emergency Room Visits, or Unscheduled Medical Office Visits Due to ILI
1 ILI
|
31 Participants
|
49 Participants
|
80 Participants
|
PRIMARY outcome
Timeframe: From Month 0 to Month 6Population: The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.
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.
Outcome measures
| Measure |
Fluarix 50-64 Years Group
n=297 Participants
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.
|
Fluarix 65+ Years Group
n=697 Participants
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.
|
Fluarix 50+ Years Group
n=994 Participants
Adult subjects aged 50 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.
|
|---|---|---|---|
|
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
|
6 Participants
|
8 Participants
|
|
Number of Subjects With Hospitalizations, Emergency Room Visits or Unscheduled Medical Office Visits, Due to Laboratory Confirmed Influenza
1 LC ILI
|
2 Participants
|
6 Participants
|
8 Participants
|
|
Number of Subjects With Hospitalizations, Emergency Room Visits or Unscheduled Medical Office Visits, Due to Laboratory Confirmed Influenza
Above 1 LC ILI
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Month 0 to Month 6Population: The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.
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).
Outcome measures
| Measure |
Fluarix 50-64 Years Group
n=297 Participants
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.
|
Fluarix 65+ Years Group
n=697 Participants
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.
|
Fluarix 50+ Years Group
n=994 Participants
Adult subjects aged 50 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.
|
|---|---|---|---|
|
Number of Subjects With Hospitalization or Emergency Room Visit for Any Cause
Any reason - at least 1
|
47 Participants
|
124 Participants
|
171 Participants
|
|
Number of Subjects With Hospitalization or Emergency Room Visit for Any Cause
Any reason - one
|
43 Participants
|
107 Participants
|
150 Participants
|
|
Number of Subjects With Hospitalization or Emergency Room Visit for Any Cause
Any reason - above one
|
4 Participants
|
17 Participants
|
21 Participants
|
|
Number of Subjects With Hospitalization or Emergency Room Visit for Any Cause
Other reason - at least 1
|
13 Participants
|
72 Participants
|
85 Participants
|
|
Number of Subjects With Hospitalization or Emergency Room Visit for Any Cause
Other reason - one
|
10 Participants
|
69 Participants
|
79 Participants
|
|
Number of Subjects With Hospitalization or Emergency Room Visit for Any Cause
Other reason - above 1
|
3 Participants
|
3 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: From Month 0 to Month 6Population: The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.
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.
Outcome measures
| Measure |
Fluarix 50-64 Years Group
n=297 Participants
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.
|
Fluarix 65+ Years Group
n=697 Participants
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.
|
Fluarix 50+ Years Group
n=994 Participants
Adult subjects aged 50 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.
|
|---|---|---|---|
|
Number of Subjects With Emergency Room Visits, or Unscheduled Medical Office Visits Due to Influenza-related Complications
At least 1 ILI complication
|
4 Participants
|
16 Participants
|
20 Participants
|
|
Number of Subjects With Emergency Room Visits, or Unscheduled Medical Office Visits Due to Influenza-related Complications
1 ILI complication
|
4 Participants
|
14 Participants
|
18 Participants
|
|
Number of Subjects With Emergency Room Visits, or Unscheduled Medical Office Visits Due to Influenza-related Complications
Above 1 ILI complication
|
0 Participants
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: From Month 0 to Month 6Population: The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.
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).
Outcome measures
| Measure |
Fluarix 50-64 Years Group
n=297 Participants
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.
|
Fluarix 65+ Years Group
n=697 Participants
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.
|
Fluarix 50+ Years Group
n=994 Participants
Adult subjects aged 50 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.
|
|---|---|---|---|
|
Number of Subjects With Influenza-related Complications
Stroke 1 episode
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Influenza-related Complications
Stroke above 1 episode
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Influenza-related Complications
Transient IA at least 1 episode
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Influenza-related Complications
Transient IA 1 episode
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Influenza-related Complications
Transient IA above 1 episode
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Influenza-related Complications
Pneumonia at least 1 episode
|
2 Participants
|
9 Participants
|
11 Participants
|
|
Number of Subjects With Influenza-related Complications
Pneumonia 1 episode
|
2 Participants
|
9 Participants
|
11 Participants
|
|
Number of Subjects With Influenza-related Complications
Pneumonia above 1 episode
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Influenza-related Complications
Ischemic HD at least 1 episode
|
2 Participants
|
3 Participants
|
5 Participants
|
|
Number of Subjects With Influenza-related Complications
Ischemic HD 1 episode
|
2 Participants
|
3 Participants
|
5 Participants
|
|
Number of Subjects With Influenza-related Complications
Unstable angina at least 1 episode
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Influenza-related Complications
Unstable angina 1 episode
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Influenza-related Complications
Unstable angina above 1 episode
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Influenza-related Complications
Myocardial infarction at least 1 episode
|
2 Participants
|
3 Participants
|
5 Participants
|
|
Number of Subjects With Influenza-related Complications
Myocardial infarction 1 episode
|
2 Participants
|
3 Participants
|
5 Participants
|
|
Number of Subjects With Influenza-related Complications
Myocardial infarction above 1 episode
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Influenza-related Complications
Congestive HF 1 episode
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Influenza-related Complications
Congestive HF above 1 episode
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Influenza-related Complications
ACD at least 1 episode
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Influenza-related Complications
ACD 1 episode
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Influenza-related Complications
Stroke at least 1 episode
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Influenza-related Complications
COPD exacerbation at least 1 episode
|
1 Participants
|
3 Participants
|
4 Participants
|
|
Number of Subjects With Influenza-related Complications
COPD exacerbation 1 episode
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Influenza-related Complications
COPD exacerbation above 1 episode
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Influenza-related Complications
Any illness at least 1 episode
|
5 Participants
|
17 Participants
|
22 Participants
|
|
Number of Subjects With Influenza-related Complications
Ischemic HD above 1 episode
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Influenza-related Complications
Congestive HF at least 1 episode
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Influenza-related Complications
ACD above 1 episode
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Influenza-related Complications
Any illness 1 episode
|
5 Participants
|
15 Participants
|
20 Participants
|
|
Number of Subjects With Influenza-related Complications
Any illness above 1 episode
|
0 Participants
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: From Month 0 to Month 6Population: The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.
Death due to lab confirmed influenza infection was recorded during the influeza period only.
Outcome measures
| Measure |
Fluarix 50-64 Years Group
n=1047 Participants
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.
|
Fluarix 65+ Years Group
n=2007 Participants
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.
|
Fluarix 50+ Years Group
n=3054 Participants
Adult subjects aged 50 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.
|
|---|---|---|---|
|
Number of Subjects With Fatal Outcomes Due to Laboratory Confirmed Influenza Infection
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Month 0 to Month 6Population: The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.
Number of deaths caused by laboratory non-confirmed ILI or other reasons were recorded during the influenza
Outcome measures
| Measure |
Fluarix 50-64 Years Group
n=1047 Participants
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.
|
Fluarix 65+ Years Group
n=2007 Participants
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.
|
Fluarix 50+ Years Group
n=3054 Participants
Adult subjects aged 50 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.
|
|---|---|---|---|
|
Number of Subjects With Fatal Outcomes
ILI not confirmed
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Fatal Outcomes
Other
|
1 Participants
|
6 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: From Month 0 to Month 6Population: The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.
RSV infection was determined by the RT-PCR assay.
Outcome measures
| Measure |
Fluarix 50-64 Years Group
n=297 Participants
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.
|
Fluarix 65+ Years Group
n=697 Participants
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.
|
Fluarix 50+ Years Group
n=994 Participants
Adult subjects aged 50 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.
|
|---|---|---|---|
|
Number of Subjects With Laboratory-confirmed Respiratory Syncytial Virus Infection (RSV)
|
16 Participants
|
27 Participants
|
43 Participants
|
PRIMARY outcome
Timeframe: From Month 0 to Month 6Population: The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.
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.
Outcome measures
| Measure |
Fluarix 50-64 Years Group
n=1047 Participants
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.
|
Fluarix 65+ Years Group
n=2007 Participants
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.
|
Fluarix 50+ Years Group
n=3054 Participants
Adult subjects aged 50 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.
|
|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
23 Participants
|
105 Participants
|
128 Participants
|
PRIMARY outcome
Timeframe: At Day 21Population: 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.
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.
Outcome measures
| Measure |
Fluarix 50-64 Years Group
n=171 Participants
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.
|
Fluarix 65+ Years Group
n=307 Participants
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.
|
Fluarix 50+ Years Group
n=478 Participants
Adult subjects aged 50 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.
|
|---|---|---|---|
|
Number of Seroconverted Subjects for Each Influenza Strain
A/New Caledonia
|
171 Participants
|
306 Participants
|
477 Participants
|
|
Number of Seroconverted Subjects for Each Influenza Strain
A/Wisconsin
|
167 Participants
|
304 Participants
|
471 Participants
|
|
Number of Seroconverted Subjects for Each Influenza Strain
B/Malaysia
|
168 Participants
|
306 Participants
|
474 Participants
|
PRIMARY outcome
Timeframe: At Day 21Population: 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.
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.
Outcome measures
| Measure |
Fluarix 50-64 Years Group
n=171 Participants
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.
|
Fluarix 65+ Years Group
n=307 Participants
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.
|
Fluarix 50+ Years Group
n=478 Participants
Adult subjects aged 50 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.
|
|---|---|---|---|
|
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease
A/New Caledonia
|
216.4 Titer
Interval 180.8 to 259.0
|
142.9 Titer
Interval 125.8 to 162.4
|
165.8 Titer
Interval 149.2 to 184.2
|
|
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease
A/Wisconsin
|
156.7 Titer
Interval 125.3 to 196.0
|
179.1 Titer
Interval 154.0 to 208.4
|
170.8 Titer
Interval 150.6 to 193.6
|
|
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease
B/Malaysia
|
149.9 Titer
Interval 124.3 to 180.9
|
184.0 Titer
Interval 161.9 to 209.2
|
171.0 Titer
Interval 153.8 to 190.2
|
PRIMARY outcome
Timeframe: 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.
A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥1:40.
Outcome measures
| Measure |
Fluarix 50-64 Years Group
n=171 Participants
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.
|
Fluarix 65+ Years Group
n=307 Participants
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.
|
Fluarix 50+ Years Group
n=478 Participants
Adult subjects aged 50 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.
|
|---|---|---|---|
|
Number of Seroprotected Subjects Against the 3 Influenza Strains
A/New Caledonia, PRE
|
91 Participants
|
184 Participants
|
275 Participants
|
|
Number of Seroprotected Subjects Against the 3 Influenza Strains
A/Wisconsin, PRE
|
48 Participants
|
106 Participants
|
154 Participants
|
|
Number of Seroprotected Subjects Against the 3 Influenza Strains
B/Malaysia, PRE
|
63 Participants
|
173 Participants
|
236 Participants
|
PRIMARY outcome
Timeframe: At Day 21Population: 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.
A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥1:40.
Outcome measures
| Measure |
Fluarix 50-64 Years Group
n=171 Participants
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.
|
Fluarix 65+ Years Group
n=307 Participants
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.
|
Fluarix 50+ Years Group
n=478 Participants
Adult subjects aged 50 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.
|
|---|---|---|---|
|
Number of Seroprotected Subjects Against the 3 Influenza Strains
A/New Caledonia, Day 21
|
161 Participants
|
294 Participants
|
455 Participants
|
|
Number of Seroprotected Subjects Against the 3 Influenza Strains
A/Wisconsin, Day 21
|
144 Participants
|
280 Participants
|
424 Participants
|
|
Number of Seroprotected Subjects Against the 3 Influenza Strains
B/Malaysia, Day 21
|
155 Participants
|
290 Participants
|
445 Participants
|
PRIMARY outcome
Timeframe: 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.
A seropositive subject was defined as a vaccinated subject with antibody titer ≥1:10.
Outcome measures
| Measure |
Fluarix 50-64 Years Group
n=171 Participants
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.
|
Fluarix 65+ Years Group
n=307 Participants
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.
|
Fluarix 50+ Years Group
n=478 Participants
Adult subjects aged 50 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.
|
|---|---|---|---|
|
Number of Seropositive Subjects for Each Influenza Strain
A/New Caledonia, PRE
|
162 Participants
|
294 Participants
|
456 Participants
|
|
Number of Seropositive Subjects for Each Influenza Strain
A/Wisconsin, PRE
|
102 Participants
|
209 Participants
|
311 Participants
|
|
Number of Seropositive Subjects for Each Influenza Strain
B/Malaysia, PRE
|
132 Participants
|
277 Participants
|
409 Participants
|
PRIMARY outcome
Timeframe: At Day 21Population: 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.
A seropositive subject was defined as a vaccinated subject with an antibody titer ≥1:10.
Outcome measures
| Measure |
Fluarix 50-64 Years Group
n=171 Participants
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.
|
Fluarix 65+ Years Group
n=307 Participants
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.
|
Fluarix 50+ Years Group
n=478 Participants
Adult subjects aged 50 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.
|
|---|---|---|---|
|
Number of Seropositive Subjects for Each Influenza Strain
A/New Caledonia, Day 21
|
171 Participants
|
306 Participants
|
477 Participants
|
|
Number of Seropositive Subjects for Each Influenza Strain
A/Wisconsin, Day 21
|
167 Participants
|
304 Participants
|
471 Participants
|
|
Number of Seropositive Subjects for Each Influenza Strain
B/Malaysia, Day 21
|
168 Participants
|
306 Participants
|
474 Participants
|
PRIMARY outcome
Timeframe: 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.
Serum HI antibody titers were expressed as Geometric Mean Titers (GMTs).
Outcome measures
| Measure |
Fluarix 50-64 Years Group
n=171 Participants
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.
|
Fluarix 65+ Years Group
n=307 Participants
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.
|
Fluarix 50+ Years Group
n=478 Participants
Adult subjects aged 50 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.
|
|---|---|---|---|
|
Serum HI Antibody Titers for Each Influenza Strain
A/Wisconsin, PRE
|
16.9 Titer
Interval 13.8 to 20.8
|
21.5 Titer
Interval 18.4 to 25.3
|
19.8 Titer
Interval 17.4 to 22.4
|
|
Serum HI Antibody Titers for Each Influenza Strain
B/Malaysia, PRE
|
21.4 Titer
Interval 18.0 to 25.4
|
38.8 Titer
Interval 34.1 to 44.2
|
31.3 Titer
Interval 28.2 to 34.9
|
|
Serum HI Antibody Titers for Each Influenza Strain
A/New Caledonia, PRE
|
40.5 Titer
Interval 33.7 to 48.8
|
43.2 Titer
Interval 38.3 to 48.7
|
42.2 Titer
Interval 38.1 to 46.7
|
PRIMARY outcome
Timeframe: At Day 21Population: 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.
Serum HI antibody titers were expressed as Geometric Mean Titers (GMTs).
Outcome measures
| Measure |
Fluarix 50-64 Years Group
n=171 Participants
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.
|
Fluarix 65+ Years Group
n=307 Participants
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.
|
Fluarix 50+ Years Group
n=478 Participants
Adult subjects aged 50 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.
|
|---|---|---|---|
|
Serum HI Antibody Titers for Each Influenza Strain
A/New Caledonia, Day 21
|
216.4 Titer
Interval 180.8 to 259.0
|
142.9 Titer
Interval 125.8 to 162.4
|
165.8 Titer
Interval 149.2 to 184.2
|
|
Serum HI Antibody Titers for Each Influenza Strain
A/Wisconsin, Day 21
|
156.7 Titer
Interval 125.3 to 196.0
|
179.1 Titer
Interval 154.0 to 208.4
|
170.8 Titer
Interval 150.6 to 193.6
|
|
Serum HI Antibody Titers for Each Influenza Strain
B/Malaysia, Day 21
|
149.9 Titer
Interval 124.3 to 180.9
|
184.0 Titer
Interval 161.9 to 209.2
|
171.0 Titer
Interval 153.8 to 190.2
|
Adverse Events
Fluarix 50-64 Years Group
Serious events: 23 serious events
Other events: 0 other events
Deaths: 2 deaths
Fluarix 65+ Years Group
Serious events: 105 serious events
Other events: 0 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Fluarix 50-64 Years Group
n=1047 participants at risk
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.
|
Fluarix 65+ Years Group
n=2007 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.19%
2/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.20%
4/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.25%
5/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.25%
5/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.20%
4/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.20%
4/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Cardiac disorders
Angina unstable
|
0.10%
1/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.10%
2/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Cardiac disorders
Cardiac arrest
|
0.10%
1/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.10%
2/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Nervous system disorders
Cerebrovascular accident
|
0.10%
1/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.10%
2/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Infections and infestations
Abdominal abscess
|
0.10%
1/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.10%
2/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.10%
2/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
General disorders
Chest pain
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.10%
2/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.10%
1/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.10%
1/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Gastrointestinal disorders
Gastritis
|
0.10%
1/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Infections and infestations
Helicobacter gastritis
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.10%
2/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.10%
1/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.10%
2/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.10%
2/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.10%
2/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.10%
2/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.10%
1/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Infections and infestations
Abscess
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Cardiac disorders
Acute myocardial infarction
|
0.10%
1/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.00%
0/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Gastrointestinal disorders
Anal fistula
|
0.10%
1/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.00%
0/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Infections and infestations
Appendicitis
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Vascular disorders
Arterial occlusive disease
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Vascular disorders
Arterial stenosis limb
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Cardiac disorders
Atrial flutter
|
0.10%
1/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.00%
0/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Infections and infestations
Bacteraemia
|
0.10%
1/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.00%
0/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Vascular disorders
Bleeding varicose vein
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Infections and infestations
Bronchitis
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Injury, poisoning and procedural complications
Cardiac pacemaker malfunction
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Vascular disorders
Carotid artery stenosis
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Respiratory, thoracic and mediastinal disorders
Chronic sinusitis
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Nervous system disorders
Concussion
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Vascular disorders
Coronary artery occlusion
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
General disorders
Death
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Injury, poisoning and procedural complications
Dislocation of joint prosthesis
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Infections and infestations
Diverticulitis
|
0.10%
1/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.00%
0/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Vascular disorders
Femoral arterial stenosis
|
0.10%
1/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.00%
0/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Vascular disorders
Femoral artery occlusion
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal carcinoma
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.10%
1/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.00%
0/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Vascular disorders
Haematemesis
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Investigations
Heart rate increased
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.10%
1/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.00%
0/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Vascular disorders
Hypertension
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Vascular disorders
Ischaemia
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Gastrointestinal disorders
Oesophagitis
|
0.10%
1/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.00%
0/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
General disorders
Organ failure
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.10%
1/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.00%
0/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.10%
1/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.00%
0/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
General disorders
Pyrexia
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Nervous system disorders
Radial nerve palsy
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.10%
1/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.00%
0/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Gastrointestinal disorders
Rectal polyp
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Eye disorders
Retinal artery occlusion
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Eye disorders
Retinitis
|
0.10%
1/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.00%
0/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Infections and infestations
Sepsis
|
0.10%
1/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.00%
0/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Vascular disorders
Shock
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Nervous system disorders
Syncope
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Vascular disorders
Transient ischemic attack
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.10%
1/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.00%
0/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/1047 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
0.05%
1/2007 • SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Other (non-serious) Adverse Events were not collected
|
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER