Trial Outcomes & Findings for Immunogenicity and Safety Study of an Inactivated Influenza Vaccine (Split Virus, Vero Cell Derived) in Adults Aged 50 Years and Older (NCT NCT00782431)
NCT ID: NCT00782431
Last Updated: 2026-01-02
Results Overview
The rate of subjects vaccinated that demonstrate seroconversion via hemagglutination inhibition (HI) antibody titer to each of the three antigens contained in the vaccine 21 days after vaccination. Seroconversion is defined as a ≥ 4-fold increase in HI antibody titer from baseline or a HI antibody titer ≥ 40 when there is no detectable HI antibody titer (HI antibody titer \< 10) at baseline.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
3208 participants
Primary outcome timeframe
21 days
Results posted on
2026-01-02
Participant Flow
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Part A began when the first subject consented to participate in the study and ended when the last subject completed Day 21. Part B began after the first subject completed Day 21 and ended when the last subject completed Day 180. All subjects were randomized to receive a single IM injection of seasonal VCIV or licensed EIV. Only subjects that completed Part A were allowed to enroll in Part B.
Participant milestones
| Measure |
VCIV (50-64 Years)
Vero cell derived, trivalent, seasonal influenza vaccine (VCIV) on Day 1 Subjects aged 50 to 64 years of age
|
VCIV (65+ Years)
Vero cell derived, trivalent, seasonal influenza vaccine (VCIV) on Day 1 Subjects aged 65 years of age and older
|
EIV (50-64 Years)
Licensed egg derived, trivalent seasonal influenza vaccine (EIV) on Day 1 Subjects aged 50 to 64 years of age
|
EIV (65+ Years)
Licensed egg derived, trivalent seasonal influenza vaccine (EIV) on Day 1 Subjects aged 65 years of age and older
|
VCIV + EIV (50-64 Years)
Subjects administered VCIV on Day 1 and accepted offer to be vaccinated received EIV after Day 21 at a time convenient to the subject.
Subjects aged 50 to 64 years of age
|
VCIV + EIV (65+ Years)
Subjects administered VCIV on Day 1 and accepted offer to be vaccinated received EIV after Day 21 at a time convenient to the subject.
Subjects aged 65 years of age and older
|
|---|---|---|---|---|---|---|
|
Part A
STARTED
|
839
|
478
|
229
|
137
|
923
|
602
|
|
Part A
COMPLETED
|
829
|
474
|
227
|
136
|
923
|
602
|
|
Part A
NOT COMPLETED
|
10
|
4
|
2
|
1
|
0
|
0
|
|
Part B
STARTED
|
828
|
474
|
227
|
136
|
923
|
602
|
|
Part B
COMPLETED
|
804
|
458
|
227
|
134
|
916
|
600
|
|
Part B
NOT COMPLETED
|
24
|
16
|
0
|
2
|
7
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Immunogenicity and Safety Study of an Inactivated Influenza Vaccine (Split Virus, Vero Cell Derived) in Adults Aged 50 Years and Older
Baseline characteristics by cohort
| Measure |
VCIV (50-64 Years)
n=1762 Participants
Vero cell derived, trivalent, seasonal influenza vaccine (VCIV) Subjects aged 50 to 64 years of age
|
VCIV (65+ Years)
n=1080 Participants
Vero cell derived, trivalent, seasonal influenza vaccine (VCIV) Subjects aged 65 years of age and older
|
EIV (50-64 Years)
n=229 Participants
Licensed egg derived, trivalent seasonal influenza vaccine (EIV) Subjects aged 50 to 64 years of age
|
EIV (65+ Years)
n=137 Participants
Licensed egg derived, trivalent seasonal influenza vaccine (EIV) Subjects aged 65 years of age and older
|
Total
n=3208 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=228 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=343 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=89 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1762 Participants
n=228 Participants
|
0 Participants
n=115 Participants
|
229 Participants
n=343 Participants
|
0 Participants
n=18 Participants
|
1991 Participants
n=89 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=228 Participants
|
1080 Participants
n=115 Participants
|
0 Participants
n=343 Participants
|
137 Participants
n=18 Participants
|
1217 Participants
n=89 Participants
|
|
Age, Continuous
|
56.3 years
STANDARD_DEVIATION 4.29 • n=228 Participants
|
71.4 years
STANDARD_DEVIATION 5.45 • n=115 Participants
|
56.7 years
STANDARD_DEVIATION 4.56 • n=343 Participants
|
71 years
STANDARD_DEVIATION 5.87 • n=18 Participants
|
63.8 years
STANDARD_DEVIATION 5.08 • n=89 Participants
|
|
Sex: Female, Male
Female
|
1068 Participants
n=228 Participants
|
478 Participants
n=115 Participants
|
91 Participants
n=343 Participants
|
64 Participants
n=18 Participants
|
1701 Participants
n=89 Participants
|
|
Sex: Female, Male
Male
|
694 Participants
n=228 Participants
|
602 Participants
n=115 Participants
|
138 Participants
n=343 Participants
|
73 Participants
n=18 Participants
|
1507 Participants
n=89 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
159 Participants
n=228 Participants
|
58 Participants
n=115 Participants
|
15 Participants
n=343 Participants
|
9 Participants
n=18 Participants
|
241 Participants
n=89 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1603 Participants
n=228 Participants
|
1022 Participants
n=115 Participants
|
214 Participants
n=343 Participants
|
128 Participants
n=18 Participants
|
2967 Participants
n=89 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=228 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=343 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=89 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
13 Participants
n=228 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=343 Participants
|
0 Participants
n=18 Participants
|
14 Participants
n=89 Participants
|
|
Race (NIH/OMB)
Asian
|
19 Participants
n=228 Participants
|
7 Participants
n=115 Participants
|
5 Participants
n=343 Participants
|
0 Participants
n=18 Participants
|
31 Participants
n=89 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
5 Participants
n=228 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=343 Participants
|
0 Participants
n=18 Participants
|
6 Participants
n=89 Participants
|
|
Race (NIH/OMB)
Black or African American
|
217 Participants
n=228 Participants
|
62 Participants
n=115 Participants
|
25 Participants
n=343 Participants
|
6 Participants
n=18 Participants
|
310 Participants
n=89 Participants
|
|
Race (NIH/OMB)
White
|
1497 Participants
n=228 Participants
|
1008 Participants
n=115 Participants
|
198 Participants
n=343 Participants
|
131 Participants
n=18 Participants
|
2834 Participants
n=89 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=228 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=343 Participants
|
0 Participants
n=18 Participants
|
8 Participants
n=89 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=228 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=343 Participants
|
0 Participants
n=18 Participants
|
5 Participants
n=89 Participants
|
|
Region of Enrollment
United States
|
1762 participants
n=228 Participants
|
1080 participants
n=115 Participants
|
229 participants
n=343 Participants
|
137 participants
n=18 Participants
|
3208 participants
n=89 Participants
|
|
Weight (kg)
|
85.6 kg
STANDARD_DEVIATION 21.06 • n=228 Participants
|
82.1 kg
STANDARD_DEVIATION 18.53 • n=115 Participants
|
86.4 kg
STANDARD_DEVIATION 21.38 • n=343 Participants
|
81.2 kg
STANDARD_DEVIATION 15.93 • n=18 Participants
|
83.83 kg
STANDARD_DEVIATION 19.31 • n=89 Participants
|
|
Height (cm)
|
168.9 cm
STANDARD_DEVIATION 9.93 • n=228 Participants
|
167.8 cm
STANDARD_DEVIATION 9.71 • n=115 Participants
|
168.8 cm
STANDARD_DEVIATION 9.7 • n=343 Participants
|
167.9 cm
STANDARD_DEVIATION 10.35 • n=18 Participants
|
168.36 cm
STANDARD_DEVIATION 9.9 • n=89 Participants
|
PRIMARY outcome
Timeframe: 21 daysPopulation: Intent-to-treat dataset contains all randomized and vaccinated subjects with immunogenicity data available at baseline and Day 21 for at least one strain.
The rate of subjects vaccinated that demonstrate seroconversion via hemagglutination inhibition (HI) antibody titer to each of the three antigens contained in the vaccine 21 days after vaccination. Seroconversion is defined as a ≥ 4-fold increase in HI antibody titer from baseline or a HI antibody titer ≥ 40 when there is no detectable HI antibody titer (HI antibody titer \< 10) at baseline.
Outcome measures
| Measure |
VCIV (65+ Years)
n=1066 Participants
Vero cell derived, trivalent, seasonal influenza vaccine (VCIV) Subjects aged 65 years of age and older
|
EIV (50-64 Years)
n=221 Participants
Licensed egg derived, trivalent seasonal influenza vaccine (EIV) Subjects aged 50 to 64 years of age
|
EIV (65+ Years)
n=134 Participants
Licensed egg derived, trivalent seasonal influenza vaccine (EIV) Subjects aged 65 years of age and older
|
VCIV (50-64 Years)
n=1730 Participants
Vero cell derived, trivalent, seasonal influenza vaccine (VCIV) Subjects aged 50 to 64 years of age
|
VCIV + EIV (50-64 Years)
Subjects administered VCIV on Day 1 and accepted offer to be vaccinated received EIV after Day 21 at a time convenient to the subject.
Subjects aged 50 to 64 years of age
|
VCIV + EIV (65+ Years)
Subjects administered VCIV on Day 1 and accepted offer to be vaccinated received EIV after Day 21 at a time convenient to the subject.
Subjects aged 65 years of age and older
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects With Seroconversion Antibody Titer
A/H1N1
|
36.8 percentage of participants
Interval 33.9 to 39.7
|
63.8 percentage of participants
Interval 57.1 to 70.1
|
37.3 percentage of participants
Interval 29.1 to 46.1
|
47.1 percentage of participants
Interval 44.7 to 49.5
|
—
|
—
|
|
Percentage of Subjects With Seroconversion Antibody Titer
A/H3N2
|
58.1 percentage of participants
Interval 55.0 to 61.1
|
85.1 percentage of participants
Interval 79.7 to 89.5
|
67.9 percentage of participants
Interval 59.3 to 75.7
|
68.3 percentage of participants
Interval 66.1 to 70.5
|
—
|
—
|
|
Percentage of Subjects With Seroconversion Antibody Titer
B
|
36.3 percentage of participants
Interval 33.4 to 39.3
|
62.9 percentage of participants
Interval 56.2 to 69.3
|
51.5 percentage of participants
Interval 42.7 to 60.2
|
46.6 percentage of participants
Interval 44.2 to 49.0
|
—
|
—
|
PRIMARY outcome
Timeframe: 21 daysPopulation: Intent-to-treat dataset contains all randomized and vaccinated subjects with immunogenicity data available at baseline and Day 21 for at least one strain.
The rate of subjects vaccinated that achieve a reciprocal HI antibody titer of 40 or higher 21 days after vaccination for each of the three antigens contained in the vaccine.
Outcome measures
| Measure |
VCIV (65+ Years)
n=1066 Participants
Vero cell derived, trivalent, seasonal influenza vaccine (VCIV) Subjects aged 65 years of age and older
|
EIV (50-64 Years)
n=221 Participants
Licensed egg derived, trivalent seasonal influenza vaccine (EIV) Subjects aged 50 to 64 years of age
|
EIV (65+ Years)
n=134 Participants
Licensed egg derived, trivalent seasonal influenza vaccine (EIV) Subjects aged 65 years of age and older
|
VCIV (50-64 Years)
n=1730 Participants
Vero cell derived, trivalent, seasonal influenza vaccine (VCIV) Subjects aged 50 to 64 years of age
|
VCIV + EIV (50-64 Years)
Subjects administered VCIV on Day 1 and accepted offer to be vaccinated received EIV after Day 21 at a time convenient to the subject.
Subjects aged 50 to 64 years of age
|
VCIV + EIV (65+ Years)
Subjects administered VCIV on Day 1 and accepted offer to be vaccinated received EIV after Day 21 at a time convenient to the subject.
Subjects aged 65 years of age and older
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects With Seroprotective Antibody Titer
A/H1N1 Day 21
|
72.6 percentage of participants
Interval 69.8 to 75.3
|
86.9 percentage of participants
Interval 81.7 to 91.0
|
75.4 percentage of participants
Interval 67.2 to 82.4
|
74.3 percentage of participants
Interval 72.2 to 76.4
|
—
|
—
|
|
Percentage of Subjects With Seroprotective Antibody Titer
A/H3N2 Day 1
|
58 percentage of participants
Interval 54.9 to 61.0
|
44.8 percentage of participants
Interval 38.1 to 51.6
|
51.5 percentage of participants
Interval 42.7 to 60.2
|
43.1 percentage of participants
Interval 40.8 to 45.5
|
—
|
—
|
|
Percentage of Subjects With Seroprotective Antibody Titer
A/H3N2 Day 21
|
91.3 percentage of participants
Interval 89.4 to 92.9
|
95.9 percentage of participants
Interval 92.4 to 98.1
|
95.5 percentage of participants
Interval 90.5 to 98.3
|
90 percentage of participants
Interval 88.5 to 91.4
|
—
|
—
|
|
Percentage of Subjects With Seroprotective Antibody Titer
B Day 1
|
49.1 percentage of participants
Interval 46.0 to 52.1
|
42.1 percentage of participants
Interval 35.5 to 48.9
|
52.2 percentage of participants
Interval 43.4 to 60.9
|
45.7 percentage of participants
Interval 43.4 to 48.1
|
—
|
—
|
|
Percentage of Subjects With Seroprotective Antibody Titer
B Day 21
|
82.6 percentage of participants
Interval 80.2 to 84.9
|
93.7 percentage of participants
Interval 89.6 to 96.5
|
94.8 percentage of participants
Interval 89.5 to 97.9
|
86.2 percentage of participants
Interval 84.5 to 87.8
|
—
|
—
|
|
Percentage of Subjects With Seroprotective Antibody Titer
A/H1N1 Day 1
|
35.3 percentage of participants
Interval 32.4 to 38.2
|
26.7 percentage of participants
Interval 21.0 to 33.0
|
36.6 percentage of participants
Interval 28.4 to 45.3
|
29.6 percentage of participants
Interval 27.5 to 31.8
|
—
|
—
|
SECONDARY outcome
Timeframe: 21 daysPopulation: Intent-to-treat dataset contains all randomized and vaccinated subjects with immunogenicity data available at baseline and Day 21 for at least one strain.
Outcome measures
| Measure |
VCIV (65+ Years)
n=1066 Participants
Vero cell derived, trivalent, seasonal influenza vaccine (VCIV) Subjects aged 65 years of age and older
|
EIV (50-64 Years)
n=221 Participants
Licensed egg derived, trivalent seasonal influenza vaccine (EIV) Subjects aged 50 to 64 years of age
|
EIV (65+ Years)
n=134 Participants
Licensed egg derived, trivalent seasonal influenza vaccine (EIV) Subjects aged 65 years of age and older
|
VCIV (50-64 Years)
n=1730 Participants
Vero cell derived, trivalent, seasonal influenza vaccine (VCIV) Subjects aged 50 to 64 years of age
|
VCIV + EIV (50-64 Years)
Subjects administered VCIV on Day 1 and accepted offer to be vaccinated received EIV after Day 21 at a time convenient to the subject.
Subjects aged 50 to 64 years of age
|
VCIV + EIV (65+ Years)
Subjects administered VCIV on Day 1 and accepted offer to be vaccinated received EIV after Day 21 at a time convenient to the subject.
Subjects aged 65 years of age and older
|
|---|---|---|---|---|---|---|
|
Hemagglutination Inhibition (HI) Antibody Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 After Vaccination
A/H1N1 Day 1
|
20.3 HIA Titers
Interval 18.9 to 21.7
|
15.5 HIA Titers
Interval 13.4 to 18.0
|
20.9 HIA Titers
Interval 17.3 to 25.3
|
17.2 HIA Titers
Interval 16.3 to 18.2
|
—
|
—
|
|
Hemagglutination Inhibition (HI) Antibody Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 After Vaccination
A/H1N1 Day 21
|
67.2 HIA Titers
Interval 62.0 to 72.9
|
106.5 HIA Titers
Interval 90.8 to 125.0
|
68.7 HIA Titers
Interval 56.3 to 83.9
|
79.5 HIA Titers
Interval 74.1 to 85.3
|
—
|
—
|
|
Hemagglutination Inhibition (HI) Antibody Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 After Vaccination
A/H3N2 Day 1
|
41.6 HIA Titers
Interval 38.0 to 45.5
|
23.8 HIA Titers
Interval 19.9 to 28.6
|
39.7 HIA Titers
Interval 30.5 to 51.5
|
24.7 HIA Titers
Interval 23.0 to 26.4
|
—
|
—
|
|
Hemagglutination Inhibition (HI) Antibody Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 After Vaccination
A/H3N2 Day 21
|
234.9 HIA Titers
Interval 214.7 to 256.9
|
358.6 HIA Titers
Interval 297.2 to 432.8
|
320 HIA Titers
Interval 252.6 to 405.5
|
221.2 HIA Titers
Interval 205.5 to 238.1
|
—
|
—
|
|
Hemagglutination Inhibition (HI) Antibody Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 After Vaccination
B Day 1
|
31.4 HIA Titers
Interval 29.0 to 34.0
|
24.6 HIA Titers
Interval 20.6 to 29.4
|
33.1 HIA Titers
Interval 26.8 to 41.0
|
28.6 HIA Titers
Interval 26.8 to 30.6
|
—
|
—
|
|
Hemagglutination Inhibition (HI) Antibody Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 After Vaccination
B Day 21
|
95.5 HIA Titers
Interval 88.4 to 103.2
|
181.6 HIA Titers
Interval 155.0 to 212.7
|
151.4 HIA Titers
Interval 124.9 to 183.6
|
122.5 HIA Titers
Interval 115.1 to 130.4
|
—
|
—
|
SECONDARY outcome
Timeframe: 21 daysPopulation: Intent-to-treat dataset contains all randomized and vaccinated subjects with immunogenicity data available at baseline and Day 21 for at least one strain.
Change in geometric mean of titers at day 21 compared to baseline
Outcome measures
| Measure |
VCIV (65+ Years)
n=1066 Participants
Vero cell derived, trivalent, seasonal influenza vaccine (VCIV) Subjects aged 65 years of age and older
|
EIV (50-64 Years)
n=221 Participants
Licensed egg derived, trivalent seasonal influenza vaccine (EIV) Subjects aged 50 to 64 years of age
|
EIV (65+ Years)
n=134 Participants
Licensed egg derived, trivalent seasonal influenza vaccine (EIV) Subjects aged 65 years of age and older
|
VCIV (50-64 Years)
n=1730 Participants
Vero cell derived, trivalent, seasonal influenza vaccine (VCIV) Subjects aged 50 to 64 years of age
|
VCIV + EIV (50-64 Years)
Subjects administered VCIV on Day 1 and accepted offer to be vaccinated received EIV after Day 21 at a time convenient to the subject.
Subjects aged 50 to 64 years of age
|
VCIV + EIV (65+ Years)
Subjects administered VCIV on Day 1 and accepted offer to be vaccinated received EIV after Day 21 at a time convenient to the subject.
Subjects aged 65 years of age and older
|
|---|---|---|---|---|---|---|
|
Change of Hemagglutination Inhibition (HI) Antibody Titer at Day 21 Compared to Baseline
A/H1N1
|
3.32 HIA Titers
Interval 3.07 to 3.59
|
6.87 HIA Titers
Interval 5.69 to 8.31
|
3.29 HIA Titers
Interval 2.7 to 4.0
|
4.61 HIA Titers
Interval 4.31 to 4.94
|
—
|
—
|
|
Change of Hemagglutination Inhibition (HI) Antibody Titer at Day 21 Compared to Baseline
A/H3N2
|
5.65 HIA Titers
Interval 5.19 to 6.15
|
15.04 HIA Titers
Interval 12.4 to 18.25
|
8.07 HIA Titers
Interval 6.21 to 10.48
|
8.96 HIA Titers
Interval 8.33 to 9.64
|
—
|
—
|
|
Change of Hemagglutination Inhibition (HI) Antibody Titer at Day 21 Compared to Baseline
B
|
3.04 HIA Titers
Interval 2.83 to 3.27
|
7.37 HIA Titers
Interval 6.09 to 8.93
|
4.57 HIA Titers
Interval 3.63 to 5.74
|
4.28 HIA Titers
Interval 4.01 to 4.57
|
—
|
—
|
SECONDARY outcome
Timeframe: 21 daysPopulation: Safety dataset contains all vaccinated subjects
Outcome measures
| Measure |
VCIV (65+ Years)
n=1080 Participants
Vero cell derived, trivalent, seasonal influenza vaccine (VCIV) Subjects aged 65 years of age and older
|
EIV (50-64 Years)
n=229 Participants
Licensed egg derived, trivalent seasonal influenza vaccine (EIV) Subjects aged 50 to 64 years of age
|
EIV (65+ Years)
n=137 Participants
Licensed egg derived, trivalent seasonal influenza vaccine (EIV) Subjects aged 65 years of age and older
|
VCIV (50-64 Years)
n=1762 Participants
Vero cell derived, trivalent, seasonal influenza vaccine (VCIV) Subjects aged 50 to 64 years of age
|
VCIV + EIV (50-64 Years)
Subjects administered VCIV on Day 1 and accepted offer to be vaccinated received EIV after Day 21 at a time convenient to the subject.
Subjects aged 50 to 64 years of age
|
VCIV + EIV (65+ Years)
Subjects administered VCIV on Day 1 and accepted offer to be vaccinated received EIV after Day 21 at a time convenient to the subject.
Subjects aged 65 years of age and older
|
|---|---|---|---|---|---|---|
|
Rate of Subjects Experiencing Any Injection Site Reactions Until the Day 21 Visit After Vaccination
|
222 Participants
|
73 Participants
|
34 Participants
|
625 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 21 daysPopulation: Safety dataset contains all vaccinated subjects
Outcome measures
| Measure |
VCIV (65+ Years)
n=1080 Participants
Vero cell derived, trivalent, seasonal influenza vaccine (VCIV) Subjects aged 65 years of age and older
|
EIV (50-64 Years)
n=229 Participants
Licensed egg derived, trivalent seasonal influenza vaccine (EIV) Subjects aged 50 to 64 years of age
|
EIV (65+ Years)
n=137 Participants
Licensed egg derived, trivalent seasonal influenza vaccine (EIV) Subjects aged 65 years of age and older
|
VCIV (50-64 Years)
n=1762 Participants
Vero cell derived, trivalent, seasonal influenza vaccine (VCIV) Subjects aged 50 to 64 years of age
|
VCIV + EIV (50-64 Years)
Subjects administered VCIV on Day 1 and accepted offer to be vaccinated received EIV after Day 21 at a time convenient to the subject.
Subjects aged 50 to 64 years of age
|
VCIV + EIV (65+ Years)
Subjects administered VCIV on Day 1 and accepted offer to be vaccinated received EIV after Day 21 at a time convenient to the subject.
Subjects aged 65 years of age and older
|
|---|---|---|---|---|---|---|
|
Rate of Subjects Experiencing Systemic Reactions Until the Day 21 Visit After Vaccination
|
465 Participants
|
119 Participants
|
53 Participants
|
985 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 180 daysOutcome measures
| Measure |
VCIV (65+ Years)
n=474 Participants
Vero cell derived, trivalent, seasonal influenza vaccine (VCIV) Subjects aged 65 years of age and older
|
EIV (50-64 Years)
n=227 Participants
Licensed egg derived, trivalent seasonal influenza vaccine (EIV) Subjects aged 50 to 64 years of age
|
EIV (65+ Years)
n=136 Participants
Licensed egg derived, trivalent seasonal influenza vaccine (EIV) Subjects aged 65 years of age and older
|
VCIV (50-64 Years)
n=828 Participants
Vero cell derived, trivalent, seasonal influenza vaccine (VCIV) Subjects aged 50 to 64 years of age
|
VCIV + EIV (50-64 Years)
n=923 Participants
Subjects administered VCIV on Day 1 and accepted offer to be vaccinated received EIV after Day 21 at a time convenient to the subject.
Subjects aged 50 to 64 years of age
|
VCIV + EIV (65+ Years)
n=602 Participants
Subjects administered VCIV on Day 1 and accepted offer to be vaccinated received EIV after Day 21 at a time convenient to the subject.
Subjects aged 65 years of age and older
|
|---|---|---|---|---|---|---|
|
Rate of Subjects Experiencing Any Systemic Adverse Events During the Entire 180 Day Follow-up Period
|
325 Participants
|
169 Participants
|
88 Participants
|
620 Participants
|
685 Participants
|
428 Participants
|
Adverse Events
VCIV (50-64 Years)
Serious events: 32 serious events
Other events: 777 other events
Deaths: 1 deaths
VCIV (65+ Years)
Serious events: 28 serious events
Other events: 297 other events
Deaths: 3 deaths
EIV (50-64 Years)
Serious events: 4 serious events
Other events: 183 other events
Deaths: 0 deaths
EIV (65+ Years)
Serious events: 10 serious events
Other events: 95 other events
Deaths: 0 deaths
VCIV + EIV (50-64 Years)
Serious events: 25 serious events
Other events: 492 other events
Deaths: 1 deaths
VCIV + EIV (65+ Years)
Serious events: 32 serious events
Other events: 346 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
VCIV (50-64 Years)
n=828 participants at risk
Vero cell derived, trivalent, seasonal influenza vaccine (VCIV) on Day 1 Subjects aged 50 to 64 years of age
|
VCIV (65+ Years)
n=474 participants at risk
Vero cell derived, trivalent, seasonal influenza vaccine (VCIV) on Day 1 Subjects aged 65 years of age and older
|
EIV (50-64 Years)
n=227 participants at risk
Licensed egg derived, trivalent seasonal influenza vaccine (EIV) on Day 1 Subjects aged 50 to 64 years of age
|
EIV (65+ Years)
n=136 participants at risk
Licensed egg derived, trivalent seasonal influenza vaccine (EIV) on Day 1 Subjects aged 65 years of age and older
|
VCIV + EIV (50-64 Years)
n=923 participants at risk
Subjects administered VCIV on Day 1 and accepted offer to be vaccinated received EIV after Day 21 at a time convenient to the subject.
Subjects aged 50 to 64 years of age
|
VCIV + EIV (65+ Years)
n=602 participants at risk
Subjects administered VCIV on Day 1 and accepted offer to be vaccinated received EIV after Day 21 at a time convenient to the subject.
Subjects aged 65 years of age and older
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Electromechanical dissociation
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.21%
1/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Cardiac disorders
Coronary artery disease
|
0.24%
2/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.42%
2/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
1.5%
2/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.12%
1/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.12%
1/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.11%
1/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.21%
1/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.44%
1/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Infections and infestations
Abscess rupture
|
0.12%
1/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.11%
1/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.12%
1/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.12%
1/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.11%
1/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.17%
1/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.11%
1/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.44%
1/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.11%
1/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.21%
1/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.11%
1/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Vascular disorders
Arteriosclerosis
|
0.12%
1/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Congenital, familial and genetic disorders
Arteriovenous malformation
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.21%
1/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.17%
1/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Cardiac disorders
Atrial fibrillation
|
0.12%
1/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.42%
2/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.22%
2/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.33%
2/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.21%
1/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.17%
1/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.12%
1/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Musculoskeletal and connective tissue disorders
Back injury
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.17%
1/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Renal and urinary disorders
Bladder prolapse
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.17%
1/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.17%
1/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.12%
1/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.24%
2/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.17%
1/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.12%
1/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.17%
1/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.44%
1/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.11%
1/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.50%
3/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Infections and infestations
Cellulitis
|
0.24%
2/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.44%
1/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.17%
1/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.74%
1/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.74%
1/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.33%
2/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Cardiac disorders
Chest pain
|
0.12%
1/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.21%
1/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.22%
2/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.74%
1/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Gastrointestinal disorders
Colon neoplasm
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.74%
1/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.11%
1/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Blood and lymphatic system disorders
Deep vein thrombosis
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.17%
1/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Nervous system disorders
Delirium
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.17%
1/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Gastrointestinal disorders
Diverticulitis
|
0.24%
2/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.17%
1/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Nervous system disorders
Dizziness
|
0.12%
1/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Musculoskeletal and connective tissue disorders
Facial bones fracture
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.17%
1/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Renal and urinary disorders
Fluid overload
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.11%
1/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Musculoskeletal and connective tissue disorders
Fracture malunion
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.11%
1/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.42%
2/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.44%
1/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Gastrointestinal disorders
Gastroenteritis viral
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.17%
1/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Gastrointestinal disorders
Gastrointestinal dysplasia
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.17%
1/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Nervous system disorders
Grand mal convulsion
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.74%
1/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.11%
1/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.12%
1/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.21%
1/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Musculoskeletal and connective tissue disorders
Hip fracture
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.17%
1/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Vascular disorders
Hypertension
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.17%
1/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.11%
1/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.17%
1/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.11%
1/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Cardiac disorders
Implantable defibrillator malfunction
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.17%
1/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.12%
1/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Cardiac disorders
Left atrial dilatation
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.11%
1/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.12%
1/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.21%
1/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.17%
1/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.21%
1/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Cardiac disorders
Myocardial infarction
|
0.12%
1/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.21%
1/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.17%
1/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.21%
1/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.11%
1/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.33%
2/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.21%
1/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Gastrointestinal disorders
Oesophageal spasm
|
0.12%
1/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.21%
1/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.12%
1/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.21%
1/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.22%
2/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.50%
3/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Musculoskeletal and connective tissue disorders
Osteomyelitis
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.11%
1/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Eye disorders
Otitis externa
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.44%
1/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.11%
1/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.11%
1/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.17%
1/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.21%
1/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.17%
1/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.36%
3/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.44%
1/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.74%
1/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.22%
2/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.12%
1/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Infections and infestations
Post procedural infection
|
0.12%
1/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.17%
1/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Vascular disorders
Pulmonary embolism
|
0.12%
1/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.11%
1/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal polyp
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.11%
1/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Retroperitoneal haematoma
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.11%
1/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.21%
1/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Vascular disorders
Sick sinus syndrome
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.33%
2/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.74%
1/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.21%
1/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.17%
1/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.21%
1/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.12%
1/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.12%
1/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Infections and infestations
Staphylococcal infection
|
0.12%
1/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Infections and infestations
Streptococcal infection
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.21%
1/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.11%
1/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.17%
1/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Surgical and medical procedures
Surgical failure
|
0.12%
1/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Nervous system disorders
Syncope
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.11%
1/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.33%
2/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Cardiac disorders
Tachycardia
|
0.12%
1/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Endocrine disorders
Thyroid adenoma
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.11%
1/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.21%
1/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.11%
1/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Cardiac disorders
Transient ischaemic attack
|
0.12%
1/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.21%
1/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Reproductive system and breast disorders
Uterovaginal prolapse
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.11%
1/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.21%
1/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Cardiac disorders
Ventricular hypertrophy
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.11%
1/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Nervous system disorders
Vertigo
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.21%
1/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Eye disorders
Vision blurred
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.17%
1/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.74%
1/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
Other adverse events
| Measure |
VCIV (50-64 Years)
n=828 participants at risk
Vero cell derived, trivalent, seasonal influenza vaccine (VCIV) on Day 1 Subjects aged 50 to 64 years of age
|
VCIV (65+ Years)
n=474 participants at risk
Vero cell derived, trivalent, seasonal influenza vaccine (VCIV) on Day 1 Subjects aged 65 years of age and older
|
EIV (50-64 Years)
n=227 participants at risk
Licensed egg derived, trivalent seasonal influenza vaccine (EIV) on Day 1 Subjects aged 50 to 64 years of age
|
EIV (65+ Years)
n=136 participants at risk
Licensed egg derived, trivalent seasonal influenza vaccine (EIV) on Day 1 Subjects aged 65 years of age and older
|
VCIV + EIV (50-64 Years)
n=923 participants at risk
Subjects administered VCIV on Day 1 and accepted offer to be vaccinated received EIV after Day 21 at a time convenient to the subject.
Subjects aged 50 to 64 years of age
|
VCIV + EIV (65+ Years)
n=602 participants at risk
Subjects administered VCIV on Day 1 and accepted offer to be vaccinated received EIV after Day 21 at a time convenient to the subject.
Subjects aged 65 years of age and older
|
|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.9%
123/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
9.7%
46/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
7.0%
16/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
9.6%
13/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
6.5%
60/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
7.3%
44/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Gastrointestinal disorders
Diarrhea
|
8.7%
72/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
8.2%
39/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
5.7%
13/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
2.9%
4/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
4.0%
37/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
4.8%
29/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.2%
209/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
17.1%
81/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
11.9%
27/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
5.9%
8/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
1.5%
14/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
1.8%
11/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
General disorders
Chills
|
26.2%
217/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
18.1%
86/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
9.3%
21/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
4.4%
6/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
1.8%
17/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.83%
5/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
General disorders
Fatigue
|
54.1%
448/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
37.6%
178/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
23.3%
53/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
14.0%
19/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
1.5%
14/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
1.5%
9/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Nervous system disorders
Headache
|
61.6%
510/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
35.0%
166/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
30.8%
70/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
13.2%
18/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
7.9%
73/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
5.1%
31/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Nervous system disorders
Hyperhidrosis
|
19.8%
164/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
9.1%
43/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
6.2%
14/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
2.9%
4/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.22%
2/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.00%
0/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Vascular disorders
Hypertension
|
7.2%
60/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
11.2%
53/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
5.3%
12/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
7.4%
10/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
1.6%
15/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
2.5%
15/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
General disorders
Injection site pain
|
67.6%
560/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
36.5%
173/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
30.4%
69/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
22.1%
30/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
3.9%
36/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
2.3%
14/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
General disorders
Malaise
|
54.5%
451/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
37.1%
176/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
21.1%
48/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
11.8%
16/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.98%
9/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.66%
4/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
44.6%
369/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
29.1%
138/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
21.1%
48/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
8.8%
12/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
1.8%
17/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
1.5%
9/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
7.7%
64/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
7.4%
35/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
7.5%
17/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
8.1%
11/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
6.1%
56/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
4.5%
27/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Gastrointestinal disorders
Nausea
|
8.6%
71/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
7.2%
34/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
4.0%
9/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.74%
1/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
3.9%
36/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
2.3%
14/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Nervous system disorders
Oropharyngeal pain
|
15.5%
128/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
10.1%
48/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
7.0%
16/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
11.0%
15/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
6.6%
61/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
4.2%
25/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
General disorders
Pyrexia
|
11.0%
91/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
7.6%
36/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
7.0%
16/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
2.2%
3/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
3.6%
33/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
1.5%
9/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
7.1%
59/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
7.4%
35/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
6.6%
15/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
5.1%
7/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
5.2%
48/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
5.1%
31/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.9%
74/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
9.9%
47/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
13.7%
31/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
8.1%
11/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
6.7%
62/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
7.8%
47/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
General disorders
Injection site erythema
|
8.5%
70/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
8.0%
38/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
2.6%
6/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
3.7%
5/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
1.1%
10/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.17%
1/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Vascular disorders
Blood pressure increased
|
8.8%
73/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
6.3%
30/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
3.5%
8/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
3.7%
5/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.54%
5/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
1.5%
9/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
General disorders
Injection site swelling
|
9.3%
77/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
8.4%
40/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
2.2%
5/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
2.2%
3/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.33%
3/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.33%
2/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
9.7%
80/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
4.2%
20/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
4.8%
11/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
5.1%
7/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
1.3%
12/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
5.0%
30/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
5.7%
47/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
3.0%
14/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
3.5%
8/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
6.6%
9/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
4.7%
43/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
2.3%
14/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
59/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
6.5%
31/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
3.5%
8/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.74%
1/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
3.3%
30/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
23.8%
143/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.2%
35/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
4.0%
19/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
3.5%
8/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
16.9%
23/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.76%
7/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
2.5%
15/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
2.9%
24/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
3.4%
16/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
4.4%
10/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
4.4%
6/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
2.3%
21/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
3.7%
22/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
6.2%
51/828
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
4.2%
20/474
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
2.6%
6/227
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
0.74%
1/136
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
2.8%
26/923
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
2.5%
15/602
Study was divided into Part A and Part B and two age strata, 50-64 and 65 and older. Only subjects that completed Part A were allowed to enroll in Part B. Per SAP the analyses were performed by treatment group and age stratum, in addition it was pre-determined to also present AEs for those subjects that received both the VCIV + EIV per age stratum.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place