Trial Outcomes & Findings for Study to Evaluate the Efficacy, Safety and Immunogenicity of Influenza Vaccine in Healthy Subjects (Aged 6 to <72 Months) Versus Control Vaccines (NCT NCT00644059)
NCT ID: NCT00644059
Last Updated: 2015-09-18
Results Overview
Safety was assessed in terms of number of subjects experiencing each of the local and systemic reactions within 7-days after any vaccination for all seasons, comparison of adjuvanted Trivalent influenza vaccine (aTIV) and flu vaccine control.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
4902 participants
Primary outcome timeframe
7 days post-vaccination
Results posted on
2015-09-18
Participant Flow
Participants were enrolled as follows: In season 2007/08: 28 active sites in Germany (Excluding Site 023); In season 2008/09: 83 active sites+ 1 coordinating site in Germany, 15 sites in Finland; In season 2009/10: 15 sites in Finland, 2 sites in Italy
All subjects enrolled were included in the trial. The data entered is for the overall study.
Participant milestones
| Measure |
TIV-adj
Subjects aged 6 to \< 36 months received 0.25 mL and those aged 36 to \<72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
|
Flu-control
Subjects aged 6 to \< 36 months received 0.25 mL and those aged 36 to \<72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Non-flu Control
Subjects aged 6 to \<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \<72 months received 2 doses of 0.25 mL of Tick-borne encephalitis (TBE) vaccine
|
|---|---|---|---|
|
Overall Study
STARTED
|
2019
|
1849
|
1034
|
|
Overall Study
COMPLETED
|
1895
|
1726
|
969
|
|
Overall Study
NOT COMPLETED
|
124
|
123
|
65
|
Reasons for withdrawal
| Measure |
TIV-adj
Subjects aged 6 to \< 36 months received 0.25 mL and those aged 36 to \<72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
|
Flu-control
Subjects aged 6 to \< 36 months received 0.25 mL and those aged 36 to \<72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Non-flu Control
Subjects aged 6 to \<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \<72 months received 2 doses of 0.25 mL of Tick-borne encephalitis (TBE) vaccine
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
37
|
34
|
16
|
|
Overall Study
Withdrawal by Subject
|
52
|
60
|
30
|
|
Overall Study
Adverse Event
|
8
|
5
|
1
|
|
Overall Study
Inappropriate Enrollment
|
1
|
3
|
0
|
|
Overall Study
Protocol Deviation/violation
|
20
|
19
|
15
|
|
Overall Study
Unable to classify
|
6
|
2
|
3
|
Baseline Characteristics
Study to Evaluate the Efficacy, Safety and Immunogenicity of Influenza Vaccine in Healthy Subjects (Aged 6 to <72 Months) Versus Control Vaccines
Baseline characteristics by cohort
| Measure |
TIV-adj
n=2019 Participants
Subjects aged 6 to \< 36 months received 0.25 mL and those aged 36 to \<72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
|
Flu-control
n=1849 Participants
Subjects aged 6 to \< 36 months received 0.25 mL and those aged 36 to \<72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Non-flu Control
n=1034 Participants
Subjects aged 6 to \<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \<72 months received 2 doses of 0.25 mL of TBE vaccine
|
Total
n=4902 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
31.9 Months
STANDARD_DEVIATION 19.8 • n=5 Participants
|
32.6 Months
STANDARD_DEVIATION 20.1 • n=7 Participants
|
32.2 Months
STANDARD_DEVIATION 19.8 • n=5 Participants
|
32.2 Months
STANDARD_DEVIATION 19.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
962 Participants
n=5 Participants
|
903 Participants
n=7 Participants
|
484 Participants
n=5 Participants
|
2349 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1057 Participants
n=5 Participants
|
946 Participants
n=7 Participants
|
550 Participants
n=5 Participants
|
2553 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 7 days post-vaccinationPopulation: The analysis was done on Safety set - All subjects in the exposed population who provided post-baseline safety data.
Safety was assessed in terms of number of subjects experiencing each of the local and systemic reactions within 7-days after any vaccination for all seasons, comparison of adjuvanted Trivalent influenza vaccine (aTIV) and flu vaccine control.
Outcome measures
| Measure |
TIV-adj (6 to <36 Months)
n=1178 Participants
Subjects aged 6 to \<36 months received 0.25 mL of each injection of Adjuvanted trivalent inactivated subunit influenza vaccine
|
Flu-control (6 to <36 Months)
n=1068 Participants
Subjects aged 6 to \<36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Flu-control (6 to <36 Months)
Subjects aged 6 to \< 36 months received 0.25 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Flu-control (36 to <72 Months)
Subjects aged 36 to \< 72 months received 0.5 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Non-Flu-control (6 to <36 Months)
Subjects aged 6 to \<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \<72 months received 2 doses of 0.25 mL of TBE vaccine
|
Non-Flu-control (36 to <72 Months)
Subjects aged 6 to \<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \<72 months received 2 doses of 0.25 mL of TBE vaccine
|
|---|---|---|---|---|---|---|
|
Number of Subjects (Unprimed) 6 to <36 Months Age With Local and Systemic Reactions After Any Vaccination for All Seasons, Comparison of Adjuvanted Trivalent Influenza Vaccine (aTIV) and Flu Vaccine Control.
Unusual crying
|
386 Number of subjects
|
345 Number of subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects (Unprimed) 6 to <36 Months Age With Local and Systemic Reactions After Any Vaccination for All Seasons, Comparison of Adjuvanted Trivalent Influenza Vaccine (aTIV) and Flu Vaccine Control.
Irritability
|
387 Number of subjects
|
353 Number of subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects (Unprimed) 6 to <36 Months Age With Local and Systemic Reactions After Any Vaccination for All Seasons, Comparison of Adjuvanted Trivalent Influenza Vaccine (aTIV) and Flu Vaccine Control.
Diarrhea
|
258 Number of subjects
|
211 Number of subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects (Unprimed) 6 to <36 Months Age With Local and Systemic Reactions After Any Vaccination for All Seasons, Comparison of Adjuvanted Trivalent Influenza Vaccine (aTIV) and Flu Vaccine Control.
Shivering
|
77 Number of subjects
|
69 Number of subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects (Unprimed) 6 to <36 Months Age With Local and Systemic Reactions After Any Vaccination for All Seasons, Comparison of Adjuvanted Trivalent Influenza Vaccine (aTIV) and Flu Vaccine Control.
Fever (>40.0°C) (N=1177,1068)
|
3 Number of subjects
|
3 Number of subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects (Unprimed) 6 to <36 Months Age With Local and Systemic Reactions After Any Vaccination for All Seasons, Comparison of Adjuvanted Trivalent Influenza Vaccine (aTIV) and Flu Vaccine Control.
Analg.Antipyr.Used (N=1176,1068)
|
358 Number of subjects
|
317 Number of subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects (Unprimed) 6 to <36 Months Age With Local and Systemic Reactions After Any Vaccination for All Seasons, Comparison of Adjuvanted Trivalent Influenza Vaccine (aTIV) and Flu Vaccine Control.
Any Local
|
625 Number of subjects
|
481 Number of subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects (Unprimed) 6 to <36 Months Age With Local and Systemic Reactions After Any Vaccination for All Seasons, Comparison of Adjuvanted Trivalent Influenza Vaccine (aTIV) and Flu Vaccine Control.
Injection Site Ecchymosis
|
147 Number of subjects
|
103 Number of subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects (Unprimed) 6 to <36 Months Age With Local and Systemic Reactions After Any Vaccination for All Seasons, Comparison of Adjuvanted Trivalent Influenza Vaccine (aTIV) and Flu Vaccine Control.
Injection Site Erythema
|
423 Number of subjects
|
322 Number of subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects (Unprimed) 6 to <36 Months Age With Local and Systemic Reactions After Any Vaccination for All Seasons, Comparison of Adjuvanted Trivalent Influenza Vaccine (aTIV) and Flu Vaccine Control.
Injection Site Induration
|
214 Number of subjects
|
131 Number of subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects (Unprimed) 6 to <36 Months Age With Local and Systemic Reactions After Any Vaccination for All Seasons, Comparison of Adjuvanted Trivalent Influenza Vaccine (aTIV) and Flu Vaccine Control.
Swelling
|
123 Number of subjects
|
89 Number of subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects (Unprimed) 6 to <36 Months Age With Local and Systemic Reactions After Any Vaccination for All Seasons, Comparison of Adjuvanted Trivalent Influenza Vaccine (aTIV) and Flu Vaccine Control.
Tender. at inj.site
|
330 Number of subjects
|
246 Number of subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects (Unprimed) 6 to <36 Months Age With Local and Systemic Reactions After Any Vaccination for All Seasons, Comparison of Adjuvanted Trivalent Influenza Vaccine (aTIV) and Flu Vaccine Control.
Any Systemic
|
785 Number of subjects
|
694 Number of subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects (Unprimed) 6 to <36 Months Age With Local and Systemic Reactions After Any Vaccination for All Seasons, Comparison of Adjuvanted Trivalent Influenza Vaccine (aTIV) and Flu Vaccine Control.
Change in eat. hab.
|
325 Number of subjects
|
261 Number of subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects (Unprimed) 6 to <36 Months Age With Local and Systemic Reactions After Any Vaccination for All Seasons, Comparison of Adjuvanted Trivalent Influenza Vaccine (aTIV) and Flu Vaccine Control.
Sleepiness
|
380 Number of subjects
|
312 Number of subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects (Unprimed) 6 to <36 Months Age With Local and Systemic Reactions After Any Vaccination for All Seasons, Comparison of Adjuvanted Trivalent Influenza Vaccine (aTIV) and Flu Vaccine Control.
Vomiting
|
131 Number of subjects
|
118 Number of subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects (Unprimed) 6 to <36 Months Age With Local and Systemic Reactions After Any Vaccination for All Seasons, Comparison of Adjuvanted Trivalent Influenza Vaccine (aTIV) and Flu Vaccine Control.
Any Other
|
358 Number of subjects
|
317 Number of subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects (Unprimed) 6 to <36 Months Age With Local and Systemic Reactions After Any Vaccination for All Seasons, Comparison of Adjuvanted Trivalent Influenza Vaccine (aTIV) and Flu Vaccine Control.
Fever (38-38.9°C) (N=1177,1068)
|
169 Number of subjects
|
143 Number of subjects
|
—
|
—
|
—
|
—
|
|
Number of Subjects (Unprimed) 6 to <36 Months Age With Local and Systemic Reactions After Any Vaccination for All Seasons, Comparison of Adjuvanted Trivalent Influenza Vaccine (aTIV) and Flu Vaccine Control.
Fever (39-39.9°C) (N=1177,1068)
|
61 Number of subjects
|
43 Number of subjects
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 3 weeks after 2nd vaccinationPopulation: Analysis was done on Full Analysis Set (FAS) - All subjects in the enrolled set who received study vaccination and provided at least one evaluable serum sample both before and after baseline.
Virus-confirmed influenza illnesses were assessed and compared between the adjuvanted influenza vaccine (TIV-adj) and non-influenza vaccines (Non-flu control) in 6 to \<36 month unprimed subjects for Absolute Efficacy. This primary endpoint is only for homologous strains.
Outcome measures
| Measure |
TIV-adj (6 to <36 Months)
n=916 Participants
Subjects aged 6 to \<36 months received 0.25 mL of each injection of Adjuvanted trivalent inactivated subunit influenza vaccine
|
Flu-control (6 to <36 Months)
n=469 Participants
Subjects aged 6 to \<36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Flu-control (6 to <36 Months)
Subjects aged 6 to \< 36 months received 0.25 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Flu-control (36 to <72 Months)
Subjects aged 36 to \< 72 months received 0.5 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Non-Flu-control (6 to <36 Months)
Subjects aged 6 to \<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \<72 months received 2 doses of 0.25 mL of TBE vaccine
|
Non-Flu-control (36 to <72 Months)
Subjects aged 6 to \<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \<72 months received 2 doses of 0.25 mL of TBE vaccine
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects (Unprimed) Aged 6 to <36 Months With Virus-Confirmed Influenza, Comparison of aTIV and Non-flu Vaccine Control (Men C/TBE Vaccine)
Season 2007/2008, Matched strain,N=187,97
|
0 Percentage of subjects
|
0 Percentage of subjects
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects (Unprimed) Aged 6 to <36 Months With Virus-Confirmed Influenza, Comparison of aTIV and Non-flu Vaccine Control (Men C/TBE Vaccine)
Season 2008/2009, Matched strain
|
0.76 Percentage of subjects
|
4.05 Percentage of subjects
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 7 days post-vaccinationPopulation: The analysis was done on Safety set
Safety was assessed as the number of subjects aged 6 to \<72 months who reported solicited local or systemic adverse events after any vaccination with TIV-adj for all seasons.
Outcome measures
| Measure |
TIV-adj (6 to <36 Months)
n=1178 Participants
Subjects aged 6 to \<36 months received 0.25 mL of each injection of Adjuvanted trivalent inactivated subunit influenza vaccine
|
Flu-control (6 to <36 Months)
n=833 Participants
Subjects aged 6 to \<36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Flu-control (6 to <36 Months)
n=1068 Participants
Subjects aged 6 to \< 36 months received 0.25 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Flu-control (36 to <72 Months)
n=778 Participants
Subjects aged 36 to \< 72 months received 0.5 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Non-Flu-control (6 to <36 Months)
n=607 Participants
Subjects aged 6 to \<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \<72 months received 2 doses of 0.25 mL of TBE vaccine
|
Non-Flu-control (36 to <72 Months)
n=422 Participants
Subjects aged 6 to \<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \<72 months received 2 doses of 0.25 mL of TBE vaccine
|
|---|---|---|---|---|---|---|
|
Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination
Inj. site induration(N=1178,833,1068,777,607,422)
|
214 Number of subjects
|
168 Number of subjects
|
131 Number of subjects
|
152 Number of subjects
|
153 Number of subjects
|
80 Number of subjects
|
|
Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination
Arthralgia (N=0,833,0,777,0,422)
|
0 Number of subjects
|
82 Number of subjects
|
0 Number of subjects
|
37 Number of subjects
|
0 Number of subjects
|
27 Number of subjects
|
|
Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination
Sweating (N=0,833,0,777,0,422)
|
0 Number of subjects
|
69 Number of subjects
|
0 Number of subjects
|
42 Number of subjects
|
0 Number of subjects
|
31 Number of subjects
|
|
Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination
Fever(38-38.9C)(N=1177,833,1068,775,607,421)
|
169 Number of subjects
|
133 Number of subjects
|
143 Number of subjects
|
55 Number of subjects
|
62 Number of subjects
|
37 Number of subjects
|
|
Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination
Fever(39-39.9C)(N=1177,833,1068,775,607,421)
|
61 Number of subjects
|
50 Number of subjects
|
43 Number of subjects
|
17 Number of subjects
|
34 Number of subjects
|
19 Number of subjects
|
|
Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination
Any Local
|
625 Number of subjects
|
569 Number of subjects
|
481 Number of subjects
|
466 Number of subjects
|
315 Number of subjects
|
232 Number of subjects
|
|
Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination
Inj. site ecchymosis(N=1178,833,1068,777,607,422)
|
147 Number of subjects
|
130 Number of subjects
|
103 Number of subjects
|
93 Number of subjects
|
69 Number of subjects
|
49 Number of subjects
|
|
Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination
Inj. site erythema(N=1178,833,1068,777,607,422)
|
423 Number of subjects
|
320 Number of subjects
|
322 Number of subjects
|
269 Number of subjects
|
239 Number of subjects
|
129 Number of subjects
|
|
Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination
Inj. site swelling(N=1178,833,1068,777,607,422)
|
123 Number of subjects
|
155 Number of subjects
|
89 Number of subjects
|
128 Number of subjects
|
82 Number of subjects
|
55 Number of subjects
|
|
Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination
Inj. site tenderness(N=1178,0,1068,0,607,0)
|
330 Number of subjects
|
0 Number of subjects
|
246 Number of subjects
|
0 Number of subjects
|
171 Number of subjects
|
0 Number of subjects
|
|
Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination
Inj. site pain (N=0,833,0,777,0,422)
|
0 Number of subjects
|
477 Number of subjects
|
0 Number of subjects
|
360 Number of subjects
|
0 Number of subjects
|
180 Number of subjects
|
|
Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination
Any Systemic
|
785 Number of subjects
|
523 Number of subjects
|
694 Number of subjects
|
341 Number of subjects
|
370 Number of subjects
|
211 Number of subjects
|
|
Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination
Change in eat. hab.(N=1178,0,1068,0,607,0)
|
325 Number of subjects
|
0 Number of subjects
|
261 Number of subjects
|
0 Number of subjects
|
162 Number of subjects
|
0 Number of subjects
|
|
Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination
Sleepiness (N=1178,0,1068,0,607,0)
|
380 Number of subjects
|
0 Number of subjects
|
312 Number of subjects
|
0 Number of subjects
|
186 Number of subjects
|
0 Number of subjects
|
|
Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination
Unusual crying (N=1178,0,1068,0,607,0)
|
386 Number of subjects
|
0 Number of subjects
|
345 Number of subjects
|
0 Number of subjects
|
175 Number of subjects
|
0 Number of subjects
|
|
Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination
Irritability (N=1178,0,1068,0,607,0)
|
387 Number of subjects
|
0 Number of subjects
|
353 Number of subjects
|
0 Number of subjects
|
187 Number of subjects
|
0 Number of subjects
|
|
Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination
Vomiting (N=1178,0,1068,0,607,0)
|
131 Number of subjects
|
0 Number of subjects
|
118 Number of subjects
|
0 Number of subjects
|
66 Number of subjects
|
0 Number of subjects
|
|
Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination
Diarrhea (N=1178,0,1068,0,607,0)
|
258 Number of subjects
|
0 Number of subjects
|
211 Number of subjects
|
0 Number of subjects
|
114 Number of subjects
|
0 Number of subjects
|
|
Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination
Shivering (N=1178,0,1068,0,607,0)
|
77 Number of subjects
|
0 Number of subjects
|
69 Number of subjects
|
0 Number of subjects
|
50 Number of subjects
|
0 Number of subjects
|
|
Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination
Chills shivering (N=0,833,0,777,0,422)
|
0 Number of subjects
|
130 Number of subjects
|
0 Number of subjects
|
51 Number of subjects
|
0 Number of subjects
|
37 Number of subjects
|
|
Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination
Malaise (N=0,833,0,777,0,422)
|
0 Number of subjects
|
196 Number of subjects
|
0 Number of subjects
|
118 Number of subjects
|
0 Number of subjects
|
63 Number of subjects
|
|
Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination
Myalgia (N=0,833,0,777,0,422)
|
0 Number of subjects
|
183 Number of subjects
|
0 Number of subjects
|
100 Number of subjects
|
0 Number of subjects
|
66 Number of subjects
|
|
Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination
Headache (N=0,833,0,777,0,422)
|
0 Number of subjects
|
197 Number of subjects
|
0 Number of subjects
|
100 Number of subjects
|
0 Number of subjects
|
54 Number of subjects
|
|
Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination
Fatigue (N=0,833,0,777,0,422)
|
0 Number of subjects
|
337 Number of subjects
|
0 Number of subjects
|
222 Number of subjects
|
0 Number of subjects
|
123 Number of subjects
|
|
Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination
Any Other
|
358 Number of subjects
|
196 Number of subjects
|
317 Number of subjects
|
94 Number of subjects
|
159 Number of subjects
|
69 Number of subjects
|
|
Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination
Fever(≥40.0C)(N=1177,833,1068,775,607,421)
|
3 Number of subjects
|
1 Number of subjects
|
3 Number of subjects
|
2 Number of subjects
|
2 Number of subjects
|
1 Number of subjects
|
|
Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination
Analg.Antipyr.Used (N=1176,833,1068,777,607,422)
|
358 Number of subjects
|
196 Number of subjects
|
317 Number of subjects
|
94 Number of subjects
|
159 Number of subjects
|
69 Number of subjects
|
SECONDARY outcome
Timeframe: Study day 1 to Study day 181Population: The analysis was done on Safety set
Number of subjects aged 6 to \<36 months and in the overall age cohort (unprimed children aged 6 to \<72 months) experiencing each of the unsolicited adverse events (AEs) throughout the study
Outcome measures
| Measure |
TIV-adj (6 to <36 Months)
n=1177 Participants
Subjects aged 6 to \<36 months received 0.25 mL of each injection of Adjuvanted trivalent inactivated subunit influenza vaccine
|
Flu-control (6 to <36 Months)
n=1069 Participants
Subjects aged 6 to \<36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Flu-control (6 to <36 Months)
n=607 Participants
Subjects aged 6 to \< 36 months received 0.25 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Flu-control (36 to <72 Months)
n=2012 Participants
Subjects aged 36 to \< 72 months received 0.5 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Non-Flu-control (6 to <36 Months)
n=1846 Participants
Subjects aged 6 to \<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \<72 months received 2 doses of 0.25 mL of TBE vaccine
|
Non-Flu-control (36 to <72 Months)
n=1029 Participants
Subjects aged 6 to \<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \<72 months received 2 doses of 0.25 mL of TBE vaccine
|
|---|---|---|---|---|---|---|
|
Number of Subjects (Unprimed) With Unsolicited Adverse Events Reported After Any Vaccination
At least possibly related SAEs
|
1 Number of subjects
|
1 Number of subjects
|
3 Number of subjects
|
2 Number of subjects
|
2 Number of subjects
|
3 Number of subjects
|
|
Number of Subjects (Unprimed) With Unsolicited Adverse Events Reported After Any Vaccination
AEs leading to discontinuation
|
6 Number of subjects
|
9 Number of subjects
|
1 Number of subjects
|
9 Number of subjects
|
10 Number of subjects
|
1 Number of subjects
|
|
Number of Subjects (Unprimed) With Unsolicited Adverse Events Reported After Any Vaccination
Any AEs
|
1045 Number of subjects
|
938 Number of subjects
|
530 Number of subjects
|
1714 Number of subjects
|
1566 Number of subjects
|
867 Number of subjects
|
|
Number of Subjects (Unprimed) With Unsolicited Adverse Events Reported After Any Vaccination
At least possibly related AEs
|
152 Number of subjects
|
124 Number of subjects
|
90 Number of subjects
|
262 Number of subjects
|
203 Number of subjects
|
137 Number of subjects
|
|
Number of Subjects (Unprimed) With Unsolicited Adverse Events Reported After Any Vaccination
Serious AEs
|
91 Number of subjects
|
104 Number of subjects
|
65 Number of subjects
|
122 Number of subjects
|
169 Number of subjects
|
110 Number of subjects
|
SECONDARY outcome
Timeframe: 3 weeks after 2nd vaccinationPopulation: The analysis was done on Full Analysis Set
Virus-confirmed influenza illnesses were assessed and compared between the adjuvanted influenza vaccine (TIV-adj) and non-influenza vaccines (Non-flu control) in subjects aged 6 to \<72 months (unprimed) for Absolute Efficacy. For Relative efficacy, the comparison was made between adjuvanted influenza vaccine (TIV-adj) and flu vaccine control.
Outcome measures
| Measure |
TIV-adj (6 to <36 Months)
n=916 Participants
Subjects aged 6 to \<36 months received 0.25 mL of each injection of Adjuvanted trivalent inactivated subunit influenza vaccine
|
Flu-control (6 to <36 Months)
n=469 Participants
Subjects aged 6 to \<36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Flu-control (6 to <36 Months)
n=902 Participants
Subjects aged 6 to \< 36 months received 0.25 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Flu-control (36 to <72 Months)
n=698 Participants
Subjects aged 36 to \< 72 months received 0.5 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Non-Flu-control (6 to <36 Months)
n=360 Participants
Subjects aged 6 to \<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \<72 months received 2 doses of 0.25 mL of TBE vaccine
|
Non-Flu-control (36 to <72 Months)
n=706 Participants
Subjects aged 6 to \<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \<72 months received 2 doses of 0.25 mL of TBE vaccine
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects (Unprimed) Aged 6 to <72 Months With Virus-Confirmed Influenza, Comparison of aTIV to Non-flu Vaccine Control and Flu-vaccine Control (Matched Strains)
Matched strain(Season2007/08)N=187,97,93,136,67,71
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
|
Percentage of Subjects (Unprimed) Aged 6 to <72 Months With Virus-Confirmed Influenza, Comparison of aTIV to Non-flu Vaccine Control and Flu-vaccine Control (Matched Strains)
Matched strain (Season2008/09)
|
0.76 Percentage of subjects
|
4.05 Percentage of subjects
|
2.44 Percentage of subjects
|
0.29 Percentage of subjects
|
6.11 Percentage of subjects
|
3.12 Percentage of subjects
|
SECONDARY outcome
Timeframe: 3 weeks after 2nd vaccinationPopulation: Analysis was done on Full Analysis Set
Virus-confirmed influenza illnesses (regardless of antigenic match to those contained in the vaccine) were assessed and compared between the adjuvanted influenza vaccine (TIV-adj) and non-influenza vaccines (Non-flu control) in subjects aged 6 to \<72 months (unprimed) for Absolute Efficacy. For Relative efficacy, the comparison was made between adjuvanted influenza vaccine (TIV-adj) and flu vaccine control.
Outcome measures
| Measure |
TIV-adj (6 to <36 Months)
n=916 Participants
Subjects aged 6 to \<36 months received 0.25 mL of each injection of Adjuvanted trivalent inactivated subunit influenza vaccine
|
Flu-control (6 to <36 Months)
n=469 Participants
Subjects aged 6 to \<36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Flu-control (6 to <36 Months)
n=902 Participants
Subjects aged 6 to \< 36 months received 0.25 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Flu-control (36 to <72 Months)
n=698 Participants
Subjects aged 36 to \< 72 months received 0.5 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Non-Flu-control (6 to <36 Months)
n=360 Participants
Subjects aged 6 to \<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \<72 months received 2 doses of 0.25 mL of TBE vaccine
|
Non-Flu-control (36 to <72 Months)
n=706 Participants
Subjects aged 6 to \<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \<72 months received 2 doses of 0.25 mL of TBE vaccine
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects (Unprimed) Aged 6 to <72 Months With Virus-Confirmed Influenza, Comparison of aTIV to Non-flu Vaccine Control and Flu Vaccine Control (Any Strains).
Any Strain (Season 2007/08)N=187,97,93,136,67,71
|
0 Percentage of subjects
|
2.06 Percentage of subjects
|
0 Percentage of subjects
|
0.74 Percentage of subjects
|
2.99 Percentage of subjects
|
0 Percentage of subjects
|
|
Percentage of Subjects (Unprimed) Aged 6 to <72 Months With Virus-Confirmed Influenza, Comparison of aTIV to Non-flu Vaccine Control and Flu Vaccine Control (Any Strains).
Any Strain (Season 2008/09)
|
0.98 Percentage of subjects
|
4.26 Percentage of subjects
|
2.77 Percentage of subjects
|
0.43 Percentage of subjects
|
6.39 Percentage of subjects
|
3.54 Percentage of subjects
|
SECONDARY outcome
Timeframe: 3 weeks after 2nd vaccinationPopulation: Analysis was done on Full Analysis Set
Virus-confirmed influenza illnesses were assessed and trivalent adjuvanted influenza vaccine (TIV-adj) was compared with Non-flu control vaccine and Flu-control vaccine in 6 to \<72 month old subjects for Influenza like illnesses for seasons 2007/08 and 2008/09.
Outcome measures
| Measure |
TIV-adj (6 to <36 Months)
n=1937 Participants
Subjects aged 6 to \<36 months received 0.25 mL of each injection of Adjuvanted trivalent inactivated subunit influenza vaccine
|
Flu-control (6 to <36 Months)
n=1772 Participants
Subjects aged 6 to \<36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Flu-control (6 to <36 Months)
n=993 Participants
Subjects aged 6 to \< 36 months received 0.25 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Flu-control (36 to <72 Months)
Subjects aged 36 to \< 72 months received 0.5 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Non-Flu-control (6 to <36 Months)
Subjects aged 6 to \<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \<72 months received 2 doses of 0.25 mL of TBE vaccine
|
Non-Flu-control (36 to <72 Months)
Subjects aged 6 to \<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \<72 months received 2 doses of 0.25 mL of TBE vaccine
|
|---|---|---|---|---|---|---|
|
Number of Subjects (Unprimed) With Influenza Like Illnesses (ILIs) in the 6 to <72 Months Age Cohort for Combined Seasons 2007/08 and 2008/09
Subjects with ILI
|
425 Number of subjects
|
436 Number of subjects
|
253 Number of subjects
|
—
|
—
|
—
|
|
Number of Subjects (Unprimed) With Influenza Like Illnesses (ILIs) in the 6 to <72 Months Age Cohort for Combined Seasons 2007/08 and 2008/09
Outpatient visits
|
290 Number of subjects
|
293 Number of subjects
|
174 Number of subjects
|
—
|
—
|
—
|
|
Number of Subjects (Unprimed) With Influenza Like Illnesses (ILIs) in the 6 to <72 Months Age Cohort for Combined Seasons 2007/08 and 2008/09
Inpatient visits
|
20 Number of subjects
|
26 Number of subjects
|
19 Number of subjects
|
—
|
—
|
—
|
|
Number of Subjects (Unprimed) With Influenza Like Illnesses (ILIs) in the 6 to <72 Months Age Cohort for Combined Seasons 2007/08 and 2008/09
Outcome (Recovered)
|
414 Number of subjects
|
431 Number of subjects
|
248 Number of subjects
|
—
|
—
|
—
|
|
Number of Subjects (Unprimed) With Influenza Like Illnesses (ILIs) in the 6 to <72 Months Age Cohort for Combined Seasons 2007/08 and 2008/09
Outcome (Alive with sequelae)
|
5 Number of subjects
|
2 Number of subjects
|
2 Number of subjects
|
—
|
—
|
—
|
|
Number of Subjects (Unprimed) With Influenza Like Illnesses (ILIs) in the 6 to <72 Months Age Cohort for Combined Seasons 2007/08 and 2008/09
Outcome (Lost to follow-up)
|
3 Number of subjects
|
1 Number of subjects
|
0 Number of subjects
|
—
|
—
|
—
|
|
Number of Subjects (Unprimed) With Influenza Like Illnesses (ILIs) in the 6 to <72 Months Age Cohort for Combined Seasons 2007/08 and 2008/09
Outcome (ILI persisting)
|
3 Number of subjects
|
1 Number of subjects
|
3 Number of subjects
|
—
|
—
|
—
|
|
Number of Subjects (Unprimed) With Influenza Like Illnesses (ILIs) in the 6 to <72 Months Age Cohort for Combined Seasons 2007/08 and 2008/09
Outcome (Not available)
|
0 Number of subjects
|
1 Number of subjects
|
0 Number of subjects
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 weeks after 2nd vaccinationPopulation: Analysis was done on Full Analysis Set
Virus-confirmed influenza illnesses were assessed and trivalent adjuvanted influenza vaccine (TIV-adj) was compared with Non-flu control vaccine and Flu-control vaccine for Influenza like illnesses for seasons 2007/08 and 2008/09.
Outcome measures
| Measure |
TIV-adj (6 to <36 Months)
n=1103 Participants
Subjects aged 6 to \<36 months received 0.25 mL of each injection of Adjuvanted trivalent inactivated subunit influenza vaccine
|
Flu-control (6 to <36 Months)
n=566 Participants
Subjects aged 6 to \<36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Flu-control (6 to <36 Months)
n=995 Participants
Subjects aged 6 to \< 36 months received 0.25 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Flu-control (36 to <72 Months)
n=1937 Participants
Subjects aged 36 to \< 72 months received 0.5 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Non-Flu-control (6 to <36 Months)
n=993 Participants
Subjects aged 6 to \<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \<72 months received 2 doses of 0.25 mL of TBE vaccine
|
Non-Flu-control (36 to <72 Months)
n=1772 Participants
Subjects aged 6 to \<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \<72 months received 2 doses of 0.25 mL of TBE vaccine
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Influenza Like Illnesses (ILIs) in the 6 to <36 Months and in Overall Age Cohort (Unprimed Subjects Aged 6 to <72 Months) for Combined Seasons 2007/08 and 2008/09
Subjects with ILI
|
280 Number of subjects
|
163 Number of subjects
|
272 Number of subjects
|
425 Number of subjects
|
253 Number of subjects
|
436 Number of subjects
|
|
Number of Subjects With Influenza Like Illnesses (ILIs) in the 6 to <36 Months and in Overall Age Cohort (Unprimed Subjects Aged 6 to <72 Months) for Combined Seasons 2007/08 and 2008/09
Outpatient visits
|
192 Number of subjects
|
113 Number of subjects
|
183 Number of subjects
|
290 Number of subjects
|
174 Number of subjects
|
293 Number of subjects
|
|
Number of Subjects With Influenza Like Illnesses (ILIs) in the 6 to <36 Months and in Overall Age Cohort (Unprimed Subjects Aged 6 to <72 Months) for Combined Seasons 2007/08 and 2008/09
Inpatient visits
|
13 Number of subjects
|
14 Number of subjects
|
19 Number of subjects
|
20 Number of subjects
|
19 Number of subjects
|
26 Number of subjects
|
|
Number of Subjects With Influenza Like Illnesses (ILIs) in the 6 to <36 Months and in Overall Age Cohort (Unprimed Subjects Aged 6 to <72 Months) for Combined Seasons 2007/08 and 2008/09
Outcome (Recovered)
|
269 Number of subjects
|
159 Number of subjects
|
267 Number of subjects
|
414 Number of subjects
|
248 Number of subjects
|
431 Number of subjects
|
|
Number of Subjects With Influenza Like Illnesses (ILIs) in the 6 to <36 Months and in Overall Age Cohort (Unprimed Subjects Aged 6 to <72 Months) for Combined Seasons 2007/08 and 2008/09
Outcome (Alive with sequelae)
|
5 Number of subjects
|
2 Number of subjects
|
2 Number of subjects
|
5 Number of subjects
|
2 Number of subjects
|
2 Number of subjects
|
|
Number of Subjects With Influenza Like Illnesses (ILIs) in the 6 to <36 Months and in Overall Age Cohort (Unprimed Subjects Aged 6 to <72 Months) for Combined Seasons 2007/08 and 2008/09
Outcome (Lost to follow-up)
|
3 Number of subjects
|
0 Number of subjects
|
1 Number of subjects
|
3 Number of subjects
|
0 Number of subjects
|
1 Number of subjects
|
|
Number of Subjects With Influenza Like Illnesses (ILIs) in the 6 to <36 Months and in Overall Age Cohort (Unprimed Subjects Aged 6 to <72 Months) for Combined Seasons 2007/08 and 2008/09
Outcome (ILI persisting)
|
3 Number of subjects
|
2 Number of subjects
|
1 Number of subjects
|
3 Number of subjects
|
3 Number of subjects
|
1 Number of subjects
|
|
Number of Subjects With Influenza Like Illnesses (ILIs) in the 6 to <36 Months and in Overall Age Cohort (Unprimed Subjects Aged 6 to <72 Months) for Combined Seasons 2007/08 and 2008/09
Outcome (Not available)
|
0 Number of subjects
|
0 Number of subjects
|
1 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
1 Number of subjects
|
SECONDARY outcome
Timeframe: 3 weeks after 2nd vaccinationPopulation: The analysis was done on Full Analysis Set
Virus-confirmed influenza illnesses were assessed and trivalent adjuvanted influenza vaccine (TIV-adj) was compared with Non-flu control vaccine and Flu-control vaccine for Influenza like illnesses for seasons 2007/08 and 2008/09.
Outcome measures
| Measure |
TIV-adj (6 to <36 Months)
n=425 Participants
Subjects aged 6 to \<36 months received 0.25 mL of each injection of Adjuvanted trivalent inactivated subunit influenza vaccine
|
Flu-control (6 to <36 Months)
n=253 Participants
Subjects aged 6 to \<36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Flu-control (6 to <36 Months)
n=436 Participants
Subjects aged 6 to \< 36 months received 0.25 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Flu-control (36 to <72 Months)
Subjects aged 36 to \< 72 months received 0.5 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Non-Flu-control (6 to <36 Months)
Subjects aged 6 to \<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \<72 months received 2 doses of 0.25 mL of TBE vaccine
|
Non-Flu-control (36 to <72 Months)
Subjects aged 6 to \<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \<72 months received 2 doses of 0.25 mL of TBE vaccine
|
|---|---|---|---|---|---|---|
|
Loss of Days of Usual Activity (Job, School, Day Care, Household/Family/Community Activities) Due to Influenza Like Illness (ILI) in Subjects in Aged 6 to <72 and 6 to <36 Months and in Direct Caregivers Living in the Household.
Mean bed days (6 to <72 mths)(N=419,250,426)
|
1.9 Days
Standard Deviation 2.3
|
2.3 Days
Standard Deviation 2.7
|
1.9 Days
Standard Deviation 2.4
|
—
|
—
|
—
|
|
Loss of Days of Usual Activity (Job, School, Day Care, Household/Family/Community Activities) Due to Influenza Like Illness (ILI) in Subjects in Aged 6 to <72 and 6 to <36 Months and in Direct Caregivers Living in the Household.
Mean bed days (6 to <36 mths)(N=274,160,263)
|
2.0 Days
Standard Deviation 2.5
|
2.1 Days
Standard Deviation 2.4
|
1.8 Days
Standard Deviation 2.4
|
—
|
—
|
—
|
|
Loss of Days of Usual Activity (Job, School, Day Care, Household/Family/Community Activities) Due to Influenza Like Illness (ILI) in Subjects in Aged 6 to <72 and 6 to <36 Months and in Direct Caregivers Living in the Household.
Mean inactive days(6 to <72 mths)(N=417,249,427)
|
3.1 Days
Standard Deviation 3.3
|
3.3 Days
Standard Deviation 3.5
|
2.9 Days
Standard Deviation 3.7
|
—
|
—
|
—
|
|
Loss of Days of Usual Activity (Job, School, Day Care, Household/Family/Community Activities) Due to Influenza Like Illness (ILI) in Subjects in Aged 6 to <72 and 6 to <36 Months and in Direct Caregivers Living in the Household.
Mean inactive days(6 to <36 mths)(N=273,160,264)
|
2.9 Days
Standard Deviation 3.3
|
3.0 Days
Standard Deviation 3.6
|
2.6 Days
Standard Deviation 3.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 weeks after 2nd vaccinationPopulation: The analysis was done on Full Analysis Set
The number of events of Influenza like Illness reported by subjects aged 6 to \<72 months was assessed for combined seasons 2007/08 and 2008/09
Outcome measures
| Measure |
TIV-adj (6 to <36 Months)
n=425 Participants
Subjects aged 6 to \<36 months received 0.25 mL of each injection of Adjuvanted trivalent inactivated subunit influenza vaccine
|
Flu-control (6 to <36 Months)
n=253 Participants
Subjects aged 6 to \<36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Flu-control (6 to <36 Months)
n=436 Participants
Subjects aged 6 to \< 36 months received 0.25 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Flu-control (36 to <72 Months)
Subjects aged 36 to \< 72 months received 0.5 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Non-Flu-control (6 to <36 Months)
Subjects aged 6 to \<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \<72 months received 2 doses of 0.25 mL of TBE vaccine
|
Non-Flu-control (36 to <72 Months)
Subjects aged 6 to \<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \<72 months received 2 doses of 0.25 mL of TBE vaccine
|
|---|---|---|---|---|---|---|
|
Number of Events of Influenza Like Illness for Combined Seasons 2007/08 and 2008/09.
Mean ILI events (6 to <72 mths)(N=425,253,436)
|
1.2 Events
Standard Deviation 0.5
|
1.3 Events
Standard Deviation 0.6
|
1.2 Events
Standard Deviation 0.5
|
—
|
—
|
—
|
|
Number of Events of Influenza Like Illness for Combined Seasons 2007/08 and 2008/09.
Mean ILI events (6 to <36 mths)(N=280,163,272)
|
1.3 Events
Standard Deviation 0.5
|
1.3 Events
Standard Deviation 0.6
|
1.3 Events
Standard Deviation 0.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: On study days 1, 29, 50 and 181Population: The analysis was done on Full Analysis Set
The immunogenicity was assessed in terms of Geometric mean titer ratios (GMRs) of study day 29/study day 1, study day 50/study day 1, study day 181/study day 1 were evaluated. The criteria for evaluation is GMR \>2.5
Outcome measures
| Measure |
TIV-adj (6 to <36 Months)
n=166 Participants
Subjects aged 6 to \<36 months received 0.25 mL of each injection of Adjuvanted trivalent inactivated subunit influenza vaccine
|
Flu-control (6 to <36 Months)
n=165 Participants
Subjects aged 6 to \<36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Flu-control (6 to <36 Months)
n=83 Participants
Subjects aged 6 to \< 36 months received 0.25 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Flu-control (36 to <72 Months)
Subjects aged 36 to \< 72 months received 0.5 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Non-Flu-control (6 to <36 Months)
Subjects aged 6 to \<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \<72 months received 2 doses of 0.25 mL of TBE vaccine
|
Non-Flu-control (36 to <72 Months)
Subjects aged 6 to \<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \<72 months received 2 doses of 0.25 mL of TBE vaccine
|
|---|---|---|---|---|---|---|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <36 Months or Season 2008/09 (Homologous and Heterologous Strains)
Day 29:1A/SolomonIsland/2006(A/H1N1)(N=165,163,82)
|
2.1 Ratios
Interval 1.81 to 2.42
|
1.41 Ratios
Interval 1.22 to 1.62
|
0.97 Ratios
Interval 0.79 to 1.18
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <36 Months or Season 2008/09 (Homologous and Heterologous Strains)
Day 29:1 A/Wisconsin/2009 (A/H3N2)(N=165,163,82)
|
4.56 Ratios
Interval 4.07 to 5.11
|
1.17 Ratios
Interval 1.05 to 1.31
|
0.95 Ratios
Interval 0.81 to 1.11
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <36 Months or Season 2008/09 (Homologous and Heterologous Strains)
Day 50:1 A/Wisconsin/2009 (A/H3N2)(N=160,162,78)
|
43 Ratios
Interval 37.0 to 50.0
|
3.01 Ratios
Interval 2.59 to 3.51
|
1.04 Ratios
Interval 0.84 to 1.29
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <36 Months or Season 2008/09 (Homologous and Heterologous Strains)
Day181:1 B/Brisbane/2008 (N=160,163,80)
|
1.04 Ratios
Interval 0.98 to 1.11
|
1.05 Ratios
Interval 0.98 to 1.11
|
1.26 Ratios
Interval 1.15 to 1.37
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <36 Months or Season 2008/09 (Homologous and Heterologous Strains)
Day 29:1 A/Brisbane/2007 (A/H1N1) (N=165,163,82)
|
17 Ratios
Interval 15.0 to 20.0
|
1.83 Ratios
Interval 1.57 to 2.13
|
1.03 Ratios
Interval 0.83 to 1.27
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <36 Months or Season 2008/09 (Homologous and Heterologous Strains)
Day 50:1 A/Brisbane/2007 (A/H1N1) (N=160,162,78)
|
83 Ratios
Interval 70.0 to 98.0
|
4.55 Ratios
Interval 3.84 to 5.39
|
1.11 Ratios
Interval 0.87 to 1.4
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <36 Months or Season 2008/09 (Homologous and Heterologous Strains)
Day 181:1 A/Brisbane/2007 (A/H1N1) (N=161,163,80)
|
19 Ratios
Interval 17.0 to 21.0
|
2.4 Ratios
Interval 2.11 to 2.73
|
1.02 Ratios
Interval 0.85 to 1.22
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <36 Months or Season 2008/09 (Homologous and Heterologous Strains)
Day 29:1 A/Brisbane/2007 (A/H3N2) (N=165,163,82)
|
15 Ratios
Interval 13.0 to 18.0
|
1.58 Ratios
Interval 1.38 to 1.81
|
1.07 Ratios
Interval 0.88 to 1.29
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <36 Months or Season 2008/09 (Homologous and Heterologous Strains)
Day 50:1 A/Brisbane/2007 (A/H3N2) (N=160,162,78)
|
86 Ratios
Interval 73.0 to 102.0
|
5.57 Ratios
Interval 4.73 to 6.55
|
1.04 Ratios
Interval 0.83 to 1.32
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <36 Months or Season 2008/09 (Homologous and Heterologous Strains)
Day 181:1 A/Brisbane/2007 (A/H3N1) (N=161,163,80)
|
30 Ratios
Interval 24.0 to 37.0
|
6.16 Ratios
Interval 4.97 to 7.63
|
2.1 Ratios
Interval 1.55 to 2.83
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <36 Months or Season 2008/09 (Homologous and Heterologous Strains)
Day 29:1 B/Florida/2006 (N=165,163,82)
|
2.11 Ratios
Interval 1.86 to 2.39
|
1.41 Ratios
Interval 1.24 to 1.6
|
1.06 Ratios
Interval 0.89 to 1.26
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <36 Months or Season 2008/09 (Homologous and Heterologous Strains)
Day 50:1 B/Florida/2006 (N=160,162,78)
|
14 Ratios
Interval 13.0 to 16.0
|
2.05 Ratios
Interval 1.81 to 2.31
|
1.02 Ratios
Interval 0.86 to 1.22
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <36 Months or Season 2008/09 (Homologous and Heterologous Strains)
Day 181:1 B/Florida/2006 (N=161,163,80)
|
4.22 Ratios
Interval 3.79 to 4.68
|
1.45 Ratios
Interval 1.31 to 1.61
|
1.05 Ratios
Interval 0.91 to 1.22
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <36 Months or Season 2008/09 (Homologous and Heterologous Strains)
Day 50:1A/SolomonIsland/2006(A/H1N1)(N=160,162,78)
|
18 Ratios
Interval 16.0 to 21.0
|
1.96 Ratios
Interval 1.7 to 2.25
|
0.98 Ratios
Interval 0.8 to 1.19
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <36 Months or Season 2008/09 (Homologous and Heterologous Strains)
Day181:1A/SolomonIsland/2006(A/H1N1)(N=161,163,80)
|
6.52 Ratios
Interval 5.79 to 7.34
|
1.6 Ratios
Interval 1.42 to 1.8
|
0.99 Ratios
Interval 0.84 to 1.16
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <36 Months or Season 2008/09 (Homologous and Heterologous Strains)
Day181:1 A/Wisconsin/2009 (A/H3N2)(N=161,163,80)
|
20 Ratios
Interval 16.0 to 25.0
|
5.06 Ratios
Interval 4.03 to 6.37
|
2.22 Ratios
Interval 1.61 to 3.06
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <36 Months or Season 2008/09 (Homologous and Heterologous Strains)
Day 29:1 B/Brisbane/2008 (N=164,163,82)
|
1.08 Ratios
Interval 1.04 to 1.11
|
1.02 Ratios
Interval 0.098 to 1.05
|
1 Ratios
Interval 0.96 to 1.05
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <36 Months or Season 2008/09 (Homologous and Heterologous Strains)
Day 50:1 B/Brisbane/2008 (N=159,162,78)
|
1.94 Ratios
Interval 1.8 to 2.08
|
1.11 Ratios
Interval 1.03 to 1.19
|
1.02 Ratios
Interval 0.93 to 1.14
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: On study days 1, 29, 50 and 181Population: The analysis was done on Full Analysis Set
Immunogenicity was analyzed in terms of Geometric Mean Titers (GMTs) as measured by hemagglutination inhibition (HI) assay. For each strain and each vaccine group, least squares GMTs, associated 2-sided 95% confidence interval were determined for all time points. Superiority analysis: GMT-TIV-adj/GMT-Flu-control \>1 should be elicited to show that GMT-TIV-adj is superior to GMT-Flu-control
Outcome measures
| Measure |
TIV-adj (6 to <36 Months)
n=166 Participants
Subjects aged 6 to \<36 months received 0.25 mL of each injection of Adjuvanted trivalent inactivated subunit influenza vaccine
|
Flu-control (6 to <36 Months)
n=165 Participants
Subjects aged 6 to \<36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Flu-control (6 to <36 Months)
n=83 Participants
Subjects aged 6 to \< 36 months received 0.25 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Flu-control (36 to <72 Months)
Subjects aged 36 to \< 72 months received 0.5 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Non-Flu-control (6 to <36 Months)
Subjects aged 6 to \<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \<72 months received 2 doses of 0.25 mL of TBE vaccine
|
Non-Flu-control (36 to <72 Months)
Subjects aged 6 to \<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \<72 months received 2 doses of 0.25 mL of TBE vaccine
|
|---|---|---|---|---|---|---|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of Geometric Mean Titers (GMTs), in Unprimed Subjects Aged 6 to <36 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 29 A/Brisbane/2007 (A/H1N1) (N=165,163,82)
|
105 Titers
Interval 82.0 to 136.0
|
14 Titers
Interval 11.0 to 18.0
|
6.13 Titers
Interval 4.33 to 8.69
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of Geometric Mean Titers (GMTs), in Unprimed Subjects Aged 6 to <36 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 29 B/Florida/2006 (N=165,163,82)
|
13 Titers
Interval 11.0 to 15.0
|
8.45 Titers
Interval 7.11 to 10.0
|
6.19 Titers
Interval 4.87 to 7.87
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of Geometric Mean Titers (GMTs), in Unprimed Subjects Aged 6 to <36 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 181 B/Florida/2006 (N=161,163,80)
|
25 Titers
Interval 22.0 to 29.0
|
8.72 Titers
Interval 7.65 to 9.95
|
6.21 Titers
Interval 5.16 to 7.48
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of Geometric Mean Titers (GMTs), in Unprimed Subjects Aged 6 to <36 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 1 A/SolomonIslands/2006(A/H1N1)
|
6.66 Titers
Interval 5.56 to 7.98
|
8.19 Titers
Interval 6.85 to 9.8
|
6.24 Titers
Interval 4.87 to 8.0
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of Geometric Mean Titers (GMTs), in Unprimed Subjects Aged 6 to <36 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 29 A/SolomonIslands/2006(A/H1N1)(N=165,163,82)
|
14 Titers
Interval 11.0 to 19.0
|
12 Titers
Interval 8.69 to 15.0
|
6.08 Titers
Interval 4.12 to 8.98
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of Geometric Mean Titers (GMTs), in Unprimed Subjects Aged 6 to <36 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day181 B/Brisbane/2008 (N=161,163,80)
|
5.21 Titers
Interval 4.89 to 5.54
|
5.23 Titers
Interval 4.92 to 5.56
|
6.28 Titers
Interval 5.75 to 6.84
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of Geometric Mean Titers (GMTs), in Unprimed Subjects Aged 6 to <36 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 1 A/Brisbane/2007 (A/H3N2)
|
5.85 Titers
Interval 5.13 to 6.67
|
5.8 Titers
Interval 5.09 to 6.6
|
5.66 Titers
Interval 4.73 to 6.77
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of Geometric Mean Titers (GMTs), in Unprimed Subjects Aged 6 to <36 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 29 A/Brisbane/2007 (A/H3N2) (N=165,163,82)
|
90 Titers
Interval 76.0 to 107.0
|
9.17 Titers
Interval 7.71 to 11.0
|
6.04 Titers
Interval 4.75 to 7.69
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of Geometric Mean Titers (GMTs), in Unprimed Subjects Aged 6 to <36 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 50 A/Brisbane/2007 (A/H3N2) (N=160,162,78)
|
510 Titers
Interval 426.0 to 609.0
|
32 Titers
Interval 27.0 to 39.0
|
6 Titers
Interval 4.68 to 7.68
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of Geometric Mean Titers (GMTs), in Unprimed Subjects Aged 6 to <36 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 181 A/Brisbane/2007 (A/H3N2) (N=161,163,80)
|
176 Titers
Interval 141.0 to 220.0
|
36 Titers
Interval 29.0 to 45.0
|
12 Titers
Interval 8.74 to 16.0
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of Geometric Mean Titers (GMTs), in Unprimed Subjects Aged 6 to <36 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 1 B/Florida/2006
|
6.01 Titers
Interval 5.59 to 6.45
|
6 Titers
Interval 5.59 to 6.44
|
5.87 Titers
Interval 5.32 to 6.47
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of Geometric Mean Titers (GMTs), in Unprimed Subjects Aged 6 to <36 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 50 B/Florida/2006 (N=160,162,78)
|
86 Titers
Interval 74.0 to 100.0
|
12 Titers
Interval 11.0 to 14.0
|
6.09 Titers
Interval 4.95 to 7.49
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of Geometric Mean Titers (GMTs), in Unprimed Subjects Aged 6 to <36 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 50 A/SolomonIslands/2006(A/H1N1)(N=160,162,78)
|
122 Titers
Interval 94.0 to 157.0
|
16 Titers
Interval 13.0 to 21.0
|
6.1 Titers
Interval 4.27 to 8.73
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of Geometric Mean Titers (GMTs), in Unprimed Subjects Aged 6 to <36 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day181 A/SolomonIslands/2006(A/H1N1)(N=161,163,80)
|
44 Titers
Interval 34.0 to 55.0
|
13 Titers
Interval 10.0 to 17.0
|
6.2 Titers
Interval 4.46 to 8.61
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of Geometric Mean Titers (GMTs), in Unprimed Subjects Aged 6 to <36 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 1 A/Wisconsin/2009 (A/H3N2)
|
6.09 Titers
Interval 5.26 to 7.06
|
6.74 Titers
Interval 5.83 to 7.8
|
6.16 Titers
Interval 5.03 to 7.53
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of Geometric Mean Titers (GMTs), in Unprimed Subjects Aged 6 to <36 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 29 A/Wisconsin/2009 (A/H3N2)(N=165,163,82)
|
28 Titers
Interval 23.0 to 33.0
|
7.86 Titers
Interval 6.57 to 9.39
|
5.87 Titers
Interval 4.59 to 7.52
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of Geometric Mean Titers (GMTs), in Unprimed Subjects Aged 6 to <36 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 50 A/Wisconsin/2009 (A/H3N2)(N=160,162,78)
|
261 Titers
Interval 218.0 to 313.0
|
20 Titers
Interval 17.0 to 24.0
|
6.47 Titers
Interval 5.03 to 8.32
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of Geometric Mean Titers (GMTs), in Unprimed Subjects Aged 6 to <36 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day181 A/Wisconsin/2009 (A/H3N2)(N=161,163,80)
|
123 Titers
Interval 97.0 to 156.0
|
34 Titers
Interval 27.0 to 43.0
|
14 Titers
Interval 9.81 to 19.0
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of Geometric Mean Titers (GMTs), in Unprimed Subjects Aged 6 to <36 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 1 A/Brisbane/2007 (A/H1N1)
|
6.21 Titers
Interval 5.33 to 7.24
|
7.52 Titers
Interval 6.45 to 8.76
|
5.93 Titers
Interval 4.8 to 7.33
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of Geometric Mean Titers (GMTs), in Unprimed Subjects Aged 6 to <36 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 50 A/Brisbane/2007 (A/H1N1) (N=160,162,78)
|
513 Titers
Interval 405.0 to 652.0
|
35 Titers
Interval 27.0 to 44.0
|
6.57 Titers
Interval 4.71 to 9.16
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of Geometric Mean Titers (GMTs), in Unprimed Subjects Aged 6 to <36 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 181 A/Brisbane/2007 (A/H1N1) (N=161,163,80)
|
118 Titers
Interval 95.0 to 146.0
|
18 Titers
Interval 15.0 to 22.0
|
6.1 Titers
Interval 4.51 to 8.25
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of Geometric Mean Titers (GMTs), in Unprimed Subjects Aged 6 to <36 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 1 B/Brisbane/2008 (N=165,165,83)
|
5 Titers
Interval 5.0 to 5.0
|
5 Titers
Interval 5.0 to 5.0
|
5 Titers
Interval 5.0 to 5.0
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of Geometric Mean Titers (GMTs), in Unprimed Subjects Aged 6 to <36 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 29 B/Brisbane/2008 (N=165,163,82)
|
5.38 Titers
Interval 5.21 to 5.56
|
5.08 Titers
Interval 4.91 to 5.24
|
5 Titers
Interval 4.78 to 5.23
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of Geometric Mean Titers (GMTs), in Unprimed Subjects Aged 6 to <36 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 50 B/Brisbane/2008 (N=160,162,78)
|
9.64 Titers
Interval 8.96 to 10.0
|
5.55 Titers
Interval 5.16 to 5.97
|
5.12 Titers
Interval 4.63 to 5.68
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: On study days 1, 29, 50, 181Population: The analysis was done on Full Analysis Set
Percentage of subjects achieving seroprotection (i.e., with HI titer ≥1:40) at study day 1, study day 29, study day 50 and a study day 181 and associated 95% CI. The lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 70%.
Outcome measures
| Measure |
TIV-adj (6 to <36 Months)
n=166 Participants
Subjects aged 6 to \<36 months received 0.25 mL of each injection of Adjuvanted trivalent inactivated subunit influenza vaccine
|
Flu-control (6 to <36 Months)
n=165 Participants
Subjects aged 6 to \<36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Flu-control (6 to <36 Months)
n=83 Participants
Subjects aged 6 to \< 36 months received 0.25 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Flu-control (36 to <72 Months)
Subjects aged 36 to \< 72 months received 0.5 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Non-Flu-control (6 to <36 Months)
Subjects aged 6 to \<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \<72 months received 2 doses of 0.25 mL of TBE vaccine
|
Non-Flu-control (36 to <72 Months)
Subjects aged 6 to \<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \<72 months received 2 doses of 0.25 mL of TBE vaccine
|
|---|---|---|---|---|---|---|
|
Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With HI Titer ≥1:40 in Season 2008/09 HI Assay(Homologous and Heterologous Strains)
Day 50 A/Brisbane/2007 (A/H1N1) (N=160,162,78)
|
100 Percentage of subjects
Interval 98.0 to 100.0
|
38 Percentage of subjects
Interval 31.0 to 46.0
|
6 Percentage of subjects
Interval 2.0 to 14.0
|
—
|
—
|
—
|
|
Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With HI Titer ≥1:40 in Season 2008/09 HI Assay(Homologous and Heterologous Strains)
Day1 A/Brisbane/2007(A/H3N2)
|
4 Percentage of subjects
Interval 1.0 to 8.0
|
4 Percentage of subjects
Interval 1.0 to 8.0
|
2 Percentage of subjects
Interval 0.0 to 8.0
|
—
|
—
|
—
|
|
Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With HI Titer ≥1:40 in Season 2008/09 HI Assay(Homologous and Heterologous Strains)
Day181A/Brisbane/2007(A/H3N2)(N=161,163,80)
|
100 Percentage of subjects
Interval 98.0 to 100.0
|
45 Percentage of subjects
Interval 37.0 to 53.0
|
21 Percentage of subjects
Interval 13.0 to 32.0
|
—
|
—
|
—
|
|
Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With HI Titer ≥1:40 in Season 2008/09 HI Assay(Homologous and Heterologous Strains)
Day 1 B/Florida/2006
|
2 Percentage of subjects
Interval 1.0 to 6.0
|
2 Percentage of subjects
Interval 0.0 to 5.0
|
1 Percentage of subjects
Interval 0.03 to 7.0
|
—
|
—
|
—
|
|
Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With HI Titer ≥1:40 in Season 2008/09 HI Assay(Homologous and Heterologous Strains)
Day29 B/Florida/2006 (N=165,163,82)
|
12 Percentage of subjects
Interval 8.0 to 18.0
|
12 Percentage of subjects
Interval 8.0 to 18.0
|
4 Percentage of subjects
Interval 1.0 to 10.0
|
—
|
—
|
—
|
|
Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With HI Titer ≥1:40 in Season 2008/09 HI Assay(Homologous and Heterologous Strains)
Day50 B/Florida/2006 (N=160,162,78)
|
88 Percentage of subjects
Interval 81.0 to 92.0
|
19 Percentage of subjects
Interval 13.0 to 25.0
|
3 Percentage of subjects
Interval 0.0 to 9.0
|
—
|
—
|
—
|
|
Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With HI Titer ≥1:40 in Season 2008/09 HI Assay(Homologous and Heterologous Strains)
Day181B/Florida/2006 (N=161,163,80)
|
40 Percentage of subjects
Interval 33.0 to 48.0
|
13 Percentage of subjects
Interval 9.0 to 20.0
|
3 Percentage of subjects
Interval 0.0 to 9.0
|
—
|
—
|
—
|
|
Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With HI Titer ≥1:40 in Season 2008/09 HI Assay(Homologous and Heterologous Strains)
Day 1 A/SolomonIslands/2006(A/H1N1)
|
5 Percentage of subjects
Interval 3.0 to 10.0
|
11 Percentage of subjects
Interval 7.0 to 17.0
|
5 Percentage of subjects
Interval 1.0 to 12.0
|
—
|
—
|
—
|
|
Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With HI Titer ≥1:40 in Season 2008/09 HI Assay(Homologous and Heterologous Strains)
Day29A/Sol.Islands/2006(A/H1N1)(N=165,163,82)
|
15 Percentage of subjects
Interval 10.0 to 21.0
|
13 Percentage of subjects
Interval 9.0 to 20.0
|
5 Percentage of subjects
Interval 1.0 to 12.0
|
—
|
—
|
—
|
|
Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With HI Titer ≥1:40 in Season 2008/09 HI Assay(Homologous and Heterologous Strains)
Day29 B/Brisbane/2008 (N=165,163,82)
|
1 Percentage of subjects
Interval 0.015 to 3.0
|
0 Percentage of subjects
Interval 0.0 to 2.0
|
0 Percentage of subjects
Interval 0.0 to 4.0
|
—
|
—
|
—
|
|
Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With HI Titer ≥1:40 in Season 2008/09 HI Assay(Homologous and Heterologous Strains)
Day 1 A/Brisbane/2007 (A/H1N1)
|
5 Percentage of subjects
Interval 3.0 to 10.0
|
11 Percentage of subjects
Interval 7.0 to 17.0
|
5 Percentage of subjects
Interval 1.0 to 12.0
|
—
|
—
|
—
|
|
Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With HI Titer ≥1:40 in Season 2008/09 HI Assay(Homologous and Heterologous Strains)
Day29 A/Brisbane/2007(A/H1N1)(N=165,163,82)
|
92 Percentage of subjects
Interval 86.0 to 95.0
|
20 Percentage of subjects
Interval 14.0 to 27.0
|
6 Percentage of subjects
Interval 2.0 to 14.0
|
—
|
—
|
—
|
|
Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With HI Titer ≥1:40 in Season 2008/09 HI Assay(Homologous and Heterologous Strains)
Day181A/Brisbane/2007(A/H1N1)(N=161,163,80)
|
98 Percentage of subjects
Interval 94.0 to 99.0
|
25 Percentage of subjects
Interval 19.0 to 33.0
|
6 Percentage of subjects
Interval 2.0 to 14.0
|
—
|
—
|
—
|
|
Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With HI Titer ≥1:40 in Season 2008/09 HI Assay(Homologous and Heterologous Strains)
Day29 A/Brisbane/2007(A/H3N2)(N=165,163,82)
|
95 Percentage of subjects
Interval 90.0 to 97.0
|
12 Percentage of subjects
Interval 7.0 to 18.0
|
4 Percentage of subjects
Interval 1.0 to 10.0
|
—
|
—
|
—
|
|
Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With HI Titer ≥1:40 in Season 2008/09 HI Assay(Homologous and Heterologous Strains)
Day50 A/Brisbane/2007(A/H3N2)(N=160,162,78)
|
99 Percentage of subjects
Interval 97.0 to 100.0
|
45 Percentage of subjects
Interval 37.0 to 53.0
|
4 Percentage of subjects
Interval 1.0 to 11.0
|
—
|
—
|
—
|
|
Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With HI Titer ≥1:40 in Season 2008/09 HI Assay(Homologous and Heterologous Strains)
Day50A/Sol.Islands/2006(A/H1N1) (N=160,162,78)
|
95 Percentage of subjects
Interval 90.0 to 98.0
|
24 Percentage of subjects
Interval 18.0 to 31.0
|
5 Percentage of subjects
Interval 1.0 to 13.0
|
—
|
—
|
—
|
|
Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With HI Titer ≥1:40 in Season 2008/09 HI Assay(Homologous and Heterologous Strains)
D181A/Sol.Islands/2006(A/H1N1) (N=161,163,80)
|
61 Percentage of subjects
Interval 53.0 to 68.0
|
19 Percentage of subjects
Interval 13.0 to 26.0
|
5 Percentage of subjects
Interval 1.0 to 12.0
|
—
|
—
|
—
|
|
Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With HI Titer ≥1:40 in Season 2008/09 HI Assay(Homologous and Heterologous Strains)
Day 1 A/Wisconsin/2009 (A/H3N2)
|
4 Percentage of subjects
Interval 1.0 to 8.0
|
5 Percentage of subjects
Interval 2.0 to 9.0
|
2 Percentage of subjects
Interval 0.0 to 8.0
|
—
|
—
|
—
|
|
Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With HI Titer ≥1:40 in Season 2008/09 HI Assay(Homologous and Heterologous Strains)
Day29 A/Wisconsin/2009(A/H3N2) (N=165,163,82)
|
37 Percentage of subjects
Interval 30.0 to 45.0
|
6 Percentage of subjects
Interval 3.0 to 10.0
|
2 Percentage of subjects
Interval 0.0 to 9.0
|
—
|
—
|
—
|
|
Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With HI Titer ≥1:40 in Season 2008/09 HI Assay(Homologous and Heterologous Strains)
Day50 A/Wisconsin/2009(A/H3N2) (N=160,162,78)
|
100 Percentage of subjects
Interval 98.0 to 100.0
|
30 Percentage of subjects
Interval 23.0 to 37.0
|
4 Percentage of subjects
Interval 1.0 to 11.0
|
—
|
—
|
—
|
|
Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With HI Titer ≥1:40 in Season 2008/09 HI Assay(Homologous and Heterologous Strains)
Day181A/Wisconsin/2009(A/H3N2) (N=161,163,80)
|
99 Percentage of subjects
Interval 97.0 to 100.0
|
42 Percentage of subjects
Interval 34.0 to 50.0
|
23 Percentage of subjects
Interval 14.0 to 33.0
|
—
|
—
|
—
|
|
Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With HI Titer ≥1:40 in Season 2008/09 HI Assay(Homologous and Heterologous Strains)
Day 1 B/Brisbane/2008
|
0 Percentage of subjects
Interval 0.0 to 2.0
|
0 Percentage of subjects
Interval 0.0 to 2.0
|
0 Percentage of subjects
Interval 0.0 to 4.0
|
—
|
—
|
—
|
|
Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With HI Titer ≥1:40 in Season 2008/09 HI Assay(Homologous and Heterologous Strains)
Day50 B/Brisbane/2008 (N=160,162,78)
|
5 Percentage of subjects
Interval 2.0 to 10.0
|
0 Percentage of subjects
Interval 0.0 to 2.0
|
0 Percentage of subjects
Interval 0.0 to 5.0
|
—
|
—
|
—
|
|
Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With HI Titer ≥1:40 in Season 2008/09 HI Assay(Homologous and Heterologous Strains)
Day181 B/Brisbane/2008 (N=161,163,80)
|
0 Percentage of subjects
Interval 0.0 to 2.0
|
1 Percentage of subjects
Interval 0.016 to 3.0
|
6 Percentage of subjects
Interval 2.0 to 14.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: On study days 1, 29, 50, 181Population: The analysis was done on Full Analysis Set
HI assay was used for the analysis. Seroconversion is defined as negative pre-vaccination serum (\<10)/ post-vaccination HI titer ≥1:40. Seroconversion is defined as either pre-vaccination HI titer \<10 and a post-vaccination HI titer ≥1:40 or a prevaccination HI titer ≥10 and a minimum four-fold rise in post-vaccination HI antibody titer. The lower bound of the two-sided 95% confidence interval (CI) for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40%.
Outcome measures
| Measure |
TIV-adj (6 to <36 Months)
n=165 Participants
Subjects aged 6 to \<36 months received 0.25 mL of each injection of Adjuvanted trivalent inactivated subunit influenza vaccine
|
Flu-control (6 to <36 Months)
n=163 Participants
Subjects aged 6 to \<36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Flu-control (6 to <36 Months)
n=82 Participants
Subjects aged 6 to \< 36 months received 0.25 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Flu-control (36 to <72 Months)
Subjects aged 36 to \< 72 months received 0.5 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Non-Flu-control (6 to <36 Months)
Subjects aged 6 to \<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \<72 months received 2 doses of 0.25 mL of TBE vaccine
|
Non-Flu-control (36 to <72 Months)
Subjects aged 6 to \<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \<72 months received 2 doses of 0.25 mL of TBE vaccine
|
|---|---|---|---|---|---|---|
|
Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains)
Day181A/Brisbane/2007(A/H3N2)(N=161,163,80)
|
98 Percentage of subjects
Interval 94.0 to 99.0
|
42 Percentage of subjects
Interval 35.0 to 50.0
|
19 Percentage of subjects
Interval 11.0 to 29.0
|
—
|
—
|
—
|
|
Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains)
Day29 B/Florida/2006
|
12 Percentage of subjects
Interval 8.0 to 18.0
|
12 Percentage of subjects
Interval 8.0 to 18.0
|
0 Percentage of subjects
Interval 0.0 to 4.0
|
—
|
—
|
—
|
|
Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains)
Day181B/Florida/2006 (N=161,163,80)
|
39 Percentage of subjects
Interval 31.0 to 46.0
|
12 Percentage of subjects
Interval 7.0 to 18.0
|
1 Percentage of subjects
Interval 0.032 to 7.0
|
—
|
—
|
—
|
|
Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains)
Day29A/Sol.Islands/2006(A/H1N1)
|
14 Percentage of subjects
Interval 9.0 to 20.0
|
13 Percentage of subjects
Interval 8.0 to 19.0
|
0 Percentage of subjects
Interval 0.0 to 4.0
|
—
|
—
|
—
|
|
Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains)
Day50A/Sol.Islands/2006(A/H1N1)(N=160,162,78)
|
94 Percentage of subjects
Interval 89.0 to 97.0
|
23 Percentage of subjects
Interval 17.0 to 30.0
|
0 Percentage of subjects
Interval 0.0 to 5.0
|
—
|
—
|
—
|
|
Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains)
Day181A/Sol.Islands/2006(A/H1N1)(N=161,163,80)
|
60 Percentage of subjects
Interval 52.0 to 68.0
|
18 Percentage of subjects
Interval 12.0 to 25.0
|
0 Percentage of subjects
Interval 0.0 to 5.0
|
—
|
—
|
—
|
|
Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains)
Day29 A/Wisconsin/2009(A/H3N2)
|
36 Percentage of subjects
Interval 28.0 to 44.0
|
4 Percentage of subjects
Interval 1.0 to 8.0
|
0 Percentage of subjects
Interval 0.0 to 4.0
|
—
|
—
|
—
|
|
Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains)
Day181 B/Brisbane/2008 (N=161,163,80)
|
0 Percentage of subjects
Interval 0.0 to 2.0
|
1 Percentage of subjects
Interval 0.016 to 3.0
|
6 Percentage of subjects
Interval 2.0 to 14.0
|
—
|
—
|
—
|
|
Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains)
Day29 A/Brisbane/2007(A/H1N1)
|
92 Percentage of subjects
Interval 86.0 to 95.0
|
19 Percentage of subjects
Interval 13.0 to 26.0
|
1 Percentage of subjects
Interval 0.031 to 7.0
|
—
|
—
|
—
|
|
Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains)
Day50 A/Brisbane/2007(A/H1N1)(N=160,162,78)
|
100 Percentage of subjects
Interval 98.0 to 100.0
|
38 Percentage of subjects
Interval 30.0 to 46.0
|
1 Percentage of subjects
Interval 0.032 to 7.0
|
—
|
—
|
—
|
|
Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains)
Day181A/Brisbane/2007(A/H1N1)(N=161,163,80)
|
97 Percentage of subjects
Interval 93.0 to 99.0
|
24 Percentage of subjects
Interval 18.0 to 31.0
|
1 Percentage of subjects
Interval 0.032 to 7.0
|
—
|
—
|
—
|
|
Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains)
Day29 A/Brisbane/2007(A/H3N2)
|
93 Percentage of subjects
Interval 88.0 to 97.0
|
10 Percentage of subjects
Interval 6.0 to 16.0
|
1 Percentage of subjects
Interval 0.031 to 7.0
|
—
|
—
|
—
|
|
Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains)
Day50 A/Brisbane/2007(A/H3N2)(N=160,162,78)
|
98 Percentage of subjects
Interval 95.0 to 100.0
|
44 Percentage of subjects
Interval 36.0 to 52.0
|
1 Percentage of subjects
Interval 0.032 to 7.0
|
—
|
—
|
—
|
|
Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains)
Day50 B/Florida/2006 (N=160,162,78)
|
88 Percentage of subjects
Interval 81.0 to 92.0
|
19 Percentage of subjects
Interval 13.0 to 25.0
|
0 Percentage of subjects
Interval 0.0 to 5.0
|
—
|
—
|
—
|
|
Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains)
Day50 A/Wisconsin/2009(A/H3N2)(N=160,162,78)
|
100 Percentage of subjects
Interval 98.0 to 100.0
|
27 Percentage of subjects
Interval 20.0 to 35.0
|
1 Percentage of subjects
Interval 0.032 to 7.0
|
—
|
—
|
—
|
|
Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains)
Day181A/Wisconsin/2009(A/H3N2)(N=161,163,80)
|
97 Percentage of subjects
Interval 93.0 to 99.0
|
39 Percentage of subjects
Interval 31.0 to 47.0
|
20 Percentage of subjects
Interval 12.0 to 30.0
|
—
|
—
|
—
|
|
Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains)
Day29 B/Brisbane/2008
|
1 Percentage of subjects
Interval 0.015 to 3.0
|
0 Percentage of subjects
Interval 0.0 to 2.0
|
0 Percentage of subjects
Interval 0.0 to 4.0
|
—
|
—
|
—
|
|
Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains)
Day 50:1 B/Brisbane/2008 (N=160,162,78)
|
5 Percentage of subjects
Interval 2.0 to 12.0
|
0 Percentage of subjects
Interval 0.0 to 2.0
|
0 Percentage of subjects
Interval 0.0 to 5.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: On study days 1, 29, 50 , 181Population: The analysis was done on Full Analysis Set
Immunogenicity was analyzed in terms of Geometric Mean Titers (GMTs) as measured by hemagglutination inhibition (HI) assay. For each strain and each vaccine group, least squares GMTs, associated 2-sided 95% confidence interval were determined for all time points Superiority analysis: GMT-TIV-adj/GMT-Flu-control \>1 and GMT-TIV-adj/GMT-Non Flu-control \>1 should be elicited to show that GMT-TIV-adj is superior to GMT-Flu-control/Non Flu-control.
Outcome measures
| Measure |
TIV-adj (6 to <36 Months)
n=319 Participants
Subjects aged 6 to \<36 months received 0.25 mL of each injection of Adjuvanted trivalent inactivated subunit influenza vaccine
|
Flu-control (6 to <36 Months)
n=316 Participants
Subjects aged 6 to \<36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Flu-control (6 to <36 Months)
n=158 Participants
Subjects aged 6 to \< 36 months received 0.25 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Flu-control (36 to <72 Months)
Subjects aged 36 to \< 72 months received 0.5 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Non-Flu-control (6 to <36 Months)
Subjects aged 6 to \<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \<72 months received 2 doses of 0.25 mL of TBE vaccine
|
Non-Flu-control (36 to <72 Months)
Subjects aged 6 to \<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \<72 months received 2 doses of 0.25 mL of TBE vaccine
|
|---|---|---|---|---|---|---|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMTs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day29A/Brisbane/2007(A/H1N1) (N=316,313,15
|
232 Titers
Interval 185.0 to 291.0
|
36 Titers
Interval 29.0 to 45.0
|
9.42 Titers
Interval 6.85 to 13.0
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMTs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 50 A/Brisbane/2007 (A/H3N2) (N=310,309,150)
|
762 Titers
Interval 634.0 to 915.0
|
95 Titers
Interval 79.0 to 115.0
|
12 Titers
Interval 9.18 to 15.0
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMTs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 181 A/Brisbane/2007 (A/H3N2) (N=309,310,151)
|
295 Titers
Interval 245.0 to 356.0
|
94 Titers
Interval 78.0 to 114.0
|
26 Titers
Interval 20.0 to 34.0
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMTs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 1 B/Florida/2006
|
6.37 Titers
Interval 6.01 to 6.75
|
6.57 Titers
Interval 6.2 to 6.96
|
6.41 Titers
Interval 5.92 to 6.95
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMTs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 181 B/Florida/2006 (N=309,310,151)
|
32 Titers
Interval 29.0 to 36.0
|
13 Titers
Interval 11.0 to 14.0
|
6.92 Titers
Interval 6.01 to 7.98
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMTs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day50 A/SolomonIslands/2006(A/H1N1)(N=310,309,150)
|
228 Titers
Interval 182.0 to 287.0
|
41 Titers
Interval 33.0 to 51.0
|
11 Titers
Interval 7.63 to 15.0
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMTs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day181A/SolomonIslands/2006(A/H1N1)(N=309,310,151)
|
88 Titers
Interval 70.0 to 109.0
|
28 Titers
Interval 23.0 to 35.0
|
11 Titers
Interval 7.76 to 14.0
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMTs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 1 A/Wisconsin/2009 (A/H3N2)
|
15 Titers
Interval 12.0 to 18.0
|
15 Titers
Interval 12.0 to 19.0
|
13 Titers
Interval 9.97 to 18.0
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMTs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 29 A/Wisconsin/2009 (A/H3N2) (N=316,313,156)
|
98 Titers
Interval 75.0 to 127.0
|
31 Titers
Interval 24.0 to 40.0
|
13 Titers
Interval 8.74 to 18.0
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMTs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 50 A/Wisconsin/2009 (A/H3N2) (N=310,309,150)
|
518 Titers
Interval 420.0 to 639.0
|
70 Titers
Interval 57.0 to 87.0
|
14 Titers
Interval 10.0 to 19.0
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMTs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day181 A/Wisconsin/2009 (A/H3N2) (N=309,310,151)
|
261 Titers
Interval 212.0 to 322.0
|
98 Titers
Interval 79.0 to 121.0
|
34 Titers
Interval 26.0 to 46.0
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMTs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 1 B/Brisbane/2008
|
5.05 Titers
Interval 4.99 to 5.11
|
5.05 Titers
Interval 5.0 to 5.11
|
5.08 Titers
Interval 5.0 to 5.16
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMTs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 50 B/Brisbane/2008 (N=310,309,150)
|
12 Titers
Interval 11.0 to 13.0
|
6.69 Titers
Interval 6.23 to 7.17
|
5.2 Titers
Interval 4.71 to 5.75
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMTs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day181 B/Brisbane/2008 (N=309,310,151)
|
6.12 Titers
Interval 5.77 to 6.49
|
5.67 Titers
Interval 5.35 to 6.01
|
6.12 Titers
Interval 5.64 to 6.65
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMTs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 1 A/Brisbane/2007 (A/H1N1)
|
9.63 Titers
Interval 8.28 to 11.0
|
10 Titers
Interval 8.59 to 12.0
|
9.48 Titers
Interval 7.67 to 12.0
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMTs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day50A/Brisbane/2007(A/H1N1) (N=310,309,150)
|
735 Titers
Interval 608.0 to 888.0
|
89 Titers
Interval 74.0 to 108.0
|
9.91 Titers
Interval 7.58 to 13.0
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMTs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day181A/Brisbane/2007(A/H1N1) (N=309,310,151)
|
186 Titers
Interval 155.0 to 225.0
|
43 Titers
Interval 35.0 to 51.0
|
9.65 Titers
Interval 7.41 to 13.0
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMTs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day1A/Brisbane/2007(A/H3N2)
|
12 Titers
Interval 10.0 to 15.0
|
12 Titers
Interval 9.83 to 14.0
|
12 Titers
Interval 8.98 to 15.0
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMTs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 29 A/Brisbane/2007 (A/H3N2) (N=316,313,156)
|
209 Titers
Interval 167.0 to 261.0
|
33 Titers
Interval 26.0 to 41.0
|
12 Titers
Interval 8.83 to 17.0
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMTs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 29 B/Florida/2006 (N=316,313,156)
|
21 Titers
Interval 18.0 to 25.0
|
14 Titers
Interval 12.0 to 16.0
|
6.54 Titers
Interval 5.26 to 8.13
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMTs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 50 B/Florida/2006 (N=310,309,150)
|
109 Titers
Interval 97.0 to 123.0
|
22 Titers
Interval 19.0 to 25.0
|
6.67 Titers
Interval 5.64 to 7.88
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMTs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 1 A/SolomonIslands/2006(A/H1N1)
|
11 Titers
Interval 9.47 to 14.0
|
12 Titers
Interval 9.89 to 14.0
|
10 Titers
Interval 8.16 to 13.0
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMTs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day29 A/SolomonIslands/2006(A/H1N1)(N=316,313,150)
|
40 Titers
Interval 30.0 to 53.0
|
23 Titers
Interval 18.0 to 31.0
|
10 Titers
Interval 7.12 to 15.0
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMTs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 29 B/Brisbane/2008 (N=316,313,156)
|
6.31 Titers
Interval 5.97 to 6.66
|
5.57 Titers
Interval 5.28 to 5.89
|
5.11 Titers
Interval 4.74 to 5.52
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: On study days 1, 29, 50, 181Population: The analysis was done on Full Analysis Set
Hemagglutination Inhibition (HI) assay was used for the analysis. Geometric mean titer ratios (GMRs) of study day 29/study day 1, study day 50/study day 1, study day 181/study day 1 were evaluated. The criteria for evaluation is GMR \>2.5
Outcome measures
| Measure |
TIV-adj (6 to <36 Months)
n=319 Participants
Subjects aged 6 to \<36 months received 0.25 mL of each injection of Adjuvanted trivalent inactivated subunit influenza vaccine
|
Flu-control (6 to <36 Months)
n=316 Participants
Subjects aged 6 to \<36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Flu-control (6 to <36 Months)
n=158 Participants
Subjects aged 6 to \< 36 months received 0.25 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Flu-control (36 to <72 Months)
Subjects aged 36 to \< 72 months received 0.5 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Non-Flu-control (6 to <36 Months)
Subjects aged 6 to \<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \<72 months received 2 doses of 0.25 mL of TBE vaccine
|
Non-Flu-control (36 to <72 Months)
Subjects aged 6 to \<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \<72 months received 2 doses of 0.25 mL of TBE vaccine
|
|---|---|---|---|---|---|---|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 29:1A/Brisbane/2007(A/H1N1;N=316,313,156)
|
24 Ratios
Interval 21.0 to 27.0
|
3.6 Ratios
Interval 3.17 to 4.08
|
0.99 Ratios
Interval 0.83 to 1.18
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 29:1B/Florida/2006(N=316,313,156)
|
3.32 Ratios
Interval 2.94 to 3.75
|
2.06 Ratios
Interval 1.83 to 2.33
|
1.03 Ratios
Interval 0.87 to 1.22
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 50:1B/Florida/2006(N=310,309,150)
|
17 Ratios
Interval 15.0 to 19.0
|
3.29 Ratios
Interval 2.98 to 3.63
|
1.03 Ratios
Interval 0.9 to 1.18
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 50:1A/Sol.Island/2006A/H1N1;N=310,309,150)
|
20 Ratios
Interval 18.0 to 22.0
|
3.49 Ratios
Interval 3.12 to 3.89
|
0.97 Ratios
Interval 0.83 to 1.14
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 181:1A/Sol.Island/2006A/H1N1;N=309,310,151)
|
7.63 Ratios
Interval 6.98 to 8.34
|
2.41 Ratios
Interval 2.2 to 2.63
|
1.01 Ratios
Interval 0.89 to 1.14
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 50:1A/Wisconsin/2009(A/H3N2;N=310,309,150)
|
34 Ratios
Interval 30.0 to 38.0
|
4.6 Ratios
Interval 4.07 to 5.2
|
0.98 Ratios
Interval 0.83 to 1.17
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 29:1B/Brisbane/2008(N=315,313,156)
|
1.25 Ratios
Interval 1.19 to 1.31
|
1.1 Ratios
Interval 1.05 to 1.16
|
1.01 Ratios
Interval 0.94 to 1.08
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 181:1B/Brisbane/2008(N=308,310,151)
|
1.21 Ratios
Interval 1.15 to 1.28
|
1.12 Ratios
Interval 1.06 to 1.19
|
1.21 Ratios
Interval 1.11 to 1.31
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 50:1A/Brisbane/2007(A/H1N1;N=10,309,150)
|
76 Ratios
Interval 67.0 to 86.0
|
9 Ratios
Interval 7.89 to 10.0
|
1.02 Ratios
Interval 0.84 to 1.22
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 181:1A/Brisbane/2007(A/H1N1;N=309,310,151)
|
19 Ratios
Interval 17.0 to 21.0
|
4.31 Ratios
Interval 3.89 to 4.77
|
1.02 Ratios
Interval 0.88 to 1.17
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 29:1A/Brisbane/2007(A/H3N2;N=316,313,156)
|
17 Ratios
Interval 15.0 to 19.0
|
2.73 Ratios
Interval 2.4 to 3.09
|
1.03 Ratios
Interval 0.86 to 1.23
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)
D50:1A/Brisbane/2007(A/H3N2;N=310,309,150)
|
60 Ratios
Interval 52.0 to 69.0
|
8.03 Ratios
Interval 6.93 to 9.3
|
0.98 Ratios
Interval 0.8 to 1.21
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 181:1A/Brisbane/2007(A/H3N2;N=309,310,151)
|
24 Ratios
Interval 20.0 to 28.0
|
7.96 Ratios
Interval 6.71 to 9.44
|
2.21 Ratios
Interval 1.73 to 2.81
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 181:1B/Florida/2006(N=309,310,151)
|
5.05 Ratios
Interval 4.67 to 5.46
|
1.92 Ratios
Interval 1.78 to 2.08
|
1.06 Ratios
Interval 0.95 to 1.19
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 29:1A/Sol.Island/2006(A/H1N1;N=316,313,156)
|
3.51 Ratios
Interval 3.09 to 3.98
|
1.96 Ratios
Interval 1.72 to 2.22
|
0.99 Ratios
Interval 0.83 to 1.18
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 29:1A/Wisconsin/2009(A/H3N2;N=316,313,156)
|
6.59 Ratios
Interval 5.92 to 7.34
|
2.04 Ratios
Interval 1.83 to 2.27
|
0.93 Ratios
Interval 0.8 to 1.09
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 181:1A/Wisconsin/2009(A/H3N2;N=309,310,151)
|
18 Ratios
Interval 15.0 to 21.0
|
6.39 Ratios
Interval 5.36 to 7.6
|
2.59 Ratios
Interval 2.0 to 3.29
|
—
|
—
|
—
|
|
Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)
Day 50:1B/Brisbane/2008(N=309,309,150)
|
2.38 Ratios
Interval 2.23 to 2.55
|
1.32 Ratios
Interval 1.24 to 1.42
|
1.02 Ratios
Interval 0.93 to 1.13
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: On study days 1, 29, 50, 181Population: The analysis was done on Full Analysis Set
Hemagglutination Inhibition (HI) assay was used for the analysis. Percentage of subjects achieving seroprotection (i.e., with HI titer ≥1:40) at study day 1, study day 29, study day 50 and a study day 181 and associated 95% Confidence Intervals. The lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 70%.
Outcome measures
| Measure |
TIV-adj (6 to <36 Months)
n=319 Participants
Subjects aged 6 to \<36 months received 0.25 mL of each injection of Adjuvanted trivalent inactivated subunit influenza vaccine
|
Flu-control (6 to <36 Months)
n=316 Participants
Subjects aged 6 to \<36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Flu-control (6 to <36 Months)
n=158 Participants
Subjects aged 6 to \< 36 months received 0.25 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Flu-control (36 to <72 Months)
Subjects aged 36 to \< 72 months received 0.5 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Non-Flu-control (6 to <36 Months)
Subjects aged 6 to \<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \<72 months received 2 doses of 0.25 mL of TBE vaccine
|
Non-Flu-control (36 to <72 Months)
Subjects aged 6 to \<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \<72 months received 2 doses of 0.25 mL of TBE vaccine
|
|---|---|---|---|---|---|---|
|
Percentages of Subjects With HI Titers ≥ 1:40 in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 Homologous and Heterologous Strains
Day1 A/Brisbane/2007(A/H1N1)
|
20 Percentage of subjects
Interval 16.0 to 25.0
|
21 Percentage of subjects
Interval 17.0 to 26.0
|
16 Percentage of subjects
Interval 11.0 to 23.0
|
—
|
—
|
—
|
|
Percentages of Subjects With HI Titers ≥ 1:40 in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 Homologous and Heterologous Strains
Day50A/Brisbane/2007(A/H1N1;N=310,309,150)
|
100 Percentage of subjects
Interval 99.0 to 100.0
|
59 Percentage of subjects
Interval 54.0 to 65.0
|
17 Percentage of subjects
Interval 12.0 to 24.0
|
—
|
—
|
—
|
|
Percentages of Subjects With HI Titers ≥ 1:40 in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 Homologous and Heterologous Strains
Day181A/Brisbane/2007(A/H1N1;N=309,310,151)
|
98 Percentage of subjects
Interval 96.0 to 99.0
|
49 Percentage of subjects
Interval 43.0 to 54.0
|
18 Percentage of subjects
Interval 12.0 to 25.0
|
—
|
—
|
—
|
|
Percentages of Subjects With HI Titers ≥ 1:40 in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 Homologous and Heterologous Strains
Day1A/Brisbane/2007(A/H3N2)
|
23 Percentage of subjects
Interval 18.0 to 28.0
|
22 Percentage of subjects
Interval 17.0 to 27.0
|
20 Percentage of subjects
Interval 14.0 to 27.0
|
—
|
—
|
—
|
|
Percentages of Subjects With HI Titers ≥ 1:40 in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 Homologous and Heterologous Strains
Day29A/Brisbane/2007(A/H3N2;N=316,313,156)
|
96 Percentage of subjects
Interval 93.0 to 98.0
|
35 Percentage of subjects
Interval 30.0 to 40.0
|
21 Percentage of subjects
Interval 15.0 to 28.0
|
—
|
—
|
—
|
|
Percentages of Subjects With HI Titers ≥ 1:40 in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 Homologous and Heterologous Strains
Day50A/Brisbane/2007(A/H3N2;N=310,309,150)
|
99 Percentage of subjects
Interval 97.0 to 100.0
|
65 Percentage of subjects
Interval 60.0 to 71.0
|
21 Percentage of subjects
Interval 14.0 to 28.0
|
—
|
—
|
—
|
|
Percentages of Subjects With HI Titers ≥ 1:40 in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 Homologous and Heterologous Strains
Day29B/Florida/2006(N=316,313,156)
|
28 Percentage of subjects
Interval 23.0 to 33.0
|
26 Percentage of subjects
Interval 21.0 to 31.0
|
4 Percentage of subjects
Interval 1.0 to 8.0
|
—
|
—
|
—
|
|
Percentages of Subjects With HI Titers ≥ 1:40 in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 Homologous and Heterologous Strains
D50A/Sol.islands/2006(A/H1N1;N=310,309,150)
|
96 Percentage of subjects
Interval 94.0 to 98.0
|
45 Percentage of subjects
Interval 39.0 to 51.0
|
18 Percentage of subjects
Interval 12.0 to 25.0
|
—
|
—
|
—
|
|
Percentages of Subjects With HI Titers ≥ 1:40 in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 Homologous and Heterologous Strains
D181A/Sol.Islands/2006(A/H1N1;N=309,310,151)
|
72 Percentage of subjects
Interval 67.0 to 77.0
|
34 Percentage of subjects
Interval 29.0 to 40.0
|
18 Percentage of subjects
Interval 12.0 to 25.0
|
—
|
—
|
—
|
|
Percentages of Subjects With HI Titers ≥ 1:40 in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 Homologous and Heterologous Strains
Day1A/Wisconsin/2009(A/H3N2)
|
25 Percentage of subjects
Interval 21.0 to 31.0
|
25 Percentage of subjects
Interval 20.0 to 30.0
|
21 Percentage of subjects
Interval 15.0 to 28.0
|
—
|
—
|
—
|
|
Percentages of Subjects With HI Titers ≥ 1:40 in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 Homologous and Heterologous Strains
Day181B/Brisbane/2008(N=309,310,151)
|
3 Percentage of subjects
Interval 1.0 to 5.0
|
3 Percentage of subjects
Interval 1.0 to 5.0
|
5 Percentage of subjects
Interval 2.0 to 10.0
|
—
|
—
|
—
|
|
Percentages of Subjects With HI Titers ≥ 1:40 in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 Homologous and Heterologous Strains
Day29A/Brisbane/2007(A/H1N1;N=316,313,156)
|
96 Percentage of subjects
Interval 93.0 to 98.0
|
40 Percentage of subjects
Interval 35.0 to 46.0
|
17 Percentage of subjects
Interval 11.0 to 23.0
|
—
|
—
|
—
|
|
Percentages of Subjects With HI Titers ≥ 1:40 in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 Homologous and Heterologous Strains
Day181A/Brisbane/2007(A/H3N2;N=309,310,151)
|
100 Percentage of subjects
Interval 98.0 to 100.0
|
65 Percentage of subjects
Interval 60.0 to 70.0
|
41 Percentage of subjects
Interval 33.0 to 49.0
|
—
|
—
|
—
|
|
Percentages of Subjects With HI Titers ≥ 1:40 in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 Homologous and Heterologous Strains
Day1B/Florida/2006
|
2 Percentage of subjects
Interval 1.0 to 4.0
|
2 Percentage of subjects
Interval 1.0 to 5.0
|
4 Percentage of subjects
Interval 1.0 to 8.0
|
—
|
—
|
—
|
|
Percentages of Subjects With HI Titers ≥ 1:40 in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 Homologous and Heterologous Strains
Day50B/Florida/2006(N=310,309,150)
|
93 Percentage of subjects
Interval 89.0 to 95.0
|
38 Percentage of subjects
Interval 33.0 to 44.0
|
3 Percentage of subjects
Interval 1.0 to 8.0
|
—
|
—
|
—
|
|
Percentages of Subjects With HI Titers ≥ 1:40 in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 Homologous and Heterologous Strains
Day181B/Florida/2006(N=309,310,151)
|
52 Percentage of subjects
Interval 46.0 to 57.0
|
23 Percentage of subjects
Interval 18.0 to 28.0
|
4 Percentage of subjects
Interval 1.0 to 8.0
|
—
|
—
|
—
|
|
Percentages of Subjects With HI Titers ≥ 1:40 in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 Homologous and Heterologous Strains
Day1A/Sol.Islands/2006(A/H1N1)
|
21 Percentage of subjects
Interval 16.0 to 26.0
|
22 Percentage of subjects
Interval 17.0 to 27.0
|
18 Percentage of subjects
Interval 12.0 to 25.0
|
—
|
—
|
—
|
|
Percentages of Subjects With HI Titers ≥ 1:40 in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 Homologous and Heterologous Strains
D29A/Sol.Islands/2006(A/H1N1;N=316,313,156)
|
32 Percentage of subjects
Interval 27.0 to 38.0
|
24 Percentage of subjects
Interval 20.0 to 29.0
|
18 Percentage of subjects
Interval 12.0 to 25.0
|
—
|
—
|
—
|
|
Percentages of Subjects With HI Titers ≥ 1:40 in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 Homologous and Heterologous Strains
Day29A/Wisconsin/2009(A/H3N2;N=316,313,156)
|
60 Percentage of subjects
Interval 54.0 to 66.0
|
29 Percentage of subjects
Interval 24.0 to 34.0
|
21 Percentage of subjects
Interval 14.0 to 28.0
|
—
|
—
|
—
|
|
Percentages of Subjects With HI Titers ≥ 1:40 in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 Homologous and Heterologous Strains
Day50A/Wisconsin/2009(A/H3N2;N=310,309,150)
|
100 Percentage of subjects
Interval 98.0 to 100.0
|
54 Percentage of subjects
Interval 48.0 to 59.0
|
21 Percentage of subjects
Interval 15.0 to 29.0
|
—
|
—
|
—
|
|
Percentages of Subjects With HI Titers ≥ 1:40 in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 Homologous and Heterologous Strains
D181A/Wisconsin/2009(A/H3N2;N=309,310,151)
|
100 Percentage of subjects
Interval 98.0 to 100.0
|
63 Percentage of subjects
Interval 57.0 to 68.0
|
43 Percentage of subjects
Interval 35.0 to 51.0
|
—
|
—
|
—
|
|
Percentages of Subjects With HI Titers ≥ 1:40 in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 Homologous and Heterologous Strains
Day1B/Brisbane/2008
|
0 Percentage of subjects
Interval 0.0 to 1.0
|
0 Percentage of subjects
Interval 0.0 to 1.0
|
1 Percentage of subjects
Interval 0.016 to 3.0
|
—
|
—
|
—
|
|
Percentages of Subjects With HI Titers ≥ 1:40 in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 Homologous and Heterologous Strains
Day29B/Brisbane/2008(N=316,313,156)
|
3 Percentage of subjects
Interval 2.0 to 6.0
|
1 Percentage of subjects
Interval 0.0 to 3.0
|
1 Percentage of subjects
Interval 0.016 to 4.0
|
—
|
—
|
—
|
|
Percentages of Subjects With HI Titers ≥ 1:40 in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 Homologous and Heterologous Strains
Day50B/Brisbane/2008(N=310,309,150)
|
10 Percentage of subjects
Interval 7.0 to 14.0
|
3 Percentage of subjects
Interval 1.0 to 5.0
|
0 Percentage of subjects
Interval 0.0 to 2.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: On study days 1, 29, 50, 181Population: The analysis was done on Full Analysis Set
HI assay was used for the analysis. Seroconversion is defined as negative pre-vaccination serum (\<10)/ post-vaccination HI titer ≥1:40. Seroconversion is defined as either pre-vaccination HI titer \<10 and a post-vaccination HI titer ≥1:40 or a prevaccination HI titer ≥10 and a minimum 4-fold rise in post-vaccination HI antibody titer. The lower bound of the two-sided 95% confidence interval (CI) for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40%.
Outcome measures
| Measure |
TIV-adj (6 to <36 Months)
n=319 Participants
Subjects aged 6 to \<36 months received 0.25 mL of each injection of Adjuvanted trivalent inactivated subunit influenza vaccine
|
Flu-control (6 to <36 Months)
n=316 Participants
Subjects aged 6 to \<36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Flu-control (6 to <36 Months)
n=158 Participants
Subjects aged 6 to \< 36 months received 0.25 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Flu-control (36 to <72 Months)
Subjects aged 36 to \< 72 months received 0.5 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Non-Flu-control (6 to <36 Months)
Subjects aged 6 to \<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \<72 months received 2 doses of 0.25 mL of TBE vaccine
|
Non-Flu-control (36 to <72 Months)
Subjects aged 6 to \<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \<72 months received 2 doses of 0.25 mL of TBE vaccine
|
|---|---|---|---|---|---|---|
|
Percentages of Subjects With Seroconversion and Vaccine Group Differences in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 (Homologous and Heterologous Strains)
Day 50:1 B/Florida/2006 (N=310,309,150)
|
93 Percentage of subjects
Interval 89.0 to 95.0
|
38 Percentage of subjects
Interval 32.0 to 43.0
|
1 Percentage of subjects
Interval 0.017 to 4.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Seroconversion and Vaccine Group Differences in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 (Homologous and Heterologous Strains)
Day 50:1 A/Brisbane/2007 (A/H1N1; N=310,309,150)
|
100 Percentage of subjects
Interval 99.0 to 100.0
|
59 Percentage of subjects
Interval 53.0 to 64.0
|
1 Percentage of subjects
Interval 0.0 to 5.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Seroconversion and Vaccine Group Differences in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 (Homologous and Heterologous Strains)
Day 29:1 A/Brisbane/2007 (A/H3N2; N=316,313,156)
|
94 Percentage of subjects
Interval 91.0 to 97.0
|
31 Percentage of subjects
Interval 26.0 to 37.0
|
1 Percentage of subjects
Interval 0.016 to 4.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Seroconversion and Vaccine Group Differences in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 (Homologous and Heterologous Strains)
Day 50:1 A/Brisbane/2007 (A/H3N2; N=310,309,150)
|
97 Percentage of subjects
Interval 95.0 to 99.0
|
63 Percentage of subjects
Interval 57.0 to 68.0
|
2 Percentage of subjects
Interval 0.0 to 6.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Seroconversion and Vaccine Group Differences in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 (Homologous and Heterologous Strains)
Day 181:1 A/Brisbane/2007 (A/H3N2; N=309,310,151)
|
93 Percentage of subjects
Interval 90.0 to 96.0
|
56 Percentage of subjects
Interval 51.0 to 62.0
|
23 Percentage of subjects
Interval 17.0 to 31.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Seroconversion and Vaccine Group Differences in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 (Homologous and Heterologous Strains)
Day 29:1 B/Florida/2006 (N=316,313,156)
|
28 Percentage of subjects
Interval 23.0 to 33.0
|
26 Percentage of subjects
Interval 21.0 to 31.0
|
0 Percentage of subjects
Interval 0.0 to 2.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Seroconversion and Vaccine Group Differences in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 (Homologous and Heterologous Strains)
Day 181:1 B/Florida/2006 (N=309,310,151)
|
50 Percentage of subjects
Interval 44.0 to 56.0
|
19 Percentage of subjects
Interval 15.0 to 24.0
|
1 Percentage of subjects
Interval 0.0 to 5.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Seroconversion and Vaccine Group Differences in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 (Homologous and Heterologous Strains)
Day 29:1A/SolomonIsland/2006(A/H1N1;N=316,313,156)
|
32 Percentage of subjects
Interval 27.0 to 37.0
|
24 Percentage of subjects
Interval 19.0 to 29.0
|
0 Percentage of subjects
Interval 0.0 to 2.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Seroconversion and Vaccine Group Differences in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 (Homologous and Heterologous Strains)
Day 50:1A/SolomonIsland/2006(A/H1N1;N=310,309,150)
|
96 Percentage of subjects
Interval 93.0 to 98.0
|
44 Percentage of subjects
Interval 39.0 to 50.0
|
0 Percentage of subjects
Interval 0.0 to 2.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Seroconversion and Vaccine Group Differences in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 (Homologous and Heterologous Strains)
Day181:1A/SolomonIsland/2006(A/H1N1;N=309,310,151)
|
72 Percentage of subjects
Interval 66.0 to 76.0
|
33 Percentage of subjects
Interval 27.0 to 38.0
|
0 Percentage of subjects
Interval 0.0 to 2.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Seroconversion and Vaccine Group Differences in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 (Homologous and Heterologous Strains)
Day 29:1 A/Wisconsin/2009 (A/H3N2; N=316,313,156)
|
58 Percentage of subjects
Interval 53.0 to 64.0
|
23 Percentage of subjects
Interval 19.0 to 28.0
|
1 Percentage of subjects
Interval 0.016 to 4.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Seroconversion and Vaccine Group Differences in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 (Homologous and Heterologous Strains)
Day 50:1 A/Wisconsin/2009 (A/H3N2; N=310,309,150)
|
98 Percentage of subjects
Interval 96.0 to 99.0
|
49 Percentage of subjects
Interval 43.0 to 54.0
|
2 Percentage of subjects
Interval 0.0 to 6.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Seroconversion and Vaccine Group Differences in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 (Homologous and Heterologous Strains)
Day181:1 A/Wisconsin/2009 (A/H3N2;N=309,310,151)
|
92 Percentage of subjects
Interval 89.0 to 95.0
|
52 Percentage of subjects
Interval 46.0 to 58.0
|
25 Percentage of subjects
Interval 18.0 to 33.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Seroconversion and Vaccine Group Differences in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 (Homologous and Heterologous Strains)
Day 29:1 B/Brisbane/2008 (N=316,313,156)
|
3 Percentage of subjects
Interval 2.0 to 6.0
|
1 Percentage of subjects
Interval 0.0 to 3.0
|
0 Percentage of subjects
Interval 0.0 to 2.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Seroconversion and Vaccine Group Differences in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 (Homologous and Heterologous Strains)
Day 29:1 A/Brisbane/2007 (A/H1N1; N=316,313,156)
|
96 Percentage of subjects
Interval 93.0 to 98.0
|
40 Percentage of subjects
Interval 34.0 to 45.0
|
1 Percentage of subjects
Interval 0.016 to 4.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Seroconversion and Vaccine Group Differences in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 (Homologous and Heterologous Strains)
Day 181:1 A/Brisbane/2007 (A/H1N1; N=309,310,151)
|
98 Percentage of subjects
Interval 96.0 to 99.0
|
48 Percentage of subjects
Interval 42.0 to 53.0
|
1 Percentage of subjects
Interval 0.0 to 5.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Seroconversion and Vaccine Group Differences in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 (Homologous and Heterologous Strains)
Day 50:1 B/Brisbane/2008 (N=310,309,150)
|
10 Percentage of subjects
Interval 7.0 to 14.0
|
3 Percentage of subjects
Interval 1.0 to 5.0
|
0 Percentage of subjects
Interval 0.0 to 2.0
|
—
|
—
|
—
|
|
Percentages of Subjects With Seroconversion and Vaccine Group Differences in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 (Homologous and Heterologous Strains)
Day181:1 B/Brisbane/2008 (N=309,310,151)
|
2 Percentage of subjects
Interval 1.0 to 5.0
|
3 Percentage of subjects
Interval 1.0 to 5.0
|
5 Percentage of subjects
Interval 2.0 to 10.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 7 days post-vaccinationPopulation: Adequate data was not available to conduct this analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 weeks after 2nd vaccinationPopulation: As per an amendment to the protocol, the Secondary efficacy endpoints were evaluated in enrolled subjects only and the household members were not included in the trial for the evaluation of indirect vaccine efficacy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 weeks after 2nd vaccinationPopulation: Adequate data was not available for assessing the incidence rates of the 2009-2010 swine pandemic caused by a novel influenza A (H1N1) virus of swine origin.
Outcome measures
Outcome data not reported
Adverse Events
TIV-adj_0.25
Serious events: 91 serious events
Other events: 1101 other events
Deaths: 0 deaths
TIV-adj_0.5
Serious events: 31 serious events
Other events: 769 other events
Deaths: 0 deaths
Flu-control_0.25
Serious events: 104 serious events
Other events: 989 other events
Deaths: 0 deaths
Flu-control_0.5
Serious events: 65 serious events
Other events: 686 other events
Deaths: 0 deaths
Non-Flu-control (TBE/Men C Vaccine)
Serious events: 65 serious events
Other events: 567 other events
Deaths: 0 deaths
Non-Flu-control (TBE Vaccine)
Serious events: 45 serious events
Other events: 375 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TIV-adj_0.25
n=1177 participants at risk
Subjects aged 6 to \< 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
|
TIV-adj_0.5
n=835 participants at risk
Subjects aged 36 to \< 72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
|
Flu-control_0.25
n=1069 participants at risk
Subjects aged 6 to \< 36 months received 0.25 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Flu-control_0.5
n=777 participants at risk
Subjects aged 36 to \< 72 months received 0.5 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Non-Flu-control (TBE/Men C Vaccine)
n=607 participants at risk
Subjects aged 6 to \<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \<72 months received 2 doses of 0.25 mL of TBE vaccine
|
Non-Flu-control (TBE Vaccine)
n=422 participants at risk
Subjects aged 6 to \<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \<72 months received 2 doses of 0.25 mL of TBE vaccine
|
|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.16%
1/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Gastrointestinal disorders
Malabsorption
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.24%
1/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.09%
1/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.12%
1/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.12%
1/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.13%
1/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.24%
1/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Injury, poisoning and procedural complications
Exposure via ingestion
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.16%
1/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
Encephalitis
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.24%
1/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Nervous system disorders
Acquired epileptic aphasia
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.13%
1/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.09%
1/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Injury, poisoning and procedural complications
Skull fractured base
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.09%
1/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
Otitis media
|
0.17%
2/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.09%
1/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.08%
1/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.13%
1/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.09%
1/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Cardiac disorders
Cyanosis
|
0.08%
1/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.09%
1/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.12%
1/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.13%
1/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.12%
1/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.13%
1/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.09%
1/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.08%
1/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.09%
1/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.24%
1/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Gastrointestinal disorders
Enteritis
|
0.17%
2/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Gastrointestinal disorders
Stomatitis
|
0.08%
1/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.28%
3/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.13%
1/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
General disorders
Developmental delay
|
0.08%
1/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
General disorders
Gait disturbance
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.09%
1/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
General disorders
Pyrexia
|
0.17%
2/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.12%
1/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.09%
1/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.26%
2/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.24%
1/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Immune system disorders
Allergy to arthropod bite
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.13%
1/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.16%
1/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.13%
1/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
Arthropod infestation
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.12%
1/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
Bronchiolitis
|
0.08%
1/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.09%
1/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.33%
2/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
Bronchitis
|
0.68%
8/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.36%
3/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.65%
7/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.49%
3/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.24%
1/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.12%
1/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.19%
2/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.13%
1/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.16%
1/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.71%
3/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
Campylobacter infection
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.09%
1/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
Exanthema subitum
|
0.08%
1/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
Febrile infection
|
0.08%
1/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
Gastroenteritis
|
1.2%
14/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.12%
1/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
1.2%
13/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.39%
3/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
1.3%
8/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.47%
2/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.08%
1/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.12%
1/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.47%
5/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.49%
3/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
Gastroenteritis viral
|
0.08%
1/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.09%
1/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.33%
2/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
H1N1 influenza
|
0.08%
1/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
Hand-foot and mouth disease
|
0.08%
1/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
Influenza
|
1.0%
12/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.96%
8/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
3.6%
39/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
5.1%
40/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
5.4%
33/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
7.3%
31/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
Laryngitis
|
0.08%
1/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.12%
1/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.19%
2/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.13%
1/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.49%
3/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
Lymphangitis
|
0.08%
1/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.13%
1/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.13%
1/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.08%
1/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.09%
1/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
Pneumococcal infection
|
0.08%
1/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.09%
1/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
Pneumococcal sepsis
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.16%
1/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
Pneumonia
|
0.42%
5/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.24%
2/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.47%
5/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.39%
3/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.33%
2/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.09%
1/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
Pseudocroup
|
0.08%
1/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.19%
2/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.09%
1/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.34%
4/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.09%
1/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
Respiratory tract infection
|
0.17%
2/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.12%
1/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
Subcutaneous abscess
|
0.17%
2/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.19%
2/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.09%
1/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
Tracheitis
|
0.08%
1/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.19%
2/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
Viral infection
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.09%
1/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Injury, poisoning and procedural complications
Accidental exposure to product
|
0.17%
2/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.16%
1/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.51%
6/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.24%
2/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.09%
1/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.13%
1/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.16%
1/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.17%
2/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.09%
1/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.26%
2/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.24%
1/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.09%
1/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Injury, poisoning and procedural complications
Electric shock
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.09%
1/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.16%
1/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.08%
1/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.09%
1/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.13%
1/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.12%
1/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Injury, poisoning and procedural complications
Perineal Injury
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.12%
1/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Injury, poisoning and procedural complications
Poisoning
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.09%
1/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.12%
1/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.09%
1/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.13%
1/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.08%
1/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.08%
1/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Injury, poisoning and procedural complications
spinal cord injury
|
0.08%
1/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.08%
1/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.13%
1/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Injury, poisoning and procedural complications
Vaccination failure
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.09%
1/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Investigations
Paracentesis
|
0.08%
1/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Metabolism and nutrition disorders
Acetonaemia
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.09%
1/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.08%
1/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.24%
2/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.09%
1/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.13%
1/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Metabolism and nutrition disorders
Feeding disorder of Infancy or Early childhood
|
0.08%
1/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.24%
1/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.16%
1/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.08%
1/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.08%
1/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.13%
1/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Nervous system disorders
Ataxia
|
0.08%
1/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Nervous system disorders
Convulsion
|
0.08%
1/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.12%
1/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.09%
1/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.33%
2/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Nervous system disorders
Febrile convulsion
|
0.17%
2/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.12%
1/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.37%
4/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Nervous system disorders
Petit mal epilepsy
|
0.08%
1/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Psychiatric disorders
Attention deficit / Hyperactivity disorder
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.13%
1/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Psychiatric disorders
Dysphemia
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.09%
1/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.24%
1/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.13%
1/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.09%
1/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.09%
1/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.17%
2/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.19%
2/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.33%
2/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.24%
1/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.08%
1/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.12%
1/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar haemorrhage
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.13%
1/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.13%
1/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.08%
1/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.08%
1/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.08%
1/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Skin and subcutaneous tissue disorders
Henoch-schonlein purpura
|
0.08%
1/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.08%
1/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Social circumstances
Child abuse
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.09%
1/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Surgical and medical procedures
Adenoidectomy
|
0.08%
1/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.12%
1/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Surgical and medical procedures
Brain tumour operation
|
0.08%
1/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Surgical and medical procedures
Patent ductus arteriosus repair
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.13%
1/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Surgical and medical procedures
Toe amputation
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.12%
1/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Surgical and medical procedures
Tonsillectomy
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.12%
1/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.08%
1/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Psychiatric disorders
Abnormal behaviour
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.16%
1/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.08%
1/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Investigations
Colonoscopy
|
0.08%
1/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Injury, poisoning and procedural complications
Foreign body
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.24%
1/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.16%
1/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.16%
1/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.24%
1/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.12%
1/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Injury, poisoning and procedural complications
Accidental poisoning
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.16%
1/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.09%
1/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
Skin infection
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.12%
1/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
Rotavirus infection
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.16%
1/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
Lice infestation
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.24%
1/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.08%
1/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.24%
1/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
Other adverse events
| Measure |
TIV-adj_0.25
n=1177 participants at risk
Subjects aged 6 to \< 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
|
TIV-adj_0.5
n=835 participants at risk
Subjects aged 36 to \< 72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
|
Flu-control_0.25
n=1069 participants at risk
Subjects aged 6 to \< 36 months received 0.25 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Flu-control_0.5
n=777 participants at risk
Subjects aged 36 to \< 72 months received 0.5 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
|
Non-Flu-control (TBE/Men C Vaccine)
n=607 participants at risk
Subjects aged 6 to \<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \<72 months received 2 doses of 0.25 mL of TBE vaccine
|
Non-Flu-control (TBE Vaccine)
n=422 participants at risk
Subjects aged 6 to \<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \<72 months received 2 doses of 0.25 mL of TBE vaccine
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Viral infection
|
5.4%
63/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
4.2%
35/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
5.6%
60/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
3.6%
28/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
3.3%
20/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
4.5%
19/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
Tonsillitis
|
5.4%
64/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
4.6%
38/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
3.9%
42/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
4.9%
38/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
4.1%
25/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
5.9%
25/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
Conjunctivitis
|
13.9%
164/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
9.9%
83/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
14.6%
156/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
8.4%
65/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
15.0%
91/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
10.7%
45/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Gastrointestinal disorders
Diarrhoea
|
26.3%
309/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
5.4%
45/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
24.3%
260/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
4.5%
35/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
24.2%
147/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
2.4%
10/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Gastrointestinal disorders
Vomiting
|
16.0%
188/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
7.7%
64/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
15.5%
166/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
9.0%
70/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
16.8%
102/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
5.5%
23/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
General disorders
Chills
|
6.5%
77/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
15.7%
131/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
6.5%
69/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
6.6%
51/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
8.2%
50/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
8.8%
37/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
General disorders
Fatigue
|
0.08%
1/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
40.5%
338/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.19%
2/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
28.8%
224/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.33%
2/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
28.9%
122/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
General disorders
Injection site erythema
|
35.9%
423/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
38.4%
321/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
30.4%
325/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
34.5%
268/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
39.5%
240/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
30.3%
128/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
General disorders
Injection site haemorrhage
|
12.4%
146/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
15.7%
131/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
10.0%
107/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
12.0%
93/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
11.4%
69/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
11.6%
49/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
General disorders
Injection site induration
|
18.2%
214/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
20.2%
169/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
12.3%
131/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
19.6%
152/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
25.4%
154/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
18.7%
79/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
General disorders
Injection site pain
|
28.4%
334/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
57.2%
478/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
23.4%
250/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
46.3%
360/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
28.5%
173/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
42.4%
179/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
General disorders
Injection site swelling
|
10.5%
123/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
18.7%
156/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
8.4%
90/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
16.5%
128/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
13.7%
83/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
12.8%
54/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
General disorders
Malaise
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
23.5%
196/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.09%
1/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
15.4%
120/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
15.2%
64/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
General disorders
Pyrexia
|
41.0%
482/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
35.8%
299/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
38.5%
412/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
23.6%
183/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
36.4%
221/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
29.6%
125/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
Bronchitis
|
14.4%
169/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
8.1%
68/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
14.3%
153/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
8.5%
66/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
15.7%
95/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
11.8%
50/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
Ear infection
|
11.1%
131/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
6.8%
57/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
12.3%
132/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
6.3%
49/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
11.9%
72/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
5.2%
22/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
Gastroenteritis
|
15.1%
178/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
9.0%
75/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
14.2%
152/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
10.9%
85/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
15.5%
94/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
8.5%
36/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
Nasopharyngitis
|
13.0%
153/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
9.3%
78/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
15.1%
161/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
9.5%
74/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
14.7%
89/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
8.5%
36/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
Otitis media
|
21.2%
250/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
13.1%
109/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
21.1%
226/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
14.2%
110/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
21.4%
130/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
14.7%
62/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
Respiratory tract infection
|
6.5%
76/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
3.5%
29/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
5.8%
62/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
4.8%
37/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
7.2%
44/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
4.0%
17/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
Rhinitis
|
22.1%
260/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
14.6%
122/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
20.5%
219/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
12.5%
97/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
20.3%
123/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
13.5%
57/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Infections and infestations
Upper respiratory tract infection
|
30.8%
362/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
20.4%
170/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
28.6%
306/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
20.1%
156/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
28.7%
174/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
20.1%
85/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
21.9%
183/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
13.1%
102/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.16%
1/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
15.6%
66/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
General disorders
Crying
|
31.7%
373/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.60%
5/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
30.4%
325/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.39%
3/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
26.9%
163/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Nervous system disorders
Headache
|
0.51%
6/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
24.1%
201/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.56%
6/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
15.4%
120/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.82%
5/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
15.6%
66/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Nervous system disorders
Somnolence
|
32.4%
381/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.12%
1/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
29.5%
315/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.13%
1/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
30.6%
186/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.00%
0/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Psychiatric disorders
Eating disorder
|
27.8%
327/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.36%
3/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
24.6%
263/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.13%
1/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
26.5%
161/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.47%
2/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.9%
246/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
21.1%
176/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
19.6%
210/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
21.4%
166/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
19.6%
119/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
23.0%
97/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
6.5%
76/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.48%
4/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
5.8%
62/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.64%
5/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
6.6%
40/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.47%
2/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.08%
1/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
8.3%
69/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.09%
1/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
5.4%
42/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.16%
1/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
7.3%
31/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.08%
1/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
10.2%
85/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.09%
1/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
5.0%
39/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
0.16%
1/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
6.2%
26/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
|
Gastrointestinal disorders
Enteritis
|
4.6%
54/1177 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
2.8%
23/835 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
5.6%
60/1069 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
2.3%
18/777 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
5.4%
33/607 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
2.6%
11/422 • 3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).
15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60