Trial Outcomes & Findings for Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Non-Elderly and Elderly Adults (NCT NCT00973349)

NCT ID: NCT00973349

Last Updated: 2015-12-07

Results Overview

Seroconversion is defined by CBER (Center for Biologics Evaluation, Research and Review) as the percentage of participants with either a prevaccination HI titer \<1:10 and a post vaccination HI titer \> 40 or a pre-vaccination HI titer \> 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as participants having HI antibody titer ≥1:40.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

2719 participants

Primary outcome timeframe

21 days after each vaccination

Results posted on

2015-12-07

Participant Flow

Participants were enrolled at 21 sites in the US.

Participant milestones

Participant milestones
Measure
3.75_(50)MF59 (18-64 Years)
50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
7.5 w/o MF59 (18-64 Years)
1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
7.5_(50)MF59 (18-64 Years)
50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
7.5_(100)MF59 (18-64 Years)
100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
15 w/o MF59 (18-64 Years)
1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
15_(50)MF59 (18-64 Years)
50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
15_(100)MF59 (18-64 Years)
100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
30 w/o MF59(18-64 Years)
1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
3.75_(50)MF59 (≥ 65 Years)
50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
7.5 w/o MF59 (≥ 65 Years)
1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
7.5_(50)MF59 (≥ 65 Years)
50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
7.5_(100)MF59 (≥ 65 Years)
100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
15 w/o MF59 (≥ 65 Years)
1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
15_(50)MF59 (≥ 65 Years)
50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
15_(100)MF59 (≥ 65 Years)
100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
30 w/o MF59(≥ 65 Years)
1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
Overall Study
STARTED
170
168
171
168
170
169
174
169
171
169
174
169
169
171
170
167
Overall Study
COMPLETED
166
165
166
163
165
165
172
166
167
163
174
167
168
171
168
165
Overall Study
NOT COMPLETED
4
3
5
5
5
4
2
3
4
6
0
2
1
0
2
2

Reasons for withdrawal

Reasons for withdrawal
Measure
3.75_(50)MF59 (18-64 Years)
50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
7.5 w/o MF59 (18-64 Years)
1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
7.5_(50)MF59 (18-64 Years)
50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
7.5_(100)MF59 (18-64 Years)
100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
15 w/o MF59 (18-64 Years)
1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
15_(50)MF59 (18-64 Years)
50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
15_(100)MF59 (18-64 Years)
100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
30 w/o MF59(18-64 Years)
1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
3.75_(50)MF59 (≥ 65 Years)
50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
7.5 w/o MF59 (≥ 65 Years)
1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
7.5_(50)MF59 (≥ 65 Years)
50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
7.5_(100)MF59 (≥ 65 Years)
100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
15 w/o MF59 (≥ 65 Years)
1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
15_(50)MF59 (≥ 65 Years)
50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
15_(100)MF59 (≥ 65 Years)
100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
30 w/o MF59(≥ 65 Years)
1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
Overall Study
Adverse Event
0
0
0
0
1
0
0
0
1
0
0
0
0
0
1
0
Overall Study
Withdrawal by Subject
1
2
2
3
2
0
2
2
0
2
0
1
0
0
0
0
Overall Study
Lost to Follow-up
3
1
2
2
1
3
0
1
2
1
0
1
0
0
0
1
Overall Study
Inappropriate enrolment
0
0
1
0
0
0
0
0
0
2
0
0
1
0
1
1
Overall Study
Protocol Violation
0
0
0
0
0
0
0
0
1
0
0
0
0
0
0
0
Overall Study
Unable to classify
0
0
0
0
1
1
0
0
0
1
0
0
0
0
0
0

Baseline Characteristics

Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Non-Elderly and Elderly Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
3.75_(50)MF59 (18 to 64)
n=155 Participants
50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen in subjects 18 to 64 years of age
7.5 w/o MF59 (18 to 64)
n=153 Participants
1 dose of 7.5 µg A/H1N1 in subjects 18 to 64 years of age
7.5_(50)MF59 (18 to 64)
n=157 Participants
50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen in subjects 18 to 64 years of age
7.5_(100)MF59 (18 to 64)
n=153 Participants
100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen in subjects 18 to 64 years of age
15 w/o MF59 (18 to 64)
n=155 Participants
1 dose of 15 µg A/H1N1 in subjects 18 to 64 years of age
15_(50)MF59 (18 to 64)
n=154 Participants
50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen in subjects 18 to 64 years of age
15_(100)MF59 (18 to 64)
n=159 Participants
100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen
30 w/o MF59 (18 to 64)
n=154 Participants
1 dose of 30 µg A/H1N1 in subjects 18 to 64 years of age
3.75_(50)MF59 (≥ 65 )
n=170 Participants
50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen in subjects ≥ 65 years of age
7.5 w/o MF59 (≥ 65)
n=168 Participants
1 dose of 7.5 µg A/H1N1 in subjects ≥ 65 years of age
7.5_(50)MF59 (≥ 65)
n=172 Participants
50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen in subjects ≥ 65 years of age
7.5_(100)MF59 (≥ 65)
n=168 Participants
100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen in subjects ≥ 65 years of age
15 w/o MF59 (≥ 65)
n=168 Participants
1 dose of 15 µg A/H1N1 in subjects ≥ 65 years of age
15_(50)MF59 (≥ 65)
n=171 Participants
50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen in subjects ≥ 65 years of age
15_(100)MF59 (≥ 65)
n=169 Participants
100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen in subjects ≥ 65 years of age
30 w/o MF59 (≥ 65)
n=166 Participants
1 dose of 30 µg A/H1N1 in subjects ≥ 65 years of age
Total
n=2592 Participants
Total of all reporting groups
Age, Continuous
40.3 years
STANDARD_DEVIATION 12.8 • n=5 Participants
39.8 years
STANDARD_DEVIATION 12.9 • n=7 Participants
39.1 years
STANDARD_DEVIATION 13.5 • n=5 Participants
40.6 years
STANDARD_DEVIATION 12.2 • n=4 Participants
41.8 years
STANDARD_DEVIATION 12.9 • n=21 Participants
39.7 years
STANDARD_DEVIATION 13.1 • n=8 Participants
38.8 years
STANDARD_DEVIATION 11.9 • n=8 Participants
40.8 years
STANDARD_DEVIATION 13.0 • n=24 Participants
70.8 years
STANDARD_DEVIATION 5.1 • n=42 Participants
71.8 years
STANDARD_DEVIATION 5.6 • n=42 Participants
71.4 years
STANDARD_DEVIATION 5.6 • n=42 Participants
70.7 years
STANDARD_DEVIATION 5.1 • n=42 Participants
71.0 years
STANDARD_DEVIATION 5.0 • n=36 Participants
70.4 years
STANDARD_DEVIATION 4.9 • n=36 Participants
71.3 years
STANDARD_DEVIATION 5.2 • n=24 Participants
70.8 years
STANDARD_DEVIATION 5.3 • n=135 Participants
39.6 years
STANDARD_DEVIATION 12.8 • n=136 Participants
Sex/Gender, Customized
Male(18 to 64 or ≥65 years)
61 participants
n=5 Participants
62 participants
n=7 Participants
57 participants
n=5 Participants
59 participants
n=4 Participants
57 participants
n=21 Participants
69 participants
n=8 Participants
71 participants
n=8 Participants
63 participants
n=24 Participants
54 participants
n=42 Participants
88 participants
n=42 Participants
71 participants
n=42 Participants
70 participants
n=42 Participants
68 participants
n=36 Participants
74 participants
n=36 Participants
79 participants
n=24 Participants
76 participants
n=135 Participants
1079 participants
n=136 Participants
Sex/Gender, Customized
Female(18 to 64 or ≥65 yrs)
94 participants
n=5 Participants
91 participants
n=7 Participants
100 participants
n=5 Participants
94 participants
n=4 Participants
98 participants
n=21 Participants
85 participants
n=8 Participants
88 participants
n=8 Participants
91 participants
n=24 Participants
116 participants
n=42 Participants
80 participants
n=42 Participants
101 participants
n=42 Participants
98 participants
n=42 Participants
100 participants
n=36 Participants
97 participants
n=36 Participants
90 participants
n=24 Participants
90 participants
n=135 Participants
1513 participants
n=136 Participants

PRIMARY outcome

Timeframe: 21 days after each vaccination

Population: The analysis was based on the per protocol population.

Seroconversion is defined by CBER (Center for Biologics Evaluation, Research and Review) as the percentage of participants with either a prevaccination HI titer \<1:10 and a post vaccination HI titer \> 40 or a pre-vaccination HI titer \> 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as participants having HI antibody titer ≥1:40.

Outcome measures

Outcome measures
Measure
3.75_(50)MF59
n=146 Participants
50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
7.5 w/o MF59
n=142 Participants
1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
7.5_(50)MF59
n=142 Participants
50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
7.5_(100)MF59
n=141 Participants
100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
15 w/o MF59
n=141 Participants
1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
15_(50)MF59
n=138 Participants
50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
15_(100)MF59
n=149 Participants
100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
30 w/o MF59
n=144 Participants
1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age
Seroconversion Day 43
118 Participants
104 Participants
123 Participants
129 Participants
126 Participants
125 Participants
139 Participants
132 Participants
Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age
Seroprotection Day 22
129 Participants
126 Participants
135 Participants
134 Participants
133 Participants
135 Participants
147 Participants
141 Participants
Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age
Seroconversion Day 22
113 Participants
100 Participants
123 Participants
126 Participants
127 Participants
124 Participants
135 Participants
130 Participants
Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age
Seroprotection Day 43
138 Participants
133 Participants
136 Participants
137 Participants
135 Participants
137 Participants
145 Participants
142 Participants
Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age
Seroprotection Day 202 (N=79,65,78,80,73,74,74,76)
68 Participants
51 Participants
67 Participants
70 Participants
56 Participants
59 Participants
65 Participants
69 Participants
Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age
Seroconversion Day 202 (N=79,65,78,80,73,74,74,76)
50 Participants
32 Participants
48 Participants
53 Participants
49 Participants
49 Participants
51 Participants
55 Participants
Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age
Seroprotection Day 387(N=105,95,88,84,91,91,106,84
76 Participants
78 Participants
66 Participants
67 Participants
66 Participants
74 Participants
89 Participants
69 Participants
Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age
Seroconversion Day387(N=105,95,88,84,91,91,106,84)
52 Participants
48 Participants
50 Participants
53 Participants
58 Participants
62 Participants
71 Participants
54 Participants

PRIMARY outcome

Timeframe: 21 days after each vaccination

Population: The analysis was on the per protocol set.

Seroconversion is defined by CBER as the percentage of participants with either a prevaccination HI titer \<1:10 and a post vaccination HI titer \> 40 or a pre-vaccination HI titer \> 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as participants having HI antibody titer ≥1:40.

Outcome measures

Outcome measures
Measure
3.75_(50)MF59
n=150 Participants
50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
7.5 w/o MF59
n=147 Participants
1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
7.5_(50)MF59
n=164 Participants
50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
7.5_(100)MF59
n=148 Participants
100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
15 w/o MF59
n=159 Participants
1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
15_(50)MF59
n=155 Participants
50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
15_(100)MF59
n=154 Participants
100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
30 w/o MF59
n=150 Participants
1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age
Seroprotection Day 22
122 Participants
119 Participants
126 Participants
122 Participants
136 Participants
141 Participants
142 Participants
135 Participants
Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age
Seroconversion Day 22
89 Participants
76 Participants
102 Participants
92 Participants
104 Participants
110 Participants
111 Participants
108 Participants
Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age
Seroprotection Day 43
131 Participants
116 Participants
132 Participants
131 Participants
126 Participants
136 Participants
143 Participants
136 Participants
Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age
Seroconversion Day 43
90 Participants
75 Participants
103 Participants
95 Participants
94 Participants
106 Participants
113 Participants
103 Participants
Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age
Seroprotection Day 202 (N=80,71,85,79,84,82,87,82)
54 Participants
41 Participants
45 Participants
52 Participants
55 Participants
45 Participants
63 Participants
57 Participants
Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age
Seroconversion Day 202 (N=80,71,85,79,84,82,87,82)
31 Participants
16 Participants
30 Participants
31 Participants
35 Participants
27 Participants
38 Participants
36 Participants
Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age
Seroprotection Day 387(N=84,87,98,86,106,93,89,99)
50 Participants
56 Participants
55 Participants
57 Participants
67 Participants
55 Participants
65 Participants
69 Participants
Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age
Seroconversion Day 387(N=84,87,98,86,106,93,89,99)
30 Participants
25 Participants
26 Participants
33 Participants
37 Participants
30 Participants
47 Participants
32 Participants

SECONDARY outcome

Timeframe: 21 days after each vaccination

Population: The analysis was on the per protocol set. For this analysis, total subjects enrolled were stratified and randomized in two age groups, according to the CBER criteria, 18 to 64 years and over 64 years of age.

Geometric mean hemagglutinin inhibition (HI) titer = GMT

Outcome measures

Outcome measures
Measure
3.75_(50)MF59
n=296 Participants
50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
7.5 w/o MF59
n=289 Participants
1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
7.5_(50)MF59
n=306 Participants
50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
7.5_(100)MF59
n=289 Participants
100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
15 w/o MF59
n=300 Participants
1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
15_(50)MF59
n=293 Participants
50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
15_(100)MF59
n=303 Participants
100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
30 w/o MF59
n=294 Participants
1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age
Day 22(18-64yrs;N=146,142,142,141,141,138,149,144)
299 Geometric Mean Titer
Interval 234.0 to 382.0
238 Geometric Mean Titer
Interval 185.0 to 306.0
379 Geometric Mean Titer
Interval 295.0 to 486.0
551 Geometric Mean Titer
Interval 429.0 to 708.0
536 Geometric Mean Titer
Interval 417.0 to 689.0
538 Geometric Mean Titer
Interval 418.0 to 693.0
677 Geometric Mean Titer
Interval 530.0 to 864.0
637 Geometric Mean Titer
Interval 497.0 to 817.0
Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age
Day 43(18-64yrs;N=146,142,142,141,141,138,149,144)
327 Geometric Mean Titer
Interval 262.0 to 409.0
239 Geometric Mean Titer
Interval 198.0 to 299.0
359 Geometric Mean Titer
Interval 286.0 to 449.0
538 Geometric Mean Titer
Interval 429.0 to 675.0
412 Geometric Mean Titer
Interval 328.0 to 517.0
494 Geometric Mean Titer
Interval 393.0 to 621.0
618 Geometric Mean Titer
Interval 496.0 to 771.0
497 Geometric Mean Titer
Interval 397.0 to 622.0
Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age
Day 22 (≥65 yrs;N=150,147,164,148,159,155,154,150)
138 Geometric Mean Titer
Interval 107.0 to 178.0
133 Geometric Mean Titer
Interval 103.0 to 172.0
146 Geometric Mean Titer
Interval 114.0 to 185.0
184 Geometric Mean Titer
Interval 143.0 to 238.0
187 Geometric Mean Titer
Interval 146.0 to 238.0
203 Geometric Mean Titer
Interval 159.0 to 261.0
252 Geometric Mean Titer
Interval 197.0 to 324.0
237 Geometric Mean Titer
Interval 184.0 to 305.0
Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age
Day 43 (≥65 yrs;N=150,147,164,148,159,155,154,150)
135 Geometric Mean Titer
Interval 107.0 to 171.0
118 Geometric Mean Titer
Interval 93.0 to 149.0
131 Geometric Mean Titer
Interval 104.0 to 164.0
167 Geometric Mean Titer
Interval 132.0 to 212.0
151 Geometric Mean Titer
Interval 120.0 to 190.0
164 Geometric Mean Titer
Interval 130.0 to 207.0
240 Geometric Mean Titer
Interval 190.0 to 302.0
211 Geometric Mean Titer
Interval 167.0 to 267.0

SECONDARY outcome

Timeframe: 21 days after each vaccination

Population: The analysis was on the per protocol set.

Immunogenicity evaluation after each vaccination by vaccine group according to CHMP (Committee for Medicinal Products for Human Use) criteria. Seroconversion is defined as the percentage of participants with either a prevaccination HI titer \<1:10 and a post vaccination HI titer \> 40 or a pre-vaccination HI titer \> 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as Hemagglutinin Inhibition (HI) antibody titer ≥1:40.

Outcome measures

Outcome measures
Measure
3.75_(50)MF59
n=135 Participants
50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
7.5 w/o MF59
n=130 Participants
1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
7.5_(50)MF59
n=132 Participants
50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
7.5_(100)MF59
n=132 Participants
100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
15 w/o MF59
n=122 Participants
1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
15_(50)MF59
n=124 Participants
50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
15_(100)MF59
n=141 Participants
100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
30 w/o MF59
n=127 Participants
1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age
Seroprotection Day 22
121 Participants
118 Participants
126 Participants
125 Participants
116 Participants
121 Participants
140 Participants
125 Participants
Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age
Seroconversion Day 22
108 Participants
95 Participants
116 Participants
118 Participants
111 Participants
113 Participants
129 Participants
116 Participants
Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age
Seroprotection Day 43
128 Participants
124 Participants
126 Participants
128 Participants
118 Participants
123 Participants
138 Participants
126 Participants
Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age
Seroconversion Day 43
112 Participants
98 Participants
115 Participants
122 Participants
110 Participants
114 Participants
132 Participants
119 Participants

SECONDARY outcome

Timeframe: 21 days after each vaccination

Population: The analysis was on the per protocol set.

Immunogenicity evaluation after each vaccination by vaccine group according to CHMP criteria. Seroconversion is defined as the percentage of participants with either a prevaccination HI titer \<1:10 and a post vaccination HI titer \> 40 or a pre-vaccination HI titer \> 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as Hemagglutinin Inhibition (HI) antibody titer ≥1:40.

Outcome measures

Outcome measures
Measure
3.75_(50)MF59
n=161 Participants
50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
7.5 w/o MF59
n=159 Participants
1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
7.5_(50)MF59
n=174 Participants
50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
7.5_(100)MF59
n=157 Participants
100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
15 w/o MF59
n=178 Participants
1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
15_(50)MF59
n=169 Participants
50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
15_(100)MF59
n=162 Participants
100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
30 w/o MF59
n=167 Participants
1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age
Seroprotection Day 22
130 Participants
127 Participants
135 Participants
131 Participants
153 Participants
155 Participants
149 Participants
151 Participants
Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age
Seroconversion Day 22
94 Participants
81 Participants
109 Participants
100 Participants
120 Participants
121 Participants
117 Participants
122 Participants
Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age
Seroprotection Day 43
140 Participants
125 Participants
142 Participants
140 Participants
143 Participants
150 Participants
150 Participants
152 Participants
Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age
Seroconversion Day 43
96 Participants
81 Participants
111 Participants
102 Participants
110 Participants
117 Participants
120 Participants
116 Participants

SECONDARY outcome

Timeframe: 21 days after vaccination

Population: The analysis was on the per protocol set. For this analysis, total subjects enrolled were stratified and randomized in two age groups, according to the CHMP criteria, 18 to 60 years and over 60 years of age.

Immunogenicity evaluation after each vaccination by vaccine group according to CHMP criteria. Geometric Mean Ratio (GMR) of the hemagglutinin inhibition (HI)titers.

Outcome measures

Outcome measures
Measure
3.75_(50)MF59
n=296 Participants
50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
7.5 w/o MF59
n=289 Participants
1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
7.5_(50)MF59
n=306 Participants
50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
7.5_(100)MF59
n=289 Participants
100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
15 w/o MF59
n=300 Participants
1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
15_(50)MF59
n=293 Participants
50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
15_(100)MF59
n=303 Participants
100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
30 w/o MF59
n=294 Participants
1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age
Day 22 (18-60y; N=135,130,132,132,122,124,141,127)
19 Geometric Mean Ratio
Interval 15.0 to 26.0
15 Geometric Mean Ratio
Interval 11.0 to 20.0
23 Geometric Mean Ratio
Interval 17.0 to 31.0
33 Geometric Mean Ratio
Interval 25.0 to 44.0
40 Geometric Mean Ratio
Interval 30.0 to 54.0
36 Geometric Mean Ratio
Interval 27.0 to 49.0
44 Geometric Mean Ratio
Interval 33.0 to 58.0
47 Geometric Mean Ratio
Interval 35.0 to 63.0
Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age
Day 43 (18-60y; N=135,130,132,132,122,124,141,127)
20 Geometric Mean Ratio
Interval 16.0 to 27.0
15 Geometric Mean Ratio
Interval 11.0 to 20.0
22 Geometric Mean Ratio
Interval 17.0 to 28.0
33 Geometric Mean Ratio
Interval 25.0 to 43.0
31 Geometric Mean Ratio
Interval 23.0 to 40.0
33 Geometric Mean Ratio
Interval 25.0 to 44.0
40 Geometric Mean Ratio
Interval 31.0 to 51.0
37 Geometric Mean Ratio
Interval 28.0 to 48.0
Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age
Day 22 (≥61yrs; N=161,159,174,157,178,169,162,167)
6.11 Geometric Mean Ratio
Interval 4.8 to 7.78
4.65 Geometric Mean Ratio
Interval 3.65 to 5.94
7.46 Geometric Mean Ratio
Interval 5.91 to 9.41
8.63 Geometric Mean Ratio
Interval 6.75 to 11.0
8.37 Geometric Mean Ratio
Interval 6.64 to 11.0
9.6 Geometric Mean Ratio
Interval 7.57 to 12.0
11 Geometric Mean Ratio
Interval 9.04 to 15.0
10 Geometric Mean Ratio
Interval 7.97 to 13.0
Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age
Day 43 (≥61 yrs;N=161,159,174,157,178,169,162,167)
6.2 Geometric Mean Ratio
Interval 4.97 to 7.75
4.18 Geometric Mean Ratio
Interval 3.34 to 5.23
6.77 Geometric Mean Ratio
Interval 5.47 to 8.4
7.78 Geometric Mean Ratio
Interval 6.21 to 9.75
6.72 Geometric Mean Ratio
Interval 5.43 to 8.31
7.78 Geometric Mean Ratio
Interval 6.25 to 9.68
11 Geometric Mean Ratio
Interval 8.76 to 14.0
8.8 Geometric Mean Ratio
Interval 7.07 to 11.0

SECONDARY outcome

Timeframe: 7 days after vaccination

Population: The population used in analysis was the safety set

Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.

Outcome measures

Outcome measures
Measure
3.75_(50)MF59
n=169 Participants
50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
7.5 w/o MF59
n=168 Participants
1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
7.5_(50)MF59
n=170 Participants
50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
7.5_(100)MF59
n=165 Participants
100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
15 w/o MF59
n=170 Participants
1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
15_(50)MF59
n=168 Participants
50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
15_(100)MF59
n=173 Participants
100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
30 w/o MF59
n=168 Participants
1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age
Pain
67 Participants
38 Participants
51 Participants
78 Participants
27 Participants
57 Participants
78 Participants
44 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age
Erythema
2 Participants
2 Participants
2 Participants
4 Participants
3 Participants
2 Participants
4 Participants
0 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age
Swelling
9 Participants
6 Participants
4 Participants
6 Participants
4 Participants
3 Participants
13 Participants
3 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age
Induration
11 Participants
5 Participants
9 Participants
9 Participants
8 Participants
8 Participants
15 Participants
7 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age
Tenderness
63 Participants
44 Participants
59 Participants
79 Participants
42 Participants
64 Participants
89 Participants
51 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age
Chills
6 Participants
9 Participants
11 Participants
8 Participants
9 Participants
8 Participants
14 Participants
10 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age
Myalgia
29 Participants
22 Participants
28 Participants
29 Participants
21 Participants
30 Participants
37 Participants
24 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age
Arthralgia
14 Participants
13 Participants
17 Participants
10 Participants
11 Participants
10 Participants
6 Participants
7 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age
Headache
37 Participants
39 Participants
42 Participants
32 Participants
43 Participants
39 Participants
36 Participants
36 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age
Nausea
14 Participants
15 Participants
19 Participants
8 Participants
12 Participants
13 Participants
16 Participants
13 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age
Vomiting (N=169, 168, 169, 165, 170, 168, 173,168)
3 Participants
3 Participants
2 Participants
1 Participants
3 Participants
2 Participants
1 Participants
2 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age
Diarrhoea
11 Participants
7 Participants
19 Participants
5 Participants
11 Participants
15 Participants
6 Participants
7 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age
Fatigue
25 Participants
28 Participants
27 Participants
17 Participants
27 Participants
27 Participants
26 Participants
27 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age
Oral Temp. (≥40°C)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age
Stay Home
6 Participants
6 Participants
4 Participants
3 Participants
8 Participants
9 Participants
9 Participants
6 Participants

SECONDARY outcome

Timeframe: 7 days after vaccination

Population: The analysis was on the safety set.

Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.

Outcome measures

Outcome measures
Measure
3.75_(50)MF59
n=164 Participants
50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
7.5 w/o MF59
n=163 Participants
1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
7.5_(50)MF59
n=162 Participants
50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
7.5_(100)MF59
n=160 Participants
100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
15 w/o MF59
n=162 Participants
1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
15_(50)MF59
n=160 Participants
50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
15_(100)MF59
n=169 Participants
100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
30 w/o MF59
n=163 Participants
1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age
Pain
46 Participants
32 Participants
39 Participants
42 Participants
35 Participants
43 Participants
54 Participants
45 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age
Erythema (N=164,163,162,160,162,160,169,163)
2 Participants
1 Participants
3 Participants
1 Participants
3 Participants
1 Participants
4 Participants
1 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age
Swelling (N=164,163,162,160,162,160,169,162)
10 Participants
2 Participants
5 Participants
8 Participants
6 Participants
4 Participants
9 Participants
2 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age
Induration (N=164,163,162,160,162,160,169,163)
7 Participants
5 Participants
6 Participants
7 Participants
5 Participants
11 Participants
13 Participants
11 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age
Tenderness (N=164,163,162,160,162,160,169,163)
51 Participants
33 Participants
52 Participants
56 Participants
44 Participants
58 Participants
66 Participants
56 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age
Chills (N=164,163,162,160,162,160,169,163)
9 Participants
3 Participants
4 Participants
5 Participants
5 Participants
7 Participants
5 Participants
2 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age
Myalgia (N=164,163,162,160,162,160,169,163)
22 Participants
18 Participants
14 Participants
20 Participants
20 Participants
16 Participants
24 Participants
10 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age
Arthralgia (N=164,163,162,160,162,160,169,163)
7 Participants
4 Participants
7 Participants
7 Participants
6 Participants
7 Participants
14 Participants
3 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age
Headache(N=164,163,162,160,162,160,169,163)
28 Participants
17 Participants
26 Participants
23 Participants
25 Participants
32 Participants
26 Participants
17 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age
Nausea(N=164,163,162,160,162,160,169,163)
5 Participants
7 Participants
9 Participants
8 Participants
4 Participants
9 Participants
13 Participants
6 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age
Vomiting (N=164,163,162,160,162,160,169,163)
0 Participants
1 Participants
1 Participants
0 Participants
1 Participants
1 Participants
2 Participants
0 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age
Diarrhoea(N=164,163,162,160,162,160,169,163)
5 Participants
11 Participants
8 Participants
5 Participants
6 Participants
8 Participants
7 Participants
5 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age
Fatigue(N=164,163,162,160,162,160,169,163)
17 Participants
12 Participants
15 Participants
18 Participants
12 Participants
18 Participants
26 Participants
10 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age
Oral Temp ≥40°C
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age
Stay Home (N=164,163,161,160,162,159,169,163)
4 Participants
3 Participants
5 Participants
0 Participants
2 Participants
3 Participants
6 Participants
0 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age
Analg/antipyr (N=164,163,162,160,162,160,169,163)
11 Participants
6 Participants
7 Participants
5 Participants
9 Participants
14 Participants
10 Participants
9 Participants

SECONDARY outcome

Timeframe: 7 days after vaccination

Population: The analysis was on the safety set.

Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.

Outcome measures

Outcome measures
Measure
3.75_(50)MF59
n=170 Participants
50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
7.5 w/o MF59
n=166 Participants
1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
7.5_(50)MF59
n=173 Participants
50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
7.5_(100)MF59
n=169 Participants
100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
15 w/o MF59
n=169 Participants
1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
15_(50)MF59
n=171 Participants
50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
15_(100)MF59
n=169 Participants
100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
30 w/o MF59
n=167 Participants
1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age
Pain
18 Participants
8 Participants
22 Participants
30 Participants
15 Participants
27 Participants
16 Participants
19 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age
Erythema
1 Participants
1 Participants
1 Participants
2 Participants
3 Participants
2 Participants
3 Participants
5 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age
Swelling
1 Participants
6 Participants
2 Participants
14 Participants
1 Participants
1 Participants
1 Participants
10 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age
Induration
8 Participants
8 Participants
5 Participants
10 Participants
2 Participants
6 Participants
7 Participants
14 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age
Tenderness
27 Participants
10 Participants
23 Participants
42 Participants
24 Participants
28 Participants
39 Participants
32 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age
Chills
6 Participants
8 Participants
5 Participants
4 Participants
6 Participants
1 Participants
5 Participants
3 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age
Myalgia
20 Participants
14 Participants
19 Participants
21 Participants
17 Participants
15 Participants
21 Participants
14 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age
Arthralgia
13 Participants
9 Participants
13 Participants
12 Participants
11 Participants
10 Participants
11 Participants
10 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age
Headache
23 Participants
21 Participants
22 Participants
25 Participants
16 Participants
22 Participants
17 Participants
14 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age
Nausea
2 Participants
4 Participants
2 Participants
3 Participants
6 Participants
5 Participants
6 Participants
7 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age
Vomitting (N=170,166,173,169.169,170,169,167)
0 Participants
2 Participants
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age
Diarrhoea
5 Participants
10 Participants
14 Participants
9 Participants
9 Participants
12 Participants
9 Participants
6 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age
Fatigue
23 Participants
20 Participants
21 Participants
19 Participants
20 Participants
15 Participants
22 Participants
13 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age
Oral Temp ≥40°C
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age
Stay Home
8 Participants
3 Participants
8 Participants
3 Participants
2 Participants
4 Participants
5 Participants
4 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age
Analg/antipyr (N=170,166,172,169.167,171,169,166)
9 Participants
7 Participants
7 Participants
11 Participants
7 Participants
6 Participants
5 Participants
2 Participants

SECONDARY outcome

Timeframe: 7 days after vaccination

Population: The analysis was on the safety set.

Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.

Outcome measures

Outcome measures
Measure
3.75_(50)MF59
n=164 Participants
50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
7.5 w/o MF59
n=156 Participants
1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
7.5_(50)MF59
n=171 Participants
50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
7.5_(100)MF59
n=160 Participants
100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
15 w/o MF59
n=166 Participants
1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
15_(50)MF59
n=168 Participants
50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
15_(100)MF59
n=165 Participants
100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
30 w/o MF59
n=165 Participants
1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age
Analg/antipyr (N=164,156,171,160,166,167,165,163)
2 Participants
7 Participants
10 Participants
4 Participants
1 Participants
1 Participants
3 Participants
3 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age
Pain (N=164,156,171,160,166,168,165,165)
12 Participants
8 Participants
17 Participants
16 Participants
17 Participants
15 Participants
17 Participants
14 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age
Erythema (N=163,156,171,160,166,168,165,164)
1 Participants
0 Participants
1 Participants
5 Participants
3 Participants
1 Participants
5 Participants
2 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age
Swelling (N=163,156,171,160,166,168,165,164)
1 Participants
1 Participants
3 Participants
4 Participants
1 Participants
3 Participants
6 Participants
3 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age
Induration (N=163,156,171,160,166,168,165,164)
3 Participants
3 Participants
7 Participants
4 Participants
2 Participants
6 Participants
7 Participants
6 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age
Tenderness (N=164,156,171,160,166,168,165,164)
22 Participants
12 Participants
26 Participants
30 Participants
25 Participants
26 Participants
31 Participants
18 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age
Chills (N=163,156,171,160,166,168,165,164)
2 Participants
7 Participants
7 Participants
4 Participants
5 Participants
3 Participants
5 Participants
3 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age
Myalgia (N=163,156,171,160,166,168,165,164)
20 Participants
14 Participants
15 Participants
9 Participants
16 Participants
12 Participants
11 Participants
7 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age
Arthralgia (N=163,156,171,160,166,168,165,164)
15 Participants
8 Participants
11 Participants
5 Participants
9 Participants
7 Participants
7 Participants
3 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age
Headache (N=163,156,171,160,166,168,165,164)
14 Participants
13 Participants
17 Participants
12 Participants
15 Participants
10 Participants
11 Participants
10 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age
Nausea (N=163,156,171,160,166,168,165,164)
4 Participants
5 Participants
5 Participants
3 Participants
7 Participants
4 Participants
4 Participants
2 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age
Vomiting (N=164,156,171,160,166,168,165,165)
0 Participants
1 Participants
2 Participants
1 Participants
1 Participants
1 Participants
0 Participants
0 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age
Diarrhoea (N=163,156,171,160,166,168,165,164)
4 Participants
5 Participants
10 Participants
2 Participants
6 Participants
6 Participants
6 Participants
2 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age
Fatigue (N=163,156,171,160,166,168,165,164)
19 Participants
9 Participants
14 Participants
7 Participants
14 Participants
8 Participants
11 Participants
5 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age
Oral Temp≥40°C (N=164,156,171,160,166,168,165,165)
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age
Stay Home(N=163,156,171,159,166,168,165,164)
3 Participants
5 Participants
5 Participants
1 Participants
2 Participants
0 Participants
0 Participants
2 Participants

Adverse Events

3.75_(50)MF59

Serious events: 5 serious events
Other events: 125 other events
Deaths: 0 deaths

7.5 w/o MF59

Serious events: 5 serious events
Other events: 108 other events
Deaths: 0 deaths

7.5_(50)MF59

Serious events: 5 serious events
Other events: 121 other events
Deaths: 0 deaths

7.5_(100)MF59

Serious events: 5 serious events
Other events: 128 other events
Deaths: 0 deaths

15 w/o MF59

Serious events: 6 serious events
Other events: 113 other events
Deaths: 0 deaths

15_(50)MF59

Serious events: 6 serious events
Other events: 122 other events
Deaths: 0 deaths

15_(100)MF59

Serious events: 5 serious events
Other events: 130 other events
Deaths: 0 deaths

30 w/o MF59

Serious events: 7 serious events
Other events: 110 other events
Deaths: 0 deaths

3.75_(50)MF59 (Above 65 Yrs)

Serious events: 9 serious events
Other events: 102 other events
Deaths: 0 deaths

7.5 w/o MF59 (≥65 Yrs)

Serious events: 16 serious events
Other events: 88 other events
Deaths: 0 deaths

7.5_(50)MF59 (≥65 Yrs)

Serious events: 18 serious events
Other events: 101 other events
Deaths: 0 deaths

7.5_(100)MF59 (≥65 Yrs)

Serious events: 11 serious events
Other events: 118 other events
Deaths: 0 deaths

15 w/o MF59 (≥ 65 Yrs)

Serious events: 12 serious events
Other events: 104 other events
Deaths: 0 deaths

15_(50)MF59 (≥65 Yrs)

Serious events: 20 serious events
Other events: 109 other events
Deaths: 0 deaths

15_(100)MF59 (≥65 Yrs)

Serious events: 14 serious events
Other events: 97 other events
Deaths: 0 deaths

30 w/o MF59 (≥65 Yrs)

Serious events: 10 serious events
Other events: 99 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
3.75_(50)MF59
n=170 participants at risk
50% of MF59 with the lowest amount of A/H1N1 antigen
7.5 w/o MF59
n=168 participants at risk
1 dose of 7.5 µg A/H1N1
7.5_(50)MF59
n=171 participants at risk
50% of MF59 with 7.5 µg A/H1N1 antigen
7.5_(100)MF59
n=165 participants at risk
100% of MF59 with 7.5 µg A/H1N1 antigen
15 w/o MF59
n=170 participants at risk
1 dose of 15 µg A/H1N1
15_(50)MF59
n=169 participants at risk
50% of MF59 with 15 µg A/H1N1 antigen
15_(100)MF59
n=174 participants at risk
100% of MF59 with 15 µg A/H1N1 antigen
30 w/o MF59
n=168 participants at risk
1 dose of 30 µg A/H1N1
3.75_(50)MF59 (Above 65 Yrs)
n=170 participants at risk
50% of MF59 with the lowest amount of A/H1N1 antigen
7.5 w/o MF59 (≥65 Yrs)
n=166 participants at risk
1 dose of 7.5 µg A/H1N1
7.5_(50)MF59 (≥65 Yrs)
n=173 participants at risk
50% of MF59 with 7.5 µg A/H1N1 antigen
7.5_(100)MF59 (≥65 Yrs)
n=169 participants at risk
100% of MF59 with 7.5 µg A/H1N1 antigen
15 w/o MF59 (≥ 65 Yrs)
n=169 participants at risk
1 dose of 15 µg A/H1N1
15_(50)MF59 (≥65 Yrs)
n=171 participants at risk
50% of MF59 with 15 µg A/H1N1 antigen
15_(100)MF59 (≥65 Yrs)
n=169 participants at risk
100% of MF59 with 15 µg A/H1N1 antigen
30 w/o MF59 (≥65 Yrs)
n=167 participants at risk
1 dose of 30 µg A/H1N1
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.58%
1/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Injury, poisoning and procedural complications
Ankle Fracture
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.58%
1/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.58%
1/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Vascular disorders
Arteriosclerosis
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Infections and infestations
Cellulitis
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.58%
1/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.58%
1/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Nervous system disorders
Cerebral Infarction
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
General disorders
Dehydration
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Psychiatric disorders
Depression
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.57%
1/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Endocrine disorders
Diabetes Mellitus
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.57%
1/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Infections and infestations
Influenza
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
1.2%
2/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
General disorders
Malaise
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Infections and infestations
Pneumonia
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
1.2%
2/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.58%
1/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
1.2%
2/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.58%
1/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
General disorders
Pyrexia
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Eye disorders
Retinal Detachment
0.59%
1/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Injury, poisoning and procedural complications
Road Traffic Accident
0.59%
1/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
1.2%
2/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
1.2%
2/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
General disorders
Suicide Attempt
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.57%
1/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Nervous system disorders
Syncope
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
1.2%
2/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Cardiac disorders
Cardiac Arrest
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.57%
1/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Cardiac disorders
Cardiomyopathy
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.58%
1/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.58%
1/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Cardiac disorders
Myocardial Infarction
0.59%
1/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.61%
1/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
1.2%
2/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
1.2%
2/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Gastrointestinal disorders
Colitis Ischaemic
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Gastrointestinal disorders
Colitis Ulcerative
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.61%
1/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Hepatobiliary disorders
Gallbladder non-functioning
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.61%
1/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Infections and infestations
Lobar Pneumonia
0.59%
1/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Injury, poisoning and procedural complications
Incisional Hernia
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Injury, poisoning and procedural complications
Splenic Rupture
0.59%
1/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Injury, poisoning and procedural complications
Traumatic Lung Injury
0.59%
1/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Investigations
Blood Pressure Increased
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Musculoskeletal and connective tissue disorders
Arthritis
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.57%
1/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Musculoskeletal and connective tissue disorders
Arthritis Reactive
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Musculoskeletal and connective tissue disorders
Intervertebral Disc Degeneration
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acoustic Neuroma
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-Cell Lymphoma
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder Cancer
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.61%
1/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Penis Carcinoma
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
1.8%
3/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Nervous system disorders
Migraine
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Nervous system disorders
Viith Nerve Paralysis
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.61%
1/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneus Complete
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.58%
1/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Pregnancy, puerperium and perinatal conditions
Eclampsia
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.58%
1/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Psychiatric disorders
Psychotic Disorder
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Psychiatric disorders
Suicidal Ideation
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Reproductive system and breast disorders
Menstruation Irregular
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.57%
1/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Respiratory, thoracic and mediastinal disorders
Pleurisy
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.61%
1/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Respiratory, thoracic and mediastinal disorders
Tonsillar Hypertrophy
0.59%
1/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Surgical and medical procedures
Intestinal Resection
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.57%
1/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Vascular disorders
Intra-abdominal Haemorrhage
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.58%
1/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Blood and lymphatic system disorders
Anaemia
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Cardiac disorders
Angina Pectoris
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Cardiac disorders
Aortic Valve imcompetence
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Cardiac disorders
Atrial Fibrillation
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.58%
1/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Cardiac disorders
Bradycardia
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Cardiac disorders
Cardiac Failure Congestive
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.58%
1/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Cardiac disorders
Cardiogenic shock
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.58%
1/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Cardiac disorders
Coronary artery disease
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
1.2%
2/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.58%
1/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
1.2%
2/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Cardiac disorders
Coronary artery occlusion
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Ear and labyrinth disorders
Vertigo
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.58%
1/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Endocrine disorders
Inappropriate antidiuretic hormone secretion
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.58%
1/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Gastrointestinal disorders
Gastric Ulcer
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
1.2%
2/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Gastrointestinal disorders
Gastritis
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Gastrointestinal disorders
Intestinal Mass
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.58%
1/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Gastrointestinal disorders
Intestinal Obstructuction
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.58%
1/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Gastrointestinal disorders
Pancreatitis
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Gastrointestinal disorders
Small Intestinal Obstruction
0.59%
1/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
General disorders
Chest Pain
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
1.2%
2/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
General disorders
Hernia
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Hepatobiliary disorders
Biliary Colic
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Hepatobiliary disorders
Cholecystitis
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Hepatobiliary disorders
Cholecystitis Acute
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Hepatobiliary disorders
Cholelithiasis
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.58%
1/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Hepatobiliary disorders
Cholestasis
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Hepatobiliary disorders
Gallbladder Disorder
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Infections and infestations
Cholecystitis Infective
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Infections and infestations
Cytomegalovirus Infection
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Infections and infestations
Diverticulitis
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Infections and infestations
Gastroenteritis Viral
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Infections and infestations
Labyrinthitis
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Infections and infestations
Sepsis
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Infections and infestations
Staphylococcal Infection
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Injury, poisoning and procedural complications
Arthropod Bite
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.58%
1/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Injury, poisoning and procedural complications
Fall
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
1.2%
2/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
1.2%
2/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Injury, poisoning and procedural complications
Head Injury
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Injury, poisoning and procedural complications
Injury
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.58%
1/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Injury, poisoning and procedural complications
Patella fracture
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.58%
1/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Injury, poisoning and procedural complications
Rib Fracture
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.58%
1/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Injury, poisoning and procedural complications
Scapula Fracture
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.58%
1/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Injury, poisoning and procedural complications
Skin Laceration
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.58%
1/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Injury, poisoning and procedural complications
Traumatic Brain Injury
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.58%
1/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Injury, poisoning and procedural complications
Urinary Retention Postoperative
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Investigations
Transaminases Increased
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.58%
1/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Metabolism and nutrition disorders
Glucose Tolerance Impaired
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Metabolism and nutrition disorders
Hypokalaemia
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Metabolism and nutrition disorders
Hyponatraemia
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Musculoskeletal and connective tissue disorders
Arthralgia
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Musculoskeletal and connective tissue disorders
Myalgia
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Musculoskeletal and connective tissue disorders
Osteoarthritis
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.58%
1/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
2.3%
4/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
1.8%
3/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Musculoskeletal and connective tissue disorders
Spinal Column Stenosis
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
1.2%
2/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Musculoskeletal and connective tissue disorders
Synovial Cyst
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.58%
1/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer Stage I
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.58%
1/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholesteatoma
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.58%
1/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Carcinoma Cell Type Unspecified Stage I
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid Tumour Benign
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid Neoplasm
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Cancer
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Nervous system disorders
Carotid Artery Occlusion
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.58%
1/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Nervous system disorders
Cerebral Haemorrhage
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Nervous system disorders
Cerebrovascular Accident
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.58%
1/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.58%
1/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Nervous system disorders
Convulsion
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.58%
1/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Nervous system disorders
Dementia
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.58%
1/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Nervous system disorders
Grand Mal Convulsion
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Nervous system disorders
Subarachnoid Haemorrhage
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.58%
1/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Nervous system disorders
Transient Ischaemic Attack
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.58%
1/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Psychiatric disorders
Anxiety
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Renal and urinary disorders
Renal Failure
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Renal and urinary disorders
Renal Failure Acute
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Renal and urinary disorders
Urinary Retention
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.58%
1/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.58%
1/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Reproductive system and breast disorders
Prostatic Obstruction
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.58%
1/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.58%
1/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Surgical and medical procedures
Ankle Operation
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Surgical and medical procedures
Knee Arthroplasty
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.58%
1/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Vascular disorders
Aneurysm
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Vascular disorders
Aortic Stenosis
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Vascular disorders
Arterial Occlusive Disease
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Vascular disorders
Haematoma
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Vascular disorders
Hypertensive Emergency
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.58%
1/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Infections and infestations
H1N1 Influenza
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.

Other adverse events

Other adverse events
Measure
3.75_(50)MF59
n=170 participants at risk
50% of MF59 with the lowest amount of A/H1N1 antigen
7.5 w/o MF59
n=168 participants at risk
1 dose of 7.5 µg A/H1N1
7.5_(50)MF59
n=171 participants at risk
50% of MF59 with 7.5 µg A/H1N1 antigen
7.5_(100)MF59
n=165 participants at risk
100% of MF59 with 7.5 µg A/H1N1 antigen
15 w/o MF59
n=170 participants at risk
1 dose of 15 µg A/H1N1
15_(50)MF59
n=169 participants at risk
50% of MF59 with 15 µg A/H1N1 antigen
15_(100)MF59
n=174 participants at risk
100% of MF59 with 15 µg A/H1N1 antigen
30 w/o MF59
n=168 participants at risk
1 dose of 30 µg A/H1N1
3.75_(50)MF59 (Above 65 Yrs)
n=170 participants at risk
50% of MF59 with the lowest amount of A/H1N1 antigen
7.5 w/o MF59 (≥65 Yrs)
n=166 participants at risk
1 dose of 7.5 µg A/H1N1
7.5_(50)MF59 (≥65 Yrs)
n=173 participants at risk
50% of MF59 with 7.5 µg A/H1N1 antigen
7.5_(100)MF59 (≥65 Yrs)
n=169 participants at risk
100% of MF59 with 7.5 µg A/H1N1 antigen
15 w/o MF59 (≥ 65 Yrs)
n=169 participants at risk
1 dose of 15 µg A/H1N1
15_(50)MF59 (≥65 Yrs)
n=171 participants at risk
50% of MF59 with 15 µg A/H1N1 antigen
15_(100)MF59 (≥65 Yrs)
n=169 participants at risk
100% of MF59 with 15 µg A/H1N1 antigen
30 w/o MF59 (≥65 Yrs)
n=167 participants at risk
1 dose of 30 µg A/H1N1
General disorders
Injection site erythema
13.5%
23/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
8.9%
15/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
12.3%
21/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
8.5%
14/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
8.8%
15/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
6.5%
11/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
13.2%
23/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
7.7%
13/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
8.8%
15/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
7.2%
12/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
8.7%
15/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
13.0%
22/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
9.5%
16/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
8.2%
14/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
13.6%
23/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
12.6%
21/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Nervous system disorders
Headache
32.9%
56/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
29.2%
49/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
29.8%
51/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
25.5%
42/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
35.3%
60/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
32.5%
55/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
28.7%
50/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
25.6%
43/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
19.4%
33/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
17.5%
29/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
19.1%
33/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
17.8%
30/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
16.6%
28/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
17.0%
29/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
14.8%
25/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
14.4%
24/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
6.5%
11/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
6.0%
10/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
4.7%
8/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
4.2%
7/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
4.7%
8/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
4.7%
8/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
3.4%
6/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
4.8%
8/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
2.4%
4/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
1.8%
3/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
1.2%
2/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
4.1%
7/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
2.4%
4/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
2.3%
4/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
3.0%
5/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
3.0%
5/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
General disorders
Injection site pain
57.1%
97/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
40.5%
68/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
52.6%
90/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
66.1%
109/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
42.4%
72/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
60.4%
102/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
64.4%
112/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
47.6%
80/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
24.7%
42/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
13.9%
23/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
24.3%
42/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
35.5%
60/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
30.2%
51/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
33.3%
57/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
29.6%
50/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
28.1%
47/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Musculoskeletal and connective tissue disorders
Myalgia
23.5%
40/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
20.2%
34/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
18.7%
32/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
26.1%
43/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
18.8%
32/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
23.1%
39/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
27.0%
47/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
17.9%
30/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
20.6%
35/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
14.5%
24/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
15.6%
27/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
16.0%
27/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
15.4%
26/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
13.5%
23/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
16.0%
27/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
11.4%
19/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
General disorders
Fatigue
19.4%
33/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
19.6%
33/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
20.5%
35/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
18.8%
31/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
18.2%
31/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
21.9%
37/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
20.7%
36/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
18.5%
31/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
21.2%
36/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
14.5%
24/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
16.8%
29/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
13.6%
23/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
15.4%
26/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
11.1%
19/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
16.6%
28/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
10.2%
17/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Gastrointestinal disorders
Nausea
11.8%
20/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
10.7%
18/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
14.6%
25/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
9.1%
15/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
9.4%
16/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
10.7%
18/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
15.5%
27/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
10.1%
17/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
3.5%
6/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
6.0%
10/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
5.2%
9/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
4.1%
7/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
7.1%
12/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
4.7%
8/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
6.5%
11/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
5.4%
9/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Gastrointestinal disorders
Diarrhoea
10.0%
17/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
10.7%
18/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
14.0%
24/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
7.9%
13/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
12.4%
21/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
10.7%
18/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
6.9%
12/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
8.9%
15/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
6.5%
11/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
10.2%
17/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
12.7%
22/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
9.5%
16/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
7.7%
13/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
9.9%
17/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
9.5%
16/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
5.4%
9/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Musculoskeletal and connective tissue disorders
Arthralgia
11.8%
20/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
10.1%
17/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
12.9%
22/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
13.3%
22/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
12.9%
22/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
9.5%
16/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
10.9%
19/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
7.7%
13/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
17.1%
29/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
10.8%
18/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
12.1%
21/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
13.6%
23/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
9.5%
16/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
9.9%
17/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
12.4%
21/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
8.4%
14/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
General disorders
Injection site induration
8.8%
15/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
5.4%
9/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
8.8%
15/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
7.9%
13/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
7.1%
12/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
8.3%
14/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
11.5%
20/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
10.1%
17/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
6.5%
11/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
6.6%
11/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
6.4%
11/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
5.9%
10/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
3.0%
5/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
5.8%
10/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
8.9%
15/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
12.0%
20/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
General disorders
Injection site swelling
9.4%
16/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
5.4%
9/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
5.8%
10/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
5.5%
9/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
5.9%
10/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
4.7%
8/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
8.6%
15/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
3.0%
5/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
1.2%
2/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
3.6%
6/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
2.9%
5/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
7.7%
13/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
1.8%
3/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
1.8%
3/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
3.6%
6/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
7.2%
12/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
General disorders
Chills
8.8%
15/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
7.7%
13/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
8.8%
15/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
7.3%
12/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
7.6%
13/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
8.9%
15/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
8.6%
15/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
6.5%
11/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
4.7%
8/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
7.2%
12/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
5.8%
10/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
4.7%
8/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
5.3%
9/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
2.3%
4/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
4.7%
8/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
3.6%
6/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Respiratory, thoracic and mediastinal disorders
Cough
7.1%
12/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
4.8%
8/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
4.1%
7/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
3.0%
5/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
4.1%
7/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
4.1%
7/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
3.4%
6/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
6.0%
10/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
3.5%
6/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
1.8%
3/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
4.6%
8/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
4.1%
7/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
3.6%
6/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
4.1%
7/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
6.5%
11/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
5.4%
9/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Infections and infestations
Nasopharyngitis
5.3%
9/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
4.8%
8/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
4.7%
8/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
3.6%
6/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
2.9%
5/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
1.8%
3/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
1.1%
2/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
4.1%
7/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
3.6%
6/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
4.6%
8/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
5.9%
10/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
2.4%
4/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
3.5%
6/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
4.1%
7/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
3.0%
5/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Infections and infestations
Sinusitis
4.7%
8/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
3.6%
6/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
11.1%
19/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
6.7%
11/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
9.4%
16/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
4.1%
7/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
3.4%
6/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
7.7%
13/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
4.7%
8/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
5.4%
9/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
7.5%
13/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
5.3%
9/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
5.3%
9/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
4.7%
8/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
3.0%
5/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
4.2%
7/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Infections and infestations
Upper Respiratory Tract infection
2.4%
4/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
8.3%
14/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
5.3%
9/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
6.7%
11/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
4.7%
8/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
5.3%
9/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
7.5%
13/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
3.6%
6/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
4.1%
7/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
5.4%
9/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
2.9%
5/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
8.3%
14/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
4.1%
7/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
3.5%
6/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
4.7%
8/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
6.6%
11/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Musculoskeletal and connective tissue disorders
Pain in Extremity
2.4%
4/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.60%
1/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
1.2%
2/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
1.8%
3/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
1.8%
3/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.57%
1/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
7.1%
12/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
2.4%
4/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.00%
0/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
3.0%
5/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
3.6%
6/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
1.8%
3/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
0.59%
1/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
3.6%
6/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
Infections and infestations
Bronchitis
1.8%
3/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
6.0%
10/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
2.3%
4/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
3.6%
6/165 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
4.1%
7/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
3.0%
5/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
1.7%
3/174 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
3.0%
5/168 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
2.4%
4/170 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
2.4%
4/166 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
3.5%
6/173 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
1.8%
3/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
3.0%
5/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
2.9%
5/171 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
3.0%
5/169 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.
1.2%
2/167 • All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).
A systematic AE is equivalent to an event that was solicited by the diary card, while a non-systematic event is equivalent to an event not solicited by the diary card. Safety was analyzed with data from all study centers; 10 enrolled participants were excluded for not receiving study vaccine or not providing safety data after first vaccination.

Additional Information

Posting Director

Novartis Vaccines and Diagnostics

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place