Trial Outcomes & Findings for A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline Biologicals' Influenza Vaccine GSK3206641A Administered in Adults 18 to 64 Years of Age and 65 Years of Age and Older (NCT NCT04789577)
NCT ID: NCT04789577
Last Updated: 2023-10-10
Results Overview
Center for Biologics Evaluation and Research (CBER) criteria for seroprotection rate (SPR) for 18 to 64 years of age is shown if the Lower Limit (LL) of the 99.17% confidence interval (CI) for the SPR meets or exceeds 70%, and for greater than or equal to (≥) 65 years of age if the LL of the 99.17% CI for the SPR meets or exceeds 60%. SPR is defined as the percentage of participants with an HI antibody titer ≥40 1/dilution (DIL). The percentage of participants was calculated along with Clopper-Pearson exact two-sided 99.17% CIs.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
833 participants
Primary outcome timeframe
At Day 43
Results posted on
2023-10-10
Participant Flow
Participant milestones
| Measure |
FLU-Q-PAN H7N9 Formulation 1_B Group
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 1_A Group
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_B Group
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_A Group
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 3_B Group
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22
|
FLU-Q-PAN H7N9 Formulation 3_A Group
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
Placebo Group
Healthy male and female participants who will receive two doses of placebo, the first dose at Day 1 and the second dose at Day 22.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
121
|
116
|
119
|
119
|
117
|
121
|
120
|
|
Overall Study
COMPLETED
|
113
|
103
|
111
|
105
|
108
|
107
|
109
|
|
Overall Study
NOT COMPLETED
|
8
|
13
|
8
|
14
|
9
|
14
|
11
|
Reasons for withdrawal
| Measure |
FLU-Q-PAN H7N9 Formulation 1_B Group
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 1_A Group
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_B Group
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_A Group
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 3_B Group
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22
|
FLU-Q-PAN H7N9 Formulation 3_A Group
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
Placebo Group
Healthy male and female participants who will receive two doses of placebo, the first dose at Day 1 and the second dose at Day 22.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
1
|
3
|
1
|
7
|
1
|
|
Overall Study
Lost to Follow-up
|
7
|
12
|
7
|
10
|
8
|
6
|
10
|
|
Overall Study
Migrated Or Moved From The Study Area
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
AE Requiring Expedited Reporting
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline Biologicals' Influenza Vaccine GSK3206641A Administered in Adults 18 to 64 Years of Age and 65 Years of Age and Older
Baseline characteristics by cohort
| Measure |
FLU-Q-PAN H7N9 Formulation 1_B Group
n=121 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 1_A Group
n=116 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_B Group
n=119 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_A Group
n=119 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 3_B Group
n=117 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22
|
FLU-Q-PAN H7N9 Formulation 3_A Group
n=121 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
Placebo Group
n=120 Participants
Healthy male and female participants who will receive two doses of placebo, the first dose at Day 1 and the second dose at Day 22.
|
Total
n=833 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Customized
18 - 64 years
|
61 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
58 Participants
n=21 Participants
|
61 Participants
n=8 Participants
|
60 Participants
n=8 Participants
|
414 Participants
n=24 Participants
|
|
Age, Customized
≥65 years
|
60 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
60 Participants
n=8 Participants
|
60 Participants
n=8 Participants
|
419 Participants
n=24 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
74 Participants
n=21 Participants
|
67 Participants
n=8 Participants
|
72 Participants
n=8 Participants
|
489 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
54 Participants
n=8 Participants
|
48 Participants
n=8 Participants
|
344 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
56 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
113 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
112 Participants
n=4 Participants
|
106 Participants
n=21 Participants
|
116 Participants
n=8 Participants
|
116 Participants
n=8 Participants
|
777 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
14 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
22 Participants
n=8 Participants
|
21 Participants
n=8 Participants
|
129 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
98 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
104 Participants
n=4 Participants
|
97 Participants
n=21 Participants
|
94 Participants
n=8 Participants
|
96 Participants
n=8 Participants
|
686 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: At Day 43Population: Analysis was performed on the Per Protocol Set (PPS), which included all participants with no major protocol deviations that lead to exclusion at or prior to Day 43, who had data collected for anti-HI antibodies, at each visit and for whom post-vaccination immunogenicity data was available at Day 43.
Center for Biologics Evaluation and Research (CBER) criteria for seroprotection rate (SPR) for 18 to 64 years of age is shown if the Lower Limit (LL) of the 99.17% confidence interval (CI) for the SPR meets or exceeds 70%, and for greater than or equal to (≥) 65 years of age if the LL of the 99.17% CI for the SPR meets or exceeds 60%. SPR is defined as the percentage of participants with an HI antibody titer ≥40 1/dilution (DIL). The percentage of participants was calculated along with Clopper-Pearson exact two-sided 99.17% CIs.
Outcome measures
| Measure |
FLU-Q-PAN H7N9 Formulation 1_B Group
n=98 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 1_A Group
n=93 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_B Group
n=97 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_A Group
n=94 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 3_B Group
n=101 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22
|
FLU-Q-PAN H7N9 Formulation 3_A Group
n=94 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
Placebo Group
n=95 Participants
Healthy male and female participants who will receive two doses of placebo, the first dose at Day 1 and the second dose at Day 22.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Seroprotected Participants for Anti-hemagglutination Inhibition (HI) Antibodies Against Vaccine-homologous H7N9
|
27.1 Percentage of Participants
Interval 16.1 to 40.6
|
27.7 Percentage of Participants
Interval 15.8 to 42.4
|
23.5 Percentage of Participants
Interval 12.7 to 37.6
|
26.5 Percentage of Participants
Interval 14.9 to 41.1
|
19.1 Percentage of Participants
Interval 9.5 to 32.3
|
40.5 Percentage of Participants
Interval 26.7 to 55.4
|
0 Percentage of Participants
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: At Day 43Population: Analysis was performed on the Per Protocol Set (PPS), which included all participants with no major protocol deviations that lead to exclusion at or prior to Day 43, who had data collected for anti-HI antibodies, at each visit and for whom post-vaccination immunogenicity data was available at Day 43.
CBER criteria for seroconversion rate (SCR) for 18 to 64 years of age is shown if LL of the 99.17% CI for the SCR meets or exceeds 40%, and for ≥65 years of age, if the LL of the 99.17% CI for the SCR meets or exceeds 30%. Seroconversion is defined as a post-vaccination antibody titer ≥40 1/DIL in the serum of participants seronegative before vaccination (i.e. titer \< assay cut-off at Day 1). For seropositive participants (i.e. titer ≥ assay cut-off at Day 1), seroconversion requires a 4-fold rise in post-vaccination HI antibody titer (but at least a titer of 40 1/DIL). The percentage of participants was calculated with Clopper-Pearson exact two-sided 99.17% CIs. Note: The cut-off value for antibody titer was defined by the laboratory before the analysis.
Outcome measures
| Measure |
FLU-Q-PAN H7N9 Formulation 1_B Group
n=98 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 1_A Group
n=93 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_B Group
n=97 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_A Group
n=94 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 3_B Group
n=101 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22
|
FLU-Q-PAN H7N9 Formulation 3_A Group
n=94 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
Placebo Group
n=95 Participants
Healthy male and female participants who will receive two doses of placebo, the first dose at Day 1 and the second dose at Day 22.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Seroconverted Participants for Anti-HI Antibodies Against Vaccine-homologous H7N9
|
27.1 Percentage of Participants
Interval 16.1 to 40.6
|
27.7 Percentage of Participants
Interval 15.8 to 42.4
|
23.5 Percentage of Participants
Interval 12.7 to 37.6
|
26.5 Percentage of Participants
Interval 14.9 to 41.1
|
19.1 Percentage of Participants
Interval 9.5 to 32.3
|
40.5 Percentage of Participants
Interval 26.7 to 55.4
|
0 Percentage of Participants
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: Within the 7-day follow-up period after Dose 1Population: Analysis was performed on the Exposed Set, which included all participants who received the first dose of study intervention and had solicited administration site adverse events data.
Solicited administered site events assessed were pain, redness and swelling. Any Pain = occurrence of symptom regardless of intensity grade. Any Redness or any Swelling symptom = any symptom having a surface diameter greater than (\>) 20 millimeters (mm).
Outcome measures
| Measure |
FLU-Q-PAN H7N9 Formulation 1_B Group
n=121 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 1_A Group
n=113 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_B Group
n=117 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_A Group
n=117 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 3_B Group
n=114 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22
|
FLU-Q-PAN H7N9 Formulation 3_A Group
n=115 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
Placebo Group
n=118 Participants
Healthy male and female participants who will receive two doses of placebo, the first dose at Day 1 and the second dose at Day 22.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Any Solicited Administration Site Events
Any Pain
|
72 Participants
|
77 Participants
|
68 Participants
|
80 Participants
|
53 Participants
|
78 Participants
|
15 Participants
|
|
Number of Participants With Any Solicited Administration Site Events
Any Redness
|
1 Participants
|
3 Participants
|
2 Participants
|
5 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Any Solicited Administration Site Events
Any Swelling
|
1 Participants
|
6 Participants
|
4 Participants
|
5 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Within the 7-day follow-up period after Dose 2Population: Analysis was performed on the Exposed Set, which included all participants who received the second dose of study intervention and had solicited administration site adverse events data.
Solicited administered site events assessed were pain, redness and swelling. Any Pain = occurrence of symptom regardless of intensity grade. Any Redness or any Swelling symptom = any symptom having a surface diameter \>20 mm.
Outcome measures
| Measure |
FLU-Q-PAN H7N9 Formulation 1_B Group
n=112 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 1_A Group
n=107 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_B Group
n=112 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_A Group
n=108 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 3_B Group
n=106 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22
|
FLU-Q-PAN H7N9 Formulation 3_A Group
n=105 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
Placebo Group
n=111 Participants
Healthy male and female participants who will receive two doses of placebo, the first dose at Day 1 and the second dose at Day 22.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Any Solicited Administration Site Events
Any Pain
|
53 Participants
|
62 Participants
|
58 Participants
|
66 Participants
|
42 Participants
|
56 Participants
|
13 Participants
|
|
Number of Participants With Any Solicited Administration Site Events
Any Redness
|
1 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Any Solicited Administration Site Events
Any Swelling
|
4 Participants
|
8 Participants
|
1 Participants
|
5 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Within the 7-day follow-up period after Dose 1Population: Analysis was performed on the Exposed Set, which included all participants who received the first dose of study intervention and had solicited systemic adverse events data.
Solicited systemic events assessed were fatigue, fever, headache, muscle ache all over body, joint pain, shivering, sweating and gastrointestinal symptoms (Nausea, vomiting, diarrhea and abdominal pain). Any = occurrence of symptom regardless of intensity grade. Fever was defined as temperature ≥38 degrees Celsius (°C) for oral route (preferred location for measuring temperature).
Outcome measures
| Measure |
FLU-Q-PAN H7N9 Formulation 1_B Group
n=121 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 1_A Group
n=112 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_B Group
n=117 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_A Group
n=117 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 3_B Group
n=114 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22
|
FLU-Q-PAN H7N9 Formulation 3_A Group
n=115 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
Placebo Group
n=118 Participants
Healthy male and female participants who will receive two doses of placebo, the first dose at Day 1 and the second dose at Day 22.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Any Solicited Systemic Events
Any Fatigue
|
41 Participants
|
39 Participants
|
31 Participants
|
36 Participants
|
27 Participants
|
41 Participants
|
37 Participants
|
|
Number of Participants With Any Solicited Systemic Events
Any Fever
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Any Solicited Systemic Events
Any Headache
|
31 Participants
|
29 Participants
|
24 Participants
|
33 Participants
|
16 Participants
|
33 Participants
|
29 Participants
|
|
Number of Participants With Any Solicited Systemic Events
Any Muscle Ache (all over body)
|
27 Participants
|
20 Participants
|
16 Participants
|
21 Participants
|
12 Participants
|
25 Participants
|
8 Participants
|
|
Number of Participants With Any Solicited Systemic Events
Any Vomiting
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Any Solicited Systemic Events
Any Joint Pain
|
13 Participants
|
13 Participants
|
19 Participants
|
11 Participants
|
12 Participants
|
16 Participants
|
10 Participants
|
|
Number of Participants With Any Solicited Systemic Events
Any Shivering
|
7 Participants
|
6 Participants
|
8 Participants
|
4 Participants
|
5 Participants
|
8 Participants
|
6 Participants
|
|
Number of Participants With Any Solicited Systemic Events
Any Sweating
|
10 Participants
|
7 Participants
|
4 Participants
|
4 Participants
|
7 Participants
|
13 Participants
|
8 Participants
|
|
Number of Participants With Any Solicited Systemic Events
Any Nausea
|
9 Participants
|
9 Participants
|
11 Participants
|
11 Participants
|
8 Participants
|
8 Participants
|
5 Participants
|
|
Number of Participants With Any Solicited Systemic Events
Any Diarrhea
|
7 Participants
|
10 Participants
|
15 Participants
|
8 Participants
|
6 Participants
|
8 Participants
|
11 Participants
|
|
Number of Participants With Any Solicited Systemic Events
Any Abdominal Pain
|
5 Participants
|
9 Participants
|
7 Participants
|
6 Participants
|
6 Participants
|
8 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Within the 7-day follow-up period after Dose 2Population: Analysis was performed on the Exposed Set, which included all participants who received the second dose of study intervention and had solicited systemic adverse events data.
Solicited systemic events assessed were fatigue, fever, headache, muscle ache all over body, joint pain, shivering, sweating and gastrointestinal symptoms (Nausea, vomiting, diarrhea and abdominal pain). Any = occurrence of symptom regardless of intensity grade. Fever was defined as temperature ≥38°C for oral route (preferred location for measuring temperature).
Outcome measures
| Measure |
FLU-Q-PAN H7N9 Formulation 1_B Group
n=112 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 1_A Group
n=107 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_B Group
n=112 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_A Group
n=108 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 3_B Group
n=106 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22
|
FLU-Q-PAN H7N9 Formulation 3_A Group
n=105 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
Placebo Group
n=111 Participants
Healthy male and female participants who will receive two doses of placebo, the first dose at Day 1 and the second dose at Day 22.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Any Solicited Systemic Events
Any Fatigue
|
34 Participants
|
20 Participants
|
28 Participants
|
29 Participants
|
21 Participants
|
34 Participants
|
20 Participants
|
|
Number of Participants With Any Solicited Systemic Events
Any Headache
|
23 Participants
|
19 Participants
|
19 Participants
|
20 Participants
|
16 Participants
|
21 Participants
|
12 Participants
|
|
Number of Participants With Any Solicited Systemic Events
Any Muscle Ache (all over body)
|
14 Participants
|
14 Participants
|
18 Participants
|
15 Participants
|
9 Participants
|
16 Participants
|
2 Participants
|
|
Number of Participants With Any Solicited Systemic Events
Any Joint Pain
|
8 Participants
|
10 Participants
|
15 Participants
|
12 Participants
|
10 Participants
|
14 Participants
|
6 Participants
|
|
Number of Participants With Any Solicited Systemic Events
Any Shivering
|
9 Participants
|
4 Participants
|
6 Participants
|
3 Participants
|
2 Participants
|
6 Participants
|
1 Participants
|
|
Number of Participants With Any Solicited Systemic Events
Any Sweating
|
6 Participants
|
4 Participants
|
7 Participants
|
7 Participants
|
6 Participants
|
8 Participants
|
5 Participants
|
|
Number of Participants With Any Solicited Systemic Events
Any Diarrhea
|
5 Participants
|
5 Participants
|
9 Participants
|
7 Participants
|
6 Participants
|
4 Participants
|
7 Participants
|
|
Number of Participants With Any Solicited Systemic Events
Any Abdominal Pain
|
5 Participants
|
1 Participants
|
10 Participants
|
5 Participants
|
5 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants With Any Solicited Systemic Events
Any Fever
|
1 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Any Solicited Systemic Events
Any Nausea
|
6 Participants
|
8 Participants
|
10 Participants
|
6 Participants
|
7 Participants
|
7 Participants
|
5 Participants
|
|
Number of Participants With Any Solicited Systemic Events
Any Vomiting
|
1 Participants
|
5 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Within the 21-day follow-up period after Dose 1Population: Analysis was performed on the ES, which included all participants who received the first dose of study intervention and had unsolicited adverse events data.
An unsolicited adverse event (AE) is an AE that was not solicited using a Participant Diary and that was spontaneously communicated by a participant who had signed the informed consent. Unsolicited AEs include serious and non-serious AEs. Potential unsolicited AEs may have been medically attended (i.e. symptoms or illnesses requiring a hospitalization, or emergency room visit, or visit to/by a health care provider). Unsolicited AEs that were not medically attended nor perceived as a concern by participant were collected during interview with the participants and by review of available medical records at the following visit. An unsolicited adverse event is any event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Outcome measures
| Measure |
FLU-Q-PAN H7N9 Formulation 1_B Group
n=121 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 1_A Group
n=116 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_B Group
n=119 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_A Group
n=119 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 3_B Group
n=117 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22
|
FLU-Q-PAN H7N9 Formulation 3_A Group
n=121 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
Placebo Group
n=120 Participants
Healthy male and female participants who will receive two doses of placebo, the first dose at Day 1 and the second dose at Day 22.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Any and Related Unsolicited Adverse Events
Any AEs
|
26 Participants
|
19 Participants
|
20 Participants
|
21 Participants
|
15 Participants
|
26 Participants
|
21 Participants
|
|
Number of Participants With Any and Related Unsolicited Adverse Events
Related AEs
|
9 Participants
|
7 Participants
|
7 Participants
|
10 Participants
|
9 Participants
|
13 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: Within the 21-day follow-up period after Dose 2Population: Analysis was performed on the ES, which included all participants who received the second dose of study intervention and had unsolicited adverse events data.
An unsolicited AE is an AE that was not solicited using a Participant Diary and that was spontaneously communicated by a participant who has signed the informed consent. Unsolicited AEs include serious and non-serious AEs. Potential unsolicited AEs may have been medically attended (i.e. symptoms or illnesses requiring a hospitalization, or emergency room visit, or visit to/by a health care provider). Unsolicited AEs that were not medically attended nor perceived as a concern by participant are collected during interview with the participants and by review of available medical records at the next visit. An unsolicited adverse event is any event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Outcome measures
| Measure |
FLU-Q-PAN H7N9 Formulation 1_B Group
n=115 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 1_A Group
n=112 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_B Group
n=113 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_A Group
n=111 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 3_B Group
n=111 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22
|
FLU-Q-PAN H7N9 Formulation 3_A Group
n=106 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
Placebo Group
n=113 Participants
Healthy male and female participants who will receive two doses of placebo, the first dose at Day 1 and the second dose at Day 22.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Any and Related Unsolicited Adverse Events
Any AEs
|
20 Participants
|
20 Participants
|
16 Participants
|
19 Participants
|
19 Participants
|
21 Participants
|
14 Participants
|
|
Number of Participants With Any and Related Unsolicited Adverse Events
Related AEs
|
4 Participants
|
7 Participants
|
5 Participants
|
3 Participants
|
8 Participants
|
7 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Within the 21-day follow-up period after Dose 1Population: Analysis was performed on the ES, which included all participants who received the first dose of study intervention and had MAEs data.
MAEs were defined as adverse events with medically-attended visits that are not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason.
Outcome measures
| Measure |
FLU-Q-PAN H7N9 Formulation 1_B Group
n=121 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 1_A Group
n=116 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_B Group
n=119 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_A Group
n=119 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 3_B Group
n=117 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22
|
FLU-Q-PAN H7N9 Formulation 3_A Group
n=121 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
Placebo Group
n=120 Participants
Healthy male and female participants who will receive two doses of placebo, the first dose at Day 1 and the second dose at Day 22.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Any and Related Medically Attended Adverse Events (MAEs)
Any MAEs
|
5 Participants
|
7 Participants
|
10 Participants
|
5 Participants
|
3 Participants
|
9 Participants
|
4 Participants
|
|
Number of Participants With Any and Related Medically Attended Adverse Events (MAEs)
Related MAEs
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Within the 21-day follow-up period after Dose 2Population: Analysis was performed on the ES, which included all participants who received the second dose of study intervention and had MAEs data.
MAEs were defined as adverse events with medically-attended visits that are not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason.
Outcome measures
| Measure |
FLU-Q-PAN H7N9 Formulation 1_B Group
n=115 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 1_A Group
n=112 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_B Group
n=113 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_A Group
n=111 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 3_B Group
n=111 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22
|
FLU-Q-PAN H7N9 Formulation 3_A Group
n=106 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
Placebo Group
n=113 Participants
Healthy male and female participants who will receive two doses of placebo, the first dose at Day 1 and the second dose at Day 22.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Any and Related MAEs
Any MAEs
|
6 Participants
|
7 Participants
|
4 Participants
|
8 Participants
|
3 Participants
|
7 Participants
|
3 Participants
|
|
Number of Participants With Any and Related MAEs
Related MAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to Day 43Population: Analysis was performed on the ES, which included all participants who received any study intervention and had SAEs data.
A SAE is any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization or result in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant. Abnormal pregnancy outcomes were also considered (e.g. spontaneous abortion, fatal death, stillbirth, congenital anomalies, ectopic pregnancy) or other situations where medical or scientific judgement was exercised in deciding whether reporting was appropriate.
Outcome measures
| Measure |
FLU-Q-PAN H7N9 Formulation 1_B Group
n=121 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 1_A Group
n=116 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_B Group
n=119 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_A Group
n=119 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 3_B Group
n=117 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22
|
FLU-Q-PAN H7N9 Formulation 3_A Group
n=121 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
Placebo Group
n=120 Participants
Healthy male and female participants who will receive two doses of placebo, the first dose at Day 1 and the second dose at Day 22.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Any and Related Serious Adverse Events (SAEs)
Any SAEs
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Any and Related Serious Adverse Events (SAEs)
Related SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to Day 43Population: Analysis was performed on the ES, which included all participants who received any study intervention and had pIMDs adverse events data.
pIMDs are a subset of adverse events of special interest that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have had an autoimmune etiology.
Outcome measures
| Measure |
FLU-Q-PAN H7N9 Formulation 1_B Group
n=121 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 1_A Group
n=116 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_B Group
n=119 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_A Group
n=119 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 3_B Group
n=117 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22
|
FLU-Q-PAN H7N9 Formulation 3_A Group
n=121 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
Placebo Group
n=120 Participants
Healthy male and female participants who will receive two doses of placebo, the first dose at Day 1 and the second dose at Day 22.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Any and Related Potential Immune Mediated Diseases (pIMDs)
Any pIMDs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Any and Related Potential Immune Mediated Diseases (pIMDs)
Related pIMDs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to Month 13Population: Analysis was performed on the ES, which included all participants who received any study intervention and had pIMDs adverse events data.
pIMDs are a subset of adverse events of special interest that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have had an autoimmune etiology.
Outcome measures
| Measure |
FLU-Q-PAN H7N9 Formulation 1_B Group
n=121 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 1_A Group
n=116 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_B Group
n=119 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_A Group
n=119 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 3_B Group
n=117 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22
|
FLU-Q-PAN H7N9 Formulation 3_A Group
n=121 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
Placebo Group
n=120 Participants
Healthy male and female participants who will receive two doses of placebo, the first dose at Day 1 and the second dose at Day 22.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Any pIMDs
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to Month 13Population: Analysis was performed on the ES, which included all participants who received any study intervention and had SAEs data.
A SAE is any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization or result in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant. Abnormal pregnancy outcomes were also considered (e.g. spontaneous abortion, fatal death, stillbirth, congenital anomalies, ectopic pregnancy) or other situations where medical or scientific judgement was exercised in deciding whether reporting was appropriate.
Outcome measures
| Measure |
FLU-Q-PAN H7N9 Formulation 1_B Group
n=121 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 1_A Group
n=116 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_B Group
n=119 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_A Group
n=119 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 3_B Group
n=117 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22
|
FLU-Q-PAN H7N9 Formulation 3_A Group
n=121 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
Placebo Group
n=120 Participants
Healthy male and female participants who will receive two doses of placebo, the first dose at Day 1 and the second dose at Day 22.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Any SAEs
|
3 Participants
|
3 Participants
|
10 Participants
|
4 Participants
|
6 Participants
|
5 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: At Day 1, Day 22 and Day 43Population: Analysis was performed on the PPS, which included all participants with no major protocol deviations that lead to exclusion at or prior to Day 43, who had data collected for HI antibody titers at each visit and for whom post-vaccination immunogenicity data was available for the specified timepoints and specific assay.
HI antibody titers were expressed as Geometric Mean Titers (GMTs). The GMTs calculations were performed by taking the anti-log of the mean of the titer transformations. Values for titers below the assay cutoff will be assigned half the assay cut-off value for the purpose of GMT computation. Note: The cut-off value for HI titer was defined by the laboratory before the analysis.
Outcome measures
| Measure |
FLU-Q-PAN H7N9 Formulation 1_B Group
n=98 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 1_A Group
n=93 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_B Group
n=97 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_A Group
n=94 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 3_B Group
n=101 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22
|
FLU-Q-PAN H7N9 Formulation 3_A Group
n=94 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
Placebo Group
n=95 Participants
Healthy male and female participants who will receive two doses of placebo, the first dose at Day 1 and the second dose at Day 22.
|
|---|---|---|---|---|---|---|---|
|
HI Antibody Titers Against Vaccine-homologous H7N9
Day 1
|
5.2 Titers
Interval 5.0 to 5.4
|
5.2 Titers
Interval 5.0 to 5.5
|
5.1 Titers
Interval 5.0 to 5.2
|
5.1 Titers
Interval 5.0 to 5.2
|
5.1 Titers
Interval 5.0 to 5.3
|
5.1 Titers
Interval 5.0 to 5.3
|
5.1 Titers
Interval 5.0 to 5.2
|
|
HI Antibody Titers Against Vaccine-homologous H7N9
Day 22
|
5.9 Titers
Interval 5.4 to 6.4
|
6.0 Titers
Interval 5.6 to 6.4
|
6.8 Titers
Interval 5.9 to 8.0
|
7.0 Titers
Interval 6.2 to 8.0
|
7.6 Titers
Interval 6.5 to 8.8
|
8.9 Titers
Interval 7.4 to 10.7
|
5.1 Titers
Interval 5.0 to 5.2
|
|
HI Antibody Titers Against Vaccine-homologous H7N9
Day 43
|
13.8 Titers
Interval 11.4 to 16.7
|
15.7 Titers
Interval 13.0 to 18.9
|
14.1 Titers
Interval 11.4 to 17.3
|
16.4 Titers
Interval 13.6 to 19.7
|
13.3 Titers
Interval 10.9 to 16.2
|
23.1 Titers
Interval 18.2 to 29.3
|
5.1 Titers
Interval 5.0 to 5.3
|
SECONDARY outcome
Timeframe: At Day 1, Day 22 and Day 43Population: Analysis was performed on the PPS, which included all participants with no major protocol deviations that lead to exclusion at or prior to Day 43, who had data collected for anti-HI antibodies, at each visit and for whom post-vaccination immunogenicity data was available for the specified timepoints and specific assay.
A seropositive participant is a participant whose antibody titer was greater than or equal to the assay cut-off value. Note: The cut-off value for antibody titer was defined by the laboratory before the analysis.
Outcome measures
| Measure |
FLU-Q-PAN H7N9 Formulation 1_B Group
n=98 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 1_A Group
n=93 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_B Group
n=97 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_A Group
n=94 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 3_B Group
n=101 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22
|
FLU-Q-PAN H7N9 Formulation 3_A Group
n=94 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
Placebo Group
n=95 Participants
Healthy male and female participants who will receive two doses of placebo, the first dose at Day 1 and the second dose at Day 22.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Seropositive Participants for HI Antibodies Against Vaccine-homologous H7N9
Day 1
|
4.1 Percentage of Participants
Interval 1.1 to 10.1
|
4.3 Percentage of Participants
Interval 1.2 to 10.6
|
3.1 Percentage of Participants
Interval 0.6 to 8.8
|
3.2 Percentage of Participants
Interval 0.7 to 9.0
|
2.0 Percentage of Participants
Interval 0.2 to 7.0
|
4.3 Percentage of Participants
Interval 1.2 to 10.5
|
2.1 Percentage of Participants
Interval 0.3 to 7.4
|
|
Percentage of Seropositive Participants for HI Antibodies Against Vaccine-homologous H7N9
Day 22
|
18.4 Percentage of Participants
Interval 11.3 to 27.5
|
24.7 Percentage of Participants
Interval 16.4 to 34.8
|
23.7 Percentage of Participants
Interval 15.7 to 33.4
|
29.8 Percentage of Participants
Interval 20.8 to 40.1
|
32.7 Percentage of Participants
Interval 23.7 to 42.7
|
44.7 Percentage of Participants
Interval 34.4 to 55.3
|
3.2 Percentage of Participants
Interval 0.7 to 9.0
|
|
Percentage of Seropositive Participants for HI Antibodies Against Vaccine-homologous H7N9
Day 43
|
65.6 Percentage of Participants
Interval 55.2 to 75.0
|
77.1 Percentage of Participants
Interval 66.6 to 85.6
|
71.8 Percentage of Participants
Interval 61.0 to 81.0
|
79.5 Percentage of Participants
Interval 69.2 to 87.6
|
69.7 Percentage of Participants
Interval 59.0 to 79.0
|
83.3 Percentage of Participants
Interval 73.6 to 90.6
|
3.7 Percentage of Participants
Interval 0.8 to 10.3
|
SECONDARY outcome
Timeframe: At Day 22Population: Analysis was performed on the PPS, which included all participants with no major protocol deviations that lead to exclusion at or prior to Day 22, who had data collected for anti-HI antibodies, at each visit and for whom post-vaccination immunogenicity data was available at Day 22.
Seroconversion rate is defined as the percentage of participants with a post-vaccination antibody titer ≥40 1/DIL in the serum of participants seronegative before vaccination (i.e. titer \< assay cut-off at Day 1). For seropositive participants (i.e. titer ≥ assay cut-off at Day 1), seroconversion required a 4-fold rise in post-vaccination HI antibody titer (but at least a titer of 40 1/DIL). Note: The cut-off value for antibody titer was defined by the laboratory before the analysis.
Outcome measures
| Measure |
FLU-Q-PAN H7N9 Formulation 1_B Group
n=98 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 1_A Group
n=93 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_B Group
n=97 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_A Group
n=94 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 3_B Group
n=101 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22
|
FLU-Q-PAN H7N9 Formulation 3_A Group
n=94 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
Placebo Group
n=95 Participants
Healthy male and female participants who will receive two doses of placebo, the first dose at Day 1 and the second dose at Day 22.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Seroconverted Participants for HI Antibodies Against Vaccine-homologous H7N9
|
0 Percentage of Participants
Interval 0.0 to 3.7
|
0 Percentage of Participants
Interval 0.0 to 3.9
|
5.2 Percentage of Participants
Interval 1.7 to 11.6
|
4.3 Percentage of Participants
Interval 1.2 to 10.5
|
6.9 Percentage of Participants
Interval 2.8 to 13.8
|
9.6 Percentage of Participants
Interval 4.5 to 17.4
|
0 Percentage of Participants
Interval 0.0 to 3.8
|
SECONDARY outcome
Timeframe: At Day 1 and Day 22Population: Analysis was performed on the Per Protocol Set (PPS), which included all participants with no major protocol deviations that lead to exclusion at or prior to Day 22, who had data collected for anti-HI antibodies, at each visit and for whom post-vaccination immunogenicity data was available at the specified timepoints and specific assay.
SPR is defined as the percentage of participants with HI antibody titer ≥40 1/DIL. Note: The cut-off value for antibody titer was defined by the laboratory before the analysis.
Outcome measures
| Measure |
FLU-Q-PAN H7N9 Formulation 1_B Group
n=98 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 1_A Group
n=93 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_B Group
n=97 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_A Group
n=94 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 3_B Group
n=101 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22
|
FLU-Q-PAN H7N9 Formulation 3_A Group
n=94 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
Placebo Group
n=95 Participants
Healthy male and female participants who will receive two doses of placebo, the first dose at Day 1 and the second dose at Day 22.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Seroprotected Participants for HI Antibodies Against Vaccine-homologous H7N9
Day 1
|
0 Percentage of Participants
Interval 0.0 to 3.7
|
1.1 Percentage of Participants
Interval 0.0 to 5.8
|
0 Percentage of Participants
Interval 0.0 to 3.7
|
0 Percentage of Participants
Interval 0.0 to 3.8
|
0 Percentage of Participants
Interval 0.0 to 3.6
|
0 Percentage of Participants
Interval 0.0 to 3.8
|
0 Percentage of Participants
Interval 0.0 to 3.8
|
|
Percentage of Seroprotected Participants for HI Antibodies Against Vaccine-homologous H7N9
Day 22
|
1.0 Percentage of Participants
Interval 0.0 to 5.6
|
0 Percentage of Participants
Interval 0.0 to 3.9
|
5.2 Percentage of Participants
Interval 1.7 to 11.6
|
4.3 Percentage of Participants
Interval 1.2 to 10.5
|
6.9 Percentage of Participants
Interval 2.8 to 13.8
|
9.6 Percentage of Participants
Interval 4.5 to 17.4
|
0 Percentage of Participants
Interval 0.0 to 3.8
|
SECONDARY outcome
Timeframe: At Day 22 (post-Dose 1/pre-vaccination) and Day 43 (post-Dose 2/pre-vaccination)Population: Analysis was performed on the PPS, which included all participants with no major protocol deviations that lead to exclusion at or prior to Day 43, who had data collected for HI antibody titers at each visit and for whom post-vaccination immunogenicity data was available for the specified timepoints and specific assay.
MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 1): post-vaccination GMT over pre-vaccination GMT.
Outcome measures
| Measure |
FLU-Q-PAN H7N9 Formulation 1_B Group
n=98 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 1_A Group
n=93 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_B Group
n=97 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_A Group
n=94 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 3_B Group
n=101 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22
|
FLU-Q-PAN H7N9 Formulation 3_A Group
n=94 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
Placebo Group
n=95 Participants
Healthy male and female participants who will receive two doses of placebo, the first dose at Day 1 and the second dose at Day 22.
|
|---|---|---|---|---|---|---|---|
|
Mean Geometric Increase (MGI) of HI Antibody Titers Against Vaccine-homologous H7N9
Day 22
|
1.1 Ratio
Interval 1.1 to 1.2
|
1.1 Ratio
Interval 1.1 to 1.2
|
1.3 Ratio
Interval 1.2 to 1.6
|
1.4 Ratio
Interval 1.2 to 1.6
|
1.5 Ratio
Interval 1.3 to 1.7
|
1.7 Ratio
Interval 1.4 to 2.1
|
1.0 Ratio
Interval 1.0 to 1.0
|
|
Mean Geometric Increase (MGI) of HI Antibody Titers Against Vaccine-homologous H7N9
Day 43
|
2.7 Ratio
Interval 2.2 to 3.3
|
3.0 Ratio
Interval 2.4 to 3.6
|
2.7 Ratio
Interval 2.2 to 3.4
|
3.2 Ratio
Interval 2.6 to 3.9
|
2.6 Ratio
Interval 2.1 to 3.2
|
4.5 Ratio
Interval 3.5 to 5.7
|
1.0 Ratio
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: At Day 1, Day 22 and Day 43Population: Analysis was performed on the MN subset (selection of approximatively 50% participants from H7N9 vaccine groups and 50% participants from Placebo group) of the Per Protocol Set, which included all participants with no major protocol deviations that lead to exclusion at or prior to Day 43, who had data collected for MN at each visit and for whom immunogenicity data was available for the specified timepoints and specific assay.
Anti-MN antibody titers were expressed as GMTs. The GMTs calculations were performed by taking the antilog of the mean of the log titer transformations. Values for the neutralisation titers below the assay cut-off were assigned half the assay cut-off value for the purpose of GMT computation. MN analyses were performed on the MN subset that included approximately 420 participants (60 per group). The first 30 participants per treatment group were selected in the ≥65 age group and then the first 15 participants in 18 to 49 years and 50 to 64 years age groups. If there were not 15 participants for the 18 to 49 or 50 to 64 years age groups, they were selected whichever had the smaller number fully and then had a total of 30 for the total among these 2 age groups per treatment group. All samples were collected first, then selected for the subset.
Outcome measures
| Measure |
FLU-Q-PAN H7N9 Formulation 1_B Group
n=48 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 1_A Group
n=46 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_B Group
n=50 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_A Group
n=51 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 3_B Group
n=50 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22
|
FLU-Q-PAN H7N9 Formulation 3_A Group
n=48 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
Placebo Group
n=51 Participants
Healthy male and female participants who will receive two doses of placebo, the first dose at Day 1 and the second dose at Day 22.
|
|---|---|---|---|---|---|---|---|
|
Anti-microneutralization (MN) Antibody Titers Against Vaccine-homologous H7N9 for a Subset of Participants
Day 1
|
14.150 Titers
The Confidence Interval could not be calculated.
|
14.150 Titers
The Confidence Interval could not be calculated.
|
14.348 Titers
Interval 14.0 to 14.8
|
14.150 Titers
The Confidence Interval could not be calculated.
|
14.150 Titers
The Confidence Interval could not be calculated.
|
14.356 Titers
Interval 13.9 to 14.8
|
14.344 Titers
Interval 14.0 to 14.7
|
|
Anti-microneutralization (MN) Antibody Titers Against Vaccine-homologous H7N9 for a Subset of Participants
Day 22
|
15.997 Titers
Interval 14.3 to 17.8
|
15.724 Titers
Interval 14.4 to 17.1
|
18.800 Titers
Interval 14.7 to 24.1
|
17.232 Titers
Interval 15.2 to 19.6
|
17.180 Titers
Interval 14.8 to 19.9
|
18.218 Titers
Interval 15.9 to 20.9
|
14.344 Titers
Interval 14.0 to 14.7
|
|
Anti-microneutralization (MN) Antibody Titers Against Vaccine-homologous H7N9 for a Subset of Participants
Day 43
|
41.784 Titers
Interval 31.4 to 55.6
|
42.453 Titers
Interval 31.6 to 57.0
|
37.153 Titers
Interval 27.5 to 50.2
|
40.926 Titers
Interval 31.0 to 54.0
|
32.792 Titers
Interval 25.9 to 41.5
|
54.297 Titers
Interval 38.6 to 76.3
|
14.603 Titers
Interval 14.0 to 15.3
|
SECONDARY outcome
Timeframe: At Day 1, Day 22 and Day 43Population: Analysis was performed on the MN subset (selection of approximatively 50% participants from H7N9 vaccine groups and 50% participants from Placebo group) of the Per Protocol Set, which included all participants with no major protocol deviations that lead to exclusion at or prior to Day 43, who had data for seropositivity of MN antibodies at each visit and for whom post-vaccination immunogenicity data was available for the specified timepoints and specific assay.
A seropositive participant is a participant whose antibody titer was greater than or equal to the assay cut-off value. Note: The cut-off value for antibody titer was defined by the laboratory before the analysis. MN analyses were performed on the MN subset.
Outcome measures
| Measure |
FLU-Q-PAN H7N9 Formulation 1_B Group
n=48 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 1_A Group
n=46 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_B Group
n=50 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_A Group
n=51 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 3_B Group
n=50 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22
|
FLU-Q-PAN H7N9 Formulation 3_A Group
n=48 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
Placebo Group
n=51 Participants
Healthy male and female participants who will receive two doses of placebo, the first dose at Day 1 and the second dose at Day 22.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Seropositive Participants for Vaccine-homologous H7N9 MN Antibody Titers for a Subset of Participants
Day 1
|
0 Percentage of Participants
Interval 0.0 to 7.4
|
0 Percentage of Participants
Interval 0.0 to 7.7
|
2.0 Percentage of Participants
Interval 0.1 to 10.6
|
0 Percentage of Participants
Interval 0.0 to 7.0
|
0 Percentage of Participants
Interval 0.0 to 7.1
|
2.1 Percentage of Participants
Interval 0.1 to 11.1
|
2.0 Percentage of Participants
Interval 0.0 to 10.4
|
|
Percentage of Seropositive Participants for Vaccine-homologous H7N9 MN Antibody Titers for a Subset of Participants
Day 22
|
12.5 Percentage of Participants
Interval 4.7 to 25.2
|
13.0 Percentage of Participants
Interval 4.9 to 26.3
|
16.0 Percentage of Participants
Interval 7.2 to 29.1
|
19.6 Percentage of Participants
Interval 9.8 to 33.1
|
16 Percentage of Participants
Interval 7.2 to 29.1
|
25.0 Percentage of Participants
Interval 13.6 to 39.6
|
2.0 Percentage of Participants
Interval 0.0 to 10.4
|
|
Percentage of Seropositive Participants for Vaccine-homologous H7N9 MN Antibody Titers for a Subset of Participants
Day 43
|
66.7 Percentage of Participants
Interval 51.6 to 79.6
|
73.2 Percentage of Participants
Interval 57.1 to 85.8
|
69.0 Percentage of Participants
Interval 52.9 to 82.4
|
67.4 Percentage of Participants
Interval 52.0 to 80.5
|
66.0 Percentage of Participants
Interval 50.7 to 79.1
|
76.2 Percentage of Participants
Interval 60.5 to 87.9
|
4.5 Percentage of Participants
Interval 0.6 to 15.5
|
SECONDARY outcome
Timeframe: At Day 22 and Day 43Population: Analysis was performed on the MN subset (selection of approximatively 50% participants from H7N9 vaccine groups and 50% participants from Placebo group) of the Per Protocol Set, which included all participants with no major protocol deviations that lead to exclusion at or prior to Day 43, who had data for VRR at each visit and for whom post-vaccination immunogenicity data was available for the specified timepoints and specific assay.
VRR is expressed as the percentage of participants with a vaccine response defined as at least a 4-fold increase in antibody titer as compared to the antibody titer at Day 1 (pre-vaccination). Antibody titers below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of vaccine response calculation. For VRR, the percentage of participants was calculated with Clopper-Pearson exact two-sided 95% CIs. MN analyses were performed on the MN subset.
Outcome measures
| Measure |
FLU-Q-PAN H7N9 Formulation 1_B Group
n=48 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 1_A Group
n=46 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_B Group
n=50 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_A Group
n=51 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 3_B Group
n=50 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22
|
FLU-Q-PAN H7N9 Formulation 3_A Group
n=48 Participants
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
Placebo Group
n=51 Participants
Healthy male and female participants who will receive two doses of placebo, the first dose at Day 1 and the second dose at Day 22.
|
|---|---|---|---|---|---|---|---|
|
Vaccine Response Rate (VRR) of Anti-MN Antibodies Against Vaccine-homologous H7N9 for a Subset of Participants
Day 43
|
45.8 Percentage of Participants
Interval 31.4 to 60.8
|
46.3 Percentage of Participants
Interval 30.7 to 62.6
|
38.1 Percentage of Participants
Interval 23.6 to 54.4
|
47.8 Percentage of Participants
Interval 32.9 to 63.1
|
34.0 Percentage of Participants
Interval 20.9 to 49.3
|
57.1 Percentage of Participants
Interval 41.0 to 72.3
|
0 Percentage of Participants
Interval 0.0 to 8.0
|
|
Vaccine Response Rate (VRR) of Anti-MN Antibodies Against Vaccine-homologous H7N9 for a Subset of Participants
Day 22
|
2.1 Percentage of Participants
Interval 0.1 to 11.1
|
2.2 Percentage of Participants
Interval 0.1 to 11.5
|
8.0 Percentage of Participants
Interval 2.2 to 19.2
|
5.9 Percentage of Participants
Interval 1.2 to 16.2
|
6.0 Percentage of Participants
Interval 1.3 to 16.5
|
8.3 Percentage of Participants
Interval 2.3 to 20.0
|
0 Percentage of Participants
Interval 0.0 to 7.0
|
Adverse Events
FLU-Q-PAN H7N9 Formulation 1_B Group
Serious events: 3 serious events
Other events: 40 other events
Deaths: 0 deaths
FLU-Q-PAN H7N9 Formulation 1_A Group
Serious events: 3 serious events
Other events: 32 other events
Deaths: 0 deaths
FLU-Q-PAN H7N9 Formulation 2_B Group
Serious events: 10 serious events
Other events: 33 other events
Deaths: 0 deaths
FLU-Q-PAN H7N9 Formulation 2_A Group
Serious events: 4 serious events
Other events: 34 other events
Deaths: 0 deaths
FLU-Q-PAN H7N9 Formulation 3_B Group
Serious events: 6 serious events
Other events: 30 other events
Deaths: 0 deaths
FLU-Q-PAN H7N9 Formulation 3_A Group
Serious events: 5 serious events
Other events: 39 other events
Deaths: 0 deaths
Placebo Group
Serious events: 7 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FLU-Q-PAN H7N9 Formulation 1_B Group
n=121 participants at risk
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 1_A Group
n=116 participants at risk
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_B Group
n=119 participants at risk
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_A Group
n=119 participants at risk
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 3_B Group
n=117 participants at risk
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22
|
FLU-Q-PAN H7N9 Formulation 3_A Group
n=121 participants at risk
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
Placebo Group
n=120 participants at risk
Healthy male and female participants who will receive two doses of placebo, the first dose at Day 1 and the second dose at Day 22.
|
|---|---|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.85%
1/117 • Number of events 1 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the tongue
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 1 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 1 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/120 • Number of events 1 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.85%
1/117 • Number of events 1 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 1 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 1 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 1 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 1 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 1 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/120 • Number of events 1 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 1 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 1 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.85%
1/117 • Number of events 1 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 1 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.83%
1/121 • Number of events 1 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Infections and infestations
Pneumonia
|
0.83%
1/121 • Number of events 1 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/120 • Number of events 1 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Infections and infestations
COVID-19
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 1 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 1 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/120 • Number of events 1 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Infections and infestations
Sepsis
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 1 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 1 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/120 • Number of events 1 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
1.7%
2/119 • Number of events 2 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 1 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/120 • Number of events 1 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Gastrointestinal disorders
Oesophagitis haemorrhagic
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.85%
1/117 • Number of events 1 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/120 • Number of events 1 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.85%
1/117 • Number of events 1 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 1 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 1 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 1 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 1 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/120 • Number of events 1 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 1 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.85%
1/117 • Number of events 1 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 1 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/120 • Number of events 1 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 1 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.83%
1/121 • Number of events 1 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 1 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 1 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 1 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 1 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/120 • Number of events 1 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.83%
1/121 • Number of events 1 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.83%
1/121 • Number of events 1 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 1 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
Other adverse events
| Measure |
FLU-Q-PAN H7N9 Formulation 1_B Group
n=121 participants at risk
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 1_A Group
n=116 participants at risk
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_B Group
n=119 participants at risk
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 2_A Group
n=119 participants at risk
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
FLU-Q-PAN H7N9 Formulation 3_B Group
n=117 participants at risk
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22
|
FLU-Q-PAN H7N9 Formulation 3_A Group
n=121 participants at risk
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
|
Placebo Group
n=120 participants at risk
Healthy male and female participants who will receive two doses of placebo, the first dose at Day 1 and the second dose at Day 22.
|
|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Infections and infestations
Tinea pedis
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
General disorders
Fatigue
|
5.0%
6/121 • Number of events 21 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
4.3%
5/116 • Number of events 27 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
1.7%
2/119 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
1.7%
2/119 • Number of events 12 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.85%
1/117 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
2.5%
3/121 • Number of events 12 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/120 • Number of events 9 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
General disorders
Injection site pain
|
1.7%
2/121 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
3.4%
4/116 • Number of events 15 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
1.7%
2/119 • Number of events 9 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
1.7%
2/117 • Number of events 9 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
1.7%
2/121 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
General disorders
Chillis
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
1.7%
2/119 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
2.5%
3/121 • Number of events 12 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
General disorders
Injection site erythema
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
1.7%
2/116 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/120 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
General disorders
Pain
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
2.5%
3/121 • Number of events 9 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
General disorders
Injection site bruising
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.85%
1/117 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/120 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
General disorders
Injection site swelling
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
1.7%
2/116 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
General disorders
Injection site warmth
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
General disorders
Injection site induration
|
0.83%
1/121 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
General disorders
Administration site swelling
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
General disorders
Asthenia
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.85%
1/117 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
General disorders
Injection site pruritus
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
General disorders
Injection site reaction
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/120 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
General disorders
Pyrexia
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
General disorders
Vaccination site erythema
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.85%
1/117 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
General disorders
Chest discomfort
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
General disorders
Foaming at mouth
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/120 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
General disorders
Hunger
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
General disorders
Injection site mass
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.85%
1/117 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
General disorders
Malaise
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
General disorders
Medical device pain
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
General disorders
Oedema peripheral
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
General disorders
Suprapubic pain
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
General disorders
Swelling face
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
General disorders
Thirst
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
General disorders
Vessel puncture site pain
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.7%
2/121 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
2.5%
3/119 • Number of events 12 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
1.7%
2/119 • Number of events 12 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
2.6%
3/117 • Number of events 15 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
5.8%
7/120 • Number of events 30 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Gastrointestinal disorders
Nausea
|
0.83%
1/121 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
1.7%
2/119 • Number of events 9 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
1.7%
2/119 • Number of events 15 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.85%
1/117 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
1.7%
2/121 • Number of events 9 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/120 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.83%
1/121 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 9 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.85%
1/117 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
1.7%
2/120 • Number of events 9 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Gastrointestinal disorders
Constipation
|
1.7%
2/121 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
1.7%
2/117 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/120 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
1.7%
2/120 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/120 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Gastrointestinal disorders
Dental caries
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.85%
1/117 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Gastrointestinal disorders
Salivary gland enlargement
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Gastrointestinal disorders
Tongue blistering
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.85%
1/117 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.7%
2/121 • Number of events 9 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
1.7%
2/119 • Number of events 9 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
3.4%
4/119 • Number of events 15 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
2.5%
3/121 • Number of events 9 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/120 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.5%
3/121 • Number of events 12 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
1.7%
2/119 • Number of events 12 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.85%
1/117 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
1.7%
2/121 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/120 • Number of events 9 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
2.6%
3/117 • Number of events 12 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/120 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.7%
2/121 • Number of events 9 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
1.7%
2/120 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
1.7%
2/119 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.85%
1/117 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.83%
1/121 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
1.7%
2/116 • Number of events 9 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/120 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Musculoskeletal and connective tissue disorders
Muscle swelling
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Musculoskeletal and connective tissue disorders
Osteochondritis
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/120 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Musculoskeletal and connective tissue disorders
Sacroiliitis
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/120 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Nervous system disorders
Headache
|
4.1%
5/121 • Number of events 24 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
3.4%
4/116 • Number of events 24 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
2.5%
3/119 • Number of events 15 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
3.4%
4/119 • Number of events 18 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
1.7%
2/117 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
2.5%
3/121 • Number of events 12 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
2.5%
3/120 • Number of events 12 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Nervous system disorders
Dizziness
|
2.5%
3/121 • Number of events 9 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
2.6%
3/116 • Number of events 9 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
1.7%
2/119 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
1.7%
2/119 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.85%
1/117 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Nervous system disorders
Disturbance in attention
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
1.7%
2/116 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
1.7%
2/119 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
1.7%
2/117 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
1.7%
2/121 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/120 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Nervous system disorders
Paraesthesia
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
1.7%
2/121 • Number of events 9 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Nervous system disorders
Migraine
|
0.83%
1/121 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/120 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/120 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Nervous system disorders
Lethargy
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Nervous system disorders
Parosmia
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Nervous system disorders
Tension headache
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
1.7%
2/116 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
1.7%
2/119 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
2.5%
3/119 • Number of events 9 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
1.7%
2/117 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
1.7%
2/121 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/120 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Infections and infestations
COVID-19
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
2.5%
3/119 • Number of events 9 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/120 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.7%
2/121 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/120 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Infections and infestations
Nasopharyngitis
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/120 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Infections and infestations
Bronchitis
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/120 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Infections and infestations
Localised infection
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Infections and infestations
Rhinitis
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
1.7%
2/120 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Infections and infestations
Cystitis
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Infections and infestations
Ear infection
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Infections and infestations
Gastroenteritis
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/120 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.85%
1/117 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Infections and infestations
Viral infection
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
1.7%
2/119 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.85%
1/117 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
1.7%
2/121 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
1.7%
2/120 • Number of events 9 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
1.7%
2/117 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.7%
2/121 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.85%
1/117 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.85%
1/117 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.85%
1/117 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Skin and subcutaneous tissue disorders
Skin warm
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.7%
2/121 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
1.7%
2/116 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.85%
1/117 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
1.7%
2/116 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.85%
1/117 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
1.7%
2/121 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/120 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.85%
1/117 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/120 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.85%
1/117 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
1.7%
2/121 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/120 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
1.7%
2/116 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/120 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.85%
1/117 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.85%
1/117 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Injury, poisoning and procedural complications
Heat exhaustion
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Injury, poisoning and procedural complications
Muscle contusion
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Injury, poisoning and procedural complications
Periorbital haemorrhage
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Injury, poisoning and procedural complications
Reactive gastropathy
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/120 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.85%
1/117 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Psychiatric disorders
Depression
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Psychiatric disorders
Insomnia
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Psychiatric disorders
Anxiety
|
0.83%
1/121 • Number of events 9 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Investigations
Blood urine present
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Investigations
Liver function test increased
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Investigations
Lymph node palpable
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Investigations
Renal function test abnormal
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.85%
1/117 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Reproductive system and breast disorders
Prostatic mass
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.85%
1/117 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Reproductive system and breast disorders
Testicular swelling
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Reproductive system and breast disorders
Uterine spasm
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
1.7%
2/117 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Renal and urinary disorders
Renal cyst
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Renal and urinary disorders
Urge incontinence
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.85%
1/117 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Ear and labyrinth disorders
Ear pruritus
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.85%
1/117 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.85%
1/117 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Vascular disorders
Hypertension
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Vascular disorders
Peripheral embolism
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
1.7%
2/121 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
1.7%
2/116 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.85%
1/117 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.85%
1/117 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian germ cell teratoma benign
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.86%
1/116 • Number of events 6 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/120 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Eye disorders
Vision blurred
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Immune system disorders
Seasonal allergy
|
0.83%
1/121 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
|
Product Issues
Device dislocation
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/116 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.84%
1/119 • Number of events 3 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/119 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/117 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/121 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
0.00%
0/120 • Solicited AEs: During the 7-day follow-up period after each vaccination. Unsolicited AEs: During the 21-day follow-up period after each vaccination. SAEs: From Day 1 up to Month 13.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER