Trial Outcomes & Findings for Second Extension Study to Evaluate Safety and Tolerability of Influenza Vaccines in Adults and Elderly, and to Evaluate Immunogenicity and Concomitant Vaccination With Pneumococcal Vaccine in a Subgroup (NCT NCT00579345)
NCT ID: NCT00579345
Last Updated: 2017-01-27
Results Overview
Safety and tolerability evaluation of influenza vaccines, within one week of single intramuscular injection. Local reactions reported for Influenza Vaccine Injection site.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1522 participants
Primary outcome timeframe
One week postvaccination
Results posted on
2017-01-27
Participant Flow
Study was conducted during the period of October 2007 to June 2008 at five sites in Poland.
All subjects enrolled were included in the trial. The data entered is for overall study.
Participant milestones
| Measure |
eTIV_a (Adults)
Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in parent (V58P4 \[NCT00492063\]) and Extension 1 (V58P4E1 \[NCT00306527\]) studies with influenza virus vaccine\[egg-derived seasonal trivalent, thiomersal free; eTIV\_a\] were allocated to receive eTIV\_a in the deltoid muscle, preferably of the non-dominant arm).
|
cTIV (Adults)
Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in the parent (V58P4 \[NCT00492063\]) and the extension 1 (V58P4E1 \[NCT00306527\]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine \[cTIV\] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
|
cTIV (Elderly)
Revaccination unrandomized group (elderly subjects (\>= 61 years of age) who were pre-vaccinated in parent (V58P4 \[NCT00492063\]) and Extension 1 (V58P4E1 \[NCT00306527\]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine \[cTIV\] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
|
eTIV_a (Elderly)
Revaccination unrandomized group (elderly subjects (\>= 61 years of age) who were pre-vaccinated in parent (V58P4 \[NCT00492063\]) and Extension 1 (V58P4E1 \[NCT00306527\]) study with influenza virus vaccine \[egg-derived seasonal trivalent, thiomersal free; eTIV\_a\] were allocated to receive eTIV\_a in the deltoid muscle, preferably of the non-dominant arm).
|
cTIV (Elderly; FLU Vaccination)
Revaccination randomized group (elderly subjects (\>= 65 years of age) were revaccinated with cell-culture derived seasonal trivalent influenza vaccine \[cTIV\]; in the deltoid muscle, preferably of the non-dominant arm) irrespective of influenza vaccination received in parent (V58P4 \[NCT00492063\]) study or extension 1 (V58P4E1 \[NCT00306527\]) study.
|
cTIV+PV (Elderly; Concomitant Vaccination )
Revaccination randomized group (elderly subjects (\>= 65 years of age) were concomitantly revaccinated with cell-culture derived seasonal trivalent influenza vaccine \[cTIV; in the deltoid muscle, preferably of the non-dominant arm\] and pneumococcal vaccine \[PV; in opposite arm\] irrespective of influenza vaccination received in parent (V58P4 \[NCT00492063\]) study or extension 1 (V58P4E1 \[NCT00306527\]) study).
|
eTIV_a (Elderly; FLU Vaccination)
Revaccination randomized group (elderly subjects (\>= 65 years of age) were revaccinated with influenza virus vaccine \[egg-derived seasonal trivalent, thiomersal free; eTIV\_a\] in the deltoid muscle, preferably of the non-dominant arm irrespective of influenza vaccination received in parent (V58P4 \[NCT00492063\]) study or extension 1 (V58P4E1 \[NCT00306527\]) study).
|
eTIV_a +PV (Elderly; Concomitant Vaccination)
Revaccination randomized group (elderly subjects (\>= 65 years of age) were concomitantly revaccinated with influenza virus vaccine \[egg-derived seasonal trivalent, thiomersal free; eTIV\_a in the deltoid muscle, preferably of the non-dominant arm\] and pneumococcal vaccine \[PV; in opposite arm\] irrespective of influenza vaccination received in parent (V58P4 \[NCT00492063\]) study or extension 1 (V58P4E1 \[NCT00306527\]) study).
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
169
|
549
|
391
|
144
|
90
|
78
|
57
|
44
|
|
Overall Study
COMPLETED
|
168
|
544
|
389
|
143
|
90
|
78
|
57
|
42
|
|
Overall Study
NOT COMPLETED
|
1
|
5
|
2
|
1
|
0
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
eTIV_a (Adults)
Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in parent (V58P4 \[NCT00492063\]) and Extension 1 (V58P4E1 \[NCT00306527\]) studies with influenza virus vaccine\[egg-derived seasonal trivalent, thiomersal free; eTIV\_a\] were allocated to receive eTIV\_a in the deltoid muscle, preferably of the non-dominant arm).
|
cTIV (Adults)
Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in the parent (V58P4 \[NCT00492063\]) and the extension 1 (V58P4E1 \[NCT00306527\]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine \[cTIV\] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
|
cTIV (Elderly)
Revaccination unrandomized group (elderly subjects (\>= 61 years of age) who were pre-vaccinated in parent (V58P4 \[NCT00492063\]) and Extension 1 (V58P4E1 \[NCT00306527\]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine \[cTIV\] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
|
eTIV_a (Elderly)
Revaccination unrandomized group (elderly subjects (\>= 61 years of age) who were pre-vaccinated in parent (V58P4 \[NCT00492063\]) and Extension 1 (V58P4E1 \[NCT00306527\]) study with influenza virus vaccine \[egg-derived seasonal trivalent, thiomersal free; eTIV\_a\] were allocated to receive eTIV\_a in the deltoid muscle, preferably of the non-dominant arm).
|
cTIV (Elderly; FLU Vaccination)
Revaccination randomized group (elderly subjects (\>= 65 years of age) were revaccinated with cell-culture derived seasonal trivalent influenza vaccine \[cTIV\]; in the deltoid muscle, preferably of the non-dominant arm) irrespective of influenza vaccination received in parent (V58P4 \[NCT00492063\]) study or extension 1 (V58P4E1 \[NCT00306527\]) study.
|
cTIV+PV (Elderly; Concomitant Vaccination )
Revaccination randomized group (elderly subjects (\>= 65 years of age) were concomitantly revaccinated with cell-culture derived seasonal trivalent influenza vaccine \[cTIV; in the deltoid muscle, preferably of the non-dominant arm\] and pneumococcal vaccine \[PV; in opposite arm\] irrespective of influenza vaccination received in parent (V58P4 \[NCT00492063\]) study or extension 1 (V58P4E1 \[NCT00306527\]) study).
|
eTIV_a (Elderly; FLU Vaccination)
Revaccination randomized group (elderly subjects (\>= 65 years of age) were revaccinated with influenza virus vaccine \[egg-derived seasonal trivalent, thiomersal free; eTIV\_a\] in the deltoid muscle, preferably of the non-dominant arm irrespective of influenza vaccination received in parent (V58P4 \[NCT00492063\]) study or extension 1 (V58P4E1 \[NCT00306527\]) study).
|
eTIV_a +PV (Elderly; Concomitant Vaccination)
Revaccination randomized group (elderly subjects (\>= 65 years of age) were concomitantly revaccinated with influenza virus vaccine \[egg-derived seasonal trivalent, thiomersal free; eTIV\_a in the deltoid muscle, preferably of the non-dominant arm\] and pneumococcal vaccine \[PV; in opposite arm\] irrespective of influenza vaccination received in parent (V58P4 \[NCT00492063\]) study or extension 1 (V58P4E1 \[NCT00306527\]) study).
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Death
|
1
|
1
|
1
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Second Extension Study to Evaluate Safety and Tolerability of Influenza Vaccines in Adults and Elderly, and to Evaluate Immunogenicity and Concomitant Vaccination With Pneumococcal Vaccine in a Subgroup
Baseline characteristics by cohort
| Measure |
cTIV (Adults)
n=549 Participants
Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in the parent (V58P4 \[NCT00492063\]) and the extension 1 (V58P4E1 \[NCT00306527\]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine \[cTIV\] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
|
eTIV_a (Adults)
n=169 Participants
Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in parent (V58P4 \[NCT00492063\]) and Extension 1 (V58P4E1 \[NCT00306527\]) studies with influenza virus vaccine\[egg-derived seasonal trivalent, thiomersal free; eTIV\_a\] were allocated to receive eTIV\_a in the deltoid muscle, preferably of the non-dominant arm).
|
cTIV (Elderly)
n=391 Participants
Revaccination unrandomized group (elderly subjects (\>= 61 years of age) who were pre-vaccinated in parent (V58P4 \[NCT00492063\]) and Extension 1 (V58P4E1 \[NCT00306527\]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine \[cTIV\] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
|
eTIV_a (Elderly)
n=144 Participants
Revaccination unrandomized group (elderly subjects (\>= 61 years of age) who were pre-vaccinated in parent (V58P4 \[NCT00492063\]) and Extension 1 (V58P4E1 \[NCT00306527\]) study with influenza virus vaccine \[egg-derived seasonal trivalent, thiomersal free; eTIV\_a\] were allocated to receive eTIV\_a in the deltoid muscle, preferably of the non-dominant arm).
|
cTIV (Elderly; FLU Vaccination)
n=90 Participants
Revaccination randomized group (elderly subjects (\>= 65 years of age) were revaccinated with cell-culture derived seasonal trivalent influenza vaccine \[cTIV\]; in the deltoid muscle, preferably of the non-dominant arm) irrespective of influenza vaccination received in parent (V58P4 \[NCT00492063\]) study or extension 1 (V58P4E1 \[NCT00306527\]) study.
|
cTIV+PV (Elderly; Concomitant Vaccination )
n=78 Participants
Revaccination randomized group (elderly subjects (\>= 65 years of age) were concomitantly revaccinated with cell-culture derived seasonal trivalent influenza vaccine \[cTIV; in the deltoid muscle, preferably of the non-dominant arm\] and pneumococcal vaccine \[PV; in opposite arm\] irrespective of influenza vaccination received in parent (V58P4 \[NCT00492063\]) study or extension 1 (V58P4E1 \[NCT00306527\]) study).
|
eTIV_a (Elderly; FLU Vaccination)
n=57 Participants
Revaccination randomized group (elderly subjects (\>= 65 years of age) were revaccinated with influenza virus vaccine \[egg-derived seasonal trivalent, thiomersal free; eTIV\_a\] in the deltoid muscle, preferably of the non-dominant arm irrespective of influenza vaccination received in parent (V58P4 \[NCT00492063\]) study or extension 1 (V58P4E1 \[NCT00306527\]) study).
|
eTIV_a +PV (Elderly; Concomitant Vaccination)
n=44 Participants
Revaccination randomized group (elderly subjects (\>= 65 years of age) were concomitantly revaccinated with influenza virus vaccine \[egg-derived seasonal trivalent, thiomersal free; eTIV\_a in the deltoid muscle, preferably of the non-dominant arm\] and pneumococcal vaccine \[PV; in opposite arm\] irrespective of influenza vaccination received in parent (V58P4 \[NCT00492063\]) study or extension 1 (V58P4E1 \[NCT00306527\]) study).
|
Total
n=1522 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
Unrandomized adults
|
44 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
43.3 years
STANDARD_DEVIATION 12.4 • n=7 Participants
|
NA years
STANDARD_DEVIATION NA • n=5 Participants
|
NA years
STANDARD_DEVIATION NA • n=4 Participants
|
NA years
STANDARD_DEVIATION NA • n=21 Participants
|
NA years
STANDARD_DEVIATION NA • n=10 Participants
|
NA years
STANDARD_DEVIATION NA • n=115 Participants
|
NA years
STANDARD_DEVIATION NA • n=6 Participants
|
43.9 years
STANDARD_DEVIATION 12.3 • n=6 Participants
|
|
Age, Continuous
Unrandomized elderly
|
NA years
STANDARD_DEVIATION NA • n=5 Participants
|
NA years
STANDARD_DEVIATION NA • n=7 Participants
|
71.5 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
72.4 years
STANDARD_DEVIATION 5.7 • n=4 Participants
|
NA years
STANDARD_DEVIATION NA • n=21 Participants
|
NA years
STANDARD_DEVIATION NA • n=10 Participants
|
NA years
STANDARD_DEVIATION NA • n=115 Participants
|
NA years
STANDARD_DEVIATION NA • n=6 Participants
|
71.7 years
STANDARD_DEVIATION 5.6 • n=6 Participants
|
|
Age, Continuous
Randomized elderly
|
NA years
STANDARD_DEVIATION NA • n=5 Participants
|
NA years
STANDARD_DEVIATION NA • n=7 Participants
|
NA years
STANDARD_DEVIATION NA • n=5 Participants
|
NA years
STANDARD_DEVIATION NA • n=4 Participants
|
71.6 years
STANDARD_DEVIATION 5.9 • n=21 Participants
|
71.5 years
STANDARD_DEVIATION 5.5 • n=10 Participants
|
71.2 years
STANDARD_DEVIATION 4.9 • n=115 Participants
|
71.1 years
STANDARD_DEVIATION 5.2 • n=6 Participants
|
71.4 years
STANDARD_DEVIATION 5.5 • n=6 Participants
|
|
Gender
Female
|
318 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
232 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
40 Participants
n=10 Participants
|
38 Participants
n=115 Participants
|
25 Participants
n=6 Participants
|
891 Participants
n=6 Participants
|
|
Gender
Male
|
231 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
159 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
38 Participants
n=10 Participants
|
19 Participants
n=115 Participants
|
19 Participants
n=6 Participants
|
631 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: One week postvaccinationPopulation: Safety set: this population consisted of all subjects who were vaccinated and who had some post-baseline safety data.
Safety and tolerability evaluation of influenza vaccines, within one week of single intramuscular injection. Local reactions reported for Influenza Vaccine Injection site.
Outcome measures
| Measure |
cTIV (Adults)
n=167 Participants
Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in the parent (V58P4) and the extension 1 (V58P4E1) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine (cTIV) were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
|
eTIV_a (Adults)
n=102 Participants
Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in parent (V58P4) and Extension 1 (V58P4E1) studies with influenza virus vaccine(egg-derived seasonal trivalent, thiomersal free; eTIV\_a) were allocated to receive eTIV\_a in the deltoid muscle, preferably of the non-dominant arm).
|
cTIV (Elderly)
Revaccination unrandomized group (elderly (\>= 61 years of age)subjects who were pre-vaccinated in parent (V58P4) and Extension 1 (V58P4E1) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine (cTIV) were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
|
eTIV_a (Elderly)
Revaccination unrandomized group (elderly (\>= 61 years of age)subjects who were pre-vaccinated in parent (V58P4) and Extension 1 (V58P4E1) study with influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV\_a) were allocated to receive eTIV\_a in the deltoid muscle, preferably of the non-dominant arm).
|
eTIV_a (Elderly; FLU Vaccination)
Revaccination randomized group (elderly subjects (\>= 65 years of age) were revaccinated with influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV\_a) in the deltoid muscle, preferably of the non-dominant arm irrespective of influenza vaccination received in parent (V58P4) study or extension 1 (V58P4E1) study).
|
eTIV_a+PV (Elderly; Concomitant Vaccination)
Revaccination randomized group (elderly subjects (\>= 65 years of age) were concomitantly revaccinated with influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV\_a) in the deltoid muscle, preferably of the non-dominant arm) and pneumococcal vaccine (PV; in opposite arm) irrespective of influenza vaccination received in parent (V58P4) study or extension 1 (V58P4E1) study).
|
|---|---|---|---|---|---|---|
|
Number of Randomized Participants Reporting Local and Systemic Reactions.
Stayed at Home Due to Vaccination Reaction
|
2 Subjects
|
0 Subjects
|
—
|
—
|
—
|
—
|
|
Number of Randomized Participants Reporting Local and Systemic Reactions.
Local Reactions
|
52 Subjects
|
37 Subjects
|
—
|
—
|
—
|
—
|
|
Number of Randomized Participants Reporting Local and Systemic Reactions.
Erythema
|
24 Subjects
|
19 Subjects
|
—
|
—
|
—
|
—
|
|
Number of Randomized Participants Reporting Local and Systemic Reactions.
Induration
|
15 Subjects
|
8 Subjects
|
—
|
—
|
—
|
—
|
|
Number of Randomized Participants Reporting Local and Systemic Reactions.
Swelling
|
9 Subjects
|
7 Subjects
|
—
|
—
|
—
|
—
|
|
Number of Randomized Participants Reporting Local and Systemic Reactions.
Ecchymosis
|
6 Subjects
|
9 Subjects
|
—
|
—
|
—
|
—
|
|
Number of Randomized Participants Reporting Local and Systemic Reactions.
Pain
|
34 Subjects
|
16 Subjects
|
—
|
—
|
—
|
—
|
|
Number of Randomized Participants Reporting Local and Systemic Reactions.
Systemic Reaction
|
32 Subjects
|
16 Subjects
|
—
|
—
|
—
|
—
|
|
Number of Randomized Participants Reporting Local and Systemic Reactions.
Chills
|
5 Subjects
|
6 Subjects
|
—
|
—
|
—
|
—
|
|
Number of Randomized Participants Reporting Local and Systemic Reactions.
Malaise
|
20 Subjects
|
8 Subjects
|
—
|
—
|
—
|
—
|
|
Number of Randomized Participants Reporting Local and Systemic Reactions.
Myalgia
|
14 Subjects
|
3 Subjects
|
—
|
—
|
—
|
—
|
|
Number of Randomized Participants Reporting Local and Systemic Reactions.
Arthralgia
|
17 Subjects
|
6 Subjects
|
—
|
—
|
—
|
—
|
|
Number of Randomized Participants Reporting Local and Systemic Reactions.
Headache
|
15 Subjects
|
6 Subjects
|
—
|
—
|
—
|
—
|
|
Number of Randomized Participants Reporting Local and Systemic Reactions.
Sweating
|
9 Subjects
|
4 Subjects
|
—
|
—
|
—
|
—
|
|
Number of Randomized Participants Reporting Local and Systemic Reactions.
Fatigue
|
16 Subjects
|
1 Subjects
|
—
|
—
|
—
|
—
|
|
Number of Randomized Participants Reporting Local and Systemic Reactions.
Fever (≥ 38°C)
|
0 Subjects
|
0 Subjects
|
—
|
—
|
—
|
—
|
|
Number of Randomized Participants Reporting Local and Systemic Reactions.
Analgesic and Antipyretics used
|
11 Subjects
|
5 Subjects
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Three weeks postvaccinationPopulation: Per protocol set: this population consisted of all subjects in the Intention To Treat population (ITT) who had no major protocol violation as defined prior to analysis (ITT=enrolled subjects who received single dose of influenza vaccine(or 2 vaccines if receiving the pneumococcal vaccine) and provided one serum sample before and one after baseline)
Non-inferiority of the influenza vaccine FLU (cell-culture derived seasonal trivalent influenza vaccine (cTIV); and influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV\_a)) when administered alone versus administered concomitantly with pneumococcal vaccine (FLU + PV) is met if lower limit of the 2-sided 95% confidence interval (CI) of postvaccination (Day 22) Geometric Mean Titer ratio (FLU+PV/FLU) is greater than 0.5.
Outcome measures
| Measure |
cTIV (Adults)
n=74 Participants
Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in the parent (V58P4) and the extension 1 (V58P4E1) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine (cTIV) were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
|
eTIV_a (Adults)
n=77 Participants
Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in parent (V58P4) and Extension 1 (V58P4E1) studies with influenza virus vaccine(egg-derived seasonal trivalent, thiomersal free; eTIV\_a) were allocated to receive eTIV\_a in the deltoid muscle, preferably of the non-dominant arm).
|
cTIV (Elderly)
Revaccination unrandomized group (elderly (\>= 61 years of age)subjects who were pre-vaccinated in parent (V58P4) and Extension 1 (V58P4E1) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine (cTIV) were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
|
eTIV_a (Elderly)
Revaccination unrandomized group (elderly (\>= 61 years of age)subjects who were pre-vaccinated in parent (V58P4) and Extension 1 (V58P4E1) study with influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV\_a) were allocated to receive eTIV\_a in the deltoid muscle, preferably of the non-dominant arm).
|
eTIV_a (Elderly; FLU Vaccination)
Revaccination randomized group (elderly subjects (\>= 65 years of age) were revaccinated with influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV\_a) in the deltoid muscle, preferably of the non-dominant arm irrespective of influenza vaccination received in parent (V58P4) study or extension 1 (V58P4E1) study).
|
eTIV_a+PV (Elderly; Concomitant Vaccination)
Revaccination randomized group (elderly subjects (\>= 65 years of age) were concomitantly revaccinated with influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV\_a) in the deltoid muscle, preferably of the non-dominant arm) and pneumococcal vaccine (PV; in opposite arm) irrespective of influenza vaccination received in parent (V58P4) study or extension 1 (V58P4E1) study).
|
|---|---|---|---|---|---|---|
|
Immunogenicity Assessment by Geometric Mean Titers (GMT).
GMT Day 22 (H1N1)
|
138 Titers
Interval 104.0 to 182.0
|
198 Titers
Interval 151.0 to 259.0
|
—
|
—
|
—
|
—
|
|
Immunogenicity Assessment by Geometric Mean Titers (GMT).
GMT Day 22 (H3N2)
|
184 Titers
Interval 141.0 to 240.0
|
228 Titers
Interval 176.0 to 296.0
|
—
|
—
|
—
|
—
|
|
Immunogenicity Assessment by Geometric Mean Titers (GMT).
GMT Day 22 (B)
|
36 Titers
Interval 27.0 to 47.0
|
52 Titers
Interval 40.0 to 68.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: One week postvaccinationPopulation: Safety set.
Safety and tolerability evaluation of influenza vaccines, within one week of single intramuscular injection.
Outcome measures
| Measure |
cTIV (Adults)
n=550 Participants
Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in the parent (V58P4) and the extension 1 (V58P4E1) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine (cTIV) were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
|
eTIV_a (Adults)
n=168 Participants
Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in parent (V58P4) and Extension 1 (V58P4E1) studies with influenza virus vaccine(egg-derived seasonal trivalent, thiomersal free; eTIV\_a) were allocated to receive eTIV\_a in the deltoid muscle, preferably of the non-dominant arm).
|
cTIV (Elderly)
n=391 Participants
Revaccination unrandomized group (elderly (\>= 61 years of age)subjects who were pre-vaccinated in parent (V58P4) and Extension 1 (V58P4E1) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine (cTIV) were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
|
eTIV_a (Elderly)
n=144 Participants
Revaccination unrandomized group (elderly (\>= 61 years of age)subjects who were pre-vaccinated in parent (V58P4) and Extension 1 (V58P4E1) study with influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV\_a) were allocated to receive eTIV\_a in the deltoid muscle, preferably of the non-dominant arm).
|
eTIV_a (Elderly; FLU Vaccination)
Revaccination randomized group (elderly subjects (\>= 65 years of age) were revaccinated with influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV\_a) in the deltoid muscle, preferably of the non-dominant arm irrespective of influenza vaccination received in parent (V58P4) study or extension 1 (V58P4E1) study).
|
eTIV_a+PV (Elderly; Concomitant Vaccination)
Revaccination randomized group (elderly subjects (\>= 65 years of age) were concomitantly revaccinated with influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV\_a) in the deltoid muscle, preferably of the non-dominant arm) and pneumococcal vaccine (PV; in opposite arm) irrespective of influenza vaccination received in parent (V58P4) study or extension 1 (V58P4E1) study).
|
|---|---|---|---|---|---|---|
|
Number of Unrandomized Participants Reporting Local and Systemic Reactions.
Arthralgia
|
18 Subjects
|
5 Subjects
|
16 Subjects
|
6 Subjects
|
—
|
—
|
|
Number of Unrandomized Participants Reporting Local and Systemic Reactions.
Local Reactions
|
185 Subjects
|
60 Subjects
|
98 Subjects
|
26 Subjects
|
—
|
—
|
|
Number of Unrandomized Participants Reporting Local and Systemic Reactions.
Erythema
|
50 Subjects
|
20 Subjects
|
36 Subjects
|
10 Subjects
|
—
|
—
|
|
Number of Unrandomized Participants Reporting Local and Systemic Reactions.
Induration
|
38 Subjects
|
14 Subjects
|
26 Subjects
|
3 Subjects
|
—
|
—
|
|
Number of Unrandomized Participants Reporting Local and Systemic Reactions.
Swelling
|
23 Subjects
|
7 Subjects
|
17 Subjects
|
3 Subjects
|
—
|
—
|
|
Number of Unrandomized Participants Reporting Local and Systemic Reactions.
Ecchymosis
|
12 Subjects
|
1 Subjects
|
14 Subjects
|
2 Subjects
|
—
|
—
|
|
Number of Unrandomized Participants Reporting Local and Systemic Reactions.
Pain
|
158 Subjects
|
51 Subjects
|
64 Subjects
|
12 Subjects
|
—
|
—
|
|
Number of Unrandomized Participants Reporting Local and Systemic Reactions.
Systemic Reaction
|
99 Subjects
|
28 Subjects
|
57 Subjects
|
25 Subjects
|
—
|
—
|
|
Number of Unrandomized Participants Reporting Local and Systemic Reactions.
Chills
|
15 Subjects
|
5 Subjects
|
5 Subjects
|
4 Subjects
|
—
|
—
|
|
Number of Unrandomized Participants Reporting Local and Systemic Reactions.
Malaise
|
52 Subjects
|
16 Subjects
|
37 Subjects
|
16 Subjects
|
—
|
—
|
|
Number of Unrandomized Participants Reporting Local and Systemic Reactions.
Myalgia
|
40 Subjects
|
8 Subjects
|
25 Subjects
|
8 Subjects
|
—
|
—
|
|
Number of Unrandomized Participants Reporting Local and Systemic Reactions.
Headache
|
39 Subjects
|
18 Subjects
|
20 Subjects
|
11 Subjects
|
—
|
—
|
|
Number of Unrandomized Participants Reporting Local and Systemic Reactions.
Sweating
|
18 Subjects
|
8 Subjects
|
13 Subjects
|
8 Subjects
|
—
|
—
|
|
Number of Unrandomized Participants Reporting Local and Systemic Reactions.
Fatigue
|
35 Subjects
|
11 Subjects
|
23 Subjects
|
11 Subjects
|
—
|
—
|
|
Number of Unrandomized Participants Reporting Local and Systemic Reactions.
Fever (≥ 38°C)
|
2 Subjects
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
—
|
|
Number of Unrandomized Participants Reporting Local and Systemic Reactions.
Analgesic and Antipyretics used
|
17 Subjects
|
11 Subjects
|
7 Subjects
|
6 Subjects
|
—
|
—
|
|
Number of Unrandomized Participants Reporting Local and Systemic Reactions.
Stay at Home Due to Vaccination Reaction
|
5 Subjects
|
5 Subjects
|
6 Subjects
|
3 Subjects
|
—
|
—
|
SECONDARY outcome
Timeframe: One week postvaccinationPopulation: Safety Set
Safety and tolerability evaluation, within one week of single intramuscular injection of influenza vaccines (cell-culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV\_a) when administered alone or concomitantly with a pneumococcal vaccine (PV)). Local reactions reported for Influenza Vaccine Injection Site.
Outcome measures
| Measure |
cTIV (Adults)
n=134 Participants
Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in the parent (V58P4) and the extension 1 (V58P4E1) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine (cTIV) were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
|
eTIV_a (Adults)
n=135 Participants
Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in parent (V58P4) and Extension 1 (V58P4E1) studies with influenza virus vaccine(egg-derived seasonal trivalent, thiomersal free; eTIV\_a) were allocated to receive eTIV\_a in the deltoid muscle, preferably of the non-dominant arm).
|
cTIV (Elderly)
n=83 Participants
Revaccination unrandomized group (elderly (\>= 61 years of age)subjects who were pre-vaccinated in parent (V58P4) and Extension 1 (V58P4E1) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine (cTIV) were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
|
eTIV_a (Elderly)
n=84 Participants
Revaccination unrandomized group (elderly (\>= 61 years of age)subjects who were pre-vaccinated in parent (V58P4) and Extension 1 (V58P4E1) study with influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV\_a) were allocated to receive eTIV\_a in the deltoid muscle, preferably of the non-dominant arm).
|
eTIV_a (Elderly; FLU Vaccination)
n=52 Participants
Revaccination randomized group (elderly subjects (\>= 65 years of age) were revaccinated with influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV\_a) in the deltoid muscle, preferably of the non-dominant arm irrespective of influenza vaccination received in parent (V58P4) study or extension 1 (V58P4E1) study).
|
eTIV_a+PV (Elderly; Concomitant Vaccination)
n=50 Participants
Revaccination randomized group (elderly subjects (\>= 65 years of age) were concomitantly revaccinated with influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV\_a) in the deltoid muscle, preferably of the non-dominant arm) and pneumococcal vaccine (PV; in opposite arm) irrespective of influenza vaccination received in parent (V58P4) study or extension 1 (V58P4E1) study).
|
|---|---|---|---|---|---|---|
|
Number of Randomized Participants Reporting Local and Systemic Reactions.
Chills
|
6 Subjects
|
5 Subjects
|
2 Subjects
|
3 Subjects
|
3 Subjects
|
3 Subjects
|
|
Number of Randomized Participants Reporting Local and Systemic Reactions.
Malaise
|
19 Subjects
|
9 Subjects
|
6 Subjects
|
14 Subjects
|
3 Subjects
|
5 Subjects
|
|
Number of Randomized Participants Reporting Local and Systemic Reactions.
Myalgia
|
8 Subjects
|
9 Subjects
|
6 Subjects
|
8 Subjects
|
3 Subjects
|
0 Subjects
|
|
Number of Randomized Participants Reporting Local and Systemic Reactions.
Arthralgia
|
14 Subjects
|
9 Subjects
|
6 Subjects
|
11 Subjects
|
3 Subjects
|
3 Subjects
|
|
Number of Randomized Participants Reporting Local and Systemic Reactions.
Headache
|
12 Subjects
|
9 Subjects
|
4 Subjects
|
11 Subjects
|
5 Subjects
|
1 Subjects
|
|
Number of Randomized Participants Reporting Local and Systemic Reactions.
Sweating
|
6 Subjects
|
7 Subjects
|
4 Subjects
|
5 Subjects
|
3 Subjects
|
1 Subjects
|
|
Number of Randomized Participants Reporting Local and Systemic Reactions.
Fatigue
|
10 Subjects
|
7 Subjects
|
6 Subjects
|
10 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Randomized Participants Reporting Local and Systemic Reactions.
Fever (≥ 38°C)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Randomized Participants Reporting Local and Systemic Reactions.
Analgesic and Antipyretics used
|
8 Subjects
|
8 Subjects
|
5 Subjects
|
6 Subjects
|
3 Subjects
|
2 Subjects
|
|
Number of Randomized Participants Reporting Local and Systemic Reactions.
Stayed at Home Due to Vaccination Reaction
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Randomized Participants Reporting Local and Systemic Reactions.
Local Reactions
|
49 Subjects
|
40 Subjects
|
20 Subjects
|
32 Subjects
|
20 Subjects
|
17 Subjects
|
|
Number of Randomized Participants Reporting Local and Systemic Reactions.
Ecchymosis
|
7 Subjects
|
8 Subjects
|
3 Subjects
|
3 Subjects
|
5 Subjects
|
4 Subjects
|
|
Number of Randomized Participants Reporting Local and Systemic Reactions.
Erythema
|
20 Subjects
|
23 Subjects
|
12 Subjects
|
12 Subjects
|
11 Subjects
|
8 Subjects
|
|
Number of Randomized Participants Reporting Local and Systemic Reactions.
Induration
|
9 Subjects
|
14 Subjects
|
9 Subjects
|
6 Subjects
|
5 Subjects
|
3 Subjects
|
|
Number of Randomized Participants Reporting Local and Systemic Reactions.
Swelling
|
6 Subjects
|
10 Subjects
|
6 Subjects
|
3 Subjects
|
4 Subjects
|
3 Subjects
|
|
Number of Randomized Participants Reporting Local and Systemic Reactions.
Pain
|
31 Subjects
|
19 Subjects
|
11 Subjects
|
23 Subjects
|
8 Subjects
|
8 Subjects
|
|
Number of Randomized Participants Reporting Local and Systemic Reactions.
Systemic Reaction
|
29 Subjects
|
19 Subjects
|
10 Subjects
|
22 Subjects
|
9 Subjects
|
7 Subjects
|
SECONDARY outcome
Timeframe: Three weeks postvaccinationPopulation: Per Protocol Set
Immunogenicity (seroconversion or significant increase in antibody titer and HI titer ≥1:40) of cell cultured and egg based trivalent influenza vaccine three weeks after a single injection, by the measurement of strain-specific hemagglutination inhibition (HI) tests according to the Committee for Medicinal Products for Human Use (CHMP) criteria (CPMP/BWP/214/96). Seroconversion was defined as negative pre-vaccination titer (\<10)/postvaccination titer ≥40. Significant increase in antibody titer was defined as at least a fourfold increase from non-negative baseline (≥10).
Outcome measures
| Measure |
cTIV (Adults)
n=95 Participants
Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in the parent (V58P4) and the extension 1 (V58P4E1) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine (cTIV) were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
|
eTIV_a (Adults)
n=23 Participants
Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in parent (V58P4) and Extension 1 (V58P4E1) studies with influenza virus vaccine(egg-derived seasonal trivalent, thiomersal free; eTIV\_a) were allocated to receive eTIV\_a in the deltoid muscle, preferably of the non-dominant arm).
|
cTIV (Elderly)
n=89 Participants
Revaccination unrandomized group (elderly (\>= 61 years of age)subjects who were pre-vaccinated in parent (V58P4) and Extension 1 (V58P4E1) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine (cTIV) were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
|
eTIV_a (Elderly)
n=62 Participants
Revaccination unrandomized group (elderly (\>= 61 years of age)subjects who were pre-vaccinated in parent (V58P4) and Extension 1 (V58P4E1) study with influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV\_a) were allocated to receive eTIV\_a in the deltoid muscle, preferably of the non-dominant arm).
|
eTIV_a (Elderly; FLU Vaccination)
Revaccination randomized group (elderly subjects (\>= 65 years of age) were revaccinated with influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV\_a) in the deltoid muscle, preferably of the non-dominant arm irrespective of influenza vaccination received in parent (V58P4) study or extension 1 (V58P4E1) study).
|
eTIV_a+PV (Elderly; Concomitant Vaccination)
Revaccination randomized group (elderly subjects (\>= 65 years of age) were concomitantly revaccinated with influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV\_a) in the deltoid muscle, preferably of the non-dominant arm) and pneumococcal vaccine (PV; in opposite arm) irrespective of influenza vaccination received in parent (V58P4) study or extension 1 (V58P4E1) study).
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Antibody Response as Assessed by Hemagglutination Inhibition Assay.
HI titer ≥1:40 (H1N1)
|
94 Subjects
|
23 Subjects
|
85 Subjects
|
55 Subjects
|
—
|
—
|
|
Number of Subjects With Antibody Response as Assessed by Hemagglutination Inhibition Assay.
seroconversion (H1N1)
|
57 Subjects
|
13 Subjects
|
62 Subjects
|
41 Subjects
|
—
|
—
|
|
Number of Subjects With Antibody Response as Assessed by Hemagglutination Inhibition Assay.
HI titer ≥1:40 (H3N2)
|
92 Subjects
|
22 Subjects
|
86 Subjects
|
59 Subjects
|
—
|
—
|
|
Number of Subjects With Antibody Response as Assessed by Hemagglutination Inhibition Assay.
seroconversion (H3N2)
|
40 Subjects
|
8 Subjects
|
32 Subjects
|
25 Subjects
|
—
|
—
|
|
Number of Subjects With Antibody Response as Assessed by Hemagglutination Inhibition Assay.
HI titer ≥1:40 (B)
|
57 Subjects
|
16 Subjects
|
56 Subjects
|
33 Subjects
|
—
|
—
|
|
Number of Subjects With Antibody Response as Assessed by Hemagglutination Inhibition Assay.
seroconversion (B)
|
39 Subjects
|
8 Subjects
|
23 Subjects
|
18 Subjects
|
—
|
—
|
SECONDARY outcome
Timeframe: Three weeks postvaccinationPopulation: Per Protocol
Immunogenicity (geometric mean titer ratio) of cell cultured and egg based trivalent influenza vaccine three weeks after a single injection, by the measurement of strain-specific hemagglutination inhibition (HI) tests according to the CHMP criteria (CPMP/BWP/214/96). CHMP Criteria fulfilled if the Geometric Mean titer Ratio (GMR) is \> 2.5.
Outcome measures
| Measure |
cTIV (Adults)
n=95 Participants
Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in the parent (V58P4) and the extension 1 (V58P4E1) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine (cTIV) were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
|
eTIV_a (Adults)
n=23 Participants
Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in parent (V58P4) and Extension 1 (V58P4E1) studies with influenza virus vaccine(egg-derived seasonal trivalent, thiomersal free; eTIV\_a) were allocated to receive eTIV\_a in the deltoid muscle, preferably of the non-dominant arm).
|
cTIV (Elderly)
n=89 Participants
Revaccination unrandomized group (elderly (\>= 61 years of age)subjects who were pre-vaccinated in parent (V58P4) and Extension 1 (V58P4E1) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine (cTIV) were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
|
eTIV_a (Elderly)
n=62 Participants
Revaccination unrandomized group (elderly (\>= 61 years of age)subjects who were pre-vaccinated in parent (V58P4) and Extension 1 (V58P4E1) study with influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV\_a) were allocated to receive eTIV\_a in the deltoid muscle, preferably of the non-dominant arm).
|
eTIV_a (Elderly; FLU Vaccination)
Revaccination randomized group (elderly subjects (\>= 65 years of age) were revaccinated with influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV\_a) in the deltoid muscle, preferably of the non-dominant arm irrespective of influenza vaccination received in parent (V58P4) study or extension 1 (V58P4E1) study).
|
eTIV_a+PV (Elderly; Concomitant Vaccination)
Revaccination randomized group (elderly subjects (\>= 65 years of age) were concomitantly revaccinated with influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV\_a) in the deltoid muscle, preferably of the non-dominant arm) and pneumococcal vaccine (PV; in opposite arm) irrespective of influenza vaccination received in parent (V58P4) study or extension 1 (V58P4E1) study).
|
|---|---|---|---|---|---|---|
|
Geometric Mean Ratio (GMR Day 22/Day1) After Single Dose of Influenza Vaccine.
GMR (H1N1; A/Solomon Islands/3/2006)
|
5.6 Ratio
Interval 4.27 to 7.34
|
4.38 Ratio
Interval 2.52 to 7.6
|
7.75 Ratio
Interval 5.93 to 10.0
|
5.92 Ratio
Interval 4.29 to 8.16
|
—
|
—
|
|
Geometric Mean Ratio (GMR Day 22/Day1) After Single Dose of Influenza Vaccine.
GMR (H3N2; A/Wisconsin/67/2005)
|
3.63 Ratio
Interval 2.83 to 4.64
|
2.33 Ratio
Interval 1.41 to 3.85
|
2.65 Ratio
Interval 2.22 to 3.16
|
2.89 Ratio
Interval 2.34 to 3.58
|
—
|
—
|
|
Geometric Mean Ratio (GMR Day 22/Day1) After Single Dose of Influenza Vaccine.
GMR (B; B/Malaysia/2506/2004)
|
4.48 Ratio
Interval 3.43 to 5.84
|
2.33 Ratio
Interval 1.35 to 3.99
|
2.51 Ratio
Interval 1.96 to 3.21
|
2.97 Ratio
Interval 2.21 to 4.0
|
—
|
—
|
Adverse Events
cTIV (Adults)
Serious events: 17 serious events
Other events: 219 other events
Deaths: 0 deaths
eTIV_a (Adults)
Serious events: 5 serious events
Other events: 73 other events
Deaths: 0 deaths
cTIV (Elderly)
Serious events: 23 serious events
Other events: 119 other events
Deaths: 0 deaths
eTIV_a (Elderly)
Serious events: 6 serious events
Other events: 40 other events
Deaths: 0 deaths
cTIV (Elderly; FLU Vaccination)
Serious events: 3 serious events
Other events: 25 other events
Deaths: 0 deaths
cTIV+PV (Elderly; Concomitant Vaccination )
Serious events: 5 serious events
Other events: 48 other events
Deaths: 0 deaths
eTIV_a (Elderly; FLU Vaccination)
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
eTIV_a +PV (Elderly; Concomitant Vaccination)
Serious events: 6 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
cTIV (Adults)
n=550 participants at risk
Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in the parent (V58P4 \[NCT00492063\]) and the extension 1 (V58P4E1 \[NCT00306527\]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine \[cTIV\] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
|
eTIV_a (Adults)
n=168 participants at risk
Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in parent (V58P4 \[NCT00492063\]) and Extension 1 (V58P4E1 \[NCT00306527\]) studies with influenza virus vaccine\[egg-derived seasonal trivalent, thiomersal free; eTIV\_a\] were allocated to receive eTIV\_a in the deltoid muscle, preferably of the non-dominant arm).
|
cTIV (Elderly)
n=391 participants at risk
Revaccination unrandomized group (elderly subjects (\>= 61 years of age) who were pre-vaccinated in parent (V58P4 \[NCT00492063\]) and Extension 1 (V58P4E1 \[NCT00306527\]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine \[cTIV\] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
|
eTIV_a (Elderly)
n=144 participants at risk
Revaccination unrandomized group (elderly subjects (\>= 61 years of age) who were pre-vaccinated in parent (V58P4 \[NCT00492063\]) and Extension 1 (V58P4E1 \[NCT00306527\]) study with influenza virus vaccine \[egg-derived seasonal trivalent, thiomersal free; eTIV\_a\] were allocated to receive eTIV\_a in the deltoid muscle, preferably of the non-dominant arm).
|
cTIV (Elderly; FLU Vaccination)
n=83 participants at risk
Revaccination randomized group (elderly subjects (\>= 65 years of age) were revaccinated with cell-culture derived seasonal trivalent influenza vaccine \[cTIV\]; in the deltoid muscle, preferably of the non-dominant arm) irrespective of influenza vaccination received in parent (V58P4 \[NCT00492063\]) study or extension 1 (V58P4E1 \[NCT00306527\]) study.
|
cTIV+PV (Elderly; Concomitant Vaccination )
n=84 participants at risk
Revaccination randomized group (elderly subjects (\>= 65 years of age)were concomitantly revaccinated with cell-culture derived seasonal trivalent influenza vaccine \[cTIV; in the deltoid muscle, preferably of the non-dominant arm\] and pneumococcal vaccine \[PV; in opposite arm\] irrespective of influenza vaccination received in parent (V58P4 \[NCT00492063\]) study or extension 1 (V58P4E1 \[NCT00306527\]) study).
|
eTIV_a (Elderly; FLU Vaccination)
n=52 participants at risk
Revaccination randomized group (elderly subjects (\>= 65 years of age)were revaccinated with influenza virus vaccine \[egg-derived seasonal trivalent, thiomersal free; eTIV\_a\] in the deltoid muscle, preferably of the non-dominant arm irrespective of influenza vaccination received in parent (V58P4 \[NCT00492063\]) study or extension 1 (V58P4E1 \[NCT00306527\]) study).
|
eTIV_a +PV (Elderly; Concomitant Vaccination)
n=50 participants at risk
Revaccination randomized group (elderly subjects (\>= 65 years of age) were concomitantly revaccinated with influenza virus vaccine \[egg-derived seasonal trivalent, thiomersal free; eTIV\_a in the deltoid muscle, preferably of the non-dominant arm\] and pneumococcal vaccine \[PV; in opposite arm\] irrespective of influenza vaccination received in parent (V58P4 \[NCT00492063\]) study or extension 1 (V58P4E1 \[NCT00306527\]) study).
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.26%
1/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Cardiac disorders
Acute myocardial infraction
|
0.55%
3/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Cardiac disorders
Angina pectoris
|
0.18%
1/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.26%
1/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.69%
1/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.26%
1/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
1.2%
1/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.26%
1/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.26%
1/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Cardiac disorders
Cardiac arrest
|
0.18%
1/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.26%
1/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.51%
2/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Cardiac disorders
Cardiac valve disease
|
0.00%
0/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.69%
1/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Cardiac disorders
Myocardial infraction
|
0.00%
0/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.60%
1/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.26%
1/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.18%
1/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
1.2%
1/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
2.0%
1/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.18%
1/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
2.0%
1/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Ear and labyrinth disorders
Inner ear disorder
|
0.00%
0/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
2.0%
1/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.18%
1/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
2.0%
1/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
2.0%
1/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Endocrine disorders
Goitre
|
0.00%
0/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.26%
1/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Eye disorders
Cataract
|
0.00%
0/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
1.2%
1/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Eye disorders
Glaucoma
|
0.00%
0/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
2.0%
1/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Eye disorders
Iridocele
|
0.00%
0/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
1.2%
1/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Eye disorders
Vitreous prolapse
|
0.00%
0/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
1.2%
1/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.26%
1/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.26%
1/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
1.9%
1/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Gastrointestinal disorders
Rectal polyp
|
0.00%
0/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.26%
1/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Gastrointestinal disorders
Vomiting
|
0.18%
1/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.26%
1/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.60%
1/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
1.2%
1/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
2.0%
1/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
2.0%
1/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.26%
1/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.26%
1/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.18%
1/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
1.2%
1/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.26%
1/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
2.0%
1/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.26%
1/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
1.2%
1/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Investigations
Diagnostic procedure
|
0.00%
0/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.26%
1/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.26%
1/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.69%
1/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.18%
1/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.18%
1/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.69%
1/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
1.2%
1/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.26%
1/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
lung neoplasm malignant
|
0.00%
0/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.26%
1/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neurilemmoma Malignant
|
0.00%
0/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.26%
1/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Adenoma
|
0.00%
0/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.26%
1/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma
|
0.18%
1/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.69%
1/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Nervous system disorders
Ischaemic Stroke
|
0.00%
0/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.69%
1/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.26%
1/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Nervous system disorders
Motor neurone disease
|
0.00%
0/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.26%
1/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Nervous system disorders
Syncope
|
0.00%
0/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.26%
1/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.26%
1/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.26%
1/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.26%
1/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Surgical and medical procedures
Cataract operation
|
0.18%
1/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.77%
3/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
2.0%
1/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
1.2%
1/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Respiratory, thoracic and mediastinal disorders
Status asthmaticus
|
0.00%
0/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
1.2%
1/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Vascular disorders
Arteriosclerosis obliterans
|
0.00%
0/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
1.2%
1/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Cardiac disorders
Sinus tachycardia
|
0.18%
1/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Cardiac disorders
Tachycardia paroxysmal
|
0.00%
0/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.60%
1/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Nervous system disorders
Epilepsy
|
0.18%
1/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Reproductive system and breast disorders
Cervix adenomatous polyp
|
0.18%
1/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.36%
2/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.18%
1/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Reproductive system and breast disorders
Uterovaginal prolapse
|
0.00%
0/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.60%
1/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.60%
1/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
Other adverse events
| Measure |
cTIV (Adults)
n=550 participants at risk
Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in the parent (V58P4 \[NCT00492063\]) and the extension 1 (V58P4E1 \[NCT00306527\]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine \[cTIV\] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
|
eTIV_a (Adults)
n=168 participants at risk
Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in parent (V58P4 \[NCT00492063\]) and Extension 1 (V58P4E1 \[NCT00306527\]) studies with influenza virus vaccine\[egg-derived seasonal trivalent, thiomersal free; eTIV\_a\] were allocated to receive eTIV\_a in the deltoid muscle, preferably of the non-dominant arm).
|
cTIV (Elderly)
n=391 participants at risk
Revaccination unrandomized group (elderly subjects (\>= 61 years of age) who were pre-vaccinated in parent (V58P4 \[NCT00492063\]) and Extension 1 (V58P4E1 \[NCT00306527\]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine \[cTIV\] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
|
eTIV_a (Elderly)
n=144 participants at risk
Revaccination unrandomized group (elderly subjects (\>= 61 years of age) who were pre-vaccinated in parent (V58P4 \[NCT00492063\]) and Extension 1 (V58P4E1 \[NCT00306527\]) study with influenza virus vaccine \[egg-derived seasonal trivalent, thiomersal free; eTIV\_a\] were allocated to receive eTIV\_a in the deltoid muscle, preferably of the non-dominant arm).
|
cTIV (Elderly; FLU Vaccination)
n=83 participants at risk
Revaccination randomized group (elderly subjects (\>= 65 years of age) were revaccinated with cell-culture derived seasonal trivalent influenza vaccine \[cTIV\]; in the deltoid muscle, preferably of the non-dominant arm) irrespective of influenza vaccination received in parent (V58P4 \[NCT00492063\]) study or extension 1 (V58P4E1 \[NCT00306527\]) study.
|
cTIV+PV (Elderly; Concomitant Vaccination )
n=84 participants at risk
Revaccination randomized group (elderly subjects (\>= 65 years of age)were concomitantly revaccinated with cell-culture derived seasonal trivalent influenza vaccine \[cTIV; in the deltoid muscle, preferably of the non-dominant arm\] and pneumococcal vaccine \[PV; in opposite arm\] irrespective of influenza vaccination received in parent (V58P4 \[NCT00492063\]) study or extension 1 (V58P4E1 \[NCT00306527\]) study).
|
eTIV_a (Elderly; FLU Vaccination)
n=52 participants at risk
Revaccination randomized group (elderly subjects (\>= 65 years of age)were revaccinated with influenza virus vaccine \[egg-derived seasonal trivalent, thiomersal free; eTIV\_a\] in the deltoid muscle, preferably of the non-dominant arm irrespective of influenza vaccination received in parent (V58P4 \[NCT00492063\]) study or extension 1 (V58P4E1 \[NCT00306527\]) study).
|
eTIV_a +PV (Elderly; Concomitant Vaccination)
n=50 participants at risk
Revaccination randomized group (elderly subjects (\>= 65 years of age) were concomitantly revaccinated with influenza virus vaccine \[egg-derived seasonal trivalent, thiomersal free; eTIV\_a in the deltoid muscle, preferably of the non-dominant arm\] and pneumococcal vaccine \[PV; in opposite arm\] irrespective of influenza vaccination received in parent (V58P4 \[NCT00492063\]) study or extension 1 (V58P4E1 \[NCT00306527\]) study).
|
|---|---|---|---|---|---|---|---|---|
|
General disorders
Chills
|
2.7%
15/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
3.0%
5/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
1.3%
5/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
2.8%
4/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
2.4%
2/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
3.6%
3/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
5.8%
3/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
6.0%
3/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
General disorders
Fatigue
|
6.4%
35/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
6.5%
11/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
5.9%
23/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
7.6%
11/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
8.4%
7/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
11.9%
10/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
3.8%
2/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
General disorders
Injection site erythema
|
9.1%
50/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
11.9%
20/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
9.2%
36/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
6.9%
10/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
14.5%
12/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
22.6%
19/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
21.2%
11/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
16.0%
8/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
General disorders
Injection site haemorrhage
|
2.2%
12/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.60%
1/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
3.6%
14/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
1.4%
2/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
3.6%
3/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
6.0%
5/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
9.6%
5/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
10.0%
5/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
General disorders
Injection site induration
|
6.9%
38/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
8.3%
14/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
6.6%
26/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
2.1%
3/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
10.8%
9/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
13.1%
11/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
9.6%
5/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
10.0%
5/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.3%
18/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
3.0%
5/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
4.1%
16/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
4.2%
6/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
8.4%
7/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
13.1%
11/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
5.8%
3/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
6.0%
3/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.5%
41/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
4.8%
8/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
6.4%
25/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
5.6%
8/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
7.2%
6/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
9.5%
8/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
5.8%
3/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
0.00%
0/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Nervous system disorders
Headache
|
7.6%
42/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
11.3%
19/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
5.1%
20/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
7.6%
11/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
6.0%
5/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
14.3%
12/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
9.6%
5/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
2.0%
1/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
General disorders
Injection site swelling
|
4.2%
23/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
4.2%
7/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
4.3%
17/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
2.1%
3/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
7.2%
6/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
4.8%
4/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
7.7%
4/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
8.0%
4/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.3%
18/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
4.8%
8/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
3.3%
13/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
5.6%
8/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
6.0%
5/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
6.0%
5/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
5.8%
3/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
2.0%
1/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
General disorders
Injection site pain
|
28.7%
158/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
30.4%
51/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
16.4%
64/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
8.3%
12/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
13.3%
11/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
38.1%
32/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
15.4%
8/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
20.0%
10/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
|
General disorders
Malaise
|
9.5%
52/550 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
9.5%
16/168 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
9.5%
37/391 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
11.1%
16/144 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
8.4%
7/83 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
16.7%
14/84 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
5.8%
3/52 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
10.0%
5/50 • Throughout the entire study period (six months)
Other Adverse Events (AEs) (\>5%) includes solicited local and systemic reactions collected within the first 7 days following vaccination along with unsolicited AEs collected within first three weeks after the vaccination. Local reactions for groups cTIV+PV and eTIV\_a+PV were collected for influenza vaccine and pneumococcal vaccine injection sites.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60