Trial Outcomes & Findings for Immunotherapy of Stage III/IV Melanoma Patients (NCT NCT00112242)
NCT ID: NCT00112242
Last Updated: 2020-06-18
Results Overview
For each patient, total CD4+ T-cells were stimulated in the presence of peptide NY-ESO-1 long peptide (lp). After 10 days, cell cultures were challenged for 4h with the peptide or left unchallenged. The activation of NY-ESO-1 long peptide (lp)-specific CD4+ T cells were analyzed in vitro by Intracellular Cytokine Staining (ICS) via detection of IFN-γ (Interferon-gamma) and TNF-α (Tumor Necrosis Factor-alpha) producing cells.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
39 participants
Primary outcome timeframe
Percentage of NY-ESO-1 lp-specific IFN-γ/TNF-α -secreting CD4+ T-cells at the end of Cycle 1 (3 months), at the end of Cycle 2 (8 months), at the end of Cycle 3 (13 months) and if applicable at the end of Boost cycles (18 to 24 months)
Results posted on
2020-06-18
Participant Flow
Subjects were screened and enrolled at 2 sites in Switzerland, the CHUV in Lausanne and the HUG in Geneva.
The assignment to a group was done according to tumor antigen (i.e., Melan-A, MAGE-A10, NY-ESO-1b\[A\]) and HLA expression (HLA-A2).
Participant milestones
| Measure |
1. Melan-A ELA
500 mcg Melan-A ELA analog peptide + 1 ml Montanide
|
2. Melan-A ELA + NY-ESO-1b(A) + MAGE-A10
500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide
|
3. Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG
500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide + 2.5 mg CpG-7909/PF-3512676
|
4. Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG
* If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
* If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
|
5. Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2
* If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2
* If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
5
|
5
|
10
|
9
|
|
Overall Study
Cycle 1 Completed
|
10
|
5
|
5
|
9
|
7
|
|
Overall Study
Cycle 2 Completed
|
8
|
3
|
4
|
8
|
4
|
|
Overall Study
Cycle 3 Completed
|
5
|
3
|
4
|
4
|
2
|
|
Overall Study
COMPLETED
|
5
|
3
|
4
|
4
|
2
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
1
|
6
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Immunotherapy of Stage III/IV Melanoma Patients
Baseline characteristics by cohort
| Measure |
Single Peptide Vaccination
n=10 Participants
Montanide + Melan-A analogue peptide
Montanide + Melan-A analogue peptide: 1 ml Montanide+ 500 mcg Melan-A analog peptide
|
Peptide Combination Vaccination
n=5 Participants
Montanide + Melan-A analog peptide + NY-ESO-1 analog peptide + Mage10 peptide
Montanide + Melan-A analog peptide + NY-ESO-1 analog peptide + Mage10 peptide: 1 ml Montanide + 500 mcg Melan-A analog peptide + 500 mcg NY-ESO-1 analog peptide + 500 mcg Mage10 peptide
|
Peptide Combination Vaccination + CpG
n=5 Participants
Montanide + CpG-7909/PF-3512676+Melan-A analog peptide + NY-ESO-1 analog peptide + Mage10 peptide
Montanide + CpG-7909 / PF-3512676+Melan-A analog peptide + NY-ESO-1 analog peptide + Mage10 peptide: 1 ml Montanide + 2.5 mg CpG-7909/PF-3512676 + 500 mcg Melan-A analog peptide, 500 mcg + NY-ESO-1 analog peptide + 500 mcg Mage10 peptide
|
Native and Analog Peptide Combination Vaccination + CpG
n=10 Participants
Montanide + CpG-7909/PF-3512676 + Melan-A native and analog peptides + NY-ESO-1 long peptide + Mage10 peptide
Montanide + CpG-7909/PF-3512676 + Melan-A native and analog peptides + NY-ESO-1 long peptide + Mage10 peptide: 1 ml Montanide + 2.5 mg CpG-7909/PF-3512676 + 100 mcg Melan-A native and analog peptides + 500 mcg NY-ESO-1 long peptide + 100 mcg Mage10 peptide
|
Native and Analog Peptide Combination Vaccination + CpG + IL-2
n=8 Participants
Montanide + CpG-7909/PF-3512676 + Melan-A native and analog peptides + NY-ESO-1 long peptide + Mage10 peptide + low dose IL-2
Montanide + CpG-7909/PF-3512676 + Melan-A native and analog peptides + NY-ESO-1 long peptide + Mage10 peptide + low dose IL-2: 1 ml Montanide + 2.5 mg CpG-7909/PF-3512676 + 100 mcg Melan-A native and analog peptides + 500 mcg NY-ESO-1 long peptide + 100 mcg Mage10 peptide + low dose IL-2
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
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
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
26 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
|
Age, Continuous
|
61.8 years
n=5 Participants
|
58.8 years
n=7 Participants
|
64.9 years
n=5 Participants
|
59.9 years
n=4 Participants
|
59.2 years
n=21 Participants
|
60.1 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
26 Participants
n=8 Participants
|
|
Region of Enrollment
Switzerland
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
38 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to end of Cycle 1 (3 months), end of Cycle 2 (8 months), end of Cycle 3 (13 months) and end of Boost Cycles (18 months to 23 months).Population: After the end of a cycle, patients could have discontinue the study for personal reasons or PD. This is why the overall number of patients analyzed could change between cycles of each arm/group.
Safety of the vaccination was assessed according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) scale. The adverse events (AE) and serious adverse events (SAE) were registered at each study visit during the 3 vaccination cycles and boost cycles.
Outcome measures
| Measure |
1.Melan-A ELA
n=10 Participants
500 mcg Melan-A ELA analog peptide + 1 ml Montanide
|
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10
n=5 Participants
500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide
|
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG
n=5 Participants
500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide + 2.5 mg CpG-7909/PF-3512676
|
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG
n=10 Participants
* If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
* If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
|
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2
n=9 Participants
* If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2
* If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2
|
|---|---|---|---|---|---|
|
Change From Baseline in Mean Number of Adverse Events (Serious and Non Serious Events)
End of Cycle 1
|
13.40 Number of adverse events
Standard Deviation 13.02
|
18.40 Number of adverse events
Standard Deviation 5.86
|
23.80 Number of adverse events
Standard Deviation 12.15
|
19.60 Number of adverse events
Standard Deviation 8.15
|
31.75 Number of adverse events
Standard Deviation 18.92
|
|
Change From Baseline in Mean Number of Adverse Events (Serious and Non Serious Events)
End of Cycle 2
|
10.44 Number of adverse events
Standard Deviation 7.46
|
10.00 Number of adverse events
Standard Deviation 7.62
|
20.25 Number of adverse events
Standard Deviation 13.33
|
21.00 Number of adverse events
Standard Deviation 12.30
|
16.80 Number of adverse events
Standard Deviation 10.45
|
|
Change From Baseline in Mean Number of Adverse Events (Serious and Non Serious Events)
End of Cycle 3
|
6.20 Number of adverse events
Standard Deviation 4.20
|
16.00 Number of adverse events
Standard Deviation 9.74
|
21.25 Number of adverse events
Standard Deviation 12.10
|
19.67 Number of adverse events
Standard Deviation 12.92
|
20.50 Number of adverse events
Standard Deviation 9.61
|
|
Change From Baseline in Mean Number of Adverse Events (Serious and Non Serious Events)
Boot cycles
|
8.50 Number of adverse events
Standard Deviation 6.54
|
9.00 Number of adverse events
Standard Deviation 5.81
|
48.67 Number of adverse events
Standard Deviation 53.87
|
50 Number of adverse events
Standard Deviation 0.00
|
—
|
PRIMARY outcome
Timeframe: Fold change from baseline in Melan-A-specific CD8+T-cells at the end of Cycle 1 (3 months), at the end of Cycle 2 (8 months), at the end of Cycle 3 (13 months) and if applicable at the end of Boost cycles (18 to 24 months).Population: This test was only performed in patients HLA-A2 positive and Melan-A peptide positive (groups 1, 2 and 3, some patients from groups 4 and 5)
Ex vivo frequency of Melan-A-specific CD8+ T cells was measured by multimer technique (tetramer assay) in a multicolor flow cytometry analysis. The fold change for each time point compared to baseline was calculated as: Melan-A-specific CD8+ T cell frequency at the time point/ Melan-A-specific CD8+ T cell frequency at baseline. Significant T cell response is defined by at least 2-fold change of Melan-A-specific CD8+ T cell frequency as compared to pre-immunotherapy.
Outcome measures
| Measure |
1.Melan-A ELA
n=10 Participants
500 mcg Melan-A ELA analog peptide + 1 ml Montanide
|
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10
n=5 Participants
500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide
|
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG
n=5 Participants
500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide + 2.5 mg CpG-7909/PF-3512676
|
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG
n=5 Participants
* If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
* If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
|
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2
n=2 Participants
* If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2
* If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2
|
|---|---|---|---|---|---|
|
Fold Change From Baseline in ex Vivo Melan-A-specific CD8+ T Cells Frequency During the Vaccination Period
End of Cycle 3
|
0.10 Fold change of % Melan-A ELA+ CD8+ T
Standard Deviation 0.07
|
0.08 Fold change of % Melan-A ELA+ CD8+ T
Standard Deviation 0.07
|
0.85 Fold change of % Melan-A ELA+ CD8+ T
Standard Deviation 1.36
|
0.09 Fold change of % Melan-A ELA+ CD8+ T
Standard Deviation 0.09
|
—
|
|
Fold Change From Baseline in ex Vivo Melan-A-specific CD8+ T Cells Frequency During the Vaccination Period
End of Boost Cycles
|
0.04 Fold change of % Melan-A ELA+ CD8+ T
Standard Deviation 0.03
|
0.09 Fold change of % Melan-A ELA+ CD8+ T
Standard Deviation 0.06
|
2.66 Fold change of % Melan-A ELA+ CD8+ T
Standard Deviation 2.72
|
—
|
—
|
|
Fold Change From Baseline in ex Vivo Melan-A-specific CD8+ T Cells Frequency During the Vaccination Period
Baseline
|
0.03 Fold change of % Melan-A ELA+ CD8+ T
Standard Deviation 0.03
|
0.01 Fold change of % Melan-A ELA+ CD8+ T
Standard Deviation 0.01
|
0.08 Fold change of % Melan-A ELA+ CD8+ T
Standard Deviation 0.15
|
0.18 Fold change of % Melan-A ELA+ CD8+ T
Standard Deviation 0.29
|
0.04 Fold change of % Melan-A ELA+ CD8+ T
Standard Deviation 0.01
|
|
Fold Change From Baseline in ex Vivo Melan-A-specific CD8+ T Cells Frequency During the Vaccination Period
End of Cycle 1
|
0.08 Fold change of % Melan-A ELA+ CD8+ T
Standard Deviation 0.11
|
0.08 Fold change of % Melan-A ELA+ CD8+ T
Standard Deviation 0.08
|
0.37 Fold change of % Melan-A ELA+ CD8+ T
Standard Deviation 0.33
|
0.12 Fold change of % Melan-A ELA+ CD8+ T
Standard Deviation 0.16
|
0.05 Fold change of % Melan-A ELA+ CD8+ T
Standard Deviation 0.01
|
|
Fold Change From Baseline in ex Vivo Melan-A-specific CD8+ T Cells Frequency During the Vaccination Period
End of Cycle 2
|
0.07 Fold change of % Melan-A ELA+ CD8+ T
Standard Deviation 0.06
|
0.14 Fold change of % Melan-A ELA+ CD8+ T
Standard Deviation 0.12
|
0.34 Fold change of % Melan-A ELA+ CD8+ T
Standard Deviation 0.31
|
0.20 Fold change of % Melan-A ELA+ CD8+ T
Standard Deviation 0.22
|
0.26 Fold change of % Melan-A ELA+ CD8+ T
Standard Deviation NA
Only values for one patient
|
PRIMARY outcome
Timeframe: Fold change from baseline in Melan-A-specific IFN-γ-secreting CD8+T-cells frequency at the end of Cycle 1 (3 months), at the end of Cycle 2 (8 months), at the end of Cycle 3 (13 months) and if applicable at the end of Boost cycles (18 to 24 months)Population: This test was only done in patients HLA-A2 positive and Melan-A peptide positive (groups 1, 2 and 3, some patients from groups 4 and 5)
Ex vivo frequency of Melan-A-specific CD8+ T cells producing IFN-γ (Interferon-gamma) was measured through the Enzyme-Linked Immunosorbent Spot (ELISpot) assay. The fold change for each time point compared to baseline was calculated as: Melan-A-specific IFN-γ-secreting CD8+ T cell frequency at the time point/ Melan-A-specific IFN-γ-secreting CD8+ T cell frequency at baseline.
Outcome measures
| Measure |
1.Melan-A ELA
n=10 Participants
500 mcg Melan-A ELA analog peptide + 1 ml Montanide
|
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10
n=5 Participants
500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide
|
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG
n=5 Participants
500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide + 2.5 mg CpG-7909/PF-3512676
|
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG
n=5 Participants
* If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
* If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
|
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2
n=1 Participants
* If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2
* If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2
|
|---|---|---|---|---|---|
|
Fold Change From Baseline in ex Vivo Frequency of Melan-A-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period
Baseline
|
0.001 Fold change of % IFN-γ+ MelanA+ CD8+ T
Standard Deviation 0.002
|
0.004 Fold change of % IFN-γ+ MelanA+ CD8+ T
Standard Deviation 0.006
|
0.065 Fold change of % IFN-γ+ MelanA+ CD8+ T
Standard Deviation 0.129
|
0.008 Fold change of % IFN-γ+ MelanA+ CD8+ T
Standard Deviation 0.012
|
0.150 Fold change of % IFN-γ+ MelanA+ CD8+ T
Standard Deviation NA
Only one patient analyzed
|
|
Fold Change From Baseline in ex Vivo Frequency of Melan-A-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period
End of Cycle 1
|
0 Fold change of % IFN-γ+ MelanA+ CD8+ T
Standard Deviation 0.003
|
0.015 Fold change of % IFN-γ+ MelanA+ CD8+ T
Standard Deviation 0.025
|
0.157 Fold change of % IFN-γ+ MelanA+ CD8+ T
Standard Deviation 0.458
|
0.018 Fold change of % IFN-γ+ MelanA+ CD8+ T
Standard Deviation 0.023
|
1.00 Fold change of % IFN-γ+ MelanA+ CD8+ T
Standard Deviation NA
Only one patient analyzed
|
|
Fold Change From Baseline in ex Vivo Frequency of Melan-A-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period
End of Cycle 2
|
-0.003 Fold change of % IFN-γ+ MelanA+ CD8+ T
Standard Deviation 0.009
|
0.006 Fold change of % IFN-γ+ MelanA+ CD8+ T
Standard Deviation 0.006
|
0.015 Fold change of % IFN-γ+ MelanA+ CD8+ T
Standard Deviation 0.014
|
0.013 Fold change of % IFN-γ+ MelanA+ CD8+ T
Standard Deviation 0.011
|
—
|
|
Fold Change From Baseline in ex Vivo Frequency of Melan-A-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period
End of Cycle 3
|
0.010 Fold change of % IFN-γ+ MelanA+ CD8+ T
Standard Deviation 0.025
|
0.008 Fold change of % IFN-γ+ MelanA+ CD8+ T
Standard Deviation 0.003
|
0.068 Fold change of % IFN-γ+ MelanA+ CD8+ T
Standard Deviation 0.061
|
-0.051 Fold change of % IFN-γ+ MelanA+ CD8+ T
Standard Deviation NA
Only one patient analyzed
|
—
|
|
Fold Change From Baseline in ex Vivo Frequency of Melan-A-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period
End of Boost Cycles
|
0.027 Fold change of % IFN-γ+ MelanA+ CD8+ T
Standard Deviation 0.060
|
0.005 Fold change of % IFN-γ+ MelanA+ CD8+ T
Standard Deviation 0.005
|
0.380 Fold change of % IFN-γ+ MelanA+ CD8+ T
Standard Deviation 0.309
|
—
|
—
|
PRIMARY outcome
Timeframe: Fold change from baseline in NY-ESO-1-specific CD8+T-cells at the end of Cycle 1 (3 months), at the end of Cycle 2 (8 months), at the end of Cycle 3 (13 months) and if applicable at the end of Boost cycles (18 to 24 months)Population: This test was only done in patients HLA-A2 positive and NY-ESO-1 peptide positive (groups 2 and 3)
Ex vivo frequency of NY-ESO-1-specific CD8+ T cells was measured by multimer technique (tetramer assay) in a multicolor flow cytometry analysis. The fold change for each time point compared to baseline was calculated as: NY-ESO-1-specific CD8+ T cell frequency at the time point/ NY-ESO-1-specific CD8+ T cell frequency at baseline.
Outcome measures
| Measure |
1.Melan-A ELA
500 mcg Melan-A ELA analog peptide + 1 ml Montanide
|
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10
n=5 Participants
500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide
|
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG
n=5 Participants
500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide + 2.5 mg CpG-7909/PF-3512676
|
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG
* If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
* If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
|
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2
* If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2
* If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2
|
|---|---|---|---|---|---|
|
Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific CD8+ T Cells During the Vaccination Period
Baseline
|
—
|
0.69 Fold change of % NY-ESO-1+ CD8+ T cells
Standard Deviation 1.54
|
0.01 Fold change of % NY-ESO-1+ CD8+ T cells
Standard Deviation 0.02
|
—
|
—
|
|
Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific CD8+ T Cells During the Vaccination Period
End of Cycle 1
|
—
|
0.96 Fold change of % NY-ESO-1+ CD8+ T cells
Standard Deviation 2.64
|
0.21 Fold change of % NY-ESO-1+ CD8+ T cells
Standard Deviation 0.28
|
—
|
—
|
|
Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific CD8+ T Cells During the Vaccination Period
End of Cycle 2
|
—
|
2.37 Fold change of % NY-ESO-1+ CD8+ T cells
Standard Deviation 4.37
|
0.19 Fold change of % NY-ESO-1+ CD8+ T cells
Standard Deviation 0.23
|
—
|
—
|
|
Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific CD8+ T Cells During the Vaccination Period
End of Cycle 3
|
—
|
2.64 Fold change of % NY-ESO-1+ CD8+ T cells
Standard Deviation 3.55
|
0.16 Fold change of % NY-ESO-1+ CD8+ T cells
Standard Deviation 0.24
|
—
|
—
|
|
Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific CD8+ T Cells During the Vaccination Period
End of Boost Cycles
|
—
|
1.40 Fold change of % NY-ESO-1+ CD8+ T cells
Standard Deviation 2.40
|
0.1 Fold change of % NY-ESO-1+ CD8+ T cells
Standard Deviation 0.08
|
—
|
—
|
PRIMARY outcome
Timeframe: Fold change from baseline in NY-ESO-1-specific IFN-γ-secreting CD8+T-cells frequency at the end of Cycle 1 (3 months), at the end of Cycle 2 (8 months), at the end of Cycle 3 (13 months) and if applicable at the end of Boost cycles (18 to 24 months)Population: This test was only done in patients HLA-A2 positive (groups 1, 2 and 3, some patients from groups 4 and 5)
Ex vivo frequency of NY-ESO-1-specific CD8+ T cells producing IFN-γ (Interferon-gamma) was measured through the Enzyme-Linked Immunosorbent Spot (ELISpot) assay. The fold change for each time point compared to baseline was calculated as: NY-ESO-1-specific IFN-γ-secreting CD8+ T cell frequency at the time point/ NY-ESO-1-specific IFN-γ-secreting CD8+ T cell frequency at baseline.
Outcome measures
| Measure |
1.Melan-A ELA
n=10 Participants
500 mcg Melan-A ELA analog peptide + 1 ml Montanide
|
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10
n=5 Participants
500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide
|
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG
n=5 Participants
500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide + 2.5 mg CpG-7909/PF-3512676
|
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG
n=5 Participants
* If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
* If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
|
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2
n=1 Participants
* If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2
* If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2
|
|---|---|---|---|---|---|
|
Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period
Baseline
|
0.004 % of spots from NYESO1 specific CD8 cell
Standard Deviation 0.01
|
0.218 % of spots from NYESO1 specific CD8 cell
Standard Deviation 0.484
|
0.001 % of spots from NYESO1 specific CD8 cell
Standard Deviation 0.001
|
0.010 % of spots from NYESO1 specific CD8 cell
Standard Deviation 0.005
|
0.050 % of spots from NYESO1 specific CD8 cell
Standard Deviation NA
Only values from one patient
|
|
Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period
End of Cycle 1
|
-0.001 % of spots from NYESO1 specific CD8 cell
Standard Deviation 0.002
|
0.237 % of spots from NYESO1 specific CD8 cell
Standard Deviation 0.491
|
0.004 % of spots from NYESO1 specific CD8 cell
Standard Deviation 0.006
|
0.001 % of spots from NYESO1 specific CD8 cell
Standard Deviation 0.005
|
0.030 % of spots from NYESO1 specific CD8 cell
Standard Deviation NA
Only values from one patient
|
|
Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period
End of Cycle 2
|
0.002 % of spots from NYESO1 specific CD8 cell
Standard Deviation 0.004
|
0.378 % of spots from NYESO1 specific CD8 cell
Standard Deviation 0.589
|
-0.004 % of spots from NYESO1 specific CD8 cell
Standard Deviation 0.040
|
-0.003 % of spots from NYESO1 specific CD8 cell
Standard Deviation 0.009
|
—
|
|
Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period
End of Cycle 3
|
-0.001 % of spots from NYESO1 specific CD8 cell
Standard Deviation 0.008
|
0.538 % of spots from NYESO1 specific CD8 cell
Standard Deviation 0.665
|
-0.002 % of spots from NYESO1 specific CD8 cell
Standard Deviation 0.065
|
-0.111 % of spots from NYESO1 specific CD8 cell
Standard Deviation NA
Only values from one patient
|
—
|
|
Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period
End of Boost Cycles
|
-0.008 % of spots from NYESO1 specific CD8 cell
Standard Deviation 0.011
|
0.045 % of spots from NYESO1 specific CD8 cell
Standard Deviation 0.088
|
0.096 % of spots from NYESO1 specific CD8 cell
Standard Deviation 0.121
|
—
|
—
|
PRIMARY outcome
Timeframe: Fold change from baseline in MAGE-A10-specific CD8+T-cells at the end of Cycle 1 (3 months), at the end of Cycle 2 (8 months), at the end of Cycle 3 (13 months) and if applicable at the end of Boost cycles (18 to 24 months)Population: This test was only done in patients MAGE-A10 positive and HLA-A2 positive (groups 2 and 3, some patients from groups 4 and 5)
Ex vivo frequency of MAGE-A10-specific CD8+ T cells was measured by multimer technique (tetramer assay) in a multicolor flow cytometry analysis. The fold change for each time point compared to baseline was calculated as: MAGE-A10-specific CD8+ T cell frequency at the time point/ MAGE-A10-specific CD8+ T cell frequency at baseline.
Outcome measures
| Measure |
1.Melan-A ELA
500 mcg Melan-A ELA analog peptide + 1 ml Montanide
|
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10
n=5 Participants
500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide
|
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG
n=5 Participants
500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide + 2.5 mg CpG-7909/PF-3512676
|
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG
n=5 Participants
* If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
* If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
|
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2
n=2 Participants
* If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2
* If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2
|
|---|---|---|---|---|---|
|
Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific CD8+ T Cells During the Vaccination Period
End of Cycle 1
|
—
|
0.03 Fold change of % MAGE-A10+ CD8+ T cells
Standard Deviation 0.03
|
0.03 Fold change of % MAGE-A10+ CD8+ T cells
Standard Deviation 0.02
|
0.01 Fold change of % MAGE-A10+ CD8+ T cells
Standard Deviation 0.01
|
0.05 Fold change of % MAGE-A10+ CD8+ T cells
Standard Deviation 0.01
|
|
Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific CD8+ T Cells During the Vaccination Period
End of Cycle 2
|
—
|
0.03 Fold change of % MAGE-A10+ CD8+ T cells
Standard Deviation 0.02
|
0.05 Fold change of % MAGE-A10+ CD8+ T cells
Standard Deviation 0.05
|
0.03 Fold change of % MAGE-A10+ CD8+ T cells
Standard Deviation 0.03
|
0.26 Fold change of % MAGE-A10+ CD8+ T cells
Standard Deviation NA
Only values from one patient
|
|
Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific CD8+ T Cells During the Vaccination Period
End of Boost Cycles
|
—
|
0.02 Fold change of % MAGE-A10+ CD8+ T cells
Standard Deviation 0.02
|
0.07 Fold change of % MAGE-A10+ CD8+ T cells
Standard Deviation 0.07
|
—
|
—
|
|
Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific CD8+ T Cells During the Vaccination Period
Baseline
|
—
|
0 Fold change of % MAGE-A10+ CD8+ T cells
Standard Deviation 0
|
0 Fold change of % MAGE-A10+ CD8+ T cells
Standard Deviation 0
|
0 Fold change of % MAGE-A10+ CD8+ T cells
Standard Deviation 0
|
0.04 Fold change of % MAGE-A10+ CD8+ T cells
Standard Deviation 0.01
|
|
Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific CD8+ T Cells During the Vaccination Period
End of Cycle 3
|
—
|
0.02 Fold change of % MAGE-A10+ CD8+ T cells
Standard Deviation 0.01
|
0.03 Fold change of % MAGE-A10+ CD8+ T cells
Standard Deviation 0.02
|
0.01 Fold change of % MAGE-A10+ CD8+ T cells
Standard Deviation 0.01
|
—
|
PRIMARY outcome
Timeframe: Fold change from baseline in MAGE-A10-specific IFN-γ-secreting CD8+T-cells frequency at the end of Cycle 1 (3 months), at the end of Cycle 2 (8 months), at the end of Cycle 3 (13 months) and if applicable at the end of Boost cycles (18 to 24 months)Population: This test was only done in patients HLA-A2 positive (groups 1, 2 and 3, some patients from groups 4 and 5)
Ex vivo frequency of MAGE-A10-specific CD8+ T cells producing IFN-γ (Interferon-gamma) was measured through the Enzyme-Linked Immunosorbent Spot (ELISpot) assay. The fold change for each time point compared to baseline was calculated as: MAGE-A10-specific IFN-γ-secreting CD8+ T cell frequency at the time point/ MAGE-A10-specific IFN-γ-secreting CD8+ T cell frequency at baseline.
Outcome measures
| Measure |
1.Melan-A ELA
n=10 Participants
500 mcg Melan-A ELA analog peptide + 1 ml Montanide
|
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10
n=5 Participants
500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide
|
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG
n=5 Participants
500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide + 2.5 mg CpG-7909/PF-3512676
|
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG
n=5 Participants
* If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
* If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
|
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2
n=1 Participants
* If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2
* If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2
|
|---|---|---|---|---|---|
|
Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period
Baseline
|
0.001 Fold change of % IFN-γ+ MAGE-A10+ CD8+ T
Standard Deviation 0.002
|
0.003 Fold change of % IFN-γ+ MAGE-A10+ CD8+ T
Standard Deviation 0.006
|
0.014 Fold change of % IFN-γ+ MAGE-A10+ CD8+ T
Standard Deviation 0.026
|
0 Fold change of % IFN-γ+ MAGE-A10+ CD8+ T
Standard Deviation 0.005
|
0.09 Fold change of % IFN-γ+ MAGE-A10+ CD8+ T
Standard Deviation NA
Only the value of one patient
|
|
Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period
End of Cycle 1
|
0 Fold change of % IFN-γ+ MAGE-A10+ CD8+ T
Standard Deviation 0.003
|
0.034 Fold change of % IFN-γ+ MAGE-A10+ CD8+ T
Standard Deviation 0.079
|
0.004 Fold change of % IFN-γ+ MAGE-A10+ CD8+ T
Standard Deviation 0.005
|
0.004 Fold change of % IFN-γ+ MAGE-A10+ CD8+ T
Standard Deviation 0.005
|
0.120 Fold change of % IFN-γ+ MAGE-A10+ CD8+ T
Standard Deviation NA
Only the value of one patient
|
|
Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period
End of Cycle 2
|
0 Fold change of % IFN-γ+ MAGE-A10+ CD8+ T
Standard Deviation 0.002
|
0.043 Fold change of % IFN-γ+ MAGE-A10+ CD8+ T
Standard Deviation 0.076
|
-0.006 Fold change of % IFN-γ+ MAGE-A10+ CD8+ T
Standard Deviation 0.012
|
0.003 Fold change of % IFN-γ+ MAGE-A10+ CD8+ T
Standard Deviation 0.002
|
—
|
|
Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period
End of Cycle 3
|
0.015 Fold change of % IFN-γ+ MAGE-A10+ CD8+ T
Standard Deviation 0.025
|
0.127 Fold change of % IFN-γ+ MAGE-A10+ CD8+ T
Standard Deviation 0.154
|
-0.016 Fold change of % IFN-γ+ MAGE-A10+ CD8+ T
Standard Deviation 0.051
|
-0.089 Fold change of % IFN-γ+ MAGE-A10+ CD8+ T
Standard Deviation NA
Only the value of one patient
|
—
|
|
Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period
End of Boost Cycles
|
-0.001 Fold change of % IFN-γ+ MAGE-A10+ CD8+ T
Standard Deviation 0.020
|
0.004 Fold change of % IFN-γ+ MAGE-A10+ CD8+ T
Standard Deviation 0.002
|
0.027 Fold change of % IFN-γ+ MAGE-A10+ CD8+ T
Standard Deviation 0.044
|
—
|
—
|
PRIMARY outcome
Timeframe: Percentage of NY-ESO-1 lp-specific IFN-γ/TNF-α -secreting CD4+ T-cells at the end of Cycle 1 (3 months), at the end of Cycle 2 (8 months), at the end of Cycle 3 (13 months) and if applicable at the end of Boost cycles (18 to 24 months)Population: Patients vaccinated with the NY-ESO-1 lp (groups 4 and 5). One patient of the group 5 received only one vaccine and thus was not included in the analysis of the immune response (the minimum dose required for immune response evaluation was 2 vaccines).
For each patient, total CD4+ T-cells were stimulated in the presence of peptide NY-ESO-1 long peptide (lp). After 10 days, cell cultures were challenged for 4h with the peptide or left unchallenged. The activation of NY-ESO-1 long peptide (lp)-specific CD4+ T cells were analyzed in vitro by Intracellular Cytokine Staining (ICS) via detection of IFN-γ (Interferon-gamma) and TNF-α (Tumor Necrosis Factor-alpha) producing cells.
Outcome measures
| Measure |
1.Melan-A ELA
500 mcg Melan-A ELA analog peptide + 1 ml Montanide
|
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10
500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide
|
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG
500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide + 2.5 mg CpG-7909/PF-3512676
|
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG
n=10 Participants
* If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
* If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
|
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2
n=8 Participants
* If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2
* If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2
|
|---|---|---|---|---|---|
|
Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNF-α -Secreting CD4+ T Cells During the Vaccination Period
NY-ESO-1lp T cells producing TNF-α_ end of cycle 1
|
—
|
—
|
—
|
5.31 % of NY-ESO-1 lp specific CD4+ T cells
Standard Deviation 3.83
|
23.69 % of NY-ESO-1 lp specific CD4+ T cells
Standard Deviation 12.22
|
|
Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNF-α -Secreting CD4+ T Cells During the Vaccination Period
NY-ESO-1lp T cells producing IFN-γ at baseline
|
—
|
—
|
—
|
0.12 % of NY-ESO-1 lp specific CD4+ T cells
Standard Deviation 0.21
|
071 % of NY-ESO-1 lp specific CD4+ T cells
Standard Deviation 1.30
|
|
Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNF-α -Secreting CD4+ T Cells During the Vaccination Period
NY-ESO-1lp T cells producing TNF-α at baseline
|
—
|
—
|
—
|
0.20 % of NY-ESO-1 lp specific CD4+ T cells
Standard Deviation 0.36
|
1.05 % of NY-ESO-1 lp specific CD4+ T cells
Standard Deviation 1.65
|
|
Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNF-α -Secreting CD4+ T Cells During the Vaccination Period
NY-ESO-1lp T cells producing IFN-γ _end of cycle 1
|
—
|
—
|
—
|
2.86 % of NY-ESO-1 lp specific CD4+ T cells
Standard Deviation 4.94
|
16.24 % of NY-ESO-1 lp specific CD4+ T cells
Standard Deviation 9.73
|
|
Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNF-α -Secreting CD4+ T Cells During the Vaccination Period
NY-ESO-1lp T cells IFN-γ_end of cycle 2
|
—
|
—
|
—
|
1.81 % of NY-ESO-1 lp specific CD4+ T cells
Standard Deviation 3.26
|
7.31 % of NY-ESO-1 lp specific CD4+ T cells
Standard Deviation 4.74
|
|
Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNF-α -Secreting CD4+ T Cells During the Vaccination Period
NY-ESO-1lp T cells producing TNF-α _end of cycle 2
|
—
|
—
|
—
|
6.02 % of NY-ESO-1 lp specific CD4+ T cells
Standard Deviation 5.79
|
17.10 % of NY-ESO-1 lp specific CD4+ T cells
Standard Deviation 7.90
|
|
Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNF-α -Secreting CD4+ T Cells During the Vaccination Period
NY-ESO-1lp T cells IFN-γ _end of cycle 3
|
—
|
—
|
—
|
7.02 % of NY-ESO-1 lp specific CD4+ T cells
Standard Deviation 14.01
|
0.52 % of NY-ESO-1 lp specific CD4+ T cells
Standard Deviation NA
Only one value from this group
|
|
Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNF-α -Secreting CD4+ T Cells During the Vaccination Period
NY-ESO-1lp T cells producing TNF-α _end of cycle 3
|
—
|
—
|
—
|
10.00 % of NY-ESO-1 lp specific CD4+ T cells
Standard Deviation 15.75
|
1.69 % of NY-ESO-1 lp specific CD4+ T cells
Standard Deviation NA
Only one value from this group
|
|
Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNF-α -Secreting CD4+ T Cells During the Vaccination Period
NY-ESO-1lp T producing IFN-γ _end of boost cycles
|
—
|
—
|
—
|
19.47 % of NY-ESO-1 lp specific CD4+ T cells
Standard Deviation NA
Only one value from this group
|
—
|
|
Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNF-α -Secreting CD4+ T Cells During the Vaccination Period
NY-ESO-1lp T producing TNF-α_end of boost cycles
|
—
|
—
|
—
|
21.11 % of NY-ESO-1 lp specific CD4+ T cells
Standard Deviation NA
Only one value from this group
|
—
|
PRIMARY outcome
Timeframe: Percentage of NY-ESO-1 lp-specific IFN-γ/TNF-α -secreting CD8+ T cells at the end of Cycle 1 (3 months), at the end of Cycle 2 (8 months), at the end of Cycle 3 (13 months) and if applicable at the end of Boost cycles (18 to 24 months)Population: Patients vaccinated with the NY-ESO-1 lp (groups 4 and 5). One patient of the group 5 received only one vaccine and thus was not included in the analysis of the immune response (the minimum dose required for immune response evaluation was 2 vaccines).
For each patient, total CD8+ T cells were stimulated in the presence of peptide NY-ESO-1 long peptide (lp). After 10 days, cell cultures were challenged for 4h with the peptide or left unchallenged. The activation of NY-ESO-1 long peptide (lp)-specific CD8+ T cells were analyzed in vitro by Intracellular Cytokine Staining (ICS) via detection of IFN-γ (Interferon-gamma) and TNF-α (Tumor Necrosis Factor-alpha) producing cells.
Outcome measures
| Measure |
1.Melan-A ELA
500 mcg Melan-A ELA analog peptide + 1 ml Montanide
|
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10
500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide
|
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG
500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide + 2.5 mg CpG-7909/PF-3512676
|
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG
n=10 Participants
* If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
* If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
|
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2
n=8 Participants
* If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2
* If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2
|
|---|---|---|---|---|---|
|
Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNFα -Secreting CD8+ T Cells During the Vaccination Period
NY-ESO-1lp T cells producing IFN-γ at baseline
|
—
|
—
|
—
|
0.03 % of NY-ESO-1 lp specific CD8+ T cells
Standard Deviation 0.08
|
0.12 % of NY-ESO-1 lp specific CD8+ T cells
Standard Deviation 0.17
|
|
Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNFα -Secreting CD8+ T Cells During the Vaccination Period
NY-ESO-1lp T cells producing TNF-α at baseline
|
—
|
—
|
—
|
0.02 % of NY-ESO-1 lp specific CD8+ T cells
Standard Deviation 0.04
|
0.15 % of NY-ESO-1 lp specific CD8+ T cells
Standard Deviation 0.26
|
|
Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNFα -Secreting CD8+ T Cells During the Vaccination Period
NY-ESO-1lp T cells producing IFN-γ_end of cycle 1
|
—
|
—
|
—
|
0.88 % of NY-ESO-1 lp specific CD8+ T cells
Standard Deviation 1.96
|
7.21 % of NY-ESO-1 lp specific CD8+ T cells
Standard Deviation 8.40
|
|
Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNFα -Secreting CD8+ T Cells During the Vaccination Period
NY-ESO-1lp T cells producing TNF-α_end of cycle 1
|
—
|
—
|
—
|
1.04 % of NY-ESO-1 lp specific CD8+ T cells
Standard Deviation 2.08
|
7.74 % of NY-ESO-1 lp specific CD8+ T cells
Standard Deviation 8.17
|
|
Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNFα -Secreting CD8+ T Cells During the Vaccination Period
NY-ESO-1lp T cells producing IFN-γ_end of cycle 2
|
—
|
—
|
—
|
0.34 % of NY-ESO-1 lp specific CD8+ T cells
Standard Deviation 0.46
|
5.38 % of NY-ESO-1 lp specific CD8+ T cells
Standard Deviation 6.69
|
|
Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNFα -Secreting CD8+ T Cells During the Vaccination Period
NY-ESO-1lp T cells producing TNF-α_end of cycle 2
|
—
|
—
|
—
|
2.18 % of NY-ESO-1 lp specific CD8+ T cells
Standard Deviation 3.48
|
4.21 % of NY-ESO-1 lp specific CD8+ T cells
Standard Deviation 4.60
|
|
Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNFα -Secreting CD8+ T Cells During the Vaccination Period
NY-ESO-1lp T cells producing IFN-γ_end of cycle 3
|
—
|
—
|
—
|
0.93 % of NY-ESO-1 lp specific CD8+ T cells
Standard Deviation 1.81
|
6.58 % of NY-ESO-1 lp specific CD8+ T cells
Standard Deviation NA
Only one value for this group
|
|
Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNFα -Secreting CD8+ T Cells During the Vaccination Period
NY-ESO-1lp T cells producing TNF-α_end of cycle 3
|
—
|
—
|
—
|
1.01 % of NY-ESO-1 lp specific CD8+ T cells
Standard Deviation 1.74
|
9.02 % of NY-ESO-1 lp specific CD8+ T cells
Standard Deviation NA
Only one value for this group
|
|
Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNFα -Secreting CD8+ T Cells During the Vaccination Period
NY-ESO-1lp T producing IFN-γ_end of boost cycles
|
—
|
—
|
—
|
0.22 % of NY-ESO-1 lp specific CD8+ T cells
Standard Deviation NA
Only one value for this group
|
—
|
|
Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNFα -Secreting CD8+ T Cells During the Vaccination Period
NY-ESO-1lp T producing TNF-α_end of boost cycles
|
—
|
—
|
—
|
0.36 % of NY-ESO-1 lp specific CD8+ T cells
Standard Deviation NA
Only one value for this group
|
—
|
SECONDARY outcome
Timeframe: Disease status at baseline, after cycle 1 (3 months), after cycle 2 (8 months), after cycle 3 (13 months) and if applicable after boost cycles (16 months, 19 months or 22 months)Population: Some patients discontinued treatment for either personal reasons or progressing disease. This is why from one cycle to other could be a decrease in the number of patients in the study.
The disease status was assessed by computed tomography (CT) or positron emission tomography (PET)/CT at baseline and after the fourth vaccination of each cycle. During the "booster vaccines" period, imagery examinations were performed every 3 months for patients with measurable disease and every 6 months for patients with non measurable disease. The tumor response was assessed according to the classification World Health Organization (WHO) 1979 and defined as: * No Evidence of Disease (NED) * Stable disease (SD): Change in size of all measurable lesions (the sum of the products of the greatest and perpendicular parameters), of less than a 25% increase or 25% decrease from baseline for at least 4 weeks, without appearance of new lesions or progression of any lesion. * Progressing disease (PD): Appearance of new tumors, or increase in size of any measurable tumor by at least 25% of the sum of the product of the greatest and perpendicular diameter.
Outcome measures
| Measure |
1.Melan-A ELA
n=10 Participants
500 mcg Melan-A ELA analog peptide + 1 ml Montanide
|
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10
n=5 Participants
500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide
|
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG
n=5 Participants
500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide + 2.5 mg CpG-7909/PF-3512676
|
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG
n=10 Participants
* If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
* If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
|
5.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2
n=9 Participants
* If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2
* If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2
|
|---|---|---|---|---|---|
|
Disease Status Assessment During the Vaccination Period
Baseline · Patients with No Evidence of Disease
|
7 Participants
|
2 Participants
|
4 Participants
|
7 Participants
|
9 Participants
|
|
Disease Status Assessment During the Vaccination Period
Baseline · Patients with Stable Disease
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Disease Status Assessment During the Vaccination Period
Baseline · Patients with Progressing Disease
|
2 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Disease Status Assessment During the Vaccination Period
End of Cycle 1 · Patients with No Evidence of Disease
|
7 Participants
|
3 Participants
|
4 Participants
|
6 Participants
|
7 Participants
|
|
Disease Status Assessment During the Vaccination Period
End of Cycle 1 · Patients with Stable Disease
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Disease Status Assessment During the Vaccination Period
End of Cycle 1 · Patients with Progressing Disease
|
2 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
|
Disease Status Assessment During the Vaccination Period
End of Cycle 2 · Patients with No Evidence of Disease
|
7 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
|
Disease Status Assessment During the Vaccination Period
End of Cycle 2 · Patients with Stable Disease
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Disease Status Assessment During the Vaccination Period
End of Cycle 2 · Patients with Progressing Disease
|
2 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
|
Disease Status Assessment During the Vaccination Period
End of Cycle 3 · Patients with Progressing Disease
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Disease Status Assessment During the Vaccination Period
End of Boost Cycles · Patients with No Evidence of Disease
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Disease Status Assessment During the Vaccination Period
End of Cycle 3 · Patients with No Evidence of Disease
|
5 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
|
Disease Status Assessment During the Vaccination Period
End of Cycle 3 · Patients with Stable Disease
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Disease Status Assessment During the Vaccination Period
End of Boost Cycles · Patients with Stable Disease
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Disease Status Assessment During the Vaccination Period
End of Boost Cycles · Patients with Progressing Disease
|
1 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
1. Melan-A ELA
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
2. Melan-A ELA + NY-ESO-1b(A) + MAGE-A10
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
3. Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
4. Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
5. Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1. Melan-A ELA
n=10 participants at risk
500 mcg Melan-A ELA analog peptide + 1 ml Montanide
|
2. Melan-A ELA + NY-ESO-1b(A) + MAGE-A10
n=5 participants at risk
500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide
|
3. Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG
n=5 participants at risk
500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide + 2.5 mg CpG-7909/PF-3512676
|
4. Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG
n=10 participants at risk
* If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
* If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
|
5. Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2
n=9 participants at risk
* If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2
* If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2
|
|---|---|---|---|---|---|
|
Renal and urinary disorders
Nephrectomy
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 2 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary granuloma
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Surgical and medical procedures
Regional chemotherapy
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
General disorders
Dehydration
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Nervous system disorders
Confusional state/ Dysarthria
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
11.1%
1/9 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
11.1%
1/9 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
Other adverse events
| Measure |
1. Melan-A ELA
n=10 participants at risk
500 mcg Melan-A ELA analog peptide + 1 ml Montanide
|
2. Melan-A ELA + NY-ESO-1b(A) + MAGE-A10
n=5 participants at risk
500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide
|
3. Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG
n=5 participants at risk
500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide + 2.5 mg CpG-7909/PF-3512676
|
4. Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG
n=10 participants at risk
* If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
* If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
|
5. Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG + IL-2
n=9 participants at risk
* If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2
* If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2
|
|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Injection site erythema
|
70.0%
7/10 • Number of events 24 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
100.0%
5/5 • Number of events 38 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
100.0%
5/5 • Number of events 72 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
90.0%
9/10 • Number of events 70 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
100.0%
9/9 • Number of events 63 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Skin and subcutaneous tissue disorders
Injection site induration
|
90.0%
9/10 • Number of events 55 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
100.0%
5/5 • Number of events 44 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
100.0%
5/5 • Number of events 70 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
100.0%
10/10 • Number of events 73 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
100.0%
9/9 • Number of events 51 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Skin and subcutaneous tissue disorders
Injection site Pain
|
60.0%
6/10 • Number of events 16 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
80.0%
4/5 • Number of events 21 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
100.0%
5/5 • Number of events 47 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
100.0%
10/10 • Number of events 73 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
77.8%
7/9 • Number of events 42 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Skin and subcutaneous tissue disorders
Injection site recall reaction
|
40.0%
4/10 • Number of events 7 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
40.0%
2/5 • Number of events 5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
40.0%
2/5 • Number of events 2 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
50.0%
5/10 • Number of events 10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
44.4%
4/9 • Number of events 9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Skin and subcutaneous tissue disorders
Injection site Warmth
|
40.0%
4/10 • Number of events 8 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 13 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
80.0%
4/5 • Number of events 44 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
80.0%
8/10 • Number of events 56 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
66.7%
6/9 • Number of events 30 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
40.0%
4/10 • Number of events 4 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
40.0%
2/5 • Number of events 3 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
40.0%
2/5 • Number of events 9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
40.0%
4/10 • Number of events 13 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
55.6%
5/9 • Number of events 19 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
General disorders
Asthenia
|
30.0%
3/10 • Number of events 4 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
2/10 • Number of events 6 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
44.4%
4/9 • Number of events 13 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
General disorders
Chills
|
20.0%
2/10 • Number of events 3 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
40.0%
2/5 • Number of events 2 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
60.0%
3/5 • Number of events 16 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
70.0%
7/10 • Number of events 32 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
55.6%
5/9 • Number of events 13 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
General disorders
Fever
|
20.0%
2/10 • Number of events 10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
60.0%
3/5 • Number of events 16 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
70.0%
7/10 • Number of events 26 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
33.3%
3/9 • Number of events 5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Nervous system disorders
Headache
|
20.0%
2/10 • Number of events 4 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
60.0%
3/5 • Number of events 8 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
60.0%
3/5 • Number of events 15 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
70.0%
7/10 • Number of events 44 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
55.6%
5/9 • Number of events 19 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
General disorders
influenza-like illness
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
80.0%
4/5 • Number of events 32 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
30.0%
3/10 • Number of events 4 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
22.2%
2/9 • Number of events 2 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
General disorders
Malaise
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
40.0%
2/5 • Number of events 2 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
80.0%
4/5 • Number of events 14 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
40.0%
4/10 • Number of events 11 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
11.1%
1/9 • Number of events 2 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
50.0%
5/10 • Number of events 6 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
40.0%
2/5 • Number of events 10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
60.0%
6/10 • Number of events 39 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
55.6%
5/9 • Number of events 25 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
40.0%
2/5 • Number of events 3 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
60.0%
3/5 • Number of events 12 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
60.0%
6/10 • Number of events 14 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
44.4%
4/9 • Number of events 12 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
General disorders
Pruritus
|
40.0%
4/10 • Number of events 7 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
2/10 • Number of events 2 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
44.4%
4/9 • Number of events 9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Ear and labyrinth disorders
Ear Discharge
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Ear and labyrinth disorders
Tinnitus
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Ear and labyrinth disorders
Chronic otitis
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Endocrine disorders
Gynecomastia
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Cardiac disorders
Chest pain-cardiac
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Cardiac disorders
Myocardial ischemia
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Cardiac disorders
Heart murmurs
|
10.0%
1/10 • Number of events 2 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Cardiac disorders
Tachycardi
|
10.0%
1/10 • Number of events 2 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
11.1%
1/9 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Cardiac disorders
Ventricular arythmia
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Cardiac disorders
Cardiac shock
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Eye disorders
Decrease visual field
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Eye disorders
Eye irritation
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
22.2%
2/9 • Number of events 4 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Eye disorders
Visual troubles
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
11.1%
1/9 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
2/10 • Number of events 2 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
22.2%
2/9 • Number of events 2 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Gastrointestinal disorders
Constipation
|
20.0%
2/10 • Number of events 2 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
22.2%
2/9 • Number of events 2 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
2/10 • Number of events 3 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 2 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
55.6%
5/9 • Number of events 11 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Gastrointestinal disorders
Colitic lesions
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Gastrointestinal disorders
Flatulence
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Gastrointestinal disorders
Glossitis
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
11.1%
1/9 • Number of events 3 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Gastrointestinal disorders
Odynosphagia
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Gastrointestinal disorders
Oral Aphtha
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Gastrointestinal disorders
Left hypoesthesia mouth
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Gastrointestinal disorders
Sensitivity of teeth
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
11.1%
1/9 • Number of events 2 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
11.1%
1/9 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
General disorders
Discomfort
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
11.1%
1/9 • Number of events 2 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Gastrointestinal disorders
fatigue
|
50.0%
5/10 • Number of events 6 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
60.0%
3/5 • Number of events 4 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 4 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
40.0%
4/10 • Number of events 4 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
55.6%
5/9 • Number of events 6 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
General disorders
pain
|
30.0%
3/10 • Number of events 3 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 2 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
General disorders
Oedema
|
30.0%
3/10 • Number of events 4 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
11.1%
1/9 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
General disorders
Localized oedema
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
40.0%
2/5 • Number of events 3 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
11.1%
1/9 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
General disorders
Throat glar
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Immune system disorders
Immune system disorders
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Immune system disorders
Granuloma
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
60.0%
3/5 • Number of events 8 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Hepatobiliary disorders
Hepatic cysts
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
11.1%
1/9 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Infections and infestations
Bronchitis
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Infections and infestations
Cystitis
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Infections and infestations
Herpes labialis
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Infections and infestations
Infection inguinal scar
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
11.1%
1/9 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Infections and infestations
Post-operative infection
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Infections and infestations
Prostate infection
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Infections and infestations
Bronchial infection
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Infections and infestations
Mucosal infection
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Infections and infestations
Skin infection
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Immune system disorders
Pharyngitis
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
11.1%
1/9 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 2 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Injury, poisoning and procedural complications
Lund injury
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Investigations
Anemia
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Investigations
Elevated CK
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
2/10 • Number of events 2 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Investigations
Karnofsky scale worsened
|
50.0%
5/10 • Number of events 8 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
60.0%
6/10 • Number of events 9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Investigations
Elevated liver values (due to Dafalgan)
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Investigations
Platelet count decreased
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Investigations
Lymphopenia
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Investigations
GGT increased
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
11.1%
1/9 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Investigations
High ALP level
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
11.1%
1/9 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Investigations
High LDH level
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
11.1%
1/9 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Investigations
High C-Reactive Protein
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
11.1%
1/9 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Investigations
Increased of liver enzymes values
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
11.1%
1/9 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Investigations
Weight decreased
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
11.1%
1/9 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Investigations
Weight increased
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 2 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Investigations
Weight loss
|
20.0%
2/10 • Number of events 4 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.0%
2/10 • Number of events 2 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
2/10 • Number of events 2 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
22.2%
2/9 • Number of events 4 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Metabolism and nutrition disorders
Dehydratation
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
2/10 • Number of events 2 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Musculoskeletal and connective tissue disorders
Axillary pain
|
20.0%
2/10 • Number of events 3 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
20.0%
2/10 • Number of events 2 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
2/10 • Number of events 4 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
40.0%
4/10 • Number of events 10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
60.0%
3/5 • Number of events 11 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis skin
|
30.0%
3/10 • Number of events 3 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
60.0%
3/5 • Number of events 7 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 2 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
11.1%
1/9 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic hyperplasia
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
11.1%
1/9 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Inguinal adenophathy
|
30.0%
3/10 • Number of events 3 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
40.0%
2/5 • Number of events 2 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
30.0%
3/10 • Number of events 4 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Axillary adenopathy
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 3 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Musculoskeletal and connective tissue disorders
Mediastinal adenopathy
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cysts
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
11.1%
1/9 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Black nodule on scar
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Increased renal kystis
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liver hemangiomas
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified-subcutaneous nodule
|
40.0%
4/10 • Number of events 9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
40.0%
2/5 • Number of events 4 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
40.0%
2/5 • Number of events 5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Nervous system disorders
Brain oedema
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 2 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Nervous system disorders
Carpal tunnel symdrome
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
11.1%
1/9 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Nervous system disorders
Convulsion
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Nervous system disorders
Paresthesi
|
30.0%
3/10 • Number of events 5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Nervous system disorders
Dysarthrya
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Nervous system disorders
Dysesthesia
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Nervous system disorders
Dysphasia
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Nervous system disorders
Migraine
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Nervous system disorders
Sleeping disorders
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Nervous system disorders
Spasticity
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Nervous system disorders
Tremor
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
11.1%
1/9 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Nervous system disorders
Vasovagal reaction
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
11.1%
1/9 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Nervous system disorders
Nervous Descompensation
|
20.0%
2/10 • Number of events 2 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Nervous system disorders
Sensitivity impairment
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Nervous system disorders
Temporal lobe
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
22.2%
2/9 • Number of events 2 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Psychiatric disorders
Agitation
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
11.1%
1/9 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
10.0%
1/10 • Number of events 2 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Psychiatric disorders
Mood alteration
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Renal and urinary disorders
Anuria
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 2 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Renal and urinary disorders
Urinary frequency
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
11.1%
1/9 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Reproductive system and breast disorders
Amenorrhoea
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Reproductive system and breast disorders
Irregular menstruation
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Reproductive system and breast disorders
Menorrhagia
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
22.2%
2/9 • Number of events 2 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
2/10 • Number of events 3 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
10.0%
1/10 • Number of events 2 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic cough
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
10.0%
1/10 • Number of events 4 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Skin and subcutaneous tissue disorders
Induration
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhydrosis
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Skin and subcutaneous tissue disorders
Itching/Pruritus
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Skin and subcutaneous tissue disorders
Dermohypodermitis
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Skin and subcutaneous tissue disorders
Keratosis lesion
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 2 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Skin and subcutaneous tissue disorders
Macular skin lesion
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
11.1%
1/9 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Skin and subcutaneous tissue disorders
Skin scab
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Skin and subcutaneous tissue disorders
Ingrown toe nail
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Skin and subcutaneous tissue disorders
Difficult cicatrization
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
2/10 • Number of events 3 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
11.1%
1/9 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
33.3%
3/9 • Number of events 3 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Skin and subcutaneous tissue disorders
Skin depigmentation
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
10.0%
1/10 • Number of events 2 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Skin and subcutaneous tissue disorders
Scar
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Skin and subcutaneous tissue disorders
Pain scar
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Surgical and medical procedures
Haematoma post-biopsy
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Surgical and medical procedures
Motor skills decrease after brain surgery
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Surgical and medical procedures
Lymph node dissection
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Surgical and medical procedures
Metastasis resection
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Surgical and medical procedures
Post-operative pain
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
2/10 • Number of events 2 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Surgical and medical procedures
Post-operative arythmia
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Surgical and medical procedures
Punch-biopsy previous injection site
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Surgical and medical procedures
Broken foot toe
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Vascular disorders
Hypertension
|
10.0%
1/10 • Number of events 2 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
40.0%
2/5 • Number of events 2 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Vascular disorders
Hypotension
|
20.0%
2/10 • Number of events 3 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
10.0%
1/10 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Vascular disorders
Haematoma
|
30.0%
3/10 • Number of events 3 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
40.0%
2/5 • Number of events 3 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
10.0%
1/10 • Number of events 2 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
33.3%
3/9 • Number of events 4 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Vascular disorders
Hot Flush
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
11.1%
1/9 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Vascular disorders
Lymphedema
|
20.0%
2/10 • Number of events 2 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
40.0%
2/5 • Number of events 2 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 2 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
11.1%
1/9 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
|
Vascular disorders
Varix
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
20.0%
1/5 • Number of events 1 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/5 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/10 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
0.00%
0/9 • Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
|
Additional Information
Prof Olivier Michielin
Department of Oncology, Division of Medical Oncology University Hospital Lausanne
Phone: +41 21 314 01 85
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place